Did you ever think the FDA or other industry-government regulatory and advisory boards were free from a conflict of interest? If so, guess again. Today the FDA is issuing some new guidelines that are more strict and may clean up some of the image and voting of the advisory committees. But to much of America and to any aggressive reporters, the new guidelines are still going to make this look somewhat sleazy or full of ongoing conflicted interests.
This is by no means the same sort of "we are looking into the consulting fees and stock trading of our members," but this one may be open for criticism in the papers over the next few days. Here is the statement I received in an email:
FDA PROPOSES NEW, TOUGHER PROCEDURES FOR MEMBERSHIP ON ADVISORY COMMITTEES
The U.S. Food and Drug Administration (FDA) todayannounced new draft guidance that would implement a more stringentapproach for considering potential conflicts of interest for itsadvisory committee members and for recommending eligibility for meetingparticipation. FDA is accepting public comments on the proposal for thenext 60 days.
“FDA is committed to making the advisorycommittee process more rigorous and transparent so that the public hasconfidence in the integrity of the recommendations made by its advisorycommittees,” said Randall Lutter, Ph.D., FDA’s acting deputycommissioner for policy. “Today’s draft guidance document shouldprovide more consistency in the consideration of who is eligible toparticipate in advisory committee meetings and would simplify theprocess.”
FDA currently screens all prospective advisorycommittee participants before each meeting to determine whether thepotential for a financial conflict of interest exists. Under law, FDAmay grant a waiver when certain criteria are met, such as when the needfor an individual’s expertise outweighs the potential for a conflict ofinterest.
The draft guidance document would replace guidance issued in 2000 on FDA Waiver Criteria (www.fda.gov/oc/advisory/conflictofinterest/intro.html).The 2000 guidance attempted to address the complex set of variablesthat can be applied in reaching a decision about an individual advisorycommittee participant. However, because of its complexity, FDAofficials found it difficult to achieve consistent results that thepublic could readily understand.
This new guidance (www.fda.gov/oc/advisory/waiver/coiguidedft.html)would reduce the likelihood that the process for recommending waiverswould vary from meeting to meeting. In addition to a more streamlinedapproach for considering who may participate in meetings, FDA wouldtighten its policy for considering eligibility for participation. If anindividual has disqualifying financial interests whose combined valueexceeds $50,000, after applying certain exemptions, the person wouldgenerally not be considered for participation in the meeting,regardless of the need for his or her expertise. If the financialinterests are $50,000 or less, after applying certain exemptions, theindividual might be recommended to participate as a non-voting member.Only individuals with no potential conflicts would be eligible to fullyparticipate in meetings as voting members.
Financial interest means the potential for gainor loss to a person (or their family and outside affiliations) as aresult of the government’s action on a particular topic. Financialinterests screened include, but are not limited to, stock ownership,related research and consulting arrangements.
A notice will appear in the Federal Register soon. To submit electronic comments on the draft guidance, visit www.regulations.gov or www.fda.gov/dockets/ecomments.Written comments may be sent to: Division of Dockets Management(HFA-305), U.S. Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD, 20852. Comments must include the docket number 2007D-0101.
Today’s announcement is part of the agency’soverall effort to improve its advisory committee process. As announcedin January, FDA will be establishing a new advisory committee on how toimprove FDA’s communication policies and practices consistent with thebest available and evolving evidence. In addition, the agency launcheda Web page dedicated to improving recruitment of advisory committeemembers and enhancing public participation in the process. For moreinformation, go to: www.fda.gov/oc/advisory/.
Advisory committees provide FDAwith independent advice from outside experts on issues related to humanand veterinary drugs, biological products, medical devices, and food.In general, advisory committees include a chair, several members, plusa consumer, industry, and sometimes a patient representative.Additional experts with special knowledge may be consulted as needed.Although the committees provide advice to the agency, theirrecommendations are not binding and FDA makes final decisions.
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