New FDA Guidelines to Minimize Expert Advisors' Conflicts of Interest

The Food and Drug Administration (FDA) has instituted more-stringent guidelines to prevent conflict-of-interest problems in its process of selecting experts to help the agency make critical regulatory decisions, according to an August 4 announcement.

A guidance released by the agency outlines new conflict-of-interest standards to screen experts who serve on FDA advisory committees. Most notable, any expert with “potentially conflicting financial interests totaling more than $50,000” cannot participate in an advisory committee meeting. This maximum amount refers to the total personal financial interests held by the individual, his or her spouse, and minor children, including consulting income for a company, stocks or investments owned, patents/royalties/trademarks owned, and teaching/speaking/writing income. It does not include grants or funding to the person's employer such as a university or a hospital.

Advisors who have financial interests of less than $50,000 that pose potential conflicts of interest with a drug or device being discussed at a meeting may be granted a waiver if FDA officials deem the person's expertise to be essential. The agency intends to tighten the criteria for granting waivers and reduce the number of waivers issued.

The FDA often relies on advisory committees' advice for important regulatory decisions. Committee members are outside experts invited by the agency and usually include scientists, statisticians, clinicians, and consumer advocates. New product approvals (or rejections), safety warnings, and major labeling changes often hinge on the votes of an advisory committee. Although advisory committees' majority opinions or recommendations are not binding on the FDA, the agency usually follows these recommendations.

In recent years the agency has been criticized for using advisors who have potential or apparent conflicts of interest that may bias their decisions in favor of an industry or manufacturer. The Food and Drug Administration Amendment Act, passed by Congress in 2007, directs the FDA to take actions to prevent conflicts of interest in this evaluation process.

Additional guidance documents released by the agency have promised greater transparency of advisory committee information to the public. The agency will make briefing materials available on its Web site no later than two business days before an advisory committee meeting. Disclosures of any member's potential conflict of interest (financial interest below $50,000) and the content of waivers the FDA has granted them will be posted at least 15 days before the advisory meeting.

“These guidelines are designed to enhance decision making, increase transparency, and strengthen public confidence and trust in our regulatory decisions,” said Randall Lutter, Ph.D., the FDA's deputy commissioner for policy, during the press conference held to announce the guidelines.

In a draft guidance released at the same time, the FDA is proposing to standardize the criteria that determine what types of questions should be referred to advisory committees. The draft guidance has been posted on the Web site for public review and comments.

Guidance documents related to FDA advisory committee policies and additional details are posted at<www.fda.gov/oc/advisory/default.htm>.▪