FDA uses advisory committees to provide expert advice and make recommendations to help the agency reach regulatory decisions, particularly concerning controversial issues or new products. FDA advisory committees are subject to the Federal Advisory Committee Act (FACA), which requires that committee memberships be fairly balanced in terms of views presented and the functions to be performed by the advisory committee. FDA advisory committees have charters that explain the purpose of the committee and specify the number of standing committee members and the expertise needed by the members. FDA advisory committee members can be medical professionals, scientists, researchers, industry leaders, consumers, and patients. At an advisory committee meeting, committee members generally meet publicly to discuss and evaluate information about a specific issue. Depending on the issues or products to be discussed at a committee meeting, a committee member may have a potential financial conflict of interest. In that event, FDA decides whether the member’s expertise is needed for discussing those issues or products, and if so, whether the member should be granted a conflict of interest determination—a waiver or an appearance authorization—to participate in the meeting. The members who do participate in the committee meeting may make recommendations to FDA—by voting or by consensus through discussions—that are nonbinding on the agency. (See app. III.) FDA Advisory Committees FDA has 31 advisory committees that are administratively attached to FDA centers or to the Office of the Commissioner. Most of the advisory committees—25—are attached to three FDA centers: CDER has 16 committees, CBER has 5, and CDRH has 4. (See app. IV.) Advisory committees usually meet as individual committees but may meet jointly to consider issues involving shared interests. Joint committee meetings may involve two advisory committees from the same center or from two different centers depending on the issue to be discussed. Advisory committees may also have subcommittees that meet to review specific information that may be presented later to the full advisory committee. FDA may permit an advisory committee member—standing or temporary—who has a conflict of interest and whose expertise is needed, to participate in a meeting under certain circumstances. There are four conflict of interest determinations—three statutory waivers and an appearance authorization as provided for in OGE regulations—that FDA can use to permit members with a conflict of interest or the appearance of a conflict of interest to participate. Federal law prohibits federal employees, including SGEs, from personally and substantially participating in an advisory committee meeting involving a particular matter that would have a direct and predictable effect on the employee’s financial interest or the interests of others specified by law. In determining whether an FDA advisory committee meeting involves a particular matter, FDA officials told us that they first consider each topic to be discussed at the meeting and determine whether it involves specific parties, a class of persons, or the interests of a large and diverse group of people. If one of the meeting topics involves specific parties or a class of persons, FDA officials then determine whether the advisory committee members who will attend the meeting have any conflicts of interest or the appearance of conflicts of interest involving that meeting topic. Officials told us if they are uncertain whether a meeting topic is a particular matter, the issue is referred to FDA’s ACOMS and EIS. EIS may refer the issue to HHS’s general counsel which may also seek advice from the OGE. The law has two waiver provisions that allow standing and temporary members to participate in an advisory committee meeting if certain criteria are met. One waiver—known as a § 208(b)(3) waiver—applies only to SGEs serving on an advisory committee subject to FACA. When granting this waiver, FDA certifies in writing in advance that the need for the SGE’s services outweighs the potential for a conflict of interest at a specific upcoming meeting. Another type of waiver—known as a § 208(b)(1) waiver— applies to federal employees generally, including SGEs and those not employed by FDA but who are members of FDA committees. When granting these waivers, FDA must determine that the interest involved is not so substantial as to be deemed likely to affect the integrity of the services which the government may expect from that individual. FDA may grant a member a full or a limited waiver—a written certification—to allow participation in the meeting. A full waiver may allow a member to participate in the discussions and to vote on recommendations. FDA may also grant a limited waiver to allow a member to discuss but not to vote on the recommendations. In addition, there are certain situations in which the member’s financial interest qualifies for an exemption from the application of the conflict of interest statutes and regulations applicable to federal employees, as provided by OGE regulations, and participation will be permitted despite the outside interest. In addition to 18 U.S.C. § 208, there was a provision in the Food and Drug Administration Modernization Act, in effect prior to October 2007, which effectively prohibited CBER and CDER advisory committee members from voting on committee meeting topics involving clinical investigations or approvals of drugs or biologics in which the member or his or her immediate family could gain financially from the committee’s advice. However, FDA could grant a waiver of this voting restriction—known as the § 355(n)(4) waiver—to a member if FDA determined that his or her participation was necessary to provide the committee with essential expertise. No waiver could be granted if the meeting involved the member’s own scientific work, such as work done by the member to develop a new drug being considered for approval by CDER. Finally, federal regulations require the consideration of the appearance of a conflict of interest for advisory committee members who will be participating in a specific-parties meeting when there are circumstances in which the member’s impartiality could be questioned. The appearance of a conflict may be created when someone in the advisory committee member’s household has a financial interest that will likely be affected by the committee’s actions or when one of the parties involved in the meeting has a close personal or professional relationship to the committee member. To grant an appearance authorization, FDA determines that the interest of the agency in the member’s participation in an advisory committee meeting’s topic outweighs the concern that a reasonable person with knowledge of the relevant facts would question the member’s impartiality in the matter before the advisory committee, which may call into question the integrity of FDA’s programs and operations. (See table 1 for a summary of the four conflict of interest determinations.) The appropriate FDA center review division and committee management staff for the advisory committee meeting decide whether a member meets the requirements for an applicable conflict of interest determination to allow him or her to participate. To assist in making conflict of interest determinations, FDA uses its Waiver Criteria 2000 guidance, which provides policies and procedures for handling conflicts of interest. On the basis of the advisory committee meeting’s topic and its designation, the center review division involved in the advisory committee meeting typically compiles a list of companies and products affected by the meeting’s topic. The advisory committee management staff then sends a memorandum with the final list of companies and products and the FDA Form 3410—the FDA financial disclosure form—to the advisory committee members. Members review the memorandum, complete the Form 3410, and report back to FDA on whether they believe they have any personal or imputed financial interests and past involvements with the affected companies and products listed for the upcoming advisory committee meeting’s topic. The FDA center advisory committee management staff for the particular advisory committee review members’ FDA financial disclosure forms and determine whether a member has a potential conflict of interest for the meeting or a part of the meeting. If a member has a conflict, FDA can accept a member’s decision to not participate because of the member’s own decision that he or she has a conflict of interest, exclude or disqualify a member from participating, seek another individual with the appropriate expertise needed to participate who has a less significant or no conflict of interest, or decide the member’s expertise is needed, and that the member meets the criteria for a conflict of interest determination to allow him or her to participate in the meeting discussion and vote. If there is a question about whether a member should be granted a determination, the center’s advisory committee management entity may seek advice from the review division. If there are further questions about whether the determination should be granted, advice may be sought from FDA’s ACOMS and EIS. ACOMS and EIS review all conflict of interest determinations before their final approval. The final decision to grant or deny a determination is made by the FDA Associate Commissioner for Policy and Planning. (See fig. 2.) Since November 2005, FDA has been subject to requirements related to public disclosure of its conflict of interest waivers on its Web site. From November 2005 until October 2007, FDA had been required by law to publicly post the nature and basis of conflict of interest waivers on its Web site. As of October 2007, the FDA Amendments Act of 2007 require FDA to publicly disclose on the agency’s Web site, prior to every advisory committee meeting, the reasons for all waivers granted as well as the type, nature, and magnitude of the financial interests being waived. In October 2007, FDA announced draft guidance to implement agencywide procedures for the public disclosure of (1) the type, nature, and magnitude of any financial conflict of interest for which an advisory committee member has been granted a waiver for a committee meeting on its Web site, and (2) conflict of interest waivers that would be written so that information protected from public disclosure would not appear in the waivers and thus would not need to be redacted. Public disclosure at an FDA advisory committee meeting can also, for example, include an announcement naming the attending members who have conflict of interest determinations. Prior to the FDA Amendments Act of 2007, FDA employed several methods to recruit candidates for advisory committees and to evaluate candidates by prescreening them for advisory committee membership.