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>.▪