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DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
BLOOD PRODUCTS ADVISORY COMMITTEE
Friday, September 15, 2000 8:00 a.m.
620 Perry Parkway Gaithersburg, Maryland
Blaine F. Hollinger, M.D., Chairperson
Linda A. Smallwood, Ph.D., Executive Secretary
John M. Boyle, Ph.D.
Mary E. Chamberland, M.D.
Richard J. Kagan, M.D. Jeanne V. Linden, M.D. Gail B. Macik, M.D. Daniel L. McGee, Ph.D. Mark A. Mitchell, M.D. Terry V. Rice
Paul J. Schmidt, M.D. David F. Stroncek, M.D. Sherri O. Stuver, Sc.D.
NON-VOTING CONSUMER REPRESENTATIVE Katherine E. Knowles
NON-VOTING INDUSTRY REPRESENTATIVE Toby L. Simon, M.D.
TEMPORARY VOTING MEMBERS
Paul R. McCurdy, M.D. Kenrad E. Nelson, M.D. Carmelita U. Tuazon, M.D.
3 C O N T E N T S
Welcome and Opening Remarks 5
Summary of Workshop on Recruiting Blood Donors,
Gilliam Conley 6
Summary of Workshop on Hemopoietic Cells from Cord Blood: Ellen Lazarus, M.D. 20
Summary of Public Meeting on Regulation of Bone Products: Ruth Solomon, M.D. 28
Summary of Joint Transmissible Spongiform Encephalopathies and Vaccines and Related Biological Products Advisory Committees Meeting:
David Asher, M.D. 37
Update on Rapid HIV Test Approval Requirements and Standards:
Kimber L. Poffenberger, Ph.D. 47
III. Current Utility of Screening Blood Donors
for Antibody to Syphilis
Chiang Syin, Ph.D. 56
Background on Clinical Syphilis:
Lauri Markowitz, M.D. 66
Background on Diagnostic Testing for Syphilis:
Roger Y. Dodd, Ph.D. 79
Syphilis Surveillance and Blood-Borne Transmission:
Lauri Markowitz, M.D. 91
American Red Cross NAT Donor Study:
Sharyn Orton, Ph.D. 116
REDS Study of Syphilis Screening as a Surrogate Test:
Alan Williams, Ph.D. 132
Maricopa County STD Study:
Lauri Markowitz, M.D. 152
CDC Proposed Studies:
Dr. Hsi Liu 164
C O N T E N T S (Continued)
Open Public Hearing
AABB, Louis Katz, M.D. 178
ABC, Celso Bianco, M.D. 182
Questions for the Committee:
Martin Ruta, J.D.,Ph.D. 185
Committee Discussion and Recommendations 186
IV. Classification of HLA Devices
FDA Presentation of the Issue:
Sheryl Kochman 209
Third-Party Review Program:
Eric Rechen 220
Open Public Hearing 235
Charge to the Committee 235
Questions for the Committee:
Sheryl Kochman 236
Committee Discussion and Recommendations 238
V. Report of Intramural Site Visit:
Laboratory of Molecular Virology,
Division of Emerging and Transfusion Transmitted Diseases
Introduction and Overview:
Hira Nakhasi, Ph.D. 252
Indira Hewlett, Ph.D. 257
Subhash Dhawan, Ph.D. 267
(Committee Discussion and Recommendations in Closed Session)
5 1 P R O C E E D I N G S
2 Welcome and Opening Remarks
3 DR. SMALLWOOD: Welcome to the 67th Meeting of the
4 Blood Products Advisory Committee. This is the second day
5 of our meeting here. I am Linda Smallwood, the Executive
6 Secretary. Yesterday, I read the conflict of interest
7 statement that applies to both days of this meeting.
8 At this time, if there is anyone who needs to make
9 any declarations regarding any affiliation that may be
10 perceived as a conflict of interest regarding this meeting,
11 please do so at this time. If not, then we will proceed. I
12 would just like to remind anyone that is speaking, when you
13 go to the mike, please give your name and your affiliation
14 so that it can be recorded appropriately in the transcript.
15 At this time, I will turn the proceedings of this
16 meeting over to the Chairman of the Blood Products Advisory
17 Committee, Dr. Blaine Hollinger.
18 Dr. Hollinger?
19 DR. HOLLINGER: Thank you, Dr. Smallwood. We have
20 two items, basically, this morning. We first start out with
21 some committee updates on several workshops that have been
22 held and several other issues from advisory committees and
23 updates. Then we go into a session on utility of screening
24 blood donors for antibodies to syphilis. That will take
25 this morning.
6 1 This afternoon, we then have something on
2 classification of HLA devices and finally a report of an
3 intramural site visit on the Laboratory of Molecular
5 So, having said that, we will start off, then,
6 with a summary of the Workshop on Recruiting Blood Donors,
7 Successful Practices, that was held July 6 to 7, 2000.
8 Gilliam Conley?
9 COMMITTEE UPDATES
10 Summary of Workshop on Recruiting Blood Donors
11 Successful Practices
12 MR. CONLEY: Good morning. It is nice to be part
13 of the opening act for the main events to follow later
16 In talking about the workshop that we held in
17 Rockville, it was difficult to fit all of the issues into
18 two days, but we pressed a lot of information in a very
19 tight time frame. So it is even more difficult to do a ten-
20 minute or so recap of that.
21 I was alarmed, as I was making bullet points, that
22 flying past some of these issues in a bullet point almost
23 makes them seem insignificant. Just keep in mind, please,
24 that each of the bullet points would all warrant a lot more
25 lengthy discussion so, if everybody will regard my
7 1 presentation this morning as the Readers Digest Condensed
2 Book that was made from the cliff notes of the meeting, then
3 we will all be in the right perspective for what we are
4 working with.
5 The committee has got a handout of the summary. I
6 will have a correction to that as I go through--a
7 clarification, really--as I go through the presentation.
8 So, even trying to condense it to a three-page summary, I
9 also made mistakes.
11 There were a lot of people, when FDA announced
12 that they were going to have this workshop, wanted to know
13 why the FDA was having a workshop about donor recruitment.
14 I have to say that FDA has always been in support,
15 certainly, of donor-recruitment issues but the Public Health
16 Service at large became much more interested when, in 1999,
17 the National Blood Data Resource Center published a report
18 where they predicted significant blood shortages sometime
19 this year.
20 In defining why we would be involved, certainly,
21 as a member of the Public Health Service Group, the mission
22 to enhance the wealth and well-being of the public is part
23 of our mission and this workshop fits easily into that. The
24 FDA mission of guarding the safety and efficacy of the blood
25 supply in the U.S., likewise, low supplies certainly will
8 1 mean that there are safety issues to be concerned about.
2 But the most important part of the workshop was
3 really to share proven donor-recruitment strategies.
5 These are just the basic facts about the meeting,
6 when it was held, where it was held. It was important to a
7 lot of our participants that, being a government-sponsored
8 workshop, they didn't have to worry about registration fees.
9 So some people on tight budgets could afford to come.
10 We advertised, as best we could, in the short time
11 frame that we had. It was published in the Federal Register
12 and our colleagues at ABC, AABB and the ADRP--and if you are
13 not familiar with that group, donor-recruitment
14 professionals group, all did the best they could to get the
15 information out.
16 We especially were appealing for donor recruiters
17 or even donor groups to participate in the workshop.
18 Indeed, about half of our participants at the workshop were
19 donor recruiters and we did have a few representatives from
20 donor groups.
21 We deliberately limited the time for the speakers
22 in the first day. We really put the pressure on them to
23 bring the most important facts out very quickly and in a
24 short time frame. In our second day, we had discussion
25 groups and we used facilitators for our discussion groups,
9 1 again to keep them on track. Each group has a focus task to
2 bring back to the main meeting.
3 I think this time pressure and this focus and this
4 facilitation kept things on track very well for the meeting.
5 Our speakers, for the most part, all rose to the challenge
6 and put a lot of information in a short period of time.
7 We also asked all of our speakers to be as fact-
8 based as they could. We wanted people who had observations
9 that showed that what they were reporting on was successful
10 over time. In the donor-recruitment literature, it is easy
11 to find anecdotal stories and we did not want to hear that
12 if we have a donor drive that has a luau theme that we get
13 more donors, unless you had done it repeatedly over a number
14 of years and could show that it made a significant
15 difference in how you were recruiting donors.
16 So that is what we were looking for. In a way,
17 the two-day session gave us both a set of fact-based
18 presentation and then a conventional wisdom because the
19 people who were there, many of whom were donor recruiters,
20 were in our discussion groups. So we compare, in some ways,
21 the things that have been proven versus the things that
22 people at a gut level think work.
23 You will see, when I present later, places where
24 there was not clear agreement. Mostly, it was because we
25 could see a difference in some of the presentations and what
10 1 people wanted to continue doing.
2 Ultimately, when we started planning this
3 workshop, our goal was to have a guidance document on donor-
4 recruitment. Again, this seemed to set a lot of people's
5 teeth on edge, the thought that the FDA might start setting
6 regulatory guidance about donor recruitment.
7 In fact, Dr. Epstein clarified at the opening of
8 the meeting that that was not the ultimate goal, that we
9 don't want to get into this in a regulatory way but in a way
10 to encourage blood donation. So we will get into areas
11 where there was clear agreement between the two days and
12 between virtually all the presenters that are key aspects
13 about blood donation and then we will cover where there is
14 not clear agreement.
16 This is the area where I am very nervous because a
17 lot of these bullet points look very simple and succinct,
18 but there is a lot of detail and a lot of information that
19 goes behind them. Successful donor-recruitment programs are
20 multifaceted with demonstrated expertise in customer
21 relations, advertising and marketing, public relations and
22 in management issues. It is a wide spectrum of business and
23 marketing practices that have to be applied well to be
25 Successful programs exhibit a culture of hard
11 1 work, innovation and cooperation, at least the speakers who
2 came forward for us and talked about their program. These
3 seemed to be aspects of their programs.
5 Successful programs have all the employees in
6 their organization focussed on blood donation and they are
7 all thanking and encouraging donors. This is especially
8 true among the collection staff, the people who have the
9 most face-to-face contact with the donors. Successful
10 programs emphasize panel recognition and there is a
11 difference between recognition and giving incentives and
13 We heard, over and over again, that the long-term
14 donor who is the altruistic donor who is donating for
15 internalized reasons really can be turned off by incentives.
16 But what they are not turned off by are those constant
17 "thank you"s, the encouragement, the celebration dinner for
18 your multi-gallon donors once a year, public recognition of
19 the importance of their altruism and those kinds of issues.
20 That is what we mean by donor recognition.
21 So it is important that their altruistic behavior
22 be reinforced at each donation and at notable milestones in
23 their donation history.
25 When it comes to advertising, successful programs
12 1 are keyed to an emotional appeal. They put a human face on
2 both donors and transfusion recipients. Pictures of empty
3 blood shelves don't really cut it. They don't do anything.
4 Those that tell the story of a transfusion recipient or tell
5 the story of a long-term donor, those advertising appeals
6 and campaigns do have an impact.
7 Advertising campaigns can definitely benefit from
8 partnerships. And we heard about partnerships with sports
9 teams, t.v. and radio stations that have been very
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