Department of health and human services




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DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

BLOOD PRODUCTS ADVISORY COMMITTEE

67th MEETING

Friday, September 15, 2000 8:00 a.m.

Hilton Gaithersburg

620 Perry Parkway Gaithersburg, Maryland

2

PARTICIPANTS

Blaine F. Hollinger, M.D., Chairperson

Linda A. Smallwood, Ph.D., Executive Secretary

MEMBERS

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

COMMITTEE UPDATES

Summary of Workshop on Recruiting Blood Donors,

Successful Practices:

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

FDA Framework:

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

4

C O N T E N T S (Continued)

Open Public Hearing

Presentations

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

4 Virology.

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

14 today.

15 [Slide.]

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.

10 [Slide.]

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.

4 [Slide.]

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.

15 [Slide.]

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

24 successful.

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.

4 [Slide.]

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

12 gifts.

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.

24 [Slide.]

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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