FDA Feeling Pressure to End Drug Company Conflicts of InterestAug 7, 2007 | Parker Waichman LLP, LLP
Critics of the Food and Drug Administration (FDA) have long said that the agency is too cozy with the pharmaceutical industry it is supposed to regulate. Now, pressure is being put on the FDA to cut some of those ties, as one congressman is attempting to push legislation that would eliminate conflicts of interest on the advisory panels that are part of the FDA’s decision-making process.
Last week, Representative Maurice Hinchey (D-NY) attached language to an appropriations bill that would ban the FDA from appointing advisory panel members who had any type of financial connections to the drug industry. Often researchers receive consulting fees and grants from pharmaceutical companies. Recently, this type of funding has attracted scrutiny, with critics of such practices questioning whether FDA advisory panel members who depend on drug companies for research grants could be completely objective when they make recommendations to the FDA. Such conflicts of interest have been cited as one reason defective drugs often make it to market.
The FDA normally grants conflict of interest waivers that allow such researches to sit on FDA advisory panels. In fact, five members of the advisory panel that looked into safety issues of the diabetes drug Avandia had received such waivers from the FDA. For example, Dr. John Teerlink, director of the heart failure clinic at the San Francisco Veterans Affairs Medical Center, had been paid as much as $50,000 by a competitor of GlaxoSmithKline, the maker of Avandia. Dr. Teerlink also owns stock in a health sector mutual fund. Dr. Teerlink was granted a waiver by the FDA, and voted to keep Avandia on the market.
Another panel member, Dr. Curt Furberg, is paid $200 each year by the National Institutes of Health to consult on a diabetes study that includes Avandia. Dr. Furberg served as an advisor for Avandia, but the FDA did not allow him to vote. Dr. Furberg has been among the critics of the FDA who have said that the agency tends to use advisors who are more likely to vote for drug approval. Dr. Steven Nissen, chairmen of cardiovascular medicine at the Cleveland Clinic and the author of a study that showed Avandia increased the risk of heart attacks, also received a conflict of interest waiver to join the panel. But like Dr. Furberg, Dr. Nissen was not allowed to vote.
While most would agree that something needs to be done to limit conflicts of interest, it is doubtful that Rep. Hinchey’s measure will make it into law. The bill moves to the Senate, where even stalwart liberals like Edward Kennedy (D-Mass) oppose it. Because so many researchers do receive funding from drug companies, critics of strict conflict of interest prohibitions fear that the FDA could end up with a serious shortage of eligible panel members.
Still, such actions are putting pressure on the FDA to mitigate the conflict of interest problem. Earlier this year, the FDA proposed rules that would disallow advisors with financial ties to drug companies over $50,000. And under the new rules, researchers who got grants or consulting fees under $50,000 within a 12 month period prior to joining a panel would be able to server as FDA advisors, but would not be allowed to vote. The FDA has yet to issue a final proposal on those rule changes.