[House Hearing, 106 Congress] [From the U.S. Government Printing Office] FACA: CONFLICTS OF INTEREST AND VACCINE DEVELOPMENT--PRESERVING THE INTEGRITY OF THE PROCESS ======================================================================= HEARING before the COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED SIXTH CONGRESS SECOND SESSION __________ JUNE 15, 2000 __________ Serial No. 106-239 __________ Printed for the use of the Committee on Government Reform Available via the World Wide Web: http://www.gpo.gov/congress/house http://www.house.gov/reform ______ U.S. GOVERNMENT PRINTING OFFICE 73-042 DTP WASHINGTON : 2001 _______________________________________________________________________ For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: (202) 512-1800 Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001 COMMITTEE ON GOVERNMENT REFORM DAN BURTON, Indiana, Chairman BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California CONSTANCE A. MORELLA, Maryland TOM LANTOS, California CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania JOHN L. MICA, Florida PATSY T. MINK, Hawaii THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington, MARK E. SOUDER, Indiana DC JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio Carolina ROD R. BLAGOJEVICH, Illinois BOB BARR, Georgia DANNY K. DAVIS, Illinois DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts ASA HUTCHINSON, Arkansas JIM TURNER, Texas LEE TERRY, Nebraska THOMAS H. ALLEN, Maine JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois DOUG OSE, California ------ PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont HELEN CHENOWETH-HAGE, Idaho (Independent) DAVID VITTER, Louisiana Kevin Binger, Staff Director Daniel R. Moll, Deputy Staff Director James C. Wilson, Chief Counsel Lisa Smith Arafune, Chief Clerk Phil Schiliro, Minority Staff Director C O N T E N T S ---------- Page Hearing held on June 15, 2000.................................... 1 Statement of: Glynn, Marilyn, general counsel, Office of Government Ethics; and James Dean, Director, Office of Governmentwide Policy, U.S. General Services Administration....................... 26 Suydam, Linda A., D.P.A., Senior Associate Commissioner, Food and Drug Administration; and Dr. Dixie Snider, Jr., M.D., executive secretary, Advisory Committee on Immunization Practices, Centers for Disease Control, accompanied by Kevin Malone, Jennie Slaughter, Bill Freas, and Nancy Cherry..................................................... 59 Letters, statements, etc., submitted for the record by: Burton, Hon. Dan, a Representative in Congress from the State of Indiana, prepared statement of.......................... 9 Chenoweth-Hage, Hon. Helen, a Representative in Congress from the State of Idaho, prepared statement of.................. 122 Davis, Hon. Danny K., a Representative in Congress from the State of Illinois, prepared statement of................... 21 Dean, James, Director, Office of Governmentwide Policy, U.S. General Services Administration, prepared statement of..... 36 Gilman, Hon. Benjamin A., a Representative in Congress from the State of New York, prepared statement of............... 107 Glynn, Marilyn, general counsel, Office of Government Ethics, prepared statement of...................................... 28 Snider, Dr. Dixie, Jr., M.D., executive secretary, Advisory Committee on Immunization Practices, Centers for Disease Control, prepared statement of............................. 89 Suydam, Linda A., D.P.A., Senior Associate Commissioner, Food and Drug Administration, prepared statement of............. 62 Waxman, Hon. Henry A., a Representative in Congress from the State of California, prepared statement of................. 18 FACA: CONFLICTS OF INTEREST AND VACCINE DEVELOPMENT--PRESERVING THE INTEGRITY OF THE PROCESS ---------- THURSDAY, JUNE 15, 2000 House of Representatives, Committee on Government Reform, Washington, DC. The committee met, pursuant to notice, at 1 p.m., in room 2154, Rayburn House Office Building, Hon. Dan Burton (chairman of the committee) presiding. Present: Representatives Burton, Gilman, Ros-Lehtinen, Waxman, Norton, Kucinich, and Davis of Illinois. Staff present: Kevin Binger, staff director; James C. Wilson, chief counsel; David A. Kass, deputy counsel and parliamentarian; Mark Corallo, director of communications; S. Elizabeth Clay and Nat Weinecke, professional staff members; Robert Briggs, clerk; John Sare, staff assistant; Robin Butler, office manager; Michael Canty, legislative aide; Toni Lightle, legislative assistant; Leneal Scott, computer systems manager; Lisa Smith Arafune, chief clerk; Corinne Zaccagnini, systems administrator; Phil Barnett, minority chief counsel; Sarah Despres, minority counsel; David McMillen, minority professional staff member; Ellen Rayner, minority chief clerk; and Jean Gosa and Earley Green, minority assistant clerks. Mr. Burton. The hearing will come to order. Before we begin, I ask unanimous consent that statements from members of the committee and witnesses before the committee may be included in the record as well as an other materials they may submit. Mr. Waxman. I reserve the right to object. I would certainly withdraw my objection to those particular documents, but I think that I, at this point, have to object to that blanket request, have to object. Mr. Burton. So you are reserving your right to object on that? Mr. Waxman. I do object at this point. Mr. Burton. Well, all right. I had one more unanimous consent request as well, Mr. Waxman, which I believe you will object to as well, so why don't we get them all together here. I ask unanimous consent that a set of exhibits which have been shared with the minority prior to the hearing be included in the record without objection. Mr. Waxman. I reserve the right to object to that. These are--Mr. Chairman, I'm reserving my right to object and I'd like to be recognized on my reservation. The reason I do not plan to object is not out of concern that we would in any way fail to disclose conflicts of interest, but because of the Ethics in Government Act. People submitted their own private financial information under a law that said once they make this submission, it will not be made public. And on that basis, those were the rules under which they have volunteered to serve on various Government panels and have given this information to the appropriate agencies. The reason they give this information is that if there's a conflict of interest, the agency will know about it, because it will be disclosed. If it's a conflict that goes to a narrow point, they may not be able to vote on that point. If it's a broader conflict, they shouldn't be serving on the advisory committee or any other commission at all. That's the Ethics in Government law. But for us to in any way disclose what was, here today in the Congress, what was given to an agency with the understanding under the Ethics of Government law that it not be made public seems to be an inappropriate thing to do. So I don't think we ought to be making anything public that was given to our committee with the expectation that the Ethics in Government law would have prevented us as it would any other agency of Government from making that information public. So on that basis, I will object to your unanimous consent request. Mr. Burton. Well, I have one more unanimous consent request which you may want to object to, too, and then I'll respond. I also ask unanimous consent that a staff report by majority staff be included in the record, and without objection---- Mr. Waxman. Mr. Chairman, I do reserve the right to object. The staff report, as I understand it, refers to some of the documents that were part of the financial disclosures that under the Ethics in Government law were not to have been made public by anyone. And on that basis, I don't think the staff report, insofar as it incorporates that kind of information, should be made public, and I wouldn't agree to it. And therefore, wouldn't want to go along with the unanimous consent request. And I particularly wouldn't want to go along and give a unanimous consent request to a report that we have not even seen. We haven't even seen this report, we who are on this committee. So we don't know what's in it. So until I know what's in it, I'm not going to agree to release it, if it has information that may be improper to release. So I do object. Mr. Burton. Well, I understand that in the case of our majority report and your minority reports, we very rarely see yours either. So I disagree, Mr. Waxman, with your interpretation of the law. I've had our lawyers review it. It's clear to us that your interpretation is incorrect. I have a letter that I've sent to you explaining our views, and I think you have that. It's clear from a reading of the entire section that the provisions refer to the agency in question and particularly their ethics officials. As you know, Congress guards its rights to conduct oversight and make information public very jealously. It doesn't make any sense to suggest that Congress would pass a law that would stop it from making public information about conflicts of interest and undue influence of special interests. Nowhere in this entire section is Congress referred to. However, I will withdraw my unanimous consent request. I will not issue our staff report today. I believe that every place where we have referred to financial disclosure form information, that information is publicly available. For instance, at the beginning of every advisory committee meeting at the CDC, the Centers for Disease Control, the members go around the table and disclose their conflicts in public. It is my intention, however, to use documents during the hearing. Under the rules, the committee documents are available for use by all Members during hearings. I think that it's pretty clear that drug companies do have influence on these advisory panels and these committees, and I don't think it's proper. I think the public needs to know about that. They have a right to know about that. And we will proceed in the proper manner. Mr. Waxman. Mr. Chairman, I'd like to make a point of order. Mr. Burton. The gentleman will state his point of order. Mr. Waxman. Under Rule 11(2)(k)(8), which refers to documents that could be disclosed, you already indicated you plan to refer to and therefore in the course of this hearing make public these very same documents that I think should not be made public. And I want you to rule, under the rules of the House, that it would not be pertinent to our hearing to release those documents. I want to read the section of the law. The section of the law, the Ethics in Government law, says, any information required to be provided by an individual under this subsection shall be confidential and shall not be disclosed to the public. Now, as I understand your argument, you think the Congress can make the disclosure to the public, even though the law says it shall not be disclosed to the public. When the Republicans took control of the House of Representatives in January 1995, we adopted rules saying that we will be subject to the same rules that outside groups have imposed upon them, whether it be OSHA rules or civil rights laws or anything else. Under the spirit of that notion that we should be guided by the same rules that apply to others, I think that the Congress of the United States should not be permitted to make available to the public or disclose to the public that which no other agency of Government, no one working for any of those agencies of Government, no one else would be permitted to do without violating the law. And in fact, I would submit that even this committee would be violating the law should we disclose this information. So I make at this point a point of order that the Chair rule that the information that he appears to be willing to disclose, not be disclosed based on these arguments, and the rules of the House that would prevent disclosure of information under Rule 11(2)(k)(8). Mr. Burton. First of all, before I rule on your point of order, there was never any agreement with Health and Human Services that these documents would not be made public. I have a copy of a letter that I sent to Dr. Shalala, and I'll read from that. It says, the documents produced to the committee in response to the October 1st request will be treated as committee documents. Committee rules state that all committee documents shall be available for use by members of the committee during committee meetings. Beyond this, if there is a determination that committee documents should be made public, it has been the practice of this committee to do so only upon agreement between the chairman and ranking minority member, or by vote of the committee. When and if committee documents are made public, appropriate redactions are made to delete personal information such as home phone numbers and addresses, social security numbers or bank account numbers. It's my intention that these documents referred to above shall be treated in this manner. Now, the documents, the documents are pertinent to this hearing, and therefore the point of order is overruled. Mr. Waxman. Mr. Chairman, before you make your decision, which I fully expect to be contrary to my argument, I do want to point out in that letter that you wrote to Donna Shalala, the Secretary of HHS, you said when and if committee documents are made public, appropriate redactions are made to delete personal information, such as home phone numbers and addresses, social security numbers or bank account numbers. It's my intention the documents referred to above shall be treated in this manner. As I understand, what you plan to do today is to refer to financial disclosures. It seems to me that in the spirit of this letter, some of those things could be redacted. But all of the information will be made public about individuals who submitted these financial disclosures with a clear understanding, because the law spells it out for them, that in doing so, when they volunteer then to serve on a committee, that their financial holdings and information about their financial personal situation would not be made public. So I want to point that out, and I don't know if that will persuade you differently on the ruling on my point of order, but I think it's important to put on the record. Mr. Burton. Well, we have said that we're not going to make those documents public today. However, the committee can use all documents that we have in the course of discussion of the hearing and will do so. And your point of order is overruled. We'll now proceed with, let's see, I have one more thing. I also ask unanimous consent that questioning under this matter proceed under clause 2(j)(2) of House rule 11 and committee rule 14, in which the chairman and the ranking minority member allocate time to members of the committee as they deem appropriate for extended questioning, not to exceed 60 minutes equally divided between the majority and the minority. And without objection, so ordered. Today we're going to continue our series of hearings on vaccine policy. For the last few months, we've been focusing on two important advisory committees. The Food and Drug Administration and the Centers for Disease Control and Prevention rely on these advisory committees to help them make vaccine policies that affect every child in America. We've looked very carefully at conflicts of interest. We've taken a good, hard look at whether the pharmaceutical industry has too much influence over these committees. From the evidence we've found, we believe that they do. The first committee is the Food and Drug Administration's Vaccine and Related Biological Products Advisory Committee. This committee makes recommendations on whether new vaccines should be licensed. The second committee is the CDC's Advisory Committee on Immunization Practices. This committee recommends which vaccines should be included in the childhood immunization schedule. To make these issues easier to understand, we're going to focus on one issue handled by these two committees, the rotavirus vaccine. There are other vaccines that we may get into later, but today we're going to use this as the primary example. It was approved for use by the FDA in August 1998. It was recommended for universal use by the CDC in March 1999. Serious problems cropped shortly after it was introduced. Children started developing serious bowel obstructions. The vaccine was pulled from the U.S. market in October 1999. So the question is, was there evidence to indicate that the vaccine was not safe, and if so, why was it licensed in the first place? How good a job did the advisory committees do? We reviewed the minutes of the meetings. At the FDA's committee, there were discussions about adverse events. They were aware of potential problems. Five children out of 10,000 developed bowel obstructions. There were also concerns about children failing to thrive and developing high fevers, which as we know from other vaccine hearings, can lead to brain injury. Even with all of these concerns, the committee voted unanimously to approve it. At the CDC's committee, there was a lot of discussion about whether the benefits of the vaccine really justified the cost. Even though the cost benefit ratio was questioned, the committee voted unanimously to approve it. Were they vigilant enough? Were they influenced by the pharmaceutical industry? Was there appropriate balance of expertise and perspective on vaccine issues? We've been reviewing their financial disclosure statements. We've interviewed staff from the FDA and the CDC. The staff has prepared a staff report summarizing what we found. At the end of this statement, while I won't ask unanimous consent to enter this report in the record today, I've already agreed not to do that, we've identified a number of problems that need to be brought to light, and we will be discussing those. Families need to have confidence that the vaccines that their children take are safe, effective and very necessary. Doctors need to feel confident that when the FDA licenses a drug, that it's really safe and that the pharmaceutical industry has not influenced the decisionmaking process. Doctors place trust in the FDA and assume that if the FDA has licensed a drug, it's safe for use. Has that trust been violated? How confident in the safety and need of specific vaccines would doctors and parents be if they learned the following: One, that members, including the chair of the FDA and CDC advisory committees who make these decisions own stock in drug companies that make the vaccines. Two, that individuals on both advisory committees own patents for vaccines under consideration, or affected by the decisions of the committees. Three, that three out of the five of the members of the FDA's advisory committee who voted for the rotavirus vaccine had conflicts of interest that were waived. Four, that 7 individuals of the 15 member FDA advisory committee were not present at the meeting. Two others were excluded from the vote, and the remaining five were joined by five temporary voting members who all voted to license the product. Five, that the CDC grants conflict of interest waivers to every member of their advisory committee a year at a time, and allows full participation in the discussions leading up to a vote by every member, whether they have a financial stake in the decision or not. So they're discussing it, influencing other members possibly, whether they have a financial stake or not. Sixth, that the CDC's advisory committee has no public members, no parents have a vote in whether or not a vaccine belongs on the childhood immunization schedule. The FDA's committee only has one public member. These are just a few of the problems we found. Specific examples of this include Dr. John Modlin. He served for 4 years on the CDC advisory committee and became the chair in February 1998. He participated in the FDA's committee as well. He owns stock in Merck, one of the largest manufacturers of the vaccine, valued at $26,000. He also serves on Merck's immunization advisory board. Dr. Modlin was the chairman of the rotavirus working group. He voted yes on eight different matters pertaining to the ACIP's rotavirus statement, including recommending for routine use and for inclusions in the Vaccines for Children program. It was not until this past year that Dr. Modlin decided to divest himself of his vaccine manufacturer stock. At our April 6th autism hearing, Dr. Paul Offit disclosed that he holds a patent on a rotavirus vaccine and receives grant money from Merck to develop this vaccine. He also disclosed that he is paid by the pharmaceutical industry to travel around the country and teach doctors that vaccines are safe. Dr. Offit is a member of the CDC's advisory committee and voted on three rotavirus issues, including making the recommendation of adding the rotavirus vaccine to the Vaccines for Children program. Dr. Patricia Ferrieri, during her tenure as chair of the FDA's advisory committee, owned stock in Merck valued at about $20,000 and was granted a full waiver. Dr. Neal Halsey, who serves as a liaison member to the CDC committee on behalf of the American Association of Pediatrics, and is a consultant to the FDA's committee, has extensive ties to the pharmaceutical industry, including having solicited and received startup funds from industry for his Vaccine Center. As a liaison member to the CDC committee, Dr. Halsey is there to represent the opinions of the organizations he represents, but was found in the transcripts to be offering his personal opinion. Dr. Harry Greenberg, who serves as chair of the FDA committee, owns $120,000 of stock in Aviron, a vaccine manufacturer. He also is a paid member of the board of advisors of Chiron, another vaccine manufacturer, and owns $40,000 of stock. This stock ownership was deemed not to be a conflict, and a waiver was granted. To the FDA's credit, he was excluded from the rotavirus discussion, because he holds the patent on the Rotashield vaccine. How confident can we be in the process when we learned that most of the work of the CDC advisory committee is done in ``working groups'' that meet behind closed doors, out of the public eye? Members who can't vote in the full committee because of conflicts of interest are allowed to work on the same issues in working groups, and there is no public scrutiny. I was appalled to learn that at least 6 of the 10 individuals who participated in the working group for the rotavirus vaccine had financial ties to pharmaceutical companies developing rotavirus vaccines. How confident can we be in the recommendations for the Food and Drug Administration when the chairman and other individuals on their advisory committee own stock in major manufacturers of vaccines? How confident can we be in a system when the agency seems to feel that the number of experts is so few around the country that everyone has a conflict and thus waivers must be granted? It almost appears that there is an ``old boys network'' of vaccine advisors that rotate between the CDC and FDA, at times serving simultaneously. Some of these individuals served for more than 4 years. We found one instance where an individual served for 16 years continuously on the CDC committee. With over 700,000 physicians in this country, how can one person be so indispensable that they stay on a committee for 16 years? It's important to determine if the Department of Health and Human Services has become complacent in their implementation of the legal requirements on conflicts of interest and committee management. If the law is too loose, we need to change it. if the agencies aren't doing their job, they need to be held accountable. That's the purpose of this hearing, to try to determine what needs to be done. Why is this review necessary? Vaccines are the only substances that a government mandates a U.S. citizen receive. State governments have the authority to mandate vaccines be given to children prior to admission to day care centers and schools. State governments rely on the recommendations of the CDC and the FDA to determine the type and schedule of vaccines. I am not alone in my concern about the increasing influence of industry on medicine. Last year, the New England Journal of Medicine learned that 18 individuals who wrote drug therapy review articles had financial ties to the manufacturer of the drugs they were discussing. The Journal, which has the most stringent conflict of interest disclosures of medical journals, had a recent editorial discussing the increasing level of academic research funded by the industry. The editor stated, ``What is at issue is not whether researchers can be `bought' in the sense of a quid pro quo, is that close and remunerative collaboration with a company naturally creates goodwill on the part of the researchers and the hope that the largesse will continue. This attitude can subtly influence scientific judgment.'' Can the FDA and the CDC really believe that scientists are more immune to self-interest than anybody else? Maintaining the highest level of integrity over the entire spectrum of vaccine development and implementation is essential. The American people have to have trust in the system. The Department of Health and Human Services has a responsibility to the American public to ensure the integrity of this process by working diligently to appoint individuals that are totally without financial ties to the vaccine industry to serve on these and all vaccine-related panels. No individual who stands to gain financially from the decisions regarding vaccines that may be mandated for use should be participating in the discussion or policymaking for vaccines. We have repeatedly heard in our hearings that vaccines are safe and needed to be protecting the public. If the panels that have made the decisions on all vaccines on the childhood immunization schedule had as many conflicts as we have found with rotavirus, then the entire process has been polluted and the public trust has been violated. I intend to find out if the individuals who have made these recommendations that affect every child in this country and around the world stood to gain financially and professionally from the decisions of the committees on which they served. The hearing record will remain open until June 28th for those who would like to submit a statement for the record. I now recognize the ranking minority member, Mr. Waxman, for his opening statement. [The prepared statement of Hon. Dan Burton follows:] [GRAPHIC] [TIFF OMITTED] T3042.001 [GRAPHIC] [TIFF OMITTED] T3042.002 [GRAPHIC] [TIFF OMITTED] T3042.003 [GRAPHIC] [TIFF OMITTED] T3042.004 [GRAPHIC] [TIFF OMITTED] T3042.005 [GRAPHIC] [TIFF OMITTED] T3042.006 Mr. Waxman. Thank you very much, Mr. Chairman. This hearing is about conflicts of interest and vaccine decisionmaking. This is an issue I take very seriously. I have probably done more than any other member of this committee to identify and oppose genuine conflicts of interest in Federal decisionmaking. In 1991, I held a hearing on conflicts of interest in Vice President Quayle's Council on Competitiveness. These hearings revealed that the executive director of the council owned 50 percent of a chemical plant subject to regulation under the Clean Air Act at the same time that he was chairing biweekly interagency meetings on Clean Air Act regulations, including regulations that dealt with toxic substances that may have affected his chemical plant. In 1998 and 1999, I was the only member to question what role a key NIH official played in selecting Rezulin in a diabetes drug trial when he was consulting for Rezulin's manufacturer, Warner Lambert. My question led directly to an ongoing inspector general review of NIH's management of its conflict of interest policies. In 1997, when the Supreme Court ruled that the Federal Advisory Committee Act applied to the National Academy of Sciences, some members wanted to exempt the Academy from those requirements. I insisted that we put in place a system to examine conflicts of interest in the membership of those advisory groups. In 1997, when the Republican Congress wanted to privatize medical device approvals and farm out product reviews to for-profit entities, I was one of the members who fought hard to ensure that conflicts of interest were prohibited and that the public interest was protected. If indeed a real threat to objective decisionmaking by our health agencies is identified during these hearings, I will call for a full investigation, as I have done in the past. I know that conflicts can be dangerous, not only because of the possibility that a financial interest could exert undue influence on critical policy decisions, but also because they can lead to loss of public confidence in the system. But there's a right way and a wrong way to investigate conflicts of interest. The right way is to investigate first and then reach conclusions later. The wrong way is to accuse first and then investigate later. Unfortunately, our chairman has a propensity to investigate in the wrong way, not just in this issue, but in other issues. He has made unsubstantiated allegations that smear people's reputations but turn out to have no basis in fact. The chairman made his latest allegation last Sunday on Meet the Press. On national TV, he accused the President, the Vice President and the Attorney General of obstruction of justice and other crimes. But when he was asked to provide evidence to back up these accusations, the chairman refused, stating, ``I can't give you the specifics of it right now.'' My fear is that the chairman has reached a predetermined conclusion that vaccines are dangerous. It is difficult for him to persuade others to agree with his conclusion because it is so far out of the scientific and medical mainstream. But rather than accept the fact that he may be wrong, the chairman has decided that those who disagree with him must be part of a drug company conspiracy. I intend to keep an open mind as I review the evidence we hear today. The chairman didn't share with us the report that he planned to release today. As a result, I've had no time to review what his staff has written, and cannot comment on the findings. But from what I've seen, I have my doubts that the chairman will be able to demonstrate that vaccine decisions have been tainted by scandal. CDC and FDA should follow the highest possible standards in applying conflict of interest rules. There may be questions about whether these rules have been properly applied in every instance. But lapse in the application of these rules, if there are any, does not mean that vaccine decisions have been made improperly. Unfortunately, CDC and FDA face a difficult challenge in assembling together expert advisory panels on vaccines. Vaccine decisions have major public health implications. For this reason, it's important, in fact it's essential, that the individuals serving on the vaccine advisory panels be the world's leading experts on vaccine issues. But some of these experts also have varying ties to the pharmaceutical industry, such as working with the industry to develop new and better vaccines. After all, their field is vaccine research. CDC and FDA have the responsibility of ensuring that the public benefits from the expertise of these individuals, while at the same time ensuring that appropriate precautions are taken against conflicts of interest. That's why those disclosures were required of all of those people that serve voluntarily on advisory committees, so CDC could see if there's a conflict, FDA could see if there's a conflict. But to get those disclosures, people are promised that their financial holdings are not going to be made public, which is why I objected to the release of this information, which I gather will be made public indirectly today. Let me give you an example. The chairman referred to Dr. John Modlin and said, he must have a conflict of interest because he owns $60,000, I think it was, maybe $40,000, of shares in Merck Pharmaceutical. Maybe it's $100,000, I don't remember the number. But the point I want to make is that this man served on an advisory committee and approved a drug by another company. It wasn't a Merck rotavirus vaccine that he voted to approve. It was a Wyeth product. Now, he was later asked, did he know that Merck was also working on a rotavirus vaccine. And he said he didn't even know that they were working on a rotavirus vaccine. Maybe if he knew, he would have voted against the competitor's product because he had a financial interest in Merck. Well, the fact of the matter is, Merck is involved with many products, as is Wyeth, as is every other pharmaceutical company. If we want to say that anybody who works as an advisor cannot own these stocks, then let's say it. But you know what? We don't say that of Members of Congress. The Roll Call newspaper today has an article about all the Senators that have stocks in high tech. Now, that's not wrong or illegal. And we even vote on issues that affect those industries. If we're going to have a requirement that no one own stocks in companies that may benefit from our decisions indirectly, then we ought to say it. But we have not said that, and therefore, people have not violated any rule because they simply have financial holdings. This hearing will serve a useful purpose if it provides an opportunity to explore objectively how good a job CDC and FDA are doing in meeting their obligations. But let's be ready to look at the evidence first, before we reach conclusions that could scare people into thinking that vaccines that are on the market are going to hurt their children, and have them run away from getting their children immunized, when one thing we do know is that those diseases that can be prevented can take an enormous toll on the lives of children. I also want to point out that rotavirus, which is the example used by the chairman, is not a vaccine that is mandated by the Federal Government to be used by children. As I understand it, the CDC had put it on its list of recommended vaccines for infants. They recommended it. They later took it off that list. But it is not required by law that children be immunized. Some States have laws that require that before children can go to school, they be immunized. This particular product, as I understand it, was never mandated to be used. But when the Centers for Disease Control says that they recommend a product, it's a very serious matter. If FDA approves a product, they're saying to the American people that this product has undergone scrutiny and is safe and effective. As I also understand in this particular case, FDA asked that they continue to monitor after the approval to be sure that if there are problems, we know about those problems. Those of us who looked at the FDA issues on the committee that has jurisdiction, the Health and Environment Subcommittee, which I once chaired, know very well that there is pressure from Congress and the American people to get drugs approved as quickly as possible. And when we press to get these products approved as quickly as possible, it means we've got to make sure that we monitor any adverse impacts so we can respond if we learn about problems. With this particular vaccine, there was an advisory that it be monitored. After it was monitored, they found that there was a problem, because adverse event reporting requirement for vaccines, and they acted to take this vaccine off the market. That appears to me to be appropriate. We wish they would have been able to catch it before it was ever used. But we want to be able to make sure that we catch it after it's being used and the decisions that are made to make a vaccine available be the decisions that are based on the science, by the leading scientists and make sure that if they are acting on these advisory panels that they not have genuine conflicts of interest. Let's be mindful of the way things work and explore the evidence before we jump to conclusions. I will do that with an open mind today as we hear from various witnesses, and hope that we can reach some conclusions based on the facts. Thank you, Mr. Chairman. [The prepared statement of Hon. Henry A. Waxman follows:] [GRAPHIC] [TIFF OMITTED] T3042.007 [GRAPHIC] [TIFF OMITTED] T3042.008 Mr. Burton. I would like to add or correct one thing that the gentleman from California said. Merck was listed as an affected company in the documents provided by the FDA to Dr. Modlin. So he was aware of that. Mr. Davis, do you have a comment you'd like to make, sir? Mr. Davis of Illinois. Yes, Mr. Chairman. Thank you very much, Mr. Chairman, and I'd like to commend you for holding this oversight hearing to examine the implementation of the Federal Advisory Committee Act and to examine the operation of the Department of Health and Human Services. Mr. Burton. Excuse me, Mr. Davis, I don't mean to interrupt you. We have 7 minutes on the clock. Would you like to continue now or---- Mr. Davis of Illinois. I'll be done in 2. Mr. Burton. OK, Mr. Davis. Mr. Davis of Illinois. And to examine the operation of the Department of Health and Human Services Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention and the Vaccine Related Biologic Products Advisory Committee of the Food and Drug Administration. A strong and prosperous America needs healthy people. Healthier people will build a stronger America. It is crucial that we provide the best health care to all Americans. And in order to ensure the health of all Americans, the two advisory committees have critical roles to recommend the kind and dosage of vaccinations that our children and adult populations receive. There is a tremendous amount of interest in this subject, as is evidenced by the numbers of people who are at this particular hearing, and in my community, especially, Mr. Chairman, there is a great deal of interest. And I note the presence of Barbara Malarkey, a representative of the Illinois Vaccine Awareness Coalition, who happens to live in my neighborhood. She is indeed a fighter, a hard worker, and has raised the level of awareness locally where we live. I simply want to commend her for taking time out to come all the way from Chicago to just simply be here today and participate and hear the information as we discuss this important subject. [The prepared statement of Hon. Danny K. Davis follows:] [GRAPHIC] [TIFF OMITTED] T3042.009 [GRAPHIC] [TIFF OMITTED] T3042.010 [GRAPHIC] [TIFF OMITTED] T3042.011 [GRAPHIC] [TIFF OMITTED] T3042.012 [GRAPHIC] [TIFF OMITTED] T3042.013 Mr. Waxman. Would the gentleman yield to me just to use this opportunity? Mr. Davis of Illinois. Yes. Mr. Waxman. Because you have a minute left. Dr. Modlin was a non-voting member on this panel. If there was a document given about Merck being an affected company, he claims he did not know about it. And the reason I say he claims that is that my staff talked to him and asked him about it. I don't know if Mr. Burton's staff talked to him and asked him that question. He said that when he served in this advisory capacity, he did not know that Merck was listed as one of the affected companies. He didn't know Merck was working on a rotavirus vaccine as well. He was looking at a Wyeth product, and used his best scientific judgments with regard to that Wyeth product. Thank you for yielding. Mr. Burton. We have a vote on the floor. We will be back very shortly. The Chair stands in recess. [Recess.] Mr. Burton. We will now proceed with the statements of Mr. Dean and Ms. Glynn. Would you please stand and raise your right hands. [Witnesses sworn.] Mr. Burton. Ms. Glynn, would you like to go first with your prepared statement? STATEMENTS OF MARILYN GLYNN, GENERAL COUNSEL, OFFICE OF GOVERNMENT ETHICS; AND JAMES DEAN, DIRECTOR, OFFICE OF GOVERNMENTWIDE POLICY, U.S. GENERAL SERVICES ADMINISTRATION Ms. Glynn. Sure. I'm pleased to be here today to talk briefly about the Federal ethics and conflict of interest statutes and regulations and how they apply to members of Federal advisory committees generally. The core conflict of interest statute is Section 208 of Title 18 of the U.S. Code. This law prohibits employees from participating personally and substantially in any particular matter which to their knowledge has a direct and predictable effect on their financial interest. It also applies when the matter would affect the financial interests of certain other persons or organizations with whom they have some connection, such as an outside employer. The law contains waiver and exemption provisions that would permit an employee to participate in a matter notwithstanding a potential conflict of interest. Section 208 applies to regular employees of the executive branch as well as to so-called special Government employees, or SGEs, as we call them. Many members of Federal advisory committees are SGEs, in fact, probably most are. The SGE category was created by Congress as a way to apply an important but limited set of conflict of interest requirements to a group of individuals who provide important but limited services to the Government. Some members of Federal advisory committees are not employees of the Government at all. These individuals serve as representatives of outside interest groups. It is understood by the Government that they represent a particular bias and they aren't covered by any of the rules that apply to regular employees or to these SGEs. There is a wavier provision in Section 208 for SGEs who serve on Federal advisory committees within the meaning of the Federal Advisory Committee Act [FACA], I think as it's known. It permits the agency employing the SGE to grant an individual waiver based on a written determination that the need for the individual services outweighs the potential for a conflict of interest created by the financial interests involved. In contrast, the waiver provision for regular Government employees under Section 208, and these employees typically provide a range of services of course far broader than those provided by SGEs, that other waiver for regular employees focuses on the size of the employee's financial interest, and the likelihood that the financial interest would affect the integrity of the employee's services. OGE has issued regulations interpreting Section 208. Included in our regulations is guidance concerning the issues of waivers and various procedural criteria required by the statute. OGE has also issued regulations granting general exemptions from the disqualification requirement in Section 208. Many of these exemptions apply to SGEs as well as to regular employees. For example, there are de minimis exemptions for ownership of publicly traded securities. Some other exemptions apply only to SGEs serving on FACA committees. The most significant of those exemptions exempts certain financial interests arising from the SGEs' outside employment. Beyond the criminal conflict of interest laws, OGE has promulgated regulations prescribing standards of ethical conduct for employees of the executive branch, including these SGEs. One of those rules provides a mechanism for dealing with potential appearances that an employee make lack impartiality when dealing in certain matters. The rule provides a balance to be struck between concerns about appearances of partiality and the Government's interest in having the employee participate in the particular matter. Most SGEs serving on advisory committees have to file financial disclosure reports with their agencies. Financial disclosure helps protect the integrity of the advisory committee process by providing the agencies an opportunity to determine whether an SGE may have any potential conflicts of interest that must be addressed. In closing, I want to emphasize, of course, that OGE shares the committee's belief that Government decisions should not be tainted by an employee's conflicts of interest. At the same time, the Government needs the services of SGEs who can contribute relevant outside expertise and perspectives to the work of an advisory committee. Balancing these two considerations is frequently a difficult task. Nevertheless, we believe that the current statutory and regulatory system that applies to advisory committees provides an appropriate framework for accommodating both objectives. Thank you, and I'd be happy to answer any questions you may have. [The prepared statement of Ms. Glynn follows:] [GRAPHIC] [TIFF OMITTED] T3042.014 [GRAPHIC] [TIFF OMITTED] T3042.015 [GRAPHIC] [TIFF OMITTED] T3042.016 [GRAPHIC] [TIFF OMITTED] T3042.017 [GRAPHIC] [TIFF OMITTED] T3042.018 Mr. Burton. Thank you, Ms. Glynn. Mr. Dean. Mr. Dean. Good afternoon, Mr. Chairman, Mr. Ranking Member, members of the committee. Thank you for the opportunity to discuss with you today the important role played by Federal advisory committees in achieving the missions assigned to the executive branch. The Federal Advisory Committee Act [FACA], operates within the body of statutes that promote access to Federal decisionmaking and information. For example, policy related to the accessibility of Government records was revised in 1966, following the enactment of the Freedom of Information Act. And the two remaining cornerstones of Federal access policy, the Privacy Act, and the Government in the Sunshine Act were enacted by the Congress in 1974 and 1976 respectively. FACA seeks to accomplish two important objectives. First, to establish the means for providing congressional and executive branch oversight over the number and costs of the advisory committees, and second, to ensure that the advisory committees operate in plain view of the public. Simply stated, the act's purpose is to illuminate how agencies make decisions, based upon advice and recommendations from individuals outside of Government, while also making sure that the costs as reported by the advisory committees are commensurate with the benefits received. Although advisory committees do not make or implement decisions, they are used by over 60 agencies to provide advice on issues that reflect the complex mandates undertaken by the Government. During fiscal year 2000, almost 50,000 committee members will serve on 1,000 committees and provide advice and recommendations on such matters as the safety of the Nation's blood supply, steps to address the management of natural resources, and the country's national defense strategies. In our full testimony, Mr. Chairman, we have provided a complete listing of the act's most significant provisions. To summarize, the Secretariat is responsible for issuing policy and providing a framework for Government oversight. Agencies have joint responsibility for implementing the act and for issuing additional guidelines that are needed to address their unique requirements. At the agency level, committee management officers [CMOs] as we know them, are responsible for implementing FACA on behalf of the agency head. Each committee has a designated Federal officer [DFO], who must work with the CMO to manage the committee's operations day to day. Together, the CMO and DFO are responsible for ensuring compliance with FACA, the agency's internal operating procedures, regulations issued by the Secretariat, and any other applicable statutes or regulations such as those issued by the U.S. Office of Government Ethics, the National Archives and Records Administration, or the Office of Personnel Management, just to name a few. Mr. Chairman, in your letter inviting us to testify before the committee today, you asked us to address how the Federal Advisory Committee Act deals with issues relating to balancing an advisory committee's membership and conflict of interest issues relating to individual members. The act does not include provisions addressing committee member conflicts of interest. The applicability of conflicts of interest laws and various ethical requirements for members of advisory committees who serve as special Government employees are covered by other laws and regulations issued by OGE. The act, however, does include two important provisions designed to promote the objectivity of advisory committee deliberations. First, FACA requires that ``the membership of the advisory committee be fairly balanced in terms of the points of view represented and the functions to be performed by the committee.'' Second, the act requires ``provisions to ensure that the advisory recommendations will not be inappropriately influenced by the appointing authority or by any special interest, but will instead be the result of the advisory committee's independent judgment.'' Thus, while the act addresses the importance of assuring an advisory committee's independent judgment, it also requires that at a minimum, the composition of the advisory committees reflect the expertise and interests that are necessary to accomplish a given committee's mission. The act does not, however, define those factors that should be considered in achieving balance. The Secretariat's regulations provide in part that ``in the selection of members for the committee, the agency will consider a cross section of those directly affected, interested and qualified as appropriate for the nature and function of the committee. Committees requiring technical expertise should include persons with demonstrated professional or personal qualifications and experience relevant to the functions and tasks to be performed.'' In their efforts to balance a committee's membership, agencies focus primarily on the subject matter to be addressed. Nevertheless, other factors may be appropriate in relation to a committee's function, such as geographical representation, racial or ethnic diversity, occupational affiliation or the need to consult with State, local or tribal governments. Similarly, the act does not outline specific steps that must be taken to ensure that advice or recommendations offered by an advisory committee are free from inappropriate influence by the appointing authority or special interest. Accordingly, each agency is responsible for developing specific operating procedures, consistent with the act and the Secretary's regulations to promote the advisory committee's independent judgment and to achieve a balanced committee membership. Although the act is quite detailed in the specific procedures agencies must follow--I see I have the stop sign. Mr. Burton. If you're close to concluding, go ahead. Mr. Dean. Probably about a minute and a half. Mr. Burton. OK. Mr. Dean. Although the act is quite detailed in specific procedures agencies must follow with respect to the establishment of advisory committees, the conduct of meetings and the availability of records, it provides substantial flexibility to agency heads in other areas such as membership selection, tenure and procedural issues such as voting. This is appropriate given the diverse needs of the executive branch and the necessity for agencies to quickly adopt new operating procedures where conditions warrant. This flexibility is balanced by a variety of procedural safeguards to ensure that the advice or recommendations tendered by an advisory committee are properly obtained by an agency through a public process prior to final agency action. In particular, the act's provisions require opening meetings and a summary of closed or partially closed meetings, the ability of the public to provide written or oral statements to a committee and access to committee minutes and records reinforce the act's goals of maintaining committee independence and freedom from inappropriate influence. These checks and balances, rooted firmly in the principle of Government in the Sunshine, have contributed greatly to the success of advisory committees over the past 28 years. Mr. Chairman, that concludes my statement. [The prepared statement of Mr. Dean follows:] [GRAPHIC] [TIFF OMITTED] T3042.019 [GRAPHIC] [TIFF OMITTED] T3042.020 [GRAPHIC] [TIFF OMITTED] T3042.021 [GRAPHIC] [TIFF OMITTED] T3042.022 [GRAPHIC] [TIFF OMITTED] T3042.023 [GRAPHIC] [TIFF OMITTED] T3042.024 [GRAPHIC] [TIFF OMITTED] T3042.025 [GRAPHIC] [TIFF OMITTED] T3042.026 [GRAPHIC] [TIFF OMITTED] T3042.027 Mr. Burton. Thank you very much. I think the one thing that was significant, or one of the things that was significant about your statement is the Sunshine aspect, that the public and the American people have a right to know where major decisions are being made. I wish Mr. Waxman was here. I see that his staff has put in his desk there a copy of a document. And so for the record, I'd like to show that Dr. Modlin was aware that Merck was involved in producing a rotavirus. He was a consultant to the FDA, he got this notification on December 12th. And it was voted on December 12th, was it? He got it on November 4th and he voted on December 12th. So he knew about this for over a month. And so I wanted to correct the record, and correct what Mr. Waxman said. Mr. Modlin did know that Merck, and he had a financial interest in Merck, he did know that Merck was involved in that process. Mr. Dean, you just said, and Ms. Glynn can comment on this as well, the whole idea we've been talking about behind the advisory committee law is openness. Do either one of you think it's appropriate for an advisory committee to do a lot of their work through working groups behind closed doors? Mr. Dean. Mr. Chairman, the act provides that most advisory committees should be open to the public. However, it does provide the opportunity to close meetings that are consistent with Government in the Sunshine Act. Many agencies find that it is necessary from time to time, in particular the agencies such as the Department of Defense, for example, with---- Mr. Burton. Well, let's confine our remarks to the health agencies. Mr. Dean. Oh, sure. Within HHS, then, many meetings are closed where necessary to discuss proprietary information, to protect material that contains information subject to the Privacy Act and other issues that are exempted under the Sunshine Act, sir. Mr. Burton. Should advisory committee members who have conflicts and financial interests, and can't vote at public sessions, be allowed to work on or in working groups on the same subject on which they have a conflict of interest? Mr. Dean. I think that OGE may want to comment on that as well. But I can address that from a structural standpoint. It is very common, and the act provides that agencies may establish working groups or subcommittees to support parent committees. All working groups and subcommittees must report to the parent, and only the parent may vote on issues before the committee. In other words, the deliberation on matters that are normally prepared at the subcommittee level or working group level are fully vetted, or are to be vetted under FACA in the parent committee. So the normal way of business is done is that the work done at the lower level will come up to the higher level. Mr. Burton. Do you have a comment? Ms. Glynn. Yes, I do. As to your question about whether it's appropriate to work sort of behind the scenes when you have a conflict of interest, I would say that it's not necessarily inappropriate if the agency has been made aware of the conflict of interest in advance, has had an opportunity to weigh whether they want that person to work behind the scenes in that capacity and has gone through the necessary procedural steps of issuing a waiver as required under the law. Mr. Burton. Let's say you have a child, and there's a new vaccine that's coming on the market. And let's say that there's an advisory committee that's going to be making a decision on whether or not that should be put in the marketplace and into your child's body. Do you think they should be totally unbiased and without any financial conflicts? Ms. Glynn. I have to say that I think, given the breadth of the criminal conflict of interest statute, it might be difficult to find someone who has the requisite expertise, that has absolutely no financial conflict at all. Mr. Burton. How many doctors did we say we had in the country? We have 700,000 physicians in America, probably a couple hundred thousand scientists as well. Now, the rotavirus, we found that many of those people that were on the advisory committees that dealt with that were on the committees year after year after year, had financial conflicts of interests and were making decisions on this vaccine knowing full well that the company that they had stock in or had financial interest in was making, was going to make a profit, which in turn would be beneficial to them. Ms. Glynn. Yes, sir, I understand. Mr. Burton. The vaccine had not been, to our knowledge, thoroughly tested, and yet they went ahead and approved it. Don't you think if you were a parent you'd be a little bit concerned about that? Ms. Glynn. Well, I am a parent, and I do have---- Mr. Burton. Would you be concerned about that? Ms. Glynn. I think with the type of knowledge that I have, having worked for many years in the ethics field and understanding that some of these conflicts of interest could really be characterized as technical. For example, the ownership of stock, I think is a good example. Remember, in evaluating your financial stake in the matter when you own stock, it's not the value of the stock you own. Let's say you own $40,000 or $50,000 worth of stock, whatever those numbers were that you were discussing earlier. The value of your financial interest in the matter is the potential for gain or loss to you. And when you own stock in a large publicly traded company such as, I think Merck was the example, you really own a billionth of an interest in the company. So the likelihood that your personal financial interest in the matter is going to be affected I think is pretty remote. So I really don't think it's inappropriate for agencies to issue waivers in those situations. Mr. Burton. What if you were getting paid to go around and make speeches for that company and you were on that payroll? Would that be a conflict, do you think? Ms. Glynn. You know, it might very well not be a conflict under the criminal conflict of interest statute. It would only really amount to that level if you were actually an employee of the company or if the honorarium or whatever it is you're receiving was dependent on the matter which was under consideration. But believe me, of course there are certainly appearance concerns in a situation like that. And so that's why my office has issued a regulation which requires the employee to consider whether his impartiality would be questioned in such a situation. And the agency can of course go ahead and make its own determination that they don't want an employee to act in such a situation, if they think the appearance is so great that the benefit of having him participate is outweighed by the appearance of a conflict of interest. Mr. Burton. Do you know that there were some serious side effects from the rotavirus and they took it off the market shortly after it was put on the market? And one child, I think, died? Ms. Glynn. I don't---- Mr. Burton. Did you know that? Ms. Glynn. No, sir, I'm not--I'm not involved in the details of this. Mr. Burton. Well, I guess the point I'm trying to make, and the question I'm trying to make is that, I have a grandchild, I have two grandchildren. One of them almost died from a vaccine, the other one is now autistic, we believe, from vaccines. And I think that I, like most people who have children or grandchildren that are having these things put into these bodies, need to be assured that they've been thoroughly tested and that the people who are making the decisions on whether or not those should be mandated, mandated by law, don't have a conflict of interest. And so what you're telling me is that the regulations, the updated regulations that you're talking about, still would allow these people, even though there are 700,000 people in this country, other physicians, and probably a couple hundred thousand scientists, that could be taking a look at these things besides a select group that continues to do it over and over again who don't have financial interests? Ms. Glynn. Yes, sir, I'm saying the statute that Congress passed gives the discretion to the agency involved to decide whether that particular individual is so important to the process that they should---- Mr. Burton. Well, do you think that it should be reviewed, the statute? Ms. Glynn. I don't think there's ever anything inappropriate about Congress reviewing a statute that they've passed. But I have to say that from the information that OGE gets from agencies that operate advisory committees, we've been led to believe that it's working well and that they feel that the exemption provision in the statute is necessary for them to continue to operate their advisory committees. Mr. Burton. Oh, me. The immunization process takes place, a vaccine has not been thoroughly tested, an advisory panel on which people serve that have financial interests in the company, some children are maimed for life or die, and you're saying that you don't think there's a problem with a conflict of interest, where they're mandating, mandating that those vaccinations be given to these children, and these people who are making the decisions do have an interest in the company? And you did say if there's an appearance of impropriety, they should recuse themselves. But you don't see any problem with the current regulations? Ms. Glynn. No. I do not. I think the regulations do provide, as our testimony says, an appropriate framework for making those decisions. Now, I'm certainly not in a position to say whether any individual serving on any particular committee was the right person to be serving, and whether the need for that particular individual was so great that that outweighed a potential conflict of interest. But I think the appropriate framework is in place for making those decisions by the agency. Mr. Burton. OK. The Code of Federal Regulations, 5 C.F.R. 2640.202(a), by the Office of Government Ethics, states that stock holdings not exceeding $5,000 on a specifically affected company or $25,000 on an affected company is considered to be a low involvement and thus is generally waived. How did OGE decide the acceptable parameters of what constitutes an acceptable financial interest? Ms. Glynn. In the particular regulation at issue, we issued a proposed regulation, proposing that figure. We got comments, I'll tell you truthfully, all over the place. Some commenters thought we should raise the amount to $100,000 I would say generally the comments that we got thought the amount was too low. We took a ballpark guesstimate at what we thought was something that would appear to be acceptable across the board. Remember, that regulation is an exemption for every Government employee, whether they're a regular Government employee or a special Government employee, acting in any type of matter. Mr. Burton. How did you arrive at that amount? Ms. Glynn. A ballpark guesstimate---- Mr. Burton. A ballpark guesstimate. Ms. Glynn [continuing]. Of what we thought would be appropriate. Mr. Burton. Did you consult with the Department of Health and Human Service officials about this policy? Ms. Glynn. I believe they commented on our regulation. Mr. Burton. What did they say? Ms. Glynn. I don't recall their specific comments. Mr. Burton. You don't remember? Ms. Glynn. No. Mr. Burton. The Food and Drug Administration has a document entitled Waiver Criteria Document 2000 which lists additional classifications for financial interests, mainly medium involvement and high involvement. The standard amounts shown in these categories are quite broad and range, for example, stock holdings in a company directly affected or more than $5,000 but less than $100,000 are deemed to be of medium involvement. Most likely to be waived. In other words, an advisory committee member could have owned $100,000 worth of stock in Wyeth Lederle, and most likely would be allowed to vote on the Rotashield vaccine, is that correct? Ms. Glynn. I don't know. I have not seen the document you're reading from. Mr. Burton. Did the FDA consult with the OGE in setting the policy I just mentioned? Ms. Glynn. I don't know if they did or not. I don't personally recall them doing it. Mr. Burton. Are you aware of who set the criteria for all of the different classifications listed in the FDA's Waiver Criteria Document 2000? Ms. Glynn. At the Department of Health and Human Services, I don't know. I think you would have to ask them. Mr. Burton. Does the OGE generally agree with the standard policy set forth in that document? Ms. Glynn. Well, sir, as I said, I haven't seen the document. But I don't think it's inappropriate for an agency to set forth general parameters of the type you describe. I guess we could argue about the numbers. But I guess one of the things you have to remember is that there are a lot of employees, regular and special Government employees, who own stock. It's not uncommon, and it's not unusual, I think, for agencies to develop a sort of internal policy in which they say, OK, interests in this sort of ballpark can be waived, interests in another ballpark would typically not be waived, and use that as a sort of standard operating procedure. I don't think there's anything inappropriate about that. Mr. Burton. I understand that the Food and Drug Administration employees cannot own stock in pharmaceutical companies of which they are maybe making determinations on. Is that correct? Ms. Glynn. You would have to ask the Food and Drug Administration. I believe that they have a statute prohibiting ownership of stock, and I know they have regulatory provisions related to it. Mr. Burton. Why do you think they have that kind of a statute? Ms. Glynn. I think you have to ask them. Mr. Burton. Well, let me just ask, because they're afraid that there would be a conflict of interest? Ms. Glynn. Well, of course they are a regulatory entity, and they deal with all these companies. Mr. Burton. What's the difference between FDA and CDC and the other agencies that are involved in the decisionmaking process on vaccines and the advisory panels? Ms. Glynn. Sir, I think these questions are more properly addressed to the FDA and to the CDC. We were invited to talk generically this morning. Our letter of invitation asked us to speak generically about the framework for conflict of interest. Mr. Burton. OK. Ms. Glynn. I have given a cursory review to waivers issued by CDC and FDA in preparation for this hearing, and we received an invitation only 1 week ago. So we haven't had much time to prepare. Mr. Burton. Well, is it your interpretation of the (b)(3) waiver under 18 U.S.C.A. Section 208 that any kind of financial interest, no matter how great, could potentially be waived if the agency determines that the need for the individual is so unique and so important to the agency that it outweighs the potential conflict of interest? In other words, Wyeth Lederle CEO could potentially be allowed to participate in the decisionmaking process, if it was deemed by the agency that he had some expertise that no one else in the United States has? Ms. Glynn. Yes. Mr. Burton. And can you think of a situation where this could actually happen? Ms. Glynn. Yes, I think theoretically, your reading of it is correct that that could happen. In practice, I think that agencies do not issue waivers where they really think there is the potential the person will be actually biased in the advice that they give. Mr. Burton. Can liaison members be considered de facto SGEs if they contribute substantially in the decisionmaking process of an advisory committee? Ms. Glynn. I think not, sir. They're actually called there to provide a kind of biased opinion. It's understood that their point of view is going to be representing an industry view or an organization view, and presumably, people involved in the decisionmaking process know how to weigh that in. They understand that it's not going to be an objective point of view. In fact, that's why they're there, to provide that. I don't think they would become SGEs because they're involved in the discussion. It's important, though, I mean, you're making a good point, which is that it's important to determine in advance whether the person serving is in fact an employee or not. The agency should determine, in advance whether they want that person there to represent the biased industry view, so to speak, or to provide a service to the Government as an employee. Mr. Burton. It's my understanding if those people have a role in the decisionmaking process in these private meetings, that the public doesn't have any access to it, is that correct? Ms. Glynn. I don't know, sir. Mr. Burton. So you're not familiar with that in your capacity? Ms. Glynn. No, sir. Mr. Burton. So I'd have to ask the FDA or CDC or those people about that. OK. Mr. Waxman. Mr. Waxman. Ms. Glynn, I know you're going to answer some questions generically about the ethics of Government law and how it applies across the board, and we'll have a chance to ask FDA and CDC about their specifics. But has the Office of Government Ethics reviewed CDC and FDA conflict of interest policies recently? Ms. Glynn. Our office has a component that does agency reviews, reviews of agency programs. And we do them on a 4-year cycle. I believe the last time we reviewed the FDA was about 3 years ago. We recently reviewed CDC; perhaps we've just issued a report in this past year. Mr. Waxman. Can you tell us what you found with regards to these two agencies? Ms. Glynn. I can. In preparation for this, I did a cursory review of documents relating to these specific agencies. And we'd be happy to provide copies of those reports for the record, if you'd like them. As to the FDA, generally I can say we gave it what you might call a clean bill of health. We found that their ethics program, which examines things such as financial disclosure, counseling and advice, ethics training and so on, we found that they had a very good program and that it was operating quite well. As to CDC, we found that they had what we call a sound ethics program. But we frankly found that they were somewhat understaffed and we recommended that they devote more staff resources to their ethics program. Mr. Waxman. What's the standard for determining whether there's been a violation of the conflict of interest law? Ms. Glynn. The law prohibits an employee from acting in a matter that affects as financial interest. The standard is very broad. And so arguably, using the stock case as an example, again, if you own one share of stock in a company and the matter affects that company, you have violated, in the absence of a waiver or exemption of course, you have violated the conflict of interest clause. The Congress created a law, as we see it, Congress created a law that was very broad that sweeps in a lot of interests. And they tempered that broad law by creating these exemption and waiver provisions--so that the agency would have the opportunity to examine the potential conflict of interest either across the board for groups of people, or on a case by case basis in individual waivers, and make its own determination about whether they want the employee involved. Mr. Waxman. Isn't the standard to determine whether an advisory committee member is acting in a particular matter that will have a direct and predictable effect on the financial interest of that employee, his spouse, his children, or an organization which he serves as an officer, director or general partner and so on? Isn't that the standard, whether there's a direct and predictable conflict? Ms. Glynn. There has to be a direct and predictable effect on the financial interest for the statute to be violated. Mr. Waxman. So the financial interest that would arise in a conflict, can't be speculative? Ms. Glynn. That's right. Mr. Waxman. It has to be an actual conflict of interest? Ms. Glynn. That's right. Mr. Waxman. So if somebody owns stock in Merck and they're voting on another company's drug? Ms. Glynn. There may or may not be a violation of the statute, depending on the facts of a particular case. You can theorize about situations where you act in a matter involving a competitor and it has the effect of virtually driving the other company out of business. It would be probably easy in a situation like that to establish the direct and predictable effect on the competitor. But oftentimes, it's a little bit more difficult. Mr. Waxman. It seems to me there are two goals that agencies should have when they put together an advisory committee. First, they should try to have the best possible experts, and second, they should try to have individuals on the committee who are without conflicts of interest. Now, if you're trying to achieve those two goals, those two goals may be in conflict at times. For example, in the case of vaccines, often the best researchers, those people with the most expertise, have had some relationship with a vaccine manufacturer, such as a research funding or honoraria from participation in a conference. Do you find that this is often the case with advisory committees? Ms. Glynn. From the copies of the waivers--remember, we don't issue the waivers at our office, the waivers are issued by the individual agencies and copies are provided to our office--from the copies of the waivers we have seen, that seems to be the typical kind of conflict of interest that is waived. I can't really say how many members of advisory committees receive waivers. We just don't keep that kind of information. Mr. Waxman. Well, the chairman said that there are 700,000 physicians in America. I presume by that statement he means, why should we rely on these people who know the most about vaccines, when we can get just another physician. I don't know that any of us would want to have brain surgery done by a physician who's licensed and his general practice is podiatry. Ms. Glynn. I believe that's why Congress gave discretion to the agencies involved in deciding which particular individuals are those that are so needed that it's reasonable to issue a waiver under the conflict of interest statute. Only the agency really is in that position to decide whether the qualifications the individual possesses are so special that a waiver is appropriate. Mr. Waxman. Mr. Dean, do you agree with the comments on these questions? Mr. Dean. Yes, I do. I would just add, Mr. Waxman, that the process that's established by the Federal Advisory Committee Act provides yet another level of protection potentially in that much of what an advisory committee does, and certainly the final recommendations issued by a parent committee, are subject to, I think, to a very public process, and at times a very intense public review by any number of people, whether it be the general public, the media, interest groups and so forth and so on. The Federal Advisory Committee Act provides a great deal of access to what advisory committees do. Mr. Waxman. And is it, in your experience, uncommon for agencies to seek waivers for its advisory committee members so they can participate in committee meetings? Mr. Dean. Mr. Waxman, I don't have any experience with the waiver process at all. I do know anecdotally that our customers do talk about the difficulty in finding qualified people to serve on advisory committees. And you alluded earlier to our hearing regarding the National Academy of Sciences, and that's certainly one of the issues that we discussed then. And I just might note that the NAS and similar organizations I think by and large use procedures that are very similar to those used in the executive branch in terms of screening for conflicts of interest, balancing advisory committees, providing access to committee deliberations and so forth. So it's not a problem that's unique to Government. I would point out that it's a problem that is, I think that we face, that universities face, that the NAS faces, that any organization that does research I think faces that very same problem. Mr. Waxman. Ms. Glynn, what's your experience? Is it uncommon for an agency to seek waivers for its advisory committee members? And do you think waivers are inappropriate if there's apparent conflict of interest? Ms. Glynn. To answer your second question first, no, I don't think it's inappropriate to seek waivers. And whether it's uncommon or not is a little hard for us to judge from OGE. We are told anecdotally by agencies, I have to support what Mr. Dean said, we are told anecdotally by agencies that they have difficulty obtaining the services of expert advisors for advisory committees, in that they would be unable to obtain the services they need in the absence of some type of waiver provision. Provided that the process is not actually tainted by bias, I don't think it's inappropriate to issue waivers at all. And I tend to think that some of these conflicts of interest tend to be more technical and it's reasonable to waive them. Mr. Waxman. Well, let me go back to Dr. Modlin. I have his CV. It's extensive. He's clearly one of the leading experts in his field. Just to cite a little bit about him, he was the medical director of the Clinical Virology Laboratory of the Mary Hitchcock Memorial Hospital in Lebanon, NH. He sat on several editorial boards. He's been a reviewer for over 20 medical journals. He's participated in numerous conferences and workshops on various vaccine issues. He's an expert. He knows more than the other 700,000 physicians in the country. So he's an expert. And he owns, as I understand it, 600 shares of Merck stock. Now, he doesn't remember getting a notice that when he looked at a Wyeth Lederle vaccine product, that another company that might have been affected by his decision might have been Merck. He doesn't recall. Mr. Burton put in the record that he was given some notice that one of the affected companies was Merck, affected products, all investigational, Merck, Virus Research Institute, NIAID, Wyeth, obviously Wyeth. So he was given that information. Is that an apparent conflict, if a man owns 600 shares of Merck? How important is a decision on this one issue going to affect the bottom line of Merck and therefore his stock price? How should we evaluate that conflict? Ms. Glynn. I'm not in a position to comment on the facts of an individual case. And I think we made clear before the hearing that I wouldn't be commenting on individual---- Mr. Waxman. Well, let me ask you a generic question. If a man owns stock in a drug company, let's say he was voting on that company's product. Would that be a conflict? Ms. Glynn. If he owns stock in a company, I'm speaking hypothetically now, if he owns stock in a company and he was voting on that company's product, yes, that would be a conflict of interest. He couldn't vote, in the absence of a waiver or some exemption applying. Mr. Waxman. Now, he's voting on another company's product, and that company may be in a competition with a company where he owns some stock. Is that an actual conflict of interest? Ms. Glynn. That may potentially be a conflict of interest, depending on whether the matter would have some sort of effect on the competitor in which he owns stock. Mr. Waxman. So just those facts alone wouldn't leap out as saying that people throughout this country should be wary that vaccines are not safe, because they're being approved by people like that example? Ms. Glynn. I certainly wouldn't be in a position to say that. But I think it's important in situations such as you described for the agency to examine these potential conflicts of interest in advance and make a determination whether they think the person should go forward acting or should be issued a waiver to permit them to go forward and act. Mr. Waxman. I presume that Dr. Modlin had to file a form or disclosure about his own financial holdings. Isn't that required of people who want to serve on these advisory committees? Ms. Glynn. Our regulations require that members of advisory committees--or I should say require that the so-called special government employees--file confidential financial disclosure forms. Mr. Waxman. And on that confidential financial disclosure, would a person have to list stock holdings? Ms. Glynn. Yes. Mr. Waxman. How about if they received compensation from that company? Ms. Glynn. Yes. Mr. Waxman. For whatever purpose? Ms. Glynn. Yes. They have to list all their assets, outside employment, typically outside consulting arrangements of any type, honoraria received or other forms of income of that type, liabilities, membership in certain organizations. It's relatively extensive. Mr. Waxman. Why isn't this public? Why can't the American people or the press go and look at all these disclosures, the way they can look at our disclosures? Ms. Glynn. Certain people in the executive branch, of course, do file public financial disclosure forms. They're the higher level employees or people who have political appointments. For the vast majority of other employees, a balance is struck that you don't want to put too many roadblocks in luring them into Government service. And for people who serve on advisory committees, they don't serve in the kind of positions that Congress has deemed appropriate for filing public forms. The criteria for filing public forms is set out in statute. And they just don't meet those criteria unless they're so highly paid by the Government and they work a certain number of days, then they would file a public form. Mr. Waxman. So the law is that that is not made public? Ms. Glynn. That's right. Mr. Waxman. Furthermore isn't the law that it can't be made public by anyone? Ms. Glynn. The law is that they may not be made public, that they're meant to be held as confidential. Mr. Waxman. Do you think that applies to the FDA? Ms. Glynn. Yes, sir. Mr. Waxman. HHS? Ms. Glynn. Yes. Mr. Waxman. CDC? How about the Congress of the United States? Ms. Glynn. I'm not in a position to comment on that. I think you would have to go to your own Ethics Committee. Mr. Waxman. But the spirit of the law that Congress passed was that that information is not to be made public. It doesn't say not to be made public only by FDA, CDC, HHS, and everybody else at Congress is--it doesn't say one way or the other. It just says shall not be made public. Ms. Glynn. The provision does not--it says it shall not be made public. When we provide confidential financial disclosure forms to Congress, for example, occasionally as part of financial disclosure review of people being nominated to certain positions, we alert Congress to the fact that they are confidential, that we're not making any public release of the form, and that Congress in effect has to make its own decision about whether they think they should. Mr. Waxman. Now, let me ask both of you, if Congress through its investigative committee started making public all these disclosures, what impact would that have on people's desire or willingness to serve in advisory committees? Ms. Glynn. My own view is I think it would have a chilling effect. What I understand from agencies is they have difficulty attracting people to these advisory positions to begin with, because they're typically low paying. And for the type of people they're trying to attract--very expert, well-known people--they're at a point in their careers where maybe isn't that much in it for them to be serving on these committees any more. And if they thought that they were giving their forms to the Government with a pledge of confidentiality, only to discover that wasn't being honored, I think it could have a chilling effect. Mr. Waxman. Mr. Dean, what do you think? Mr. Dean. I would tend to agree with that, Mr. Waxman. Mr. Waxman. So Congress ought to be very careful if we're going to start making public information that people were told was not going to be made public, not just because we're maybe violating the rights of those individuals, but we could have a chilling effect on people being willing to come in and serve on these advisory committees. Mr. Dean. I think it ought to be looked at very carefully before we make them public. Mr. Waxman. Mr. Chairman, I'm going to yield back the balance of my time. Mr. Burton. I'll just take a couple of minutes to make a couple of comments. We're talking about, what's the gentleman's name, Dr. Modlin, is that how you pronounce his name? He was a paid consultant for Merck. When the rotavirus was approved, it had a positive impact on other companies who were producing the rotavirus, because it showed that it has been approved for one company, and if it was a similar product, it would be approved for the other company. So Merck was going to be the beneficiary of that. Not only that, he was a paid consultant for Merck. Now, we don't know how much he was paid by Merck, but we know he was a paid consultant in addition to owning stock in Merck. Now, I don't know how the bureaucracy in Washington feels, but I think I can speak for an awful lot of parents around the country who want to have confidence that the vaccinations their kids are getting have been tested, and that there's been an unbiased judgment made as to whether or not they're going to be safe as well as effective. And the problem with the bureaucracy is, you keep saying, well, we can't do this because we might not be able to attract people to these advisory committees. Look, there are 700,000 doctors. There must be somebody else out there in that vast mass of humanity that has the expertise to be able to be on these advisory boards. And if a parent knew that there was a financial interest, possible conflict of interest from the person making the decisions on the vaccination, especially if we find out after the fact that kids died or are ruined for life, then I think the parents would say, you know, maybe we ought to make absolutely sure there's no conflict before we allow these people to be on these advisory panels making these decisions. Now, you know, you may disagree because you serve in a position in the bureaucracy where these decisions are made, and you think that that's the way it ought to be. I speak from a little bit of experience. I have two grandchildren, two. One got a hepatitis B shot and within 3 hours she was dying. She wasn't breathing any longer. They had to rush her to the hospital and she survived. Now, there's a lot of parents who have had that kind of problem with other drugs and other vaccinations. My grandson got nine shots in 1 day. He was a perfectly normal child. And within about 3 or 4 or 5 days, a week, he became autistic. Now, it may be a coincidence. A lot of people say that's coincidental. But the one thing I want to make sure of as a grandparent or as a parent is that the guys making these decisions or the ladies making these decisions, these doctors, these experts, don't have some kind of a conflict of interest that skews their judgment in one direction or the other. And the American people, well, you can say, we shouldn't be making this stuff public. Let me tell you something. Everybody in American who has a child who's had this kind of a problem wants this stuff made public, because they want to know if the people making these decisions do have a conflict of interest. We go to the doctors and we get these shots for our kids, and we do it believing that the health agencies are above reproach, that there's no danger to our children, or at least it's minimal. And we put great confidence in CDC and FDA and all of our health agencies. And if we find out after the fact that our child has had a terrible, serious problem, and then we find out after the fact that people on that advisory committee that made those decisions did have a conflict of interest, it will weigh on us very heavily, because we'll wonder, always wonder, if that conflict of interest led to the problem that we have in our family. And that's why the people on these advisory committees need to be above reproach. They need to be above reproach. If they have a conflict of interest, if they're a paid consultant for a company that has an interest in that product, if they have a large amount of stock in that company, and they're going to benefit from that product, or if they have some other reason to be tied to that company, they're getting grants from that company for scientific research, whatever it might be, they should not be on those advisory committees. And if they are, it should be made known at the outset so that people can make a decision based upon information, total information. And I just think it's wrong. You may shade this one way or the other, based upon what you feel is being with the Department of Ethics in this country. But if that's the way it is right now, I think the law should be reviewed and changed. There's got to be people out there that can serve on these advisory panels that don't have conflicts, who may have their judgment skewed in one direction or another. And there's got to be people out there that are going to make decisions based upon what's best for the people of this country and the kids of this country without any bias whatsoever. And that's what the American people, I believe, want. And I know as one who's been affected by this, that's what I want. Mr. Waxman. Mr. Chairman, my heart goes out to you, for your personal family tragedy. I don't know whether it was connected to the immunization or not. I just don't know the answer to that. I think you feel that it was connected, and I understand your strong feelings about it. But I don't think we ought to pick on Ms. Glynn and say that she believes something because she's part of the bureaucracy. After all, we're talking about laws that were adopted by the Congress. She didn't vote on these laws, we did. And under the law that we voted there is a whole mechanism to try to avoid against conflicts of interest. The disclosure had to be made by each of these people who wanted to be on an advisory committee, or we tried to get on advisory committees, and we told them, we want you on, you have to make a disclosure. So they made a disclosure, the agencies had the information. We'll find out when we hear from the next panel whether they had disclosures. But I presume they had disclosures about everybody on the advisory committee. Second, they may or may not have had waivers if they thought that it was important to allow these people to continue to serve, notwithstanding the fact that they may have had a conflict, such as owning shares. But what would gall me the most, as a parent and as a grandparent, was to think they got people who didn't have expertise in the science and started having them sit on these committees and approve drugs or vaccines that later turn out to be a problem. Now, it turned out there was a problem with this particular rotavirus vaccine. The fact that there was a problem with the rotavirus vaccine, and I don't know why they didn't foresee it, but it seems like from what I understand, they had some concerns about it and they were watching to see if this problem might develop that they feared might result from this vaccine. I have not heard any evidence that anybody, even if they had no conflict of interest to even talk about, made any decision that wasn't completely proper, scientifically and otherwise proper in terms of their evaluation of this particular vaccine. So, to say that because there's an apparent conflict with some of the people on the advisory committee, that that apparent conflict meant that the vaccine might have had a problem, is a huge leap. It is a huge leap, and we ought to have a lot more evidence before we make that kind of a statement publicly, because it does tend to scare people into thinking that decisions are made at FDA on drugs and vaccines or at the CDC on public health issues, by people who are sitting there thinking about how they're going to enrich themselves, and they're not evaluating the science. If they've evaluated the science, that's the first thing that's important. And we have no evidence that they didn't do that which was necessary. I don't want people who are beyond reproach. I don't want saints. I want people who know what they're doing and if there's a problem or a possible conflict, I want that disclosed and dealt with. And as I understand it, in the case of each and every one of these people who served on these advisory committees, their holdings, their income, were all disclosed to the people who were having them serve on the committee. So I don't think, notwithstanding the frustration that you and others may feel, that we ought to leap to conclusions based on what we have heard so far about some of the individuals that served on the advisory committee. Look at how Members of Congress are dealt with. We disclose our information and we assume therefore there's no conflict. Look how we handle our campaign finance laws. We disclose--we thought, except for some loophole that's now come up in the form of these non-profit organizations that are now being used to subvert the disclosure laws--but we worked under the assumption that we disclosed from whom we get the campaign money and therefore we've done what's necessary to show that if we act, people can judge whether we've acted in a conflict. These people who serve on advisory committees had to make that disclosure, and therefore for those who work in the agencies and handle the ethical questions, they can evaluate whether there was a breach of ethics. From Ms. Glynn's testimony, FDA seems to have a good record in ethics. CDC apparently has a good record in ethics. You're not talking about agencies that have a bad record on how they handle their ethics. And I think we need to get more information before you reach some of those conclusions that you've mentioned. Mr. Burton. I'd like to just ask my colleague one question, because I don't want to prolong this. The rotavirus that we're talking about, before the advisory committee made its recommendation, they already knew that there were adverse events, 1 out of 2,000 children had severe side effects. And yet they went ahead and approved this rotavirus anyhow. And it was put on the market and then withdrawn in less than a year because of severe side effects and problems. That's the thing I have concerns about. Mr. Waxman. I understand, and I share that concern as well. But without knowing more, it could well have been a judgment that was a mistaken judgment on the scientific evaluation of whether they thought that this was a likely result and therefore they should have foreseen it, or whether it was an unlikely result and they didn't know about it in the instance in which they reviewed it, and thought maybe these were isolated cases, and let the vaccine go forward. After all, vaccines can prevent a virus that is a killer all around the world of children and of infants. And you have to evaluate, with all products, the risk benefit calculation. Mr. Burton. I want to thank this panel for being here. We'll now go to our next panel. Our next panel consists of Linda Suydam, Dixie Snider, Kevin Malone, Jennie Slaughter, Bill Freas, and Nancy Cherry. Would you please come forward. Would you please stand. As I understand it, one person from each agency is going to be the principal spokesman, and the others will be there to help you, to assist you. So I guess you don't need to come forward, as long as you're sworn in. [Witnesses sworn.] Mr. Burton. Please be seated. Ms. Suydam, do you have an opening statement? Ms. Suydam. I do, Mr. Chairman. Mr. Burton. You're recognized. STATEMENTS OF LINDA A. SUYDAM, D.P.A., SENIOR ASSOCIATE COMMISSIONER, FOOD AND DRUG ADMINISTRATION; AND DR. DIXIE SNIDER, JR., M.D., EXECUTIVE SECRETARY, ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES, CENTERS FOR DISEASE CONTROL, ACCOMPANIED BY KEVIN MALONE, JENNIE SLAUGHTER, BILL FREAS, AND NANCY CHERRY Ms. Suydam. Thank you. Mr. Chairman, members of the Committee, I'm Linda Suydam, Senior Associate Commissioner of the Food and Drug Administration. I'm pleased to have the opportunity to be here today to discuss with you FDA's advisory committees. FDA is committed to selecting the most qualified members for our advisory committees, and to rigorously complying with the statutes and regulations governing those committees. FDA is a science based regulatory agency with regulatory responsibility for approximately 25 percent of the gross national product, including food, drugs and medical devices. FDA's mission is to protect and promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner. FDA's advisory committees play a critical role in this public health mission. FDA's decisions must be based on the highest clinical and scientific standards. To provide this critical scientific base, FDA has over 1,500 outside experts who provide FDA with essential expertise in highly specialized areas. Many of these experts serve as members on or consultants to our advisory committees. These members are public servants in every sense of the word. While they are compensated for their time at meetings, the amount of time and effort these members and consultants put into the public health needs of this Nation is a true public service. Currently, FDA is administratively responsible for a total of 32 advisory committees. Each has a core membership identified with each committee's charter. This membership is developed based on the complexity of the issues to be considered and the assessment of the issues by the agency as to the types and degrees of expertise needed. FDA's advisory committee system assists FDA's mission in the following seven ways: by providing independent expertise and technical assistance related to the development and evaluation of products regulated by FDA; by lending credibility to the product review process; by speeding the review of products by providing visible sharing of the responsibility for the evaluation and judgment of these products; by providing a forum for public discussion on matters of significant public interest; by allowing sponsors and consumers to stay abreast of trends in product development by reviewing process and changes in regulations and guidelines related to FDA-regulated industries; and providing external review of FDA's internal research projects. Committee members with voting status vote on substantive scientific and policy matters. It is extremely important to note, however, that these advisory committee recommendations are not binding and that panel members are not asked approval or disapproval questions. The agency retains all final decisionmaking authority. Thus, FDA alone decides to approve a product for marketing as safe and effective. The standing membership of advisory committees includes academicians, clinicians, consumers, and in some cases industry reps and patient or patient caregivers. In addition to the standing membership, temporary voting members and cons