FDA House Committee Investigating Advisory Panels
The Washington Times today examines FDA advisory committees, the subject of "mismanagement and influence peddling" claims and consequently, an investigation by the House Government Reform Committee. Since the 1970s, the FDA has employed independent medical specialists to study and evaluate drugs and medical devices submitted to the agency for approval. Advisers analyze test results and documentation from medical manufacturers and host public hearings during which the manufacturers explain their products. Advisers, who receive $386.80 per day for their participation in hearings, serve for four years and cannot be reappointed until at least one year has passed. In addition, advisers cannot be on a committee for longer than eight years in a 12-year period. Advisers can only be removed for "special cause," a situation that has never occurred, the Times reports. According to John Treacy, director of the FDA's advisers and consultants staff, advisers work for the FDA as a "public service" and consider the appointment one of "prestige."
But in a letter sent last summer to then HHS Secretary Donna Shalala, House Government Reform Committee Chair Dan Burton (R-Ind.) charged that certain committees are "dominated by individuals with close working relationships" to drug manufacturers. He added that "conflict-of-interest rules employed by the FDA ... have been weak and inconsistent, enforcement has been lax and committee members with substantial ties to ... manufacturers are routinely given waivers to participate in committee proceedings." Before hearings, advisers are required to fill out disclosure forms by which they voluntarily declare any conflicts of interest. The Times reports that members "[c]ommonly" have some connection to manufacturers or products, whether they have served as a paid consultant or received money to design or test the drug maker's product. However, the FDA often finds conflicts of interest "inconsequential" or says a conflict is consequential but waives it because the individual has "special knowledge or expertise." Thus, an adviser who has helped develop a drug can evaluate its safety and efficacy, the Times reports.
Currently, the Government Reform Committee is investigating charges that the Cardiovascular and Renal Drugs Committee retains physicians with "multiple ties" to heart drug manufacturers and that certain committee members are "using the knowledge and influence gained from long FDA tenure and the implied promise of favorable consideration to gain consulting positions from drug makers or employment as designers or directors of late-stage clinical trials." The Times reports that FDA documents show that the committee's chair, Dr. Milton Packer, chief of circulatory physiology and director of the Center for Heart Failure Research at New York-based Columbia Presbyterian Medical Center, has served on FDA committees "almost continuously" since 1986 -- an apparent violation of the FDA's tenure rules. For his part, Parker says he served his term starting in 1986, then left "for years" before receiving the chair appointment in 1997. Even though records have shown that Packer has had direct ties to 17 "major" cardiovascular drug makers during his tenure as an adviser, consultant or expert, Parker "routinely receive[d] conflict-of-interest waivers [because] the FDA values his judgment," the Times reports. The Times adds that it is "easy to see why drug companies would benefit from employing someone like Dr. Packer, whose professional virtues include extensive knowledge of FDA workings and drug-approval requirements." It also is "easy to see why advisers who will sit in judgment of a drug maker's product might have little difficulty convincing manufacturers that it's wise to use their services as a consultant or clinical trial director -- and foolish not to," the Times reports (Gribbin, Washington Times, 6/18).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.