FOOD AND DRUG ADMINISTRATION

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

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FDA SCIENCE REVIEW SUBCOMMITTEE

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EXTERNAL SCIENCE REVIEW

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OPEN SESSION

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WEDNESDAY,

JULY 25, 2001

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The Subcommittee met in Room O, Center for Devices and Radiological Health, 9200 Corporate Boulevard, Rockville, Maryland, at 10:19 a.m., Dr. Robert M. Nerem, Chairman, presiding.

PRESENT:

ROBERT M. NEREM, Ph.D., Chairman

ALEXA I. CANADY, M.D., Co-Chairperson

ROGER C. BARR, Ph.D.

BARRY H. BEITH, Ph.D.

PRESENT (Continued):

LOUIS J. BLAZY, Ph.D.

ANNE B. CURTIS, M.D.

DOMINIQUE M. DURAND, Ph.D.

JOHN D. FISHER, M.D.

PATRICIA L. GARVEY, Ph.D.

KINLEY LARNTZ, Ph.D.

ELIZABETH N. PIETERSON

RHALL E. POPE, Ph.D.

HANY W. DEMIAN, Executive Secretary

C-O-N-T-E-N-T-S

PAGE

Introductions 232

Conflict of Interest Statement 232

Public Comments:

Bob Young 237

P-R-O-C-E-E-D-I-N-G-S

(1:01 p.m.)

CHAIRPERSON NEREM: Okay. We are now in public session, and I want to welcome any who might have joined us for this public session.

I believe Hany will read some things into the record.

MR. DEMIAN: Good afternoon, everybody. We're ready to begin this public portion of the meeting of the Subcommittee to the FDA Science Board for the Center Devices and Radiological Health science review.

My name is Hany Demian, and I'm the Executive Secretary for this panel.

I will read two statements that must be read into the record. The first is the deputization for temporary voting member statement.

Appointment to temporary voting status. Pursuant to the authority granted under the Medical Devices Advisory Committee charter, dated October 27th, 1990, as amended August 18th, 1999, and November 16th, 1999, I appoint the following individuals as voting members of the CDRH Science Review Subcommittee of the Science Board to FDA for this meeting on July 24th, 25th, and 26th, 2001: Roger Barr, Barry Beith, Louis Blazy, Alexa Canady, and Curtis Dominique Durand, John Fisher, Patrician Garvey, Kinley Larntz, Elizabeth Pieterson, and Rhall Pope.

For the record, these individuals are special government employees and are consultants to CDRH or to panels under the Medical Devices Advisory Committee. They have undergone the customary conflict of interest review and have reviewed the material to be considered at this meeting.

And this is signed by the Director for CDRH, David Feigal.

The second statement is the conflict of interest statement.

The following announcement addresses conflicts of interest issues associated with this meeting as made part of the record to preclude even the appearance of any impropriety.

To determine if a conflict existed, the agency reviewed the submitted agenda and all financial interests reported by the subcommittee participants. The conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employer's financial interest.

However, the agenda may determine that participation of certain members and consultants, the need for whose services outweigh the potential conflict of interest involved, is in the best interest of the government.

For the participation in this three-day meeting, all of the subcommittee participants have been granted general matters limited waivers for their employment, professional relationships, or financial interests in firms that could be potentially affected by the subcommittee's deliberations.

These individuals are: Dr. Robert Nerem, Martin Rosenberg, Roger Barr, Barry Beith, Louis Blazy, Alexa Canady, and Curtis Dominique Durand, John Fisher, Patricia Garvey, Kinley Larntz, Rhall Pope, and Ms. Elizabeth Pieterson.

The waivers permit these individuals to participate in all general matters before the subcommittee. Copies of these waivers may be obtained from the agency's Freedom of Information Office, Room 12A-15 of the Parklawn Building.

In the event that the discussions involve any issues not related on the agenda for which an FDA participant has a financial interest, the participant should excuse him or herself from such involvement, and the exclusion will be noted for the record.

With respect to all other participants, we ask in the interest of fairness that all persons making statements or presentations disclose any current or previous financial involvement with any firm whose products they may wish to comment upon.

Before turning this meeting over to Dr. Nerem, I would like to introduce our distinguished panel members who have generously given their time to help FDA in matters being discussed today and other FDA staff seated at the table.

So we'll just go around the room and have everybody introduce themselves and give their area of interest.

Dr. Nerem.

CHAIRPERSON NEREM: I'm Nerem from Georgia Tech, professor in biomedical engineering at Georgia Institute of Technology.

DR. CURTIS: Anne Curtis. I'm a cardiologist at the University of Florida.

DR. FISHER: John Fisher, cardiologist, Albert Einstein College of Medicine.

DR. BLAZY: Louis Blazy, software engineer from NASA.

DR. BEITH: Barry Beith, human factors psychologist, Human Centric Technologies.

DR. GARVEY: Patricia Garvey, Vice President of Regulatory Quality and Clinical for Edwards Life Sciences.

DR. POPE: Rhall Pope, Vice President of Research and Development, Deltec.

DR. LARNTZ: Kinley Larntz. I'm a statistician, professor emeritus, University of Minnesota.

MS. PIETERSON: Beth Pieterson. I'm Director of Medical Devices, Bureau of Health, Canada.

DR. DURAND: Dominique Durand, professor of biomedical engineering, Case Western Reserve University.

VICE CHAIRPERSON CANADY: Alexa Canady, professor of neurosurgery at Wayne State University.

CHAIRPERSON NEREM: Okay. Well, I want to again welcome everyone who's joined us for this public session.

I am chair of this subcommittee, and Alexa Canady is my co-chair, and I would like to note that for the record, and that we constitute a quorum as required by 21 CFR, Part 14.

We are now in the open public hearing session of this meeting, and I would ask at this time all persons addressing the panel come forward and speak clearly into the microphone as the transcriptionist is dependent on this means of providing an accurate record of this meeting.

We are requesting that all persons making statements during the open public hearing of the meeting disclose whether they have financial interest in any medical device company before making your presentation to the panel. In addition to stating your name and affiliation, please state the nature of your financial interest, if any.

At this time is there anyone wishing to address the panel? I'm looking for a show of hands of individuals who might wish to address the panel. Was there a hand?

Oh, I'm sorry.

MR. DEMIAN: You're FDA?

MR. YOUNG: I'm from NTEU.

MR. DEMIAN: Okay.

MR. YOUNG: Well, good afternoon. The first thing I'd like to do is thank all of the members of the panel because you really do a great service, and we really appreciate it.

We basically need all of the help we can get, and anyone who can help us do our job more efficiently, make this a better place to work, and increase the degree of consumer protection we offer to the American people certainly are welcome.

I sat for 20 years as a trustee of the Jackson Labs up in the, as they say, Bar Harbor, Maine, and, you know, they're outside panels, and I hear with the work they do, and it really does contribute.

What I'd like to do today is I know we have a meeting schedule tomorrow at two o'clock, but you're leaving at 2:45, and if you've seen the traffic out here, you're probably scared already. So what I want to do is just give you some background material on the information on the union, and I want to try to find out what you really want to hear about because it's easier to speak to you or address, you know, whatever concern you have if we know ahead of time.

It's like you guys are all medical devices. So it's like putting off an X-ray, a chest X-ray. You tell the radiologist, you know, "What is this?" They'll just describe it.

But if you have a particular problem, when you give it to them, they have a much easier time trying to help you out deciding what a particular patient has.

NTEU is a federal union. It has been around for about 60 years. It's mainly Treasury employees because that's where it got started. So the bulk of the members are in the IRS and U.S. Customs.

About ten years ago, this Union began organizing outside of Treasury, and that's how FDA happens to be in a union that's mostly Treasury employees.

The chapter here at FDA headquarters is called Chapter 282, and we represent the employees in headquarters in the Washington, D.C. area. There are approximately 4,000 employees in this unit.

The national union, the union overall represents about 150,000 federal employees. Some people are interested that we actually have unions in the federal government, but actually federal unions represent more than half of the federal employees. So over one and a half million employees.

So the purpose of having the unions in the federal sector is the same as it would be in the private. Hopefully what will happen is by having the employees contribute to what's going on, meaning not the management of the enterprise, but at least the operation of it, basically everybody comes out with a better product.

This union has been certified for four years now, and our contract was signed about a year and a half ago. So we're really just getting started. There was never a union before at FDA in headquarters. We've had unions outside in the field offices, such as the districts or the regions, but not here. So everybody, meaning FDA and the employees who are just getting started working together.

So if you can indicate to me kind of what you're interested in for tomorrow it would be just easier for us to try to address it.

CHAIRPERSON NEREM: You've talked already to -- one of your colleagues, Cathy --

MR. YOUNG: Cathy Hobbs, one of our Vice Presidents.

CHAIRPERSON NEREM: Yeah, right. I think we view the employees of FDA, the staff of FDA as an extremely important part of the whole activity as we think about the future and think about how FDA can not only continue to do the job it's doing, but enhance its activities, issues related to staff support, career paths, processes that are in place are important, and so that's why we reached out to have a conversation with you and others that you might choose to have joining you.

MR. YOUNG: Right. Well, tomorrow we have something like 20 Vice Presidents. They're mostly organized along unit lines. So there are four in Drugs, for example, and three, I think, in CDRH.

Actually I work in Drugs,a nd so Cathy is one of the Vice Presidents, and Joy Lazaroff is the Executive Vice President for the entire chapter, but actually the both of them are CDRH employees.

CHAIRPERSON NEREM: It would be good if they were there. What I'm looking for is meeting the 20 people, but a small group of three or four people.

MR. YOUNG: Right. Okay. They're going to be here tomorrow.

Let me tell you just a little bit about the federal employees under --

DR. BLAZY: If I could amplify --

MR. YOUNG: Sure.

DR. BLAZY: -- you asked a question about what we would be interested in. What are the issues from the union's perspective in terms of your priorities and representing the employees? What are the issues that are most dominant in terms of labor relations, management relations?

That's what we would be interested in. This could be with regards to training. This could be with regards to promotion potential, better work environment, office sites, a whole host of issues that could be brought to one steward and union representative as conditions of employment.

Which ones have surfaced that are priorities to you representing your employees that you can discuss with us very concisely?

CHAIRPERSON NEREM: Bob, once this public session is over, I'd be glad to meet with you and talk to you one on one.

MR. YOUNG: Sure. Let me just spend a couple more minutes. Let me tell you under the statute, which is, you know, everything operates under statute, including devices; under the statute, you know, there's a federal employee. You can have federal employee unions. That's so long as the employees want it, meaning they have to vote, and the majority have to vote in favor of it.

The union is going to address what are called the conditions of work. They cannot get into the work itself. How the work itself is done and what the work is and how the work is assigned belongs to the agency, and I think that's properly so because they're responsible for it.

CHAIRPERSON NEREM: Can we actually talk about this tomorrow?

MR. YOUNG: Yeah. I just thought I'd just spend a second on this just to frame it a little bit for the questions.

We could only get involved in the conditions of work. That's the work environment itself, and that's, I think, what you're interested -- it sounds like the kind of thing that you're interested in. So we'll look at that tomorrow.

I just wanted to draw the distinction between the work itself and the conditions of work.

CHAIRPERSON NEREM: Well, I'm sure we'll have many more questions. So thank you very much, and even though you're at the end of our session, tomorrow, you know, this activity, the committee will be going on beyond that to write the report.

MR. YOUNG: Great.

CHAIRPERSON NEREM: So your input will be timely. Thank you very much.

MR. YOUNG: Okay. Thank you.

CHAIRPERSON NEREM: Is there anyone else who raised their hand to make a comment in this public session?

There is a letter to be read into the record.

MR. DEMIAN: Yes. I'm going to summarize this letter. This letter was sent by King & Spalding, Ed Basile and Ashley Whitesides, and it was addressed to Dr. David Feigal.

It says, "Urgent immediate attention requested." To summarize this letter, basically Ed Basile was concerned that this is a three-day panel meeting and that 22.5 hours of the meeting are going to be closed to the public to discuss trade secret and/or confidential information, and Ed was unclear why we needed to have that much of the meeting closed because there's only one hour for open public session.

We are justified in closing the meeting, and we only had to indicate that we would be discussing trade secret and/or confidential information.

The report will be presented to the FDA Science Board on November 16, 2001. So that will be the culmination of this subcommittee and the report will be aired out in the public.

Okay. I think now we're going to clear the room because this meeting, the rest of this meeting will be closed to the public again. Only previously designated individuals who have proper identification will be permitted to stay for this closed session of the meeting to discuss trade secret and/or confidential information.

(Whereupon, at 1:17 p.m., the Open Session was concluded and proceedings resumed in Closed Session at 1:18 p.m.)