The U.S. Food and Drug Administration (FDA) released in March a new draft
guidance that would implement more stringent restrictions on financial ties
that present potential conflicts of interest for researchers and clinicians on
its advisory committees. The FDA is accepting public comments on the draft
guidance through May 21.
"The FDA is committed to making the advisory-committee process more
rigorous and transparent so that the public has confidence in the integrity of
the recommendations made by its advisory committees," said Randall
Lutter, Ph.D., the agency's acting deputy commissioner for policy."
Today's draft guidance document should provide more consistency in the
consideration of who is eligible to participate in advisory committee meetings
and would simplify the process."
Potential conflicts of interest for members of FDA advisory committees
became a critical issue for the agency in 2005. At that time an expanding
group of agency critics contended that conflicts of interest and undue
industry influence were the silent administrators in charge of the FDA.
As an example, critics cited advisory-committee votes that allowed the
non-steroidal anti-inflammatory drugs valdicoxib (Bextra) to remain on the
market and rofecoxib (Vioxx) to return to the market, despite serious concerns
over associations between both medications and cardiovascular adverse events.
Out of 32 members who voted to keep the drugs on the market, 10 had financial
connections to either Pfizer (maker of Bextra) or Merck (maker of Vioxx), or
In the end, the votes became moot as the FDA ordered Bextra removed from
the market, and Vioxx never returned. The controversy, however, has been alive
and well ever since and has included investigations by congressional
committees with jurisdiction over the FDA.
According to FDA officials, the agency currently screens all prospective
advisory-committee members before each meeting to determine whether the
potential for a financial conflict of interest exists. Under the law, the
agency may grant a waiver when certain criteria are met, such as when the need
for an individual's expertise out-weighs the potential for a conflict of
interest. However, waivers have been granted for many reasons, and critics
have charged that the agency has used different criteria to grant waivers to
members of different advisory committees, depending on the agency's needs at
The draft guidance, once finalized, would reduce the likelihood that the
process for recommending waivers would vary from meeting to meeting. If an
individual has disqualifying financial interests whose combined value exceeds
$50,000, after applying certain exemptions, the person would generally not be
considered for participation in the meeting, regardless of the need for his or
her expertise. If the financial interests are $50,000 or less, after applying
certain exemptions, the individual might be recommended to participate as a
nonvoting member. Only individuals with no potential conflicts would be
eligible to participate in meetings as voting members.
Under the guidance, "financial interest" means "the
potential for gain or loss to a person (or their family and outside
affiliations) as a result of the government's action on a particular topic.
Financial interests to be screened include, but are not limited to, stock
ownership, related research, and consulting arrangements."
"Guidance for Industry and FDA Staff: Procedures for
Determining Conflict of Interest and Eligibility for Participation in FDA
Advisory Committees" is posted at<www.fda.gov/oc/advisory/waiver/coiguidedft.html>.
Electronic comments on the draft guidance can be submitted at<www.fda.gov/dockets/ecomments>.▪