youtube - Updated FDA Blood and Plasma Donation Guidelines

summary from kimi  - 

In this webinar summary, we'll be discussing the updated FDA guidelines for blood and plasma donation. Specifically, we'll focus on the changes that affect men who have sex with men (MSM). We'll explore the historical context of donation policies during the HIV/AIDS crisis and how there has been a shift towards a fairer, science-based approach.

Although these new guidelines are not mandatory for all donation centers, major blood banks like the American Red Cross and the New York Blood Center have already adopted them. This shows a commitment to promoting health equity. During the webinar, we will highlight how patient advocacy organizations such as the National Hemophilia Foundation (NHF) have played a crucial role in influencing policy decisions.

We will also emphasize why it's important to maintain a safe and sufficient blood supply for treating bleeding disorders and other medical conditions. While this policy change may not lead to a dramatic increase in donations, it is expected to enhance the safety of blood products and improve public trust in the donation process.

10/2023

00:00:25,279 --> 00:00:28,320
welcome to today's Wednesday webinar

00:00:27,000 --> 00:00:31,960
we'll just give people another minute or

00:00:28,320 --> 00:00:31,960
so to join and then we'll go live

00:01:04,920 --> 00:01:08,360
good afternoon and thank you for joining

00:01:06,799 --> 00:01:10,600
us for this week's National bleeding

00:01:08,360 --> 00:01:13,400
disorders Foundation formerly National

00:01:10,600 --> 00:01:15,200
hemophilia Foundation Wednesday webinar

00:01:13,400 --> 00:01:17,920
my name is Fiona Robinson and I am the

00:01:15,200 --> 00:01:20,040
series host in today's webinar we will

00:01:17,920 --> 00:01:22,000
learn about the updated FDA blood and

00:01:20,040 --> 00:01:23,720
plasma donation guidelines what the

00:01:22,000 --> 00:01:25,960
bleeding disorders Community needs to

00:01:23,720 --> 00:01:28,079
know we encourage you to ask any

00:01:25,960 --> 00:01:30,320
questions you may have today you can ask

00:01:28,079 --> 00:01:32,079
your question by using the Q&A feature

00:01:30,320 --> 00:01:34,360
at the bottom of your screen at any time

00:01:32,079 --> 00:01:36,079
during the webinar we will monitor these

00:01:34,360 --> 00:01:38,119
questions and following the speaker's

00:01:36,079 --> 00:01:41,000
presentation I will put your questions

00:01:38,119 --> 00:01:42,640
to them this webinar is being recorded

21
00:01:41,000 --> 00:01:46,040
and will be available to the community

22
00:01:42,640 --> 00:01:47,680
beginning on Friday October 27th today

00:01:46,040 --> 00:01:50,119
we are joined by two of the national

00:01:47,680 --> 00:01:51,719
leading disorders foundation's very own

25
00:01:50,119 --> 00:01:54,000
government Relations Specialist Matt

26
00:01:51,719 --> 00:01:56,880
Delaney and Senior vice president of

00:01:54,000 --> 00:01:58,320
public policy and access Nathan schaer

28
00:01:56,880 --> 00:02:00,719
I'd like to thank Matt and Nathan for
00:01:58,320 --> 00:02:03,520
joining us today and I will turn things
00:02:00,719 --> 00:02:05,719
over now to Matt to get us started

00:02:03,520 --> 00:02:07,640
wonderful thank you so much Fiona and
00:02:05,719 --> 00:02:10,599
thank you all for joining us here today

33
00:02:07,640 --> 00:02:12,920
on our Wednesday webinar updated FDA

34
00:02:10,599 --> 00:02:14,800
blood and plasma donation guidelines

35
00:02:12,920 --> 00:02:17,280
what the bleeding disorders Community

36
00:02:14,800 --> 00:02:19,519
needs to know um and as Fiona said I'm

37
00:02:17,280 --> 00:02:21,480
joined today by Nathan schaer our senior

38
00:02:19,519 --> 00:02:24,040
vice president for public policy and

39
00:02:21,480 --> 00:02:27,360
access and today we're going to go over

40
00:02:24,040 --> 00:02:30,040
um the uh most updated FDA blood and

41
00:02:27,360 --> 00:02:33,160
plasma donation guidelines particular

42
00:02:30,040 --> 00:02:35,440
for individuals allowing individuals um

43
00:02:33,160 --> 00:02:38,760
known as men who have sex with men being

44
00:02:35,440 --> 00:02:41,000
able to donate blood and plasma kind of

45
00:02:38,760 --> 00:02:42,640
how we got there and also what this

46
00:02:41,000 --> 00:02:44,200
means for The Bling disorders community

47
00:02:42,640 --> 00:02:47,720
and we're going to go through all of

48
00:02:44,200 --> 00:02:49,720
kind of the multi-year steps um and data

49
00:02:47,720 --> 00:02:53,239
that has been reviewed over a long

50
00:02:49,720 --> 00:02:55,560
period of time that ultimately um led to

51
00:02:53,239 --> 00:02:57,959
this decision um really excited for

52
00:02:55,560 --> 00:03:00,440
today's webinar particularly um

53
00:02:57,959 --> 00:03:02,640
interested I am a individual Von Willebrand disease myself and utilize a

55
00:03:02,640 --> 00:03:08,799
plasma derived treatment um um for my

56
00:03:05,480 --> 00:03:10,799
treatment of my vwd so this an issue um

57
00:03:08,799 --> 00:03:14,400
that has been of particular relevance

58
00:03:10,799 --> 00:03:16,560
and interest to me um in our work in um

59
00:03:14,400 --> 00:03:19,360
the public policy staff public policy

60
00:03:16,560 --> 00:03:22,599
and access staff of NBF alongside the

61
00:03:19,360 --> 00:03:24,560
work in Blood and product safety as well

62
00:03:22,599 --> 00:03:26,640
so here's a little bit about our mission

63
00:03:24,560 --> 00:03:28,319
M BDF were dedicated to finding cures

64
00:03:26,640 --> 00:03:30,120
for inheritable blood and bleeding

65
00:03:28,319 --> 00:03:31,879
disorders and to address Ing and

66
00:03:30,120 --> 00:03:33,560
preventing the complications of these

67
00:03:31,879 --> 00:03:36,640
disorders and we do that through

68
00:03:33,560 --> 00:03:40,159
research education advocacy enabling

69
00:03:36,640 --> 00:03:42,760
people and their families to thrive and

70
00:03:40,159 --> 00:03:44,720
here are just some of the pieces that

71
00:03:42,760 --> 00:03:47,400
fit into our

72
00:03:44,720 --> 00:03:49,040
mission so as I said a little bit of

73
00:03:47,400 --> 00:03:51,239
what we're going to cover today we want

74
00:03:49,040 --> 00:03:53,120
to set the stage a little bit more about

75
00:03:51,239 --> 00:03:55,680
why is blood in plasma and therefore the

76
00:03:53,120 --> 00:03:58,319
safety of blood and plasma so important

77
00:03:55,680 --> 00:04:00,519
to the bleeding disorders community in

78
00:03:58,319 --> 00:04:02,159
particular we then want to go into a

79
00:04:00,519 --> 00:04:04,400
little bit about all the time that has

80
00:04:02,159 --> 00:04:06,200
been spent on nbf's front alongside

81
00:04:04,400 --> 00:04:08,400
other members of the community that

82
00:04:06,200 --> 00:04:11,439
ultimately led up to this decision and

83
00:04:08,400 --> 00:04:14,120
the spaces in which NBF is involved in

84
00:04:11,439 --> 00:04:15,920
the blood and plasma safety space we're

85
00:04:14,120 --> 00:04:17,759
going to go over a little bit about the

86
00:04:15,920 --> 00:04:21,320
data and the studies that were used to

87
00:04:17,759 --> 00:04:22,800
lead up to this decision um and talk a

88
00:04:21,320 --> 00:04:25,040
little bit about what the decision

89
00:04:22,800 --> 00:04:26,840
actually is and its history and then

90
00:04:25,040 --> 00:04:30,280
moving forward to implementation and

91
00:04:26,840 --> 00:04:32,560
kind of where we go to from here but a

92
00:04:30,280 --> 00:04:34,360
little bit about uh background on plasma

93
00:04:32,560 --> 00:04:37,639
and how it relates to bleeding disorders

94
00:04:34,360 --> 00:04:39,840
particularly in today's um treatment

95
00:04:37,639 --> 00:04:42,039
landscape um previously you know blood

96
00:04:39,840 --> 00:04:43,759
and plasma has been used for a very long

97
00:04:42,039 --> 00:04:46,240
time to treat bleeding disorders

98
00:04:43,759 --> 00:04:48,600
hemophilia Von Willebrand rare bleeding disorders

99
00:04:46,240 --> 00:04:50,840
alike but especially with today's

100
00:04:48,600 --> 00:04:53,120
treatments it still plays a rather large

101
00:04:50,840 --> 00:04:55,400
role in treatment and treatment options

102
00:04:53,120 --> 00:04:58,120
today there are still plasma derived

103
00:04:55,400 --> 00:05:01,440
therapies um that are used uh very

104
00:04:58,120 --> 00:05:04,320
widely amongst Von Willebrand disease patients

105
00:05:01,440 --> 00:05:07,600
bleeding disorders but also hemophilia A

106
00:05:04,320 --> 00:05:09,560
and B as well and as part of NBF we

107
00:05:07,600 --> 00:05:11,600
always want to encourage uh the most

108
00:05:09,560 --> 00:05:13,919
amount of access and the most amount of

109
00:05:11,600 --> 00:05:15,720
choice for patients to treat their

110
00:05:13,919 --> 00:05:17,440
bleeding disorder and up here we just

111
00:05:15,720 --> 00:05:19,880
have some of the plasma derived

112
00:05:17,440 --> 00:05:23,319
therapies um for both hemophilia a and

113
00:05:19,880 --> 00:05:25,880
Von Willebrand but there also are um ways that

114
00:05:23,319 --> 00:05:28,479
plasma can affect other um rare bleeding

115
00:05:25,880 --> 00:05:32,240
disorders as

116
00:05:28,479 --> 00:05:34,880
well but another reason of why we pay

117
00:05:32,240 --> 00:05:38,919
particular interest to blood plasma

118
00:05:34,880 --> 00:05:40,759
Safety and Supply is one um is because

119
00:05:38,919 --> 00:05:43,160
we have a commitment to protect the

120
00:05:40,759 --> 00:05:45,680
blood supply and part of that goes back

121
00:05:43,160 --> 00:05:48,080
to um the devastating history of the

122
00:05:45,680 --> 00:05:50,560
bleeding disorders Community regarding

123
00:05:48,080 --> 00:05:53,560
this space and why we want to remain

124
00:05:50,560 --> 00:05:56,600
Vigilant in these spaces to ensure

125
00:05:53,560 --> 00:05:58,319
safety as well as Supply as many of

126
00:05:56,600 --> 00:06:00,199
people know who are tuning into this

127
00:05:58,319 --> 00:06:01,880
webinar and perhaps some do not the

128
00:06:00,199 --> 00:06:04,199
bleeding disorders Community was

129
00:06:01,880 --> 00:06:07,120
particularly affected by Blood and

130
00:06:04,199 --> 00:06:07,840
plasma safety particularly in the 1970s

131
00:06:07,120 --> 00:06:10,479
and

132
00:06:07,840 --> 00:06:13,280
1980s um where many individuals with

133
00:06:10,479 --> 00:06:17,039
bleeding disorders um thousands um

134
00:06:13,280 --> 00:06:20,319
contracted HIV and or hepatitis and also

135
00:06:17,039 --> 00:06:21,880
LED um to many deaths as well we have a

136
00:06:20,319 --> 00:06:24,120
little timeline here it doesn't

137
00:06:21,880 --> 00:06:26,039
necessarily do any of the Justice

138
00:06:24,120 --> 00:06:28,160
related to this time in our history but

139
00:06:26,039 --> 00:06:32,080
we also wanted to just point out the

140
00:06:28,160 --> 00:06:34,800
timeline of the impact of Blood and

141
00:06:32,080 --> 00:06:36,919
plasma safety on the bleeding disorders

142
00:06:34,800 --> 00:06:39,759
community Through the tainted blood

143
00:06:36,919 --> 00:06:43,199
crisis that ultimately led to so many

144
00:06:39,759 --> 00:06:46,599
HIV infections AIDS diagnoses as well as

145
00:06:43,199 --> 00:06:48,680
hepatitis um which ultimately also led

146
00:06:46,599 --> 00:06:51,160
to a lot of our advocacy initiatives

147
00:06:48,680 --> 00:06:53,599
today um like Ricky Ray and the Ryan

148
00:06:51,160 --> 00:06:55,879
Wright Care Act um it also led to the

149
00:06:53,599 --> 00:06:58,120
proliferation of blood plasma and tissue

150
00:06:55,879 --> 00:07:00,360
safety committees stakeholders and

151
00:06:58,120 --> 00:07:01,960
places in government to make sure

152
00:07:00,360 --> 00:07:04,639
something like this would never happen

153
00:07:01,960 --> 00:07:06,879
again and NBF has a long-standing

154
00:07:04,639 --> 00:07:09,520
commitment on these issues and will

155
00:07:06,879 --> 00:07:11,919
continue to do so in the future hence as

156
00:07:09,520 --> 00:07:13,639
we talk about all of the ways that mbf

157
00:07:11,919 --> 00:07:15,639
and the community has been involved in

158
00:07:13,639 --> 00:07:18,319
this space leading to the course of this

159
00:07:15,639 --> 00:07:21,039
decision we will continue um to be

160
00:07:18,319 --> 00:07:23,680
engaged in these issues as

161
00:07:21,039 --> 00:07:25,560
well but we want to frame before we go

162
00:07:23,680 --> 00:07:27,919
into kind of some of the history that

163
00:07:25,560 --> 00:07:29,919
led up to this decision for men who have

164
00:07:27,919 --> 00:07:32,080
sex with men now being being allowed to

165
00:07:29,919 --> 00:07:34,280
donate blood and plasma we want to talk

166
00:07:32,080 --> 00:07:37,599
a little bit about the landscape what

167
00:07:34,280 --> 00:07:39,919
we've been doing um as as a foundation

168
00:07:37,599 --> 00:07:42,360
um in this work as well as some of the

169
00:07:39,919 --> 00:07:44,840
relevant players that led up to this

170
00:07:42,360 --> 00:07:48,039
decision so after the tainted blood

171
00:07:44,840 --> 00:07:49,680
crisis of the 1970s 80s and 90s talking

172
00:07:48,039 --> 00:07:52,240
about those government stakeholders and

173
00:07:49,680 --> 00:07:53,919
committees one of which of particular

174
00:07:52,240 --> 00:07:56,120
relevance and will be mention throughout

175
00:07:53,919 --> 00:07:58,560
the webinar today is the health and

176
00:07:56,120 --> 00:08:01,720
human services advisory committee on

177
00:07:58,560 --> 00:08:06,440
blood and tissue safety also known as

178
00:08:01,720 --> 00:08:08,680
ACB TSA this is a uh Federal advisory

179
00:08:06,440 --> 00:08:10,599
committee that reports to the Secretary

180
00:08:08,680 --> 00:08:13,639
of the US Department of Health and Human

181
00:08:10,599 --> 00:08:15,759
Services it meets multiple times a year

182
00:08:13,639 --> 00:08:18,000
and is a 31 member committee that

183
00:08:15,759 --> 00:08:20,560
encompasses all individuals in this

184
00:08:18,000 --> 00:08:23,879
spectrum and space of Blood and Tissue

185
00:08:20,560 --> 00:08:25,879
safety so this includes scientists and

186
00:08:23,879 --> 00:08:27,759
medical professionals of course the

187
00:08:25,879 --> 00:08:29,520
relevant manufacturing and healthc Care

188
00:08:27,759 --> 00:08:32,159
organizations that are in the blood and

189
00:08:29,520 --> 00:08:34,360
tissue plasma spaces health

190
00:08:32,159 --> 00:08:36,919
professionals scientists but also

191
00:08:34,360 --> 00:08:39,000
Patient Advocates um Patient Advocates

192
00:08:36,919 --> 00:08:41,919
have always played a huge role in this

193
00:08:39,000 --> 00:08:44,880
committee and NBF has always been um

194
00:08:41,919 --> 00:08:46,519
engaging either through members um of

195
00:08:44,880 --> 00:08:49,720
the committee that we've been able to

196
00:08:46,519 --> 00:08:51,279
nominate to this advisory committee um

197
00:08:49,720 --> 00:08:53,120
but also really making sure that

198
00:08:51,279 --> 00:08:55,680
bleeding disorders continues to be

199
00:08:53,120 --> 00:08:57,560
represented on this committee as well

200
00:08:55,680 --> 00:09:00,240
given both our the role of blood and

201
00:08:57,560 --> 00:09:03,680
Plasma in treatment options as well as

202
00:09:00,240 --> 00:09:05,040
um tissue and organ safety but also the

203
00:09:03,680 --> 00:09:07,160
lived experience and the lived

204
00:09:05,040 --> 00:09:09,040
experience experts in our community that

205
00:09:07,160 --> 00:09:11,720
are so vital in some of these

206
00:09:09,040 --> 00:09:13,440
decision-making processes um so we have

207
00:09:11,720 --> 00:09:16,959
often had bleeding disorders

208
00:09:13,440 --> 00:09:18,880
representation on ACB TSA and really

209
00:09:16,959 --> 00:09:22,000
provides these policy and science

210
00:09:18,880 --> 00:09:23,920
recommendations to HHS and in turn

211
00:09:22,000 --> 00:09:26,240
involves the FDA and other relevant

212
00:09:23,920 --> 00:09:28,120
governmental stakeholders as well that

213
00:09:26,240 --> 00:09:30,680
ultimately leads to these decisions

214
00:09:28,120 --> 00:09:33,160
including um this new Universal

215
00:09:30,680 --> 00:09:36,760
risk-based deferral um questionnaire and

216
00:09:33,160 --> 00:09:38,040
policy that was um implemented in May of

217
00:09:36,760 --> 00:09:40,839
this

218
00:09:38,040 --> 00:09:43,360
year but some of the other work um that

219
00:09:40,839 --> 00:09:46,160
mbf has done and how we've been engaged

220
00:09:43,360 --> 00:09:49,079
with um government stakeholders but also

221
00:09:46,160 --> 00:09:51,120
other members um and patient advocacy

222
00:09:49,079 --> 00:09:53,880
organizations surrounding rare disease

223
00:09:51,120 --> 00:09:56,320
groups that um rely on blood plasma

224
00:09:53,880 --> 00:09:59,720
Safety and Supply we have been involved

225
00:09:56,320 --> 00:10:01,720
for quite a long time um with something

226
00:09:59,720 --> 00:10:05,240
called the American plasma users

227
00:10:01,720 --> 00:10:08,360
Coalition or A+ Coalition it's largely

228
00:10:05,240 --> 00:10:11,240
modeled after um and works with the plus

229
00:10:08,360 --> 00:10:13,680
Coalition in Europe it includes 12

230
00:10:11,240 --> 00:10:16,320
patient advocacy organizations National

231
00:10:13,680 --> 00:10:18,880
patient advocacy organizations that

232
00:10:16,320 --> 00:10:20,839
represent the end users of plasma so

233
00:10:18,880 --> 00:10:23,640
this is not just bleeding disorders but

234
00:10:20,839 --> 00:10:28,200
it is also primary immune deficiency it

235
00:10:23,640 --> 00:10:32,200
is um um het hereditary angio EMA GBS

236
00:10:28,200 --> 00:10:35,720
cidp platelet disorders and um and and

237
00:10:32,200 --> 00:10:37,959
many other disease groups that um that

238
00:10:35,720 --> 00:10:40,240
may need to be treated through biologics

239
00:10:37,959 --> 00:10:44,200
or or treatments that are derived from

240
00:10:40,240 --> 00:10:46,320
blood and plasma so we in this chain of

241
00:10:44,200 --> 00:10:48,279
plasma and blood supply are the end

242
00:10:46,320 --> 00:10:50,639
users that are ultimately affected by

243
00:10:48,279 --> 00:10:52,200
these policies with our health right so

244
00:10:50,639 --> 00:10:54,519
we should have a seat at the table and

245
00:10:52,200 --> 00:10:56,760
Coalition work is always a really great

246
00:10:54,519 --> 00:10:59,480
way of doing that so we engage on a

247
00:10:56,760 --> 00:11:02,440
multitude of issues and the Coalition

248
00:10:59,480 --> 00:11:05,680
runs in twoe spans corresponding with

249
00:11:02,440 --> 00:11:07,279
each um Congressional cycle for the

250
00:11:05,680 --> 00:11:09,320
118th

251
00:11:07,279 --> 00:11:12,480
Congress um and over the course of the

252
00:11:09,320 --> 00:11:15,000
next couple years um NBF has been

253
00:11:12,480 --> 00:11:17,000
chairing the A+ Coalition it has been

254
00:11:15,000 --> 00:11:19,399
chaired by other groups in the past but

255
00:11:17,000 --> 00:11:22,279
we also took over last year chairing the

256
00:11:19,399 --> 00:11:25,040
A+ Coalition of all these patient groups

257
00:11:22,279 --> 00:11:28,160
and we have several activities um that

258
00:11:25,040 --> 00:11:30,760
that we engage in um we comment on state

259
00:11:28,160 --> 00:11:34,040
and federal legislation relating to

260
00:11:30,760 --> 00:11:37,040
blood plasma Safety and Supply we have

261
00:11:34,040 --> 00:11:40,079
made comments to the FDA in the past ACB

262
00:11:37,040 --> 00:11:41,920
TSA um nominating individuals to these

263
00:11:40,079 --> 00:11:44,839
advisory committees so we're speaking as

264
00:11:41,920 --> 00:11:46,839
one voice of end users we engage with

265
00:11:44,839 --> 00:11:50,040
members of Congress quite a bit which I

266
00:11:46,839 --> 00:11:53,200
will talk to in a moment and also um

267
00:11:50,040 --> 00:11:54,880
engage on things um that that may affect

268
00:11:53,200 --> 00:11:57,680
blood and plasma Safety and Supply in

269
00:11:54,880 --> 00:12:00,600
the United States and in turn the entire

270
00:11:57,680 --> 00:12:04,040
world as much um much of the world also

271
00:12:00,600 --> 00:12:07,959
relies in some extent to domestically in

272
00:12:04,040 --> 00:12:10,079
the US um gathered plasma so these are

273
00:12:07,959 --> 00:12:12,720
just the organizations that are involved

274
00:12:10,079 --> 00:12:14,800
and NBF has been proud to chair this

275
00:12:12,720 --> 00:12:18,440
Coalition which myself and Nathan have

276
00:12:14,800 --> 00:12:20,880
been working on um over the past year or

277
00:12:18,440 --> 00:12:23,440
so some of the activities that we want

278
00:12:20,880 --> 00:12:25,199
to go into outside of some of the topics

279
00:12:23,440 --> 00:12:28,000
and the scope of topics that we talk

280
00:12:25,199 --> 00:12:31,279
about um we have been quite busy with A+

281
00:12:28,000 --> 00:12:32,880
over the past few months um one thing of

282
00:12:31,279 --> 00:12:34,519
note that we have been particularly

283
00:12:32,880 --> 00:12:38,160
proud of is the creation of a

284
00:12:34,519 --> 00:12:40,839
congressional plasma caucus that is Led

285
00:12:38,160 --> 00:12:44,240
um and chaired by Congress Congressman

286
00:12:40,839 --> 00:12:46,240
Larry bushan of Indiana a Republican and

287
00:12:44,240 --> 00:12:48,680
representative Scott Peters of

288
00:12:46,240 --> 00:12:50,399
California who is a Democrat so a

289
00:12:48,680 --> 00:12:53,560
Republican and a Democrat it is a

290
00:12:50,399 --> 00:12:56,399
bipartisan caucus and both caucus chairs

291
00:12:53,560 --> 00:12:59,160
are Physicians themselves so um we have

292
00:12:56,399 --> 00:13:01,240
several champions in Congress but um

293
00:12:59,160 --> 00:13:03,040
particularly um we want to work with

294
00:13:01,240 --> 00:13:05,279
those Champions but also bring new

295
00:13:03,040 --> 00:13:08,160
people in as well and new members of

296
00:13:05,279 --> 00:13:09,959
Congress and part of that is explaining

297
00:13:08,160 --> 00:13:12,519
all the different uses of blood and

298
00:13:09,959 --> 00:13:14,480
plasma not only for the chronic disease

299
00:13:12,519 --> 00:13:17,240
Community but also an emergency room

300
00:13:14,480 --> 00:13:19,160
settings as well right there are many um

301
00:13:17,240 --> 00:13:21,519
areas in which can members of Congress

302
00:13:19,160 --> 00:13:23,639
can be brought in so this newly created

303
00:13:21,519 --> 00:13:25,519
plasma cocket this year has been a huge

304
00:13:23,639 --> 00:13:27,440
opportunity for all the patient groups

305
00:13:25,519 --> 00:13:30,360
to really bring members of Congress to

306
00:13:27,440 --> 00:13:33,000
the table and talk about our experiences

307
00:13:30,360 --> 00:13:34,959
our concerns and things that will really

308
00:13:33,000 --> 00:13:36,399
affect the blood and plasma Safety and

309
00:13:34,959 --> 00:13:38,560
Supply in the United States and

310
00:13:36,399 --> 00:13:41,360
therefore patients we had our first

311
00:13:38,560 --> 00:13:43,199
caucus briefing in May um I was there

312
00:13:41,360 --> 00:13:45,240
alongside other members of the coalition

313
00:13:43,199 --> 00:13:47,160
to talk from the patient experience we

314
00:13:45,240 --> 00:13:49,959
also had individuals from throughout the

315
00:13:47,160 --> 00:13:53,279
different sectors um including the

316
00:13:49,959 --> 00:13:55,759
emergency room setting we have also been

317
00:13:53,279 --> 00:13:58,199
um participating in Hill days we have

318
00:13:55,759 --> 00:13:59,399
had two Hill days as part of the A+

319
00:13:58,199 --> 00:14:01,839
coalition

320
00:13:59,399 --> 00:14:03,440
um just in September where we have been

321
00:14:01,839 --> 00:14:05,399
advocating for members to join the

322
00:14:03,440 --> 00:14:08,480
plasma caucus we have talked to them

323
00:14:05,399 --> 00:14:10,639
about this topic as well and we continue

324
00:14:08,480 --> 00:14:12,320
to try to get them to engage on these

325
00:14:10,639 --> 00:14:14,839
topics a little bit more and having them

326
00:14:12,320 --> 00:14:17,920
recognize um how important these topics

327
00:14:14,839 --> 00:14:20,320
are no matter how maybe Niche it may be

328
00:14:17,920 --> 00:14:22,000
in in Congress as a whole and we've had

329
00:14:20,320 --> 00:14:24,519
a lot of success we've had many many

330
00:14:22,000 --> 00:14:26,199
members join the plasma caucus from all

331
00:14:24,519 --> 00:14:29,000
different parts of the country different

332
00:14:26,199 --> 00:14:30,920
sides of the aisle um and as been a

333
00:14:29,000 --> 00:14:32,959
really good conduit for these patient ad

334
00:14:30,920 --> 00:14:35,560
advocacy organizations including

335
00:14:32,959 --> 00:14:37,040
bleeding disorders um to really have

336
00:14:35,560 --> 00:14:39,160
more connections with members of

337
00:14:37,040 --> 00:14:41,519
Congress as well we look forward to

338
00:14:39,160 --> 00:14:44,480
having more briefings we want to um

339
00:14:41,519 --> 00:14:47,360
really explain the uh vinto vain concept

340
00:14:44,480 --> 00:14:49,120
from a donor all the way to a uh end

341
00:14:47,360 --> 00:14:51,920
user such as a person with a bleeding

342
00:14:49,120 --> 00:14:53,320
disorder two members of Congress um and

343
00:14:51,920 --> 00:14:54,800
really getting them to further

344
00:14:53,320 --> 00:14:56,600
understand the issues and why they're so

345
00:14:54,800 --> 00:15:01,399
important um to the rare disease

346
00:14:56,600 --> 00:15:01,399
Community but also the entire country as

347
00:15:01,600 --> 00:15:07,560
well so the Congressional plasma caucus

348
00:15:04,920 --> 00:15:09,079
um that is uh something that we've

349
00:15:07,560 --> 00:15:11,759
obviously been trying to work on for the

350
00:15:09,079 --> 00:15:14,160
last couple of months here we have an

351
00:15:11,759 --> 00:15:16,320
action alert which um I can post into

352
00:15:14,160 --> 00:15:19,040
the chat relatively shortly I should

353
00:15:16,320 --> 00:15:21,000
have given it to Fiona my apologies but

354
00:15:19,040 --> 00:15:24,000
um where you can actually directly go to

355
00:15:21,000 --> 00:15:27,000
this page and you can um fill out your

356
00:15:24,000 --> 00:15:29,440
information and it will send a um email

357
00:15:27,000 --> 00:15:32,759
or a letter to to your member of

358
00:15:29,440 --> 00:15:35,519
Congress encouraging them to join the H

359
00:15:32,759 --> 00:15:37,839
uh Congressional plasma caucus um it's

360
00:15:35,519 --> 00:15:40,440
super easy it will take you around 60

361
00:15:37,839 --> 00:15:42,000
seconds total um and will ultimately

362
00:15:40,440 --> 00:15:44,199
play a huge role in getting more

363
00:15:42,000 --> 00:15:46,240
individuals um and members of Congress

364
00:15:44,199 --> 00:15:48,000
involved on these issues so we did want

365
00:15:46,240 --> 00:15:50,600
to make sure we gave a shout out to that

366
00:15:48,000 --> 00:15:52,920
as we move forward into how A+ has been

367
00:15:50,600 --> 00:15:55,759
involved where it fits in this space and

368
00:15:52,920 --> 00:16:00,920
also where we're moving in the future as

369
00:15:55,759 --> 00:16:03,959
well so how did A+ engage um on this uh

370
00:16:00,920 --> 00:16:06,600
policy change um with uh men who have

371
00:16:03,959 --> 00:16:08,800
sex with men being able to um donate

372
00:16:06,600 --> 00:16:10,680
blood and plasma A+ played a pretty

373
00:16:08,800 --> 00:16:13,839
pivotal role from the patient advocacy

374
00:16:10,680 --> 00:16:15,519
perspective on these changes being made

375
00:16:13,839 --> 00:16:17,880
it had been clear from the beginning

376
00:16:15,519 --> 00:16:20,079
from the FDA and the relevant government

377
00:16:17,880 --> 00:16:23,040
officials that they really want the

378
00:16:20,079 --> 00:16:25,399
patient advocacy input before making

379
00:16:23,040 --> 00:16:27,560
decisions such as these as for the

380
00:16:25,399 --> 00:16:30,240
reasons that we've explained before

381
00:16:27,560 --> 00:16:32,199
right so this real conversation's been

382
00:16:30,240 --> 00:16:34,160
happening for some time but in terms of

383
00:16:32,199 --> 00:16:38,639
action really starting in around

384
00:16:34,160 --> 00:16:40,440
December 2022 January 2023 of this year

385
00:16:38,639 --> 00:16:43,199
when the proposed guidance which was

386
00:16:40,440 --> 00:16:46,040
ultimately adopted was released for an

387
00:16:43,199 --> 00:16:49,720
individualized risk-based assessment no

388
00:16:46,040 --> 00:16:52,720
matter um of any sexual orientation um

389
00:16:49,720 --> 00:16:55,560
for blood and plasma donation the FDA

390
00:16:52,720 --> 00:16:57,600
was engaged we had spoken with um as a

391
00:16:55,560 --> 00:16:59,959
coalition as well as other patient ADC

392
00:16:57,600 --> 00:17:01,839
groups with Dr Peter marks in the FDA

393
00:16:59,959 --> 00:17:04,039
who held many listening sessions and

394
00:17:01,839 --> 00:17:05,520
feedback sessions regarding this but

395
00:17:04,039 --> 00:17:08,240
they encouraged comment from patient

396
00:17:05,520 --> 00:17:10,039
advocacy organizations um particularly

397
00:17:08,240 --> 00:17:13,480
those representing end users of blood

398
00:17:10,039 --> 00:17:17,400
and plasma which is exactly where A+

399
00:17:13,480 --> 00:17:19,959
comes in so this took quite some time um

400
00:17:17,400 --> 00:17:21,640
amongst conversations with the Coalition

401
00:17:19,959 --> 00:17:23,520
going through all of the data and

402
00:17:21,640 --> 00:17:25,360
timeline and history that Nathan's going

403
00:17:23,520 --> 00:17:27,640
to talk a little bit about in a minute

404
00:17:25,360 --> 00:17:31,160
that led up to this decision and

405
00:17:27,640 --> 00:17:33,640
ultimately um we came together as a

406
00:17:31,160 --> 00:17:35,320
coalition um of these 12 National

407
00:17:33,640 --> 00:17:37,320
patient advy groups reviewing the

408
00:17:35,320 --> 00:17:39,799
guidance the data everything that has

409
00:17:37,320 --> 00:17:42,240
gone into this proposed decision um

410
00:17:39,799 --> 00:17:45,120
which we'll talk about in a moment and

411
00:17:42,240 --> 00:17:48,039
voted to support these draft guidelines

412
00:17:45,120 --> 00:17:49,919
so we as A+ part of the letter is on the

413
00:17:48,039 --> 00:17:52,640
right side of your screen there um

414
00:17:49,919 --> 00:17:55,520
encouraging the FDA to finalize these

415
00:17:52,640 --> 00:17:58,440
decisions why it's important for supply

416
00:17:55,520 --> 00:18:01,320
and why there this is still a safe and

417
00:17:58,440 --> 00:18:04,280
Equitable change to um the guidelines

418
00:18:01,320 --> 00:18:06,039
for donation of blood and plasma um and

419
00:18:04,280 --> 00:18:08,600
we include things such as the data the

420
00:18:06,039 --> 00:18:11,000
pathogen and activation um many other

421
00:18:08,600 --> 00:18:12,880
things that went into this decision we

422
00:18:11,000 --> 00:18:15,000
submitted that in about March or April

423
00:18:12,880 --> 00:18:18,640
of this year alongside comment on

424
00:18:15,000 --> 00:18:21,520
regulations.gov to the FDA formal um uh

425
00:18:18,640 --> 00:18:24,600
letter of support and ultimately these

426
00:18:21,520 --> 00:18:27,000
guidelines were finalized in May of 2023

427
00:18:24,600 --> 00:18:29,039
which we'll be talking about more later

428
00:18:27,000 --> 00:18:31,000
um but after that the

429
00:18:29,039 --> 00:18:33,679
continued engagement of the FDA has been

430
00:18:31,000 --> 00:18:35,440
there um they continue to engage patient

431
00:18:33,679 --> 00:18:37,240
groups see how things are going and

432
00:18:35,440 --> 00:18:39,600
we're also going to talk about a little

433
00:18:37,240 --> 00:18:41,880
bit of the implementation later but for

434
00:18:39,600 --> 00:18:43,919
now I'm going to turn it over to Nathan

435
00:18:41,880 --> 00:18:45,960
who has been involved in this issue for

436
00:18:43,919 --> 00:18:48,080
quite some time to talk a little bit

437
00:18:45,960 --> 00:18:49,720
more about the history as well as what

438
00:18:48,080 --> 00:18:53,200
these current guidelines are and how we

439
00:18:49,720 --> 00:18:56,320
got there so Nathan it is over to

440
00:18:53,200 --> 00:18:57,880
you great thank you Matt I want to say

441
00:18:56,320 --> 00:19:01,200
thank you to everybody who joined today

442
00:18:57,880 --> 00:19:03,720
this is a topic that has uh received a

443
00:19:01,200 --> 00:19:06,320
lot of focus and controversy over the

444
00:19:03,720 --> 00:19:09,080
years we're really excited where the

445
00:19:06,320 --> 00:19:10,559
ultimate policy has ended up but wanted

446
00:19:09,080 --> 00:19:12,360
to spend a few minutes just talking

447
00:19:10,559 --> 00:19:15,440
about the history of the policy

448
00:19:12,360 --> 00:19:17,679
specifically in the United States so I

449
00:19:15,440 --> 00:19:19,960
think we all know as Matt outlined the

450
00:19:17,679 --> 00:19:22,240
first cases of HIV were identified in

451
00:19:19,960 --> 00:19:26,640
June of

452
00:19:22,240 --> 00:19:30,720
1981 it was realized it was in a uh baby

453
00:19:26,640 --> 00:19:35,480
uh hemophilia child um in the spring or

454
00:19:30,720 --> 00:19:38,280
summer of 1982 in 1983 the FDA um

455
00:19:35,480 --> 00:19:40,000
implemented a policy that asked if you

456
00:19:38,280 --> 00:19:43,000
were a man who has had sex with other

457
00:19:40,000 --> 00:19:46,480
men with multiple partners recently that

458
00:19:43,000 --> 00:19:48,159
was first adopted in 1983 in 1985 they

459
00:19:46,480 --> 00:19:50,760
realized that they needed to be more

460
00:19:48,159 --> 00:19:53,440
strict about the specific behavior that

461
00:19:50,760 --> 00:19:56,520
they were asking about and so for a very

462
00:19:53,440 --> 00:19:58,760
long time the uh question on the donor

463
00:19:56,520 --> 00:20:01,320
history questionnaire was are you a man

464
00:19:58,760 --> 00:20:02,919
who's had sex with another man Even once

465
00:20:01,320 --> 00:20:05,880
since

466
00:20:02,919 --> 00:20:08,799
1977 um and we'll talk about the focus

467
00:20:05,880 --> 00:20:11,320
on that policy and where people poked

468
00:20:08,799 --> 00:20:15,600
holes into some of the inconsistencies

469
00:20:11,320 --> 00:20:19,559
in a moment um in 2015 in December the

470
00:20:15,600 --> 00:20:20,919
FDA moved to a oneyear deferral meaning

471
00:20:19,559 --> 00:20:22,280
if your a man who's had sex with another

472
00:20:20,919 --> 00:20:24,720
man as long as that encounter was more

473
00:20:22,280 --> 00:20:28,840
than 12 months ago you'd be eligible to

474
00:20:24,720 --> 00:20:30,799
donate either blood or plasma um that

475
00:20:28,840 --> 00:20:33,120
the policy changes that were happening

476
00:20:30,799 --> 00:20:35,200
in quite a number of other countries

477
00:20:33,120 --> 00:20:40,039
which we'll talk about in a subsequent

478
00:20:35,200 --> 00:20:43,240
slide in 2020 in April in the midst of

479
00:20:40,039 --> 00:20:44,880
the co 19 epidemic the FDA recommended

480
00:20:43,240 --> 00:20:47,679
that they'd be moving from a one-year

481
00:20:44,880 --> 00:20:50,200
deferral to a three-month deferral and

482
00:20:47,679 --> 00:20:52,280
I'll speak about the focus on that

483
00:20:50,200 --> 00:20:54,520
momentarily specifically about the

484
00:20:52,280 --> 00:20:57,520
window period now this happened during

485
00:20:54,520 --> 00:20:59,440
the coid epidemic and the FDA pointed to

486
00:20:57,520 --> 00:21:01,679
two just Jus ifications for the policy

487
00:20:59,440 --> 00:21:04,280
change at that time one they'd been

488
00:21:01,679 --> 00:21:07,360
re-evaluating the data and considering

489
00:21:04,280 --> 00:21:10,440
relaxing the policy for a while but the

490
00:21:07,360 --> 00:21:12,760
co epidemic prompted some urgency

491
00:21:10,440 --> 00:21:15,679
because of the lack of blood and plasma

492
00:21:12,760 --> 00:21:17,240
donations during the pandemic however

493
00:21:15,679 --> 00:21:19,559
when they made that announcement in

494
00:21:17,240 --> 00:21:21,480
April of 2020 they announced that it

495
00:21:19,559 --> 00:21:23,640
would be durable and that it would

496
00:21:21,480 --> 00:21:26,120
remain despite what was going to happen

497
00:21:23,640 --> 00:21:28,440
with the coid epidemic and then as Matt

498
00:21:26,120 --> 00:21:31,200
outlined earlier this year they first

499
00:21:28,440 --> 00:21:34,159
proposed and then moved forward adopting

500
00:21:31,200 --> 00:21:37,159
the new individual risk-based assessment

501
00:21:34,159 --> 00:21:39,799
which brings us to

502
00:21:37,159 --> 00:21:42,440
today so um Matt already talked about

503
00:21:39,799 --> 00:21:45,440
this but um you know the HIV crisis and

504
00:21:42,440 --> 00:21:48,760
the impact on the community cannot be

505
00:21:45,440 --> 00:21:52,240
overlooked the impact still is felt by

506
00:21:48,760 --> 00:21:55,760
many across the globe and I want to

507
00:21:52,240 --> 00:21:58,799
reiterate our sensitivity to what the

508
00:21:55,760 --> 00:22:02,360
community experienced and why

509
00:21:58,799 --> 00:22:04,520
now safety is still of utmost importance

510
00:22:02,360 --> 00:22:08,000
because we have to learn from the

511
00:22:04,520 --> 00:22:10,279
lessons pasted so that we never repeat

512
00:22:08,000 --> 00:22:12,640
um history two things I want to point

513
00:22:10,279 --> 00:22:15,799
out about this slide in the mid90s there

514
00:22:12,640 --> 00:22:19,760
was a Institute of medicine report a um

515
00:22:15,799 --> 00:22:21,640
I report that Donna shalela really LED

516
00:22:19,760 --> 00:22:24,039
and reported back to Congress on a

517
00:22:21,640 --> 00:22:26,240
number of findings about how the blood

518
00:22:24,039 --> 00:22:28,000
supply had been so thoroughly

519
00:22:26,240 --> 00:22:29,760
contaminated one of those

520
00:22:28,000 --> 00:22:31,440
recommendations was the establishment of

521
00:22:29,760 --> 00:22:34,159
the advisory committee on Blood and

522
00:22:31,440 --> 00:22:36,679
Tissue safety and availability and when

523
00:22:34,159 --> 00:22:38,080
it was first established it was required

524
00:22:36,679 --> 00:22:40,400
that there would be patient

525
00:22:38,080 --> 00:22:43,200
representation on that Federal advisory

526
00:22:40,400 --> 00:22:46,679
committee and we as NBD and on behalf of

527
00:22:43,200 --> 00:22:48,679
the A+ Coalition continue to suggest

528
00:22:46,679 --> 00:22:50,400
appropriate folks from the bleeding

529
00:22:48,679 --> 00:22:52,679
disorders Community to serve in that

530
00:22:50,400 --> 00:22:54,640
capacity and if anybody listening and

531
00:22:52,679 --> 00:22:56,960
wants to learn more we'd be more than

532
00:22:54,640 --> 00:23:00,520
happy to share that with

533
00:22:56,960 --> 00:23:02,559
you so um I just want to speak about the

534
00:23:00,520 --> 00:23:06,120
indefinite deferral that was in place

535
00:23:02,559 --> 00:23:08,840
from 1985 until 2015 and really

536
00:23:06,120 --> 00:23:11,240
highlights some of the um criticisms of

537
00:23:08,840 --> 00:23:13,279
it but also some of the progress along

538
00:23:11,240 --> 00:23:15,480
the way first of all we've talked a bit

539
00:23:13,279 --> 00:23:17,400
about the ACB TSA Federal advisory

540
00:23:15,480 --> 00:23:19,159
committee there is another one of the

541
00:23:17,400 --> 00:23:21,559
Food and Drug Administration called the

542
00:23:19,159 --> 00:23:23,320
blood products advisory committee both

543
00:23:21,559 --> 00:23:25,400
of those advisory committees I don't

544
00:23:23,320 --> 00:23:28,760
have these specific years but I know at

545
00:23:25,400 --> 00:23:31,000
least in 2003 and 2006 they looked at

546
00:23:28,760 --> 00:23:33,400
the policy specific to men who have sex

547
00:23:31,000 --> 00:23:35,320
with men and voted repeatedly that they

548
00:23:33,400 --> 00:23:37,840
wanted to maintain the current

549
00:23:35,320 --> 00:23:40,640
indefinite policy primarily because

550
00:23:37,840 --> 00:23:42,679
there were not data to support a move

551
00:23:40,640 --> 00:23:44,840
which we'll talk about momentarily

552
00:23:42,679 --> 00:23:47,480
there's been a lot of focus on the

553
00:23:44,840 --> 00:23:51,080
window period And there's a tremendous

554
00:23:47,480 --> 00:23:53,000
focus on HIV when it comes to blood and

555
00:23:51,080 --> 00:23:55,080
plasma donations for reasons that I

556
00:23:53,000 --> 00:23:57,400
think we can all appreciate given the

557
00:23:55,080 --> 00:23:59,120
crisis and the history that we just um

558
00:23:57,400 --> 00:24:04,159
reminded ourselves

559
00:23:59,120 --> 00:24:07,200
up excuse me however HIV testing has

560
00:24:04,159 --> 00:24:09,799
advanced significantly in recent years

561
00:24:07,200 --> 00:24:12,039
now when you go to donate blood it's um

562
00:24:09,799 --> 00:24:16,279
it's called nucleic acid testing which

563
00:24:12,039 --> 00:24:18,200
can detect for HIV within 9 to 11 days

564
00:24:16,279 --> 00:24:21,080
so a lot of people say well if you can

565
00:24:18,200 --> 00:24:23,559
detect for HIV then what's the point of

566
00:24:21,080 --> 00:24:25,240
having this discriminatory policy and

567
00:24:23,559 --> 00:24:27,520
there was this long-standing question

568
00:24:25,240 --> 00:24:29,679
was this discrimination and one of the

569
00:24:27,520 --> 00:24:31,919
things we said along the way was it is

570
00:24:29,679 --> 00:24:33,880
and it's discriminatory for a reason

571
00:24:31,919 --> 00:24:36,600
because we can't have people who are at

572
00:24:33,880 --> 00:24:39,559
high risk for things like HIV and other

573
00:24:36,600 --> 00:24:42,080
infectious agents to be allowed into the

574
00:24:39,559 --> 00:24:44,039
blood and plasma Supply and I want to

575
00:24:42,080 --> 00:24:46,240
speak briefly about the thre month

576
00:24:44,039 --> 00:24:49,320
deferral that the FDA adopted in April

577
00:24:46,240 --> 00:24:51,200
of 2020 during that time they were asked

578
00:24:49,320 --> 00:24:54,559
about the window period and they

579
00:24:51,200 --> 00:24:56,760
explained that they have to the FDA

580
00:24:54,559 --> 00:24:59,200
operates with a cautionary principle

581
00:24:56,760 --> 00:25:01,320
whereby if they know about a window

582
00:24:59,200 --> 00:25:04,399
period with an infectious agent they

583
00:25:01,320 --> 00:25:06,840
have to multiply that at least by three

584
00:25:04,399 --> 00:25:09,080
now HIV can be detected within 9 to 11

585
00:25:06,840 --> 00:25:12,080
days I've already explained that however

586
00:25:09,080 --> 00:25:14,240
Hepatitis B which is another infectious

587
00:25:12,080 --> 00:25:16,440
agent that we're very to worried about

588
00:25:14,240 --> 00:25:19,799
um Can the window period for that is

589
00:25:16,440 --> 00:25:21,799
about 34 days so that was part of the

590
00:25:19,799 --> 00:25:24,200
rationale that the FDA explained when

591
00:25:21,799 --> 00:25:27,080
they announc the three-month deferral

592
00:25:24,200 --> 00:25:29,039
the point here is it's not just HIV and

593
00:25:27,080 --> 00:25:32,039
I mentioned how Hepatitis B but the

594
00:25:29,039 --> 00:25:34,799
other reality is we're worried about new

595
00:25:32,039 --> 00:25:37,679
emergent pathogens that we don't yet

596
00:25:34,799 --> 00:25:39,919
know about and the unfortunate reality

597
00:25:37,679 --> 00:25:42,520
that oftentimes they are more commonly

598
00:25:39,919 --> 00:25:45,200
found in men who have sex with men if

599
00:25:42,520 --> 00:25:48,520
you want a recent example monkey pox is

600
00:25:45,200 --> 00:25:50,520
one of those from a couple of years ago

601
00:25:48,520 --> 00:25:52,880
however there were other behavioral

602
00:25:50,520 --> 00:25:55,720
criteria that resulted in an indefinite

603
00:25:52,880 --> 00:25:57,120
deferral at that time if you're you

604
00:25:55,720 --> 00:26:00,320
would have been asked have you ever

605
00:25:57,120 --> 00:26:02,120
engaged in sex for drugs or Money

606
00:26:00,320 --> 00:26:06,000
commercial sex work was a deferral

607
00:26:02,120 --> 00:26:07,919
criteria so was intravenous drug use um

608
00:26:06,000 --> 00:26:10,039
if you ever had a history of that even

609
00:26:07,919 --> 00:26:12,799
once you'd be indefinitely deferred

610
00:26:10,039 --> 00:26:14,679
those moved to a three-month deferral

611
00:26:12,799 --> 00:26:16,679
for sex work and for intravenous drug

612
00:26:14,679 --> 00:26:19,880
use in April of

613
00:26:16,679 --> 00:26:22,320
2020 but one of the things that was

614
00:26:19,880 --> 00:26:25,360
commonly pointed out as an

615
00:26:22,320 --> 00:26:28,080
inconsistency in the way highrisk donors

616
00:26:25,360 --> 00:26:31,679
were deferred was for heteros sexual

617
00:26:28,080 --> 00:26:35,200
people if you had had sex with a known

618
00:26:31,679 --> 00:26:37,200
HIV positive partner you could donate

619
00:26:35,200 --> 00:26:40,120
after that encounter had been more than

620
00:26:37,200 --> 00:26:42,159
12 months ago so the indefinite deferral

621
00:26:40,120 --> 00:26:44,440
for men who have sex with men asking

622
00:26:42,159 --> 00:26:46,840
about have you ever had sex even once

623
00:26:44,440 --> 00:26:49,120
without asking about what kind of sex

624
00:26:46,840 --> 00:26:50,520
whether or not it was protected whether

625
00:26:49,120 --> 00:26:53,159
or not you were in a monogamous

626
00:26:50,520 --> 00:26:55,279
relationship was inconsistent in the way

627
00:26:53,159 --> 00:26:57,279
that heterosexual people who had sex

628
00:26:55,279 --> 00:27:00,480
with somebody who was known to be HIV

629
00:26:57,279 --> 00:27:02,600
positive was deferred so those were some

630
00:27:00,480 --> 00:27:04,240
of the um the highlights and the

631
00:27:02,600 --> 00:27:07,799
controversies that surrounded that

632
00:27:04,240 --> 00:27:07,799
indefinite deferral for

633
00:27:08,440 --> 00:27:12,760
decades um I just want to talk briefly

634
00:27:10,840 --> 00:27:15,080
about how the LGBT and bleeding

635
00:27:12,760 --> 00:27:18,120
disorders communities came together way

636
00:27:15,080 --> 00:27:20,039
back in 2010 and I'm sharing this from a

637
00:27:18,120 --> 00:27:21,799
um different perspective at the time I

638
00:27:20,039 --> 00:27:23,279
used to be the director of public policy

639
00:27:21,799 --> 00:27:25,919
for a group in New York City called Gay

640
00:27:23,279 --> 00:27:28,360
Men's Health crisis and in February of

641
00:27:25,919 --> 00:27:32,600
that year we issued a report

642
00:27:28,360 --> 00:27:35,399
um uh criticizing the current FDA policy

643
00:27:32,600 --> 00:27:38,679
and fortuitously I got to know the

644
00:27:35,399 --> 00:27:40,080
bleeding disorders Community just before

645
00:27:38,679 --> 00:27:42,399
the advisory committee on Blood and

646
00:27:40,080 --> 00:27:44,720
Tissue and safety and availability

647
00:27:42,399 --> 00:27:47,559
officially met in June of that year to

648
00:27:44,720 --> 00:27:49,440
review the policy um I also have to

649
00:27:47,559 --> 00:27:52,440
acknowledge that it was around that time

650
00:27:49,440 --> 00:27:54,159
that I ran into and met Marilyn Nest who

651
00:27:52,440 --> 00:27:57,600
was the director of The Bad Blood

652
00:27:54,159 --> 00:28:00,120
documentary which gave me a much more

653
00:27:57,600 --> 00:28:02,440
valid and comprehensive appreciation of

654
00:28:00,120 --> 00:28:04,480
the history of HIV as it impacted the

655
00:28:02,440 --> 00:28:07,200
bleeding disorders community and I'll

656
00:28:04,480 --> 00:28:11,600
speak more about that um on the next

657
00:28:07,200 --> 00:28:14,399
slide so um I just want to be very clear

658
00:28:11,600 --> 00:28:16,720
that uh formerly nhf and now NBF are

659
00:28:14,399 --> 00:28:18,519
positioned historically about the

660
00:28:16,720 --> 00:28:21,080
deferral criteria for men who have sex

661
00:28:18,519 --> 00:28:24,799
with them we have always said that any

662
00:28:21,080 --> 00:28:28,399
policy chain should follow science and

663
00:28:24,799 --> 00:28:31,799
that sufficient science are necess Neary

664
00:28:28,399 --> 00:28:34,960
to justify any change in policy we also

665
00:28:31,799 --> 00:28:38,080
acknowledge that we need as many healthy

666
00:28:34,960 --> 00:28:40,480
eligible reliable donors to donate both

667
00:28:38,080 --> 00:28:43,200
blood and Plasma on a consistent basis

668
00:28:40,480 --> 00:28:45,600
we need as many donors as possible

669
00:28:43,200 --> 00:28:48,440
however considering all of that no

670
00:28:45,600 --> 00:28:51,640
change in policy should ever result in

671
00:28:48,440 --> 00:28:54,960
any elevated risk to end users of blood

672
00:28:51,640 --> 00:28:57,000
and plasma derived products um so we

673
00:28:54,960 --> 00:28:59,960
want the highest number possible to

674
00:28:57,000 --> 00:29:02,200
donate and we have to be sure that none

675
00:28:59,960 --> 00:29:04,600
of that will result in any elevated risk

676
00:29:02,200 --> 00:29:08,039
to end

677
00:29:04,600 --> 00:29:10,480
users um in regarding the June um 2010

678
00:29:08,039 --> 00:29:11,919
meeting uh the advisory committee was

679
00:29:10,480 --> 00:29:14,519
asked if there were sufficient data to

680
00:29:11,919 --> 00:29:16,600
move to a 10-year deferral which was the

681
00:29:14,519 --> 00:29:18,519
case in some countries a five-year

682
00:29:16,600 --> 00:29:21,000
deferral which was also the case in some

683
00:29:18,519 --> 00:29:23,320
countries or a one-year deferral and at

684
00:29:21,000 --> 00:29:25,279
that time I was representing Gay Men's

685
00:29:23,320 --> 00:29:27,399
Health crisis and presented the gay

686
00:29:25,279 --> 00:29:29,440
men's perspective and our friend and

687
00:29:27,399 --> 00:29:32,760
colleague Mark Skinner was representing

688
00:29:29,440 --> 00:29:34,679
A+ with the patient perspective um the

689
00:29:32,760 --> 00:29:36,760
committee ultimately voted at that time

690
00:29:34,679 --> 00:29:39,279
that there would be no change in the

691
00:29:36,760 --> 00:29:42,120
policy but they advis Research into what

692
00:29:39,279 --> 00:29:46,480
is called a quarantine release error and

693
00:29:42,120 --> 00:29:49,559
here's the deal with qres if a HIV

694
00:29:46,480 --> 00:29:51,000
positive unit of blood is donated yes

695
00:29:49,559 --> 00:29:54,399
there are sufficient screening

696
00:29:51,000 --> 00:29:56,720
mechanisms to identify that however if a

697
00:29:54,399 --> 00:29:58,679
unit is found to be HIV positive it

698
00:29:56,720 --> 00:30:01,360
needs to go into to quarantine for them

699
00:29:58,679 --> 00:30:03,960
to do further analysis of the origin of

700
00:30:01,360 --> 00:30:07,559
that donation when they do that there is

701
00:30:03,960 --> 00:30:09,960
a risk albeit infinitesimal that that

702
00:30:07,559 --> 00:30:12,799
could result in getting into the blood

703
00:30:09,960 --> 00:30:15,399
and plasma Supply so at the time they

704
00:30:12,799 --> 00:30:17,880
voted to establish a research monitoring

705
00:30:15,399 --> 00:30:20,320
system called ttim transfusion

706
00:30:17,880 --> 00:30:22,600
transmission infectious monitoring

707
00:30:20,320 --> 00:30:25,919
system that monitoring system had not

708
00:30:22,600 --> 00:30:28,399
been in place in the US before that that

709
00:30:25,919 --> 00:30:31,120
set the stage to to allow for more

710
00:30:28,399 --> 00:30:33,760
research into the potential risk of any

711
00:30:31,120 --> 00:30:36,120
kind of policy change and ultimately

712
00:30:33,760 --> 00:30:39,360
some additional research that led to the

713
00:30:36,120 --> 00:30:41,399
ultimate policy change earlier this year

714
00:30:39,360 --> 00:30:43,799
so just want to acknowledge that in June

715
00:30:41,399 --> 00:30:45,960
of 2010 it was one of the first times

716
00:30:43,799 --> 00:30:48,039
that the LGBT and the bleeding disorders

717
00:30:45,960 --> 00:30:50,919
Community came together and I'm very

718
00:30:48,039 --> 00:30:52,919
proud to say we still remain in close

719
00:30:50,919 --> 00:30:55,240
contact even though we don't agree on

720
00:30:52,919 --> 00:30:58,039
everything um it has gone a very long

721
00:30:55,240 --> 00:31:00,960
way towards reducing the tension

722
00:30:58,039 --> 00:31:03,679
that um surround this

723
00:31:00,960 --> 00:31:05,279
issue so the new policy Matt already

724
00:31:03,679 --> 00:31:08,399
sort of walked through this but what it

725
00:31:05,279 --> 00:31:11,679
does is it asks all potential donors

726
00:31:08,399 --> 00:31:14,200
regardless of the sex of their Partners

727
00:31:11,679 --> 00:31:18,399
if they've had sex with multiple

728
00:31:14,200 --> 00:31:21,639
partners recently um if so they are

729
00:31:18,399 --> 00:31:24,840
asked a series of additional questions

730
00:31:21,639 --> 00:31:26,960
this applies to all potential donors not

731
00:31:24,840 --> 00:31:30,200
only gay and bisexual men or men who

732
00:31:26,960 --> 00:31:32,799
have sex with men what this gets at is

733
00:31:30,200 --> 00:31:35,799
those who were at elevated risk

734
00:31:32,799 --> 00:31:38,360
heterosexual donors like the case I um

735
00:31:35,799 --> 00:31:40,240
was explaining earlier if they had known

736
00:31:38,360 --> 00:31:43,279
to have sex with somebody who's HIV

737
00:31:40,240 --> 00:31:45,600
positive there were um a number of

738
00:31:43,279 --> 00:31:48,279
highrisk heterosexuals that were

739
00:31:45,600 --> 00:31:51,679
permissible to donate under the the

740
00:31:48,279 --> 00:31:54,200
former policy this gets at that and

741
00:31:51,679 --> 00:31:55,639
removes the discriminatory element about

742
00:31:54,200 --> 00:31:58,080
sexual

743
00:31:55,639 --> 00:32:00,360
orientation um in large part this was

744
00:31:58,080 --> 00:32:02,080
informed by the advanced study which was

745
00:32:00,360 --> 00:32:04,840
commissioned by FDA which I'll speak

746
00:32:02,080 --> 00:32:07,399
about very briefly in a moment um but I

747
00:32:04,840 --> 00:32:09,480
also want to be clear blood and plasma

748
00:32:07,399 --> 00:32:12,399
collectors are working to implement this

749
00:32:09,480 --> 00:32:14,480
new policy the Red Cross I believe just

750
00:32:12,399 --> 00:32:16,720
earlier this month um announced that

751
00:32:14,480 --> 00:32:19,600
they were going to implement it but I

752
00:32:16,720 --> 00:32:23,559
also want to be clear these new policies

753
00:32:19,600 --> 00:32:26,480
are um not required uh blood and plasma

754
00:32:23,559 --> 00:32:30,240
collection facilities do not have to um

755
00:32:26,480 --> 00:32:32,760
relax their uh policies to this extent

756
00:32:30,240 --> 00:32:34,919
they can but they're not required to

757
00:32:32,760 --> 00:32:37,039
Matt and I visited a um plasma

758
00:32:34,919 --> 00:32:39,320
collection facility here in my home

759
00:32:37,039 --> 00:32:41,559
state of Illinois recently and they were

760
00:32:39,320 --> 00:32:43,960
still operating with a four-month

761
00:32:41,559 --> 00:32:45,159
deferral for men who have sex with men

762
00:32:43,960 --> 00:32:46,559
we don't need to get into their

763
00:32:45,159 --> 00:32:48,720
rationale but I just want to be clear

764
00:32:46,559 --> 00:32:51,880
they don't have to implement

765
00:32:48,720 --> 00:32:54,240
this um next we so this is the advanced

766
00:32:51,880 --> 00:32:56,440
study um it is a was a very

767
00:32:54,240 --> 00:32:58,720
comprehensive study and what I want you

768
00:32:56,440 --> 00:33:02,240
to take away from this is the FDA

769
00:32:58,720 --> 00:33:04,480
acknowledged that in order to um inform

770
00:33:02,240 --> 00:33:06,360
an individual risk-based assessment we

771
00:33:04,480 --> 00:33:08,960
had to determine whether or not we could

772
00:33:06,360 --> 00:33:12,120
actually ask additional questions that

773
00:33:08,960 --> 00:33:14,519
got into individual risk specifically

774
00:33:12,120 --> 00:33:16,519
for men who have sex with men it was a

775
00:33:14,519 --> 00:33:19,720
study that enrolled over 1500

776
00:33:16,519 --> 00:33:21,679
participants from all across the country

777
00:33:19,720 --> 00:33:23,360
um one of the things that came out of it

778
00:33:21,679 --> 00:33:26,399
and um we'll get into this if there are

779
00:33:23,360 --> 00:33:28,760
questions was the use of pre-exposure

780
00:33:26,399 --> 00:33:31,440
prophylatic ACC and whether or not those

781
00:33:28,760 --> 00:33:34,440
donors should be permissible to um

782
00:33:31,440 --> 00:33:36,799
donate and the shorter answer is no not

783
00:33:34,440 --> 00:33:38,679
at this time with some stipulations

784
00:33:36,799 --> 00:33:40,519
which we can get into I also want to

785
00:33:38,679 --> 00:33:43,360
acknowledge the FDA pointed to this

786
00:33:40,519 --> 00:33:45,679
study um even though the official

787
00:33:43,360 --> 00:33:47,639
results were have not yet been made

788
00:33:45,679 --> 00:33:50,080
public which is not an uncommon practice

789
00:33:47,639 --> 00:33:52,880
of the FDA sometimes they have some

790
00:33:50,080 --> 00:33:55,720
knowledge that inform their decision um

791
00:33:52,880 --> 00:33:57,600
even before it becomes public but what I

792
00:33:55,720 --> 00:33:59,880
want you to know is the FDA was an

793
00:33:57,600 --> 00:34:02,039
active partner in this they funded the

794
00:33:59,880 --> 00:34:02,840
study but it also was in partnership

795
00:34:02,039 --> 00:34:05,960
with

796
00:34:02,840 --> 00:34:08,800
lgbtqia plus organizations across the

797
00:34:05,960 --> 00:34:12,280
country it was hugely significant and

798
00:34:08,800 --> 00:34:14,599
had a decisive impact on the policy

799
00:34:12,280 --> 00:34:18,240
change I think on the next slide we're

800
00:34:14,599 --> 00:34:20,320
gonna so um this is a a map of the world

801
00:34:18,240 --> 00:34:23,040
and um let me just be clear because the

802
00:34:20,320 --> 00:34:26,000
shading is a little confusing the green

803
00:34:23,040 --> 00:34:28,639
countries are places where it's it's

804
00:34:26,000 --> 00:34:31,159
determined to not not heavy specific MSM

805
00:34:28,639 --> 00:34:33,480
deferral so for example in the United

806
00:34:31,159 --> 00:34:34,919
States um it's about individual risk

807
00:34:33,480 --> 00:34:37,119
based assessment not the sexual

808
00:34:34,919 --> 00:34:39,560
orientation of your partners and I have

809
00:34:37,119 --> 00:34:41,960
to also acknowledge that that policy

810
00:34:39,560 --> 00:34:44,119
change in the US was informed

811
00:34:41,960 --> 00:34:48,359
specifically by policy changes that

812
00:34:44,119 --> 00:34:50,119
predated it in Canada and in the UK and

813
00:34:48,359 --> 00:34:52,079
it's important to acknowledge that

814
00:34:50,119 --> 00:34:54,480
because when the FDA looks at what other

815
00:34:52,079 --> 00:34:58,760
countries have implemented they consider

816
00:34:54,480 --> 00:35:01,839
countries that have a similar h HIV

817
00:34:58,760 --> 00:35:04,560
epidemiology um so for example in most

818
00:35:01,839 --> 00:35:07,720
places in Africa um HIV predominantly

819
00:35:04,560 --> 00:35:12,079
impacts heterosexual people in the US

820
00:35:07,720 --> 00:35:14,000
and um the UK uh it is not the case so

821
00:35:12,079 --> 00:35:17,000
they look specifically at countries that

822
00:35:14,000 --> 00:35:18,280
have other similar HIV epidemiologies

823
00:35:17,000 --> 00:35:20,359
the other thing I want to acknowledge

824
00:35:18,280 --> 00:35:21,960
here is um if you look at all the green

825
00:35:20,359 --> 00:35:24,920
countries and you think none of them

826
00:35:21,960 --> 00:35:27,000
have a specific MSM deferral criteria

827
00:35:24,920 --> 00:35:28,839
that doesn't mean that they used to most

828
00:35:27,000 --> 00:35:31,960
the countries in Africa have never had a

829
00:35:28,839 --> 00:35:33,920
policy specific to MSM um but many of

830
00:35:31,960 --> 00:35:36,280
the others have adopted it in more

831
00:35:33,920 --> 00:35:37,960
recent years um but there are still

832
00:35:36,280 --> 00:35:40,960
places that have a three-month deferral

833
00:35:37,960 --> 00:35:43,119
a six-month deferral and a one-year

834
00:35:40,960 --> 00:35:44,960
deferral um and I think with that I'm

835
00:35:43,119 --> 00:35:47,240
going to turn it back over to Matt and I

836
00:35:44,960 --> 00:35:49,480
see we got some questions in the Q&A so

837
00:35:47,240 --> 00:35:52,079
I'll look forward to those awesome thank

838
00:35:49,480 --> 00:35:54,160
you Nathan I appreciate it and um going

839
00:35:52,079 --> 00:35:56,480
into policy implementation especially we

840
00:35:54,160 --> 00:35:59,800
wanted to make sure that we framed um

841
00:35:56,480 --> 00:36:02,760
the notion that these guidelines not all

842
00:35:59,800 --> 00:36:05,839
the manufacturers donation centers need

843
00:36:02,760 --> 00:36:08,960
to necessarily accept these guidelines

844
00:36:05,839 --> 00:36:12,119
but it is more what they can do rather

845
00:36:08,960 --> 00:36:14,280
than what they must do um so we'll get

846
00:36:12,119 --> 00:36:16,079
into that in a moment but again just you

847
00:36:14,280 --> 00:36:18,400
know I think that's important context to

848
00:36:16,079 --> 00:36:19,880
add um ahead of this next slide but also

849
00:36:18,400 --> 00:36:22,440
looking at all of the different

850
00:36:19,880 --> 00:36:25,960
countries here um with their deferral

851
00:36:22,440 --> 00:36:30,040
policies as well so this decision was

852
00:36:25,960 --> 00:36:33,880
made in May 2023 like we stated before

853
00:36:30,040 --> 00:36:36,160
and like any law regulation um anything

854
00:36:33,880 --> 00:36:38,079
done um you know by the government or in

855
00:36:36,160 --> 00:36:42,720
the public sector it can take some time

856
00:36:38,079 --> 00:36:45,040
for um stakeholders to react right or

857
00:36:42,720 --> 00:36:48,560
for um guidelines to be followed there

858
00:36:45,040 --> 00:36:51,079
needs to be time for that to be done um

859
00:36:48,560 --> 00:36:54,480
so with the policy implementation this

860
00:36:51,079 --> 00:36:57,480
is still a very new policy change in the

861
00:36:54,480 --> 00:37:00,680
landscape of blood plasma donation um as

862
00:36:57,480 --> 00:37:04,000
well as the manufacturing um um of these

863
00:37:00,680 --> 00:37:05,920
of these different therapies um however

864
00:37:04,000 --> 00:37:09,240
um we have seen some implementation

865
00:37:05,920 --> 00:37:12,359
already start to occur or signaling

866
00:37:09,240 --> 00:37:14,640
support for uh um accepting these

867
00:37:12,359 --> 00:37:17,119
guidelines from some major blood and

868
00:37:14,640 --> 00:37:20,240
plasma donation centers so the first

869
00:37:17,119 --> 00:37:22,920
major one um that um dropped was pretty

870
00:37:20,240 --> 00:37:24,800
shortly after the May 2020 guidelines

871
00:37:22,920 --> 00:37:27,480
this was in August of this year the

872
00:37:24,800 --> 00:37:29,680
American Red Cross as Nate said

873
00:37:27,480 --> 00:37:30,960
previously um stated that they were

874
00:37:29,680 --> 00:37:33,960
going to be implementing these

875
00:37:30,960 --> 00:37:36,119
guidelines as recommended by the FDA and

876
00:37:33,960 --> 00:37:39,319
the Red Cross being such a large

877
00:37:36,119 --> 00:37:42,640
organization and such a large um um

878
00:37:39,319 --> 00:37:45,040
donation center and organization um we

879
00:37:42,640 --> 00:37:47,160
had some others follow um New York blood

880
00:37:45,040 --> 00:37:49,480
center which is a massive donation

881
00:37:47,160 --> 00:37:51,280
center um I always remember in college

882
00:37:49,480 --> 00:37:53,400
and even today seeing blood drives we

883
00:37:51,280 --> 00:37:55,560
see the big New York blood center trucks

884
00:37:53,400 --> 00:37:57,480
um they Supply most of the Tri-State

885
00:37:55,560 --> 00:38:00,400
region of New York City including

886
00:37:57,480 --> 00:38:02,760
Connecticut New Jersey um that blood

887
00:38:00,400 --> 00:38:04,680
center just shortly after the American

888
00:38:02,760 --> 00:38:06,880
Red Cross announced their implementation

889
00:38:04,680 --> 00:38:09,560
also stated that they will be following

890
00:38:06,880 --> 00:38:11,520
these guidelines alongside after that

891
00:38:09,560 --> 00:38:13,440
several local blood center networks

892
00:38:11,520 --> 00:38:16,480
similar to the New York blood center but

893
00:38:13,440 --> 00:38:19,560
throughout the country so we have seen

894
00:38:16,480 --> 00:38:21,520
several um donation organizations

895
00:38:19,560 --> 00:38:25,280
already accept these guidelines as

896
00:38:21,520 --> 00:38:27,319
recommended by the FDA um however like

897
00:38:25,280 --> 00:38:30,480
we said they do not have have to be

898
00:38:27,319 --> 00:38:34,240
accepted and many donation centers are

899
00:38:30,480 --> 00:38:37,040
taking um are still using deferrals um

900
00:38:34,240 --> 00:38:39,920
in a ways that they see fit with they

901
00:38:37,040 --> 00:38:41,000
want to um run their organization so a

902
00:38:39,920 --> 00:38:43,079
lot of them are still in the

903
00:38:41,000 --> 00:38:45,359
deliberation process this will take a

904
00:38:43,079 --> 00:38:47,880
lot of time and I think we will see

905
00:38:45,359 --> 00:38:50,280
overtime more and more

906
00:38:47,880 --> 00:38:51,880
organizations um and donation centers

907
00:38:50,280 --> 00:38:54,359
adopt something closer to these

908
00:38:51,880 --> 00:38:56,000
guidelines but as we stated not all of

909
00:38:54,359 --> 00:38:58,440
them are doing so some have four-month

910
00:38:56,000 --> 00:39:02,560
deferrals some have five month deferrals

911
00:38:58,440 --> 00:39:06,280
it really ranges but the FDA this was a

912
00:39:02,560 --> 00:39:09,240
massive um suggestion that organizations

913
00:39:06,280 --> 00:39:11,400
it is safe to end users as well as to

914
00:39:09,240 --> 00:39:14,040
the donor and everywhere in between for

915
00:39:11,400 --> 00:39:16,160
these guidelines to exist and is also a

916
00:39:14,040 --> 00:39:18,160
major step in Health Equity in a variety

917
00:39:16,160 --> 00:39:21,359
of different lenses but we did want to

918
00:39:18,160 --> 00:39:23,520
state that this is not universally um

919
00:39:21,359 --> 00:39:25,640
what the guidelines are many places are

920
00:39:23,520 --> 00:39:27,760
still deliberating or have chosen to

921
00:39:25,640 --> 00:39:30,200
stick with different policy or deferral

922
00:39:27,760 --> 00:39:33,359
guidelines um but this will also take

923
00:39:30,200 --> 00:39:35,800
time and I think we'll see more and more

924
00:39:33,359 --> 00:39:38,920
centers maybe adjust closer to this

925
00:39:35,800 --> 00:39:42,200
policy over time so but the American Red

926
00:39:38,920 --> 00:39:45,160
Cross was a massive massive organization

927
00:39:42,200 --> 00:39:47,839
to accept these we saw many follow suit

928
00:39:45,160 --> 00:39:50,280
um and we and we may continue um to see

929
00:39:47,839 --> 00:39:53,119
so but this was a massive step in Health

930
00:39:50,280 --> 00:39:54,839
Equity while also recognizing that these

931
00:39:53,119 --> 00:39:57,359
that individuals men who have sex with

932
00:39:54,839 --> 00:39:59,640
men can donate blood give given these

933
00:39:57,359 --> 00:40:02,079
criteria and guidelines without an

934
00:39:59,640 --> 00:40:05,240
adverse safety effect um to the blood

935
00:40:02,079 --> 00:40:07,359
and plasma donation Supply so um with

936
00:40:05,240 --> 00:40:09,839
that we are happy to take your questions

937
00:40:07,359 --> 00:40:12,200
again we thank you for joining us um we

938
00:40:09,839 --> 00:40:16,720
just have our contact info here but I

939
00:40:12,200 --> 00:40:16,720
think with that we are happy to take any

940
00:40:17,319 --> 00:40:22,720
questions super thank you very much Matt

941
00:40:20,240 --> 00:40:25,560
and Nathan for a really informative

942
00:40:22,720 --> 00:40:27,520
presentation um I did pop that link into

943
00:40:25,560 --> 00:40:28,800
the chat you were speaking there Matt at

944
00:40:27,520 --> 00:40:31,280
the end did you want to just say once

945
00:40:28,800 --> 00:40:35,760
more Matt what that link is

946
00:40:31,280 --> 00:40:38,560
for uh oh yes thank you Fiona um that is

947
00:40:35,760 --> 00:40:40,880
the link to our action alert for

948
00:40:38,560 --> 00:40:43,880
individuals to contact their members of

949
00:40:40,880 --> 00:40:46,760
Congress to urge them to join the

950
00:40:43,880 --> 00:40:49,280
Congressional plasma caucus um you will

951
00:40:46,760 --> 00:40:51,960
see there in the field this was created

952
00:40:49,280 --> 00:40:54,680
um with our other member organizations

953
00:40:51,960 --> 00:40:57,160
of A+ alongside um the hemophilia

954
00:40:54,680 --> 00:40:59,560
Federation of America which um we have

955
00:40:57,160 --> 00:41:01,680
partnered with on this project um there

956
00:40:59,560 --> 00:41:05,119
is a sample letter there that you can

957
00:41:01,680 --> 00:41:06,800
fill out to your member of Congress um

958
00:41:05,119 --> 00:41:09,560
it is editable as well if you want to

959
00:41:06,800 --> 00:41:11,520
put a personal anecdote or story um but

960
00:41:09,560 --> 00:41:13,000
also you can fill it out automatically

961
00:41:11,520 --> 00:41:15,520
shows your members of Congress to

962
00:41:13,000 --> 00:41:17,520
contact you click Send and it is already

963
00:41:15,520 --> 00:41:19,079
out to their offices so it's a really

964
00:41:17,520 --> 00:41:20,920
easy way to do it I did it with my

965
00:41:19,079 --> 00:41:23,520
member of Congress it took me less than

966
00:41:20,920 --> 00:41:26,599
60 seconds so um again if people would

967
00:41:23,520 --> 00:41:28,800
be willing to do that um it really allow

968
00:41:26,599 --> 00:41:31,079
us to have further engagement with

969
00:41:28,800 --> 00:41:33,400
Congressional caucuses not only on these

970
00:41:31,079 --> 00:41:35,400
issues um but bringing them more

971
00:41:33,400 --> 00:41:37,440
awareness of bleeding disorders and the

972
00:41:35,400 --> 00:41:41,000
other rare conditions that A+ represents

973
00:41:37,440 --> 00:41:43,240
as well that's super thank you for that

974
00:41:41,000 --> 00:41:45,400
I would just like to remind our audience

975
00:41:43,240 --> 00:41:46,880
that uh we are ready to take their

976
00:41:45,400 --> 00:41:49,079
questions if they have any questions

977
00:41:46,880 --> 00:41:50,839
you'd like to submit you can just enter

978
00:41:49,079 --> 00:41:52,839
them into the Q&A feature at the bottom

979
00:41:50,839 --> 00:41:54,440
of your screen and we'll do our best to

980
00:41:52,839 --> 00:41:57,160
answer all of your

981
00:41:54,440 --> 00:41:59,520
questions uh maybe we can start with a

982
00:41:57,160 --> 00:42:00,720
question that we have received I'm going

983
00:41:59,520 --> 00:42:03,040
to start with a question of my own I'm

984
00:42:00,720 --> 00:42:04,880
going to take moderator's prerogative um

985
00:42:03,040 --> 00:42:07,079
it's really impressive the work that you

986
00:42:04,880 --> 00:42:09,520
do the advocacy work that you do the way

987
00:42:07,079 --> 00:42:12,200
that the the nvf is positioned and

988
00:42:09,520 --> 00:42:14,560
established do you have advice for

989
00:42:12,200 --> 00:42:16,800
people in in countries where maybe there

990
00:42:14,560 --> 00:42:19,559
is not such a strong strong presence or

991
00:42:16,800 --> 00:42:21,480
or opportunity for stakeholders to have

992
00:42:19,559 --> 00:42:24,960
a voice in the policies and regulations

993
00:42:21,480 --> 00:42:27,000
that infect in inlu Impact sorry impact

994
00:42:24,960 --> 00:42:28,440
or influence so much their safety and

995
00:42:27,000 --> 00:42:30,359
they you know they are the people for

996
00:42:28,440 --> 00:42:33,920
whom it is the most important they often

997
00:42:30,359 --> 00:42:36,559
don't have such a strong voice um do you

998
00:42:33,920 --> 00:42:39,200
have any any advice about how to go

999
00:42:36,559 --> 00:42:41,960
about you know strengthening that

1000
00:42:39,200 --> 00:42:43,760
position yeah I have a couple responses

1001
00:42:41,960 --> 00:42:46,079
to that first of all I mean we're really

1002
00:42:43,760 --> 00:42:47,839
lucky in the United States because we

1003
00:42:46,079 --> 00:42:49,920
have the ability to influence the

1004
00:42:47,839 --> 00:42:52,440
structure of the federal government so

1005
00:42:49,920 --> 00:42:54,359
we um helped establish this advisory

1006
00:42:52,440 --> 00:42:56,559
committee that is required to have

1007
00:42:54,359 --> 00:42:59,000
patient representation many other

1008
00:42:56,559 --> 00:43:01,559
countries don't have that kind of luxury

1009
00:42:59,000 --> 00:43:03,839
of having a seat at the table so in

1010
00:43:01,559 --> 00:43:06,839
places like that I would say your best

1011
00:43:03,839 --> 00:43:09,839
bet is to try and find someone who is

1012
00:43:06,839 --> 00:43:12,839
influential some policy maker that you

1013
00:43:09,839 --> 00:43:15,319
can get in front of and make a case I

1014
00:43:12,839 --> 00:43:18,079
would also say one thing that does not

1015
00:43:15,319 --> 00:43:20,559
help with reform in something that is

1016
00:43:18,079 --> 00:43:22,760
this complicated is

1017
00:43:20,559 --> 00:43:25,800
divisiveness um and and I think that was

1018
00:43:22,760 --> 00:43:28,079
part of what um held up the change in

1019
00:43:25,800 --> 00:43:29,920
the United States because the bleeding

1020
00:43:28,079 --> 00:43:33,400
disorders community and the LGBT

1021
00:43:29,920 --> 00:43:35,599
community were perceived to be at odds

1022
00:43:33,400 --> 00:43:38,319
when they actually got together and

1023
00:43:35,599 --> 00:43:40,440
realized that there was common ground

1024
00:43:38,319 --> 00:43:43,480
and we all agreed we don't want to

1025
00:43:40,440 --> 00:43:46,319
increase um any risk of end users and we

1026
00:43:43,480 --> 00:43:48,480
want more um donors um those were

1027
00:43:46,319 --> 00:43:51,240
fundamentally what we could agree upon

1028
00:43:48,480 --> 00:43:55,480
when there's consensus that tends to

1029
00:43:51,240 --> 00:43:57,520
drive change um more swiftly than if

1030
00:43:55,480 --> 00:43:59,920
there's divice iess because policy

1031
00:43:57,520 --> 00:44:00,960
makers see conflict they don't want to

1032
00:43:59,920 --> 00:44:04,480
touch

1033
00:44:00,960 --> 00:44:06,040
it right thank you Matt maybe a question

1034
00:44:04,480 --> 00:44:08,319
I can direct to you about some of the

1035
00:44:06,040 --> 00:44:10,760
advocacy you mentioned you talked about

1036
00:44:08,319 --> 00:44:12,200
explaining the vinto vain concept I

1037
00:44:10,760 --> 00:44:14,200
think uh when you were advocating in

1038
00:44:12,200 --> 00:44:16,720
Congress can you explain that concept to

1039
00:44:14,200 --> 00:44:20,040
me I'm I'm not super familiar with it

1040
00:44:16,720 --> 00:44:23,200
yeah absolutely great question Fiona um

1041
00:44:20,040 --> 00:44:25,319
I think as members of A+ and also myself

1042
00:44:23,200 --> 00:44:27,520
as an individual who uses a plasma

1043
00:44:25,319 --> 00:44:30,000
derived treatment to treat my Von

1044
00:44:27,520 --> 00:44:32,079
gulbrand's disease it has been really

1045
00:44:30,000 --> 00:44:34,000
enlightening both from a policy

1046
00:44:32,079 --> 00:44:36,720
perspective working in policy before

1047
00:44:34,000 --> 00:44:37,960
coming to mbf um but also as a patient

1048
00:44:36,720 --> 00:44:40,680
experience to

1049
00:44:37,960 --> 00:44:42,319
realize all of the pieces that go

1050
00:44:40,680 --> 00:44:44,760
involved in creating these kinds of

1051
00:44:42,319 --> 00:44:47,800
treatments that work for so many people

1052
00:44:44,760 --> 00:44:50,640
including myself I you know when using a

1053
00:44:47,800 --> 00:44:52,520
plasma derived treatment I mean I knew

1054
00:44:50,640 --> 00:44:56,119
it was a plasma derived treatment but I

1055
00:44:52,520 --> 00:44:58,880
didn't necessarily understand fully how

1056
00:44:56,119 --> 00:45:00,839
it goes from a human being in a donation

1057
00:44:58,880 --> 00:45:04,040
center such as the one we toured in

1058
00:45:00,839 --> 00:45:08,160
Illinois all the way to my vein when I

1059
00:45:04,040 --> 00:45:10,480
Infuse myself so I think having that

1060
00:45:08,160 --> 00:45:12,720
misconception myself I think we have

1061
00:45:10,480 --> 00:45:14,200
seen that proliferate especially when

1062
00:45:12,720 --> 00:45:16,040
we're talking about these issues to a

1063
00:45:14,200 --> 00:45:18,160
member of Congress or to any other

1064
00:45:16,040 --> 00:45:21,480
stakeholder so what we've been trying to

1065
00:45:18,160 --> 00:45:24,160
do alongside all of our partners with A+

1066
00:45:21,480 --> 00:45:28,040
um as well as some of the donation

1067
00:45:24,160 --> 00:45:30,960
centers is to educate members of

1068
00:45:28,040 --> 00:45:33,640
Congress how plasma is truly different

1069
00:45:30,960 --> 00:45:36,680
there is a raw material there that needs

1070
00:45:33,640 --> 00:45:38,480
to be collected in order to create these

1071
00:45:36,680 --> 00:45:40,520
therapeutic medications not just for

1072
00:45:38,480 --> 00:45:42,480
bleeding disorders but for for all the

1073
00:45:40,520 --> 00:45:46,520
members of A+ like primary immune

1074
00:45:42,480 --> 00:45:50,160
deficiency um for example so the way we

1075
00:45:46,520 --> 00:45:51,960
want to show that is to have members um

1076
00:45:50,160 --> 00:45:55,119
understand what the donation process is

1077
00:45:51,960 --> 00:45:57,040
like and and hear from donors as well on

1078
00:45:55,119 --> 00:45:59,599
why they donate plasma or why they

1079
00:45:57,040 --> 00:46:01,200
donate blood um and kind of the

1080
00:45:59,599 --> 00:46:03,599
infrastructure in place that's needed

1081
00:46:01,200 --> 00:46:06,400
for that the safety that's involved of

1082
00:46:03,599 --> 00:46:08,880
collecting the plasma storing the plasma

1083
00:46:06,400 --> 00:46:11,200
before manufacturing into a

1084
00:46:08,880 --> 00:46:13,240
therapeutic um one thing that we like to

1085
00:46:11,200 --> 00:46:16,359
show is like through plasma FIS there's

1086
00:46:13,240 --> 00:46:18,720
a machine that spins the plasma um that

1087
00:46:16,359 --> 00:46:20,280
is able to separate all the proteins

1088
00:46:18,720 --> 00:46:22,200
that is used for manufacturing of

1089
00:46:20,280 --> 00:46:25,359
Therapeutics so actually seeing that

1090
00:46:22,200 --> 00:46:27,960
process is really enlightening and then

1091
00:46:25,359 --> 00:46:31,480
ultimately to the manufacturing process

1092
00:46:27,960 --> 00:46:34,400
to the end user um so we kind of want to

1093
00:46:31,480 --> 00:46:35,520
show that entire supply chain the best

1094
00:46:34,400 --> 00:46:37,400
we can through having all those

1095
00:46:35,520 --> 00:46:39,319
stakeholders there and also some

1096
00:46:37,400 --> 00:46:41,160
physical examples which is always really

1097
00:46:39,319 --> 00:46:44,160
helpful for myself members of Congress

1098
00:46:41,160 --> 00:46:45,920
to show you know how does it go from an

1099
00:46:44,160 --> 00:46:47,760
individual walking into a donation

1100
00:46:45,920 --> 00:46:50,400
center filling out the questionnaire and

1101
00:46:47,760 --> 00:46:52,200
everything donating their plasma all the

1102
00:46:50,400 --> 00:46:53,960
way to the vein of the end user with a

1103
00:46:52,200 --> 00:46:56,760
chronic condition who uses a plasma

1104
00:46:53,960 --> 00:46:59,960
derive therapy to treat treat their

1105
00:46:56,760 --> 00:47:01,640
chronic condition um and we found that

1106
00:46:59,960 --> 00:47:03,079
when we show that through various

1107
00:47:01,640 --> 00:47:05,119
different ways whether it be a printed

1108
00:47:03,079 --> 00:47:08,480
material or a full-on congressional

1109
00:47:05,119 --> 00:47:11,319
briefing it really shows the importance

1110
00:47:08,480 --> 00:47:14,359
of how these medications are made but

1111
00:47:11,319 --> 00:47:16,000
also the importance and stab why it's

1112
00:47:14,359 --> 00:47:18,559
important to keep the stability of the

1113
00:47:16,000 --> 00:47:20,760
supply as well so I think seeing the

1114
00:47:18,559 --> 00:47:22,240
whole process is really important and

1115
00:47:20,760 --> 00:47:24,119
was really enlightening to me but I

1116
00:47:22,240 --> 00:47:25,920
think is particularly enlightening to

1117
00:47:24,119 --> 00:47:27,720
policy makers who have influence over

1118
00:47:25,920 --> 00:47:30,240
these decisions as

1119
00:47:27,720 --> 00:47:32,040
well yeah that makes a lot of sense and

1120
00:47:30,240 --> 00:47:33,520
it really is an interesting process and

1121
00:47:32,040 --> 00:47:35,640
one that has evolved a lot over the

1122
00:47:33,520 --> 00:47:37,240
years and and so many of the details of

1123
00:47:35,640 --> 00:47:38,880
it have advanced to a point where you

1124
00:47:37,240 --> 00:47:41,760
know you can have a lot more

1125
00:47:38,880 --> 00:47:44,079
confidence um some questions about this

1126
00:47:41,760 --> 00:47:45,760
new policies one question that we've had

1127
00:47:44,079 --> 00:47:47,400
come in is is asking what do you think

1128
00:47:45,760 --> 00:47:49,400
might be the biggest barriers to the

1129
00:47:47,400 --> 00:47:51,240
implementation of the new policy I mean

1130
00:47:49,400 --> 00:47:53,720
I think you did mention that it's not

1131
00:47:51,240 --> 00:47:55,880
obligatory right so centers have got to

1132
00:47:53,720 --> 00:47:58,640
make the choice to implement this policy

1133
00:47:55,880 --> 00:48:02,240
are do you envisage any

1134
00:47:58,640 --> 00:48:04,440
barriers yes the biggest barrier is

1135
00:48:02,240 --> 00:48:07,040
funding um this is what the blood banks

1136
00:48:04,440 --> 00:48:09,359
tell us in order to adopt any kind of

1137
00:48:07,040 --> 00:48:11,280
change to the donor history

1138
00:48:09,359 --> 00:48:15,480
questionnaire um I mean they have to

1139
00:48:11,280 --> 00:48:17,000
reprint all of the actual um physical

1140
00:48:15,480 --> 00:48:20,079
questionnaires but they have to train

1141
00:48:17,000 --> 00:48:22,520
their staff um and frankly a lot of the

1142
00:48:20,079 --> 00:48:25,240
questions that are now being asked are

1143
00:48:22,520 --> 00:48:26,440
of Greater sensitivity than former

1144
00:48:25,240 --> 00:48:28,680
questions

1145
00:48:26,440 --> 00:48:31,400
so um that's been and that's been

1146
00:48:28,680 --> 00:48:33,319
consistent um every policy change along

1147
00:48:31,400 --> 00:48:36,880
the way I can tell you that when they

1148
00:48:33,319 --> 00:48:39,119
adopted the one-year deferral in 2015 we

1149
00:48:36,880 --> 00:48:42,599
were hearing from

1150
00:48:39,119 --> 00:48:45,240
um donors who should be eligible under

1151
00:48:42,599 --> 00:48:48,240
the new policy who went to donate a year

1152
00:48:45,240 --> 00:48:50,559
and a half after December of 2015 and

1153
00:48:48,240 --> 00:48:52,880
their local blood bank still didn't even

1154
00:48:50,559 --> 00:48:56,040
know about the policy change so it's

1155
00:48:52,880 --> 00:48:58,920
about funding for the um the blood banks

1156
00:48:56,040 --> 00:49:00,880
to actually implement it training and

1157
00:48:58,920 --> 00:49:03,079
awareness how that communication all

1158
00:49:00,880 --> 00:49:05,240
gets trickled down because the FDA makes

1159
00:49:03,079 --> 00:49:09,640
an announcement like this but they don't

1160
00:49:05,240 --> 00:49:11,960
come up with a formal um roll out of how

1161
00:49:09,640 --> 00:49:15,280
everybody that's going to be impacted is

1162
00:49:11,960 --> 00:49:19,160
aware of and trained to be able to do so

1163
00:49:15,280 --> 00:49:21,200
so ultimately the biggest barrier is

1164
00:49:19,160 --> 00:49:22,640
resources that actually leads very well

1165
00:49:21,200 --> 00:49:24,680
on to the next question that we have

1166
00:49:22,640 --> 00:49:27,240
which is how are these centers educated

1167
00:49:24,680 --> 00:49:29,319
on policy change

1168
00:49:27,240 --> 00:49:32,160
there's not really a formal mechanism

1169
00:49:29,319 --> 00:49:34,960
for it to be honest um I do think that

1170
00:49:32,160 --> 00:49:37,240
there is like um some written guidance

1171
00:49:34,960 --> 00:49:39,359
that most of them receive you heard

1172
00:49:37,240 --> 00:49:41,240
about the American Red Cross who I

1173
00:49:39,359 --> 00:49:47,160
neglected to mention was also a key

1174
00:49:41,240 --> 00:49:50,160
partner um on the advanced study um but

1175
00:49:47,160 --> 00:49:52,440
um I think the larger blood banks

1176
00:49:50,160 --> 00:49:54,160
probably have more resources more

1177
00:49:52,440 --> 00:49:57,559
infrastructure so their ability to

1178
00:49:54,160 --> 00:50:00,280
implement them is is swifter than many

1179
00:49:57,559 --> 00:50:03,079
of the smaller ones but I don't really

1180
00:50:00,280 --> 00:50:06,640
know that there is a formal training or

1181
00:50:03,079 --> 00:50:08,040
frankly urgency to adopt a lot of the

1182
00:50:06,640 --> 00:50:10,400
new

1183
00:50:08,040 --> 00:50:12,520
policies is there any way that National

1184
00:50:10,400 --> 00:50:16,720
organizations and maybe more local

1185
00:50:12,520 --> 00:50:16,720
chapters can support the implementation

1186
00:50:18,799 --> 00:50:23,839
process I think um I mean I see in the

1187
00:50:21,720 --> 00:50:26,720
attendee list we've got some Community

1188
00:50:23,839 --> 00:50:29,359
leaders here some chapter leaders here I

1189
00:50:26,720 --> 00:50:31,680
think um the more education we can do

1190
00:50:29,359 --> 00:50:35,040
and raise awareness um and people can

1191
00:50:31,680 --> 00:50:37,640
start to ask questions about it um

1192
00:50:35,040 --> 00:50:39,240
frankly I've um been waiting to but I

1193
00:50:37,640 --> 00:50:41,280
think one of the things I can do as

1194
00:50:39,240 --> 00:50:43,880
somebody who's really informed is to go

1195
00:50:41,280 --> 00:50:45,680
to my local blood bank and see whether

1196
00:50:43,880 --> 00:50:48,040
or not they've implemented it and

1197
00:50:45,680 --> 00:50:50,200
whether or not I can donate um and not

1198
00:50:48,040 --> 00:50:52,640
to be too personal but you know I'm in a

1199
00:50:50,200 --> 00:50:55,760
I'm married in a monogamous relationship

1200
00:50:52,640 --> 00:50:57,599
so under the new policy I am eligible

1201
00:50:55,760 --> 00:50:59,760
but I don't know that my local blood

1202
00:50:57,599 --> 00:51:02,160
bank here in Chicago has actually

1203
00:50:59,760 --> 00:51:04,920
implemented that it probably is a

1204
00:51:02,160 --> 00:51:06,880
cumbent upon me to go there and let them

1205
00:51:04,920 --> 00:51:09,480
know in the event that I'm not able to

1206
00:51:06,880 --> 00:51:12,160
donate there is this new policy how can

1207
00:51:09,480 --> 00:51:14,359
I as somebody who's invested in this

1208
00:51:12,160 --> 00:51:16,640
help in some way so I think it's really

1209
00:51:14,359 --> 00:51:18,359
about educating yourself which everybody

1210
00:51:16,640 --> 00:51:20,720
who has tuned in today is clearly

1211
00:51:18,359 --> 00:51:23,240
committed to doing so um but talking

1212
00:51:20,720 --> 00:51:26,799
with your neighbors your local elected

1213
00:51:23,240 --> 00:51:27,880
officials your member of Congress um

1214
00:51:26,799 --> 00:51:30,000
those are some of the things I would

1215
00:51:27,880 --> 00:51:31,720
suggest yeah and Nathan just bouncing

1216
00:51:30,000 --> 00:51:34,799
off of that I think it's another you

1217
00:51:31,720 --> 00:51:37,160
know this was a national change but

1218
00:51:34,799 --> 00:51:40,000
again a lot of policy and policy

1219
00:51:37,160 --> 00:51:42,400
implementation happens locally um so we

1220
00:51:40,000 --> 00:51:44,680
engage with the larger men uh the larger

1221
00:51:42,400 --> 00:51:46,880
Blood Centers or America's Blood Centers

1222
00:51:44,680 --> 00:51:48,960
which can represent a lot of the larger

1223
00:51:46,880 --> 00:51:51,200
Blood Centers but I think also this is

1224
00:51:48,960 --> 00:51:53,200
another issue that um is brought up

1225
00:51:51,200 --> 00:51:56,240
within the house plasma caucus not for

1226
00:51:53,200 --> 00:51:58,319
another Shameless plug but um they're in

1227
00:51:56,240 --> 00:51:59,799
their communities and we educate them

1228
00:51:58,319 --> 00:52:02,359
about the blood banks that are in their

1229
00:51:59,799 --> 00:52:06,480
communities the best we can um but these

1230
00:52:02,359 --> 00:52:08,319
are exactly topics that are utilized or

1231
00:52:06,480 --> 00:52:12,599
or or talked about within the Forum of

1232
00:52:08,319 --> 00:52:14,280
the plasma caucus as well so um that

1233
00:52:12,599 --> 00:52:16,520
that is another opportunity for a member

1234
00:52:14,280 --> 00:52:19,720
to join the plasma caucus to learn more

1235
00:52:16,520 --> 00:52:22,559
about this um and the ecosystem um

1236
00:52:19,720 --> 00:52:25,319
surrounding plasma um but ultimately

1237
00:52:22,559 --> 00:52:27,119
again a lot of that policy is local so

1238
00:52:25,319 --> 00:52:29,119
the more we can inform you know our

1239
00:52:27,119 --> 00:52:31,359
members of Congress or or even like as

1240
00:52:29,119 --> 00:52:33,640
Nathan said going to the blood bank and

1241
00:52:31,359 --> 00:52:35,119
finding out more and following up that's

1242
00:52:33,640 --> 00:52:37,960
really where it's going to happen

1243
00:52:35,119 --> 00:52:40,200
particularly for those for those smaller

1244
00:52:37,960 --> 00:52:42,040
um blood banks that aren't necessarily

1245
00:52:40,200 --> 00:52:43,400
like the American Red Cross or like New

1246
00:52:42,040 --> 00:52:46,520
York blood

1247
00:52:43,400 --> 00:52:48,160
center so let's say that you are kind of

1248
00:52:46,520 --> 00:52:51,119
going out there and and sort of trying

1249
00:52:48,160 --> 00:52:53,480
to put the word about has there any been

1250
00:52:51,119 --> 00:52:55,920
any push back to these changes and um do

1251
00:52:53,480 --> 00:52:57,000
you have any sort of advice on dealing

1252
00:52:55,920 --> 00:52:58,680
with like are there sort of common

1253
00:52:57,000 --> 00:53:00,079
objections that you come across and some

1254
00:52:58,680 --> 00:53:01,319
advice that you have about how to handle

1255
00:53:00,079 --> 00:53:03,119
those objections because this has

1256
00:53:01,319 --> 00:53:05,400
clearly been very carefully thought

1257
00:53:03,119 --> 00:53:07,520
through but you know there are often

1258
00:53:05,400 --> 00:53:09,680
sort of knee-jerk responses to some of

1259
00:53:07,520 --> 00:53:13,319
these

1260
00:53:09,680 --> 00:53:16,160
things so I would say um I would say two

1261
00:53:13,319 --> 00:53:19,720
things first of all um we talked about

1262
00:53:16,160 --> 00:53:22,799
the A+ Coalition and their response to

1263
00:53:19,720 --> 00:53:26,799
the suggested policy change not every

1264
00:53:22,799 --> 00:53:28,960
member of A+ signed up on to that letter

1265
00:53:26,799 --> 00:53:30,559
so we'd be remiss if we didn't

1266
00:53:28,960 --> 00:53:32,119
acknowledge that there are some folks

1267
00:53:30,559 --> 00:53:33,839
within the bleeding disorders Community

1268
00:53:32,119 --> 00:53:36,000
for whatever reason which we have not

1269
00:53:33,839 --> 00:53:38,119
really dived into that why they didn't

1270
00:53:36,000 --> 00:53:39,799
want to sign on to that um so their

1271
00:53:38,119 --> 00:53:41,960
rationale for push back I can't really

1272
00:53:39,799 --> 00:53:45,280
speak to I will say that there has been

1273
00:53:41,960 --> 00:53:47,720
some push back from some LGBT groups

1274
00:53:45,280 --> 00:53:50,079
particularly around prep use and the

1275
00:53:47,720 --> 00:53:52,280
deferral thereof um and let me just

1276
00:53:50,079 --> 00:53:55,559
address that for a moment please so the

1277
00:53:52,280 --> 00:53:57,400
way the policy um works is soep just so

1278
00:53:55,559 --> 00:53:59,520
we're all on the same page pre-exposure

1279
00:53:57,400 --> 00:54:01,920
prophylaxis that is a medication that

1280
00:53:59,520 --> 00:54:04,720
can be taken orally on a daily basis or

1281
00:54:01,920 --> 00:54:08,280
with an injection once a month if taken

1282
00:54:04,720 --> 00:54:11,319
consistently it has been proven um to

1283
00:54:08,280 --> 00:54:15,640
prevent someone from seroc converting to

1284
00:54:11,319 --> 00:54:19,520
become HIV positive even if they've been

1285
00:54:15,640 --> 00:54:22,599
exposed and um the the the but um if

1286
00:54:19,520 --> 00:54:25,280
you're taking the oral medication um the

1287
00:54:22,599 --> 00:54:27,520
deferral criteria are you need to

1288
00:54:25,280 --> 00:54:29,359
continue that for 3 months before you

1289
00:54:27,520 --> 00:54:31,559
might be considered eligible if you're

1290
00:54:29,359 --> 00:54:35,079
taking the injectable you're deferred

1291
00:54:31,559 --> 00:54:38,000
for one year now keep in mind this that

1292
00:54:35,079 --> 00:54:42,280
is a medication that is intended for

1293
00:54:38,000 --> 00:54:46,839
people who are at elevated risk for HIV

1294
00:54:42,280 --> 00:54:49,400
exposure and um infection um and and the

1295
00:54:46,839 --> 00:54:52,000
whole intent of deferral criteria are to

1296
00:54:49,400 --> 00:54:56,520
defer people who are at elevated risk of

1297
00:54:52,000 --> 00:54:59,520
things like HIV prep again if taken

1298
00:54:56,520 --> 00:55:01,359
consistently is very very effective

1299
00:54:59,520 --> 00:55:03,559
whether or not you confirm how can

1300
00:55:01,359 --> 00:55:06,880
confirm how consistent that is that

1301
00:55:03,559 --> 00:55:09,160
remains to be seen however um so so some

1302
00:55:06,880 --> 00:55:12,079
of the criticism is well people who are

1303
00:55:09,160 --> 00:55:14,000
taking prep are clearly very responsible

1304
00:55:12,079 --> 00:55:15,799
for their health and well-being so

1305
00:55:14,000 --> 00:55:18,680
shouldn't we consider them to be

1306
00:55:15,799 --> 00:55:22,319
eligible donors however what I say to

1307
00:55:18,680 --> 00:55:25,319
that is again prep is intended to

1308
00:55:22,319 --> 00:55:27,480
prevent HIV but I've already t talked

1309
00:55:25,319 --> 00:55:29,880
about the other infectious agents that

1310
00:55:27,480 --> 00:55:32,440
we know about now and the ones that we

1311
00:55:29,880 --> 00:55:36,559
don't know about and the reality is prep

1312
00:55:32,440 --> 00:55:39,559
does not um impact one's exposure to

1313
00:55:36,559 --> 00:55:42,599
Hepatitis B syphilis gonorrhea chlamidia

1314
00:55:39,559 --> 00:55:45,240
any of those things so um there is push

1315
00:55:42,599 --> 00:55:47,720
back that more people who are using prep

1316
00:55:45,240 --> 00:55:49,760
should be considered to be eligible but

1317
00:55:47,720 --> 00:55:52,160
some recent Studies have come out that

1318
00:55:49,760 --> 00:55:54,559
have Justified that that probably is

1319
00:55:52,160 --> 00:55:56,599
unlikely in the foreseeable future

1320
00:55:54,559 --> 00:56:01,079
because there are still ways that that

1321
00:55:56,599 --> 00:56:03,119
could result in elevated risk to end

1322
00:56:01,079 --> 00:56:04,760
users great yeah thank you that's a

1323
00:56:03,119 --> 00:56:06,960
really important distinction I think we

1324
00:56:04,760 --> 00:56:08,359
we really tend to over focus on the HIV

1325
00:56:06,960 --> 00:56:10,119
and there there really are a lot of

1326
00:56:08,359 --> 00:56:13,160
other things to think about as well

1327
00:56:10,119 --> 00:56:15,640
thank you maybe I can finish with um a

1328
00:56:13,160 --> 00:56:18,400
crystal ball question if you would would

1329
00:56:15,640 --> 00:56:19,839
like to venture a prediction or or

1330
00:56:18,400 --> 00:56:21,640
whether you maybe even already have some

1331
00:56:19,839 --> 00:56:24,559
data about this how do you think this

1332
00:56:21,640 --> 00:56:26,880
might impact um sort of the capacity to

1333
00:56:24,559 --> 00:56:29,240
produce the products that are so so

1334
00:56:26,880 --> 00:56:31,559
desperately needed that that are derived

1335
00:56:29,240 --> 00:56:32,960
from plasma and from blood donations I

1336
00:56:31,559 --> 00:56:34,760
don't know if there's any data from the

1337
00:56:32,960 --> 00:56:36,960
change that was made in 2020 that might

1338
00:56:34,760 --> 00:56:39,160
give some indication or or even from the

1339
00:56:36,960 --> 00:56:41,480
change earlier this year but is it

1340
00:56:39,160 --> 00:56:43,559
something that you um Can foresee

1341
00:56:41,480 --> 00:56:46,160
increasing the capacity to produce those

1342
00:56:43,559 --> 00:56:48,599
those those treatment

1343
00:56:46,160 --> 00:56:54,480
products I I I can start with some of

1344
00:56:48,599 --> 00:56:57,039
this um so the US in particular is in a

1345
00:56:54,480 --> 00:56:58,839
unique position because not only do we

1346
00:56:57,039 --> 00:57:00,440
produce plasma for plasma derived

1347
00:56:58,839 --> 00:57:04,079
treatments in the United States but we

1348
00:57:00,440 --> 00:57:06,839
are also a larger exporter of plasma to

1349
00:57:04,079 --> 00:57:09,559
other places around the world as well I

1350
00:57:06,839 --> 00:57:12,079
believe in the EU about four countries

1351
00:57:09,559 --> 00:57:14,359
make up about 50% of their plasma Supply

1352
00:57:12,079 --> 00:57:18,440
there's just different infrastructures

1353
00:57:14,359 --> 00:57:21,280
there um for plasma collection so the US

1354
00:57:18,440 --> 00:57:25,079
um well we need to make sure the supply

1355
00:57:21,280 --> 00:57:27,280
um is is adequate here um and we saw a

1356
00:57:25,079 --> 00:57:30,880
big drop off with coid that is steadily

1357
00:57:27,280 --> 00:57:32,559
coming back um we need to um this is

1358
00:57:30,880 --> 00:57:34,400
just one of the decisions that was made

1359
00:57:32,559 --> 00:57:36,720
but also this was a decision that was in

1360
00:57:34,400 --> 00:57:38,760
the works as we know now for a very long

1361
00:57:36,720 --> 00:57:41,920
time before that you know before that

1362
00:57:38,760 --> 00:57:44,240
Supply dropped off um but needless to

1363
00:57:41,920 --> 00:57:47,359
say the decisions that are made here as

1364
00:57:44,240 --> 00:57:50,559
well affect the supply around the world

1365
00:57:47,359 --> 00:57:52,720
as well so the US is just in a very um

1366
00:57:50,559 --> 00:57:55,079
interesting position there there are

1367
00:57:52,720 --> 00:57:57,640
many different ways and um you know

1368
00:57:55,079 --> 00:57:59,559
there are always ideas that are bounced

1369
00:57:57,640 --> 00:58:01,640
around to increase Supply in some way

1370
00:57:59,559 --> 00:58:04,319
reoccurring donors specifically are

1371
00:58:01,640 --> 00:58:06,559
something that's that uh blood banks and

1372
00:58:04,319 --> 00:58:08,680
others are particularly relied upon to

1373
00:58:06,559 --> 00:58:10,640
increase Supply however with each

1374
00:58:08,680 --> 00:58:12,400
individual issue as we did for this

1375
00:58:10,640 --> 00:58:15,319
issue we need to look at the impact of

1376
00:58:12,400 --> 00:58:17,240
safety to the end user as well um and

1377
00:58:15,319 --> 00:58:18,880
we've taken stances on both sides

1378
00:58:17,240 --> 00:58:20,799
throughout throughout the years this

1379
00:58:18,880 --> 00:58:23,240
being the most major that we were in

1380
00:58:20,799 --> 00:58:25,359
support of in a very long time both from

1381
00:58:23,240 --> 00:58:29,440
a supply as well as a Health Equity lens

1382
00:58:25,359 --> 00:58:30,960
but um these will continue to occur and

1383
00:58:29,440 --> 00:58:33,119
we will have to look at the data and the

1384
00:58:30,960 --> 00:58:34,720
science each time um but yes this

1385
00:58:33,119 --> 00:58:36,839
certainly will have an impact on an

1386
00:58:34,720 --> 00:58:38,960
increase of supply and um I think

1387
00:58:36,839 --> 00:58:41,359
through a lot of the A+ activities not

1388
00:58:38,960 --> 00:58:45,039
only um you know safety is going to be

1389
00:58:41,359 --> 00:58:47,559
Paramount always but um Supply is also a

1390
00:58:45,039 --> 00:58:51,039
part of that safety conversation as well

1391
00:58:47,559 --> 00:58:52,880
so um we are hoping to you know keep

1392
00:58:51,039 --> 00:58:55,039
seeing those reoccurring donors and

1393
00:58:52,880 --> 00:58:57,760
donations increase um but but I'll leave

1394
00:58:55,039 --> 00:59:00,079
it to Nathan for for any other comments

1395
00:58:57,760 --> 00:59:03,400
there yeah I would say I mean look the

1396
00:59:00,079 --> 00:59:06,440
reality is that the number of additional

1397
00:59:03,400 --> 00:59:08,720
donations from this policy change is

1398
00:59:06,440 --> 00:59:11,119
probably going to be nominal it's not

1399
00:59:08,720 --> 00:59:13,400
going to dramatically impact the number

1400
00:59:11,119 --> 00:59:15,440
of donations that we receive however

1401
00:59:13,400 --> 00:59:20,039
there are impact in a couple of other

1402
00:59:15,440 --> 00:59:23,400
ways um first of all I think it makes

1403
00:59:20,039 --> 00:59:25,520
the blood manufacturing and collection

1404
00:59:23,400 --> 00:59:29,240
process safe

1405
00:59:25,520 --> 00:59:31,839
by screening for um individual risk

1406
00:59:29,240 --> 00:59:34,119
behavior of all potential donors I do

1407
00:59:31,839 --> 00:59:36,520
firmly believe that will result in an

1408
00:59:34,119 --> 00:59:38,920
increase in the ultimate safety of the

1409
00:59:36,520 --> 00:59:40,760
products the other reality is that I

1410
00:59:38,920 --> 00:59:42,319
talked about whether or not the policy

1411
00:59:40,760 --> 00:59:43,599
for the deferral criteria for men who

1412
00:59:42,319 --> 00:59:45,920
have sex with men was actually

1413
00:59:43,599 --> 00:59:48,319
discrimination we can say unequivocally

1414
00:59:45,920 --> 00:59:49,720
there was a perception of discrimination

1415
00:59:48,319 --> 00:59:52,880
I can't tell you how many people I've

1416
00:59:49,720 --> 00:59:55,880
met throughout my life either um gay men

1417
00:59:52,880 --> 00:59:57,480
or Allies who have thought that first of

1418
00:59:55,880 --> 00:59:59,640
all this was a policy of the American

1419
00:59:57,480 --> 01:00:02,160
Red Cross and so they have disdain for

1420
00:59:59,640 --> 01:00:03,799
the Red Cross and they don't donate or

1421
01:00:02,160 --> 01:00:06,280
encourage people to donate because of

1422
01:00:03,799 --> 01:00:07,720
the perceptions of discrimination that I

1423
01:00:06,280 --> 01:00:11,319
think is where we're going to have the

1424
01:00:07,720 --> 01:00:14,280
greatest impact with a more Equitable

1425
01:00:11,319 --> 01:00:16,920
policy great that's a great Point yeah

1426
01:00:14,280 --> 01:00:18,920
yeah I really like that well with that

1427
01:00:16,920 --> 01:00:21,319
we conclude the questions for today

1428
01:00:18,920 --> 01:00:23,280
thank you both very much um I'd like to

1429
01:00:21,319 --> 01:00:25,520
thank Matt Delaney and Nathan Schaefer

1430
01:00:23,280 --> 01:00:27,960
for sharing your time and expertise with

1431
01:00:25,520 --> 01:00:29,799
us this afternoon I'd also like to thank

1432
01:00:27,960 --> 01:00:32,079
each of you in our audience for

1433
01:00:29,799 --> 01:00:34,520
joining this recorded webinar will be

1434
01:00:32,079 --> 01:00:37,039
available on Friday October 27th at

1435
01:00:34,520 --> 01:00:39,559
hemophilia

1436
01:00:37,039 --> 01:00:41,960
toorgle past events you will find all of

1437
01:00:39,559 --> 01:00:43,480
our archived webinars there also

1438
01:00:41,960 --> 01:00:45,359
available in the events tab is the

1439
01:00:43,480 --> 01:00:47,799
schedule of upcoming webinars in this

1440
01:00:45,359 --> 01:00:50,880
series please join us next week when

1441
01:00:47,799 --> 01:00:53,720
Maria santel and Dr Michael re also from

1442
01:00:50,880 --> 01:00:55,760
NBF will update us on recent work on the

1443
01:00:53,720 --> 01:00:58,520
national National research blueprint and

1444
01:00:55,760 --> 01:00:59,839
invite public comment on it thank you

1445
01:00:58,520 --> 01:01:03,079
all so much for joining us this

1446
01:00:59,839 --> 01:01:03,079
afternoon and have a great

1447
01:01:05,839 --> 01:01:08,839
week