FDA announces improved policies on transparency, disclosure for advisory committees

U.S. Food and Drug Administration (FDA) officials announced they have introduced several improved policies and procedures designed to strengthen the agency's management of FDA advisory committees.

The improvements include stricter limits on financial conflicts of interest for committee members, refined voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to matters discussed at advisory committee meetings.

FDA officials described the policies and procedures in four final guidance documents and detailed the proposed policy changes in a draft guidance, according to an FDA news release. The FDA announced the availability of the guidance documents in this week's issue of the Federal Register.

Copies of all of the guidances are available on the FDA's Web site [www.fda.gov].

Most of the changes in the final guidance documents will go into effect immediately, and all are expected to be fully implemented within 120 days, according to the news release.

"The FDA's regulatory decisions affect the health of millions of Americans, and we don't make those decisions in a vacuum," Randall Lutter, PhD, deputy commissioner for policy, said in the press release. "It's imperative that we seek advice from independent experts and that we do so in a way that is public, open and transparent. [This week's] announcement strengthens our processes."

Two of the guidance documents address the FDA's processes for evaluating and disclosing information about potential conflicts of interest, as well as the FDA's waivers allowing participation in advisory committee meetings.

Prior to each meeting, advisory committee members are screened by FDA staff to determine whether they have a potential financial conflict of interest, such as owning grants, stock holdings or contracts with a company that would be affected by the committee's recommendations. With the new policy, the FDA instituted a cap of $50,000 as the maximum personal financial interest an adviser may have in all companies that may be affected by a particular meeting.

If an adviser's personal financial interest is greater than $50,000, he or she will not be allowed to participate in that meeting. If it is less than $50,000, FDA officials may, in certain situations, grant a waiver, but will do so only if they determine that there is an essential need for the adviser's particular expertise, according to the press release.

Waivers, which include a description of the adviser's personal financial interest and why the need for the expertise was essential, will be posted on the FDA's Web site in advance of the meeting.

The FDA also reported that the agency intends to post briefing materials given to advisory committee members prior to a meeting on the FDA's Web site at least 48 hours before the meeting is scheduled to occur.

Also in their new report, FDA officials are recommending that advisory committees use a process of simultaneous voting in their meetings, rather than voting sequentially. Simultaneous voting avoids "voting momentum" in which some voters may be influenced, even subconsciously, by the votes of those who precede them, according to the press release.

The agency also recommends that the results of votes be announced immediately in the meeting, and the FDA intends to post on the FDA Web site a list indicating how each member voted. Any posted list will be part of the permanent record of the meeting, according to the news release.

For more information:
www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html