Congress Grapples With Industry Influence at FDA

Efforts to free the Food and Drug Administration from the pharmaceutical industry's excessive influence seesawed between success and failure in the same week, as the House voted to ban drug company scientists from FDA advisory committees while an agency whistleblower revealed that a new drug safety board has been tilted in favor of the drug companies. New Drug Safety Board Biased Towards Industry David Graham, the FDA scientist who publicly revealed the agency's missteps in the Vioxx scandal, recently told the Washington Post that a new drug safety office created in the aftermath of the scandal is already "severely biased in favor of industry." Reeling from disclosures of the agency's failure to address the safety of Vioxx and other drugs after they have been introduced to the market, FDA announced in February the creation of a new Drug Safety Oversight Board (DSB) charged with focusing on post-market drug safety issues. Although intended to provide independent oversight of the Center for Drug Evaluation and Research (CDER), the DSB has been located within CDER, and 11 of the 15 voting members are senior CDER management. The new DSB has been compromised not just by its membership roster but also by its lack of authority to do the job it was created to do. Although it was created in the wake of FDA's inaction in the Vioxx case, the new DSB has been given no authority to pull drugs deemed dangerous off the market. Sen. Chuck Grassley (R-IA) echoed Graham's criticism of the DSB, adding in a letter to acting FDA commissioner Lester Crawford that the board does not go far enough in ensuring drug safety and, in fact, amounts to "nothing more than the status quo." Grassley also questioned FDA's decision to make the proceedings of DSB private. Unlike advisory committee meetings, which are required by law to be conducted in the open, DSB deliberations will be kept from the public. In his letter, Grassley expressed surprise "that the FDA has chosen to make DSB deliberations private at a time when the agency should be making every effort to improve transparency and accountability." Grassley asked Crawford to explain how FDA will ensure the independence and objectivity of the board. House Works to Block Industry Bias on Advisory Panels Meanwhile, the House appropriations committee voted on June 8 to limit conflicts of interest on FDA advisory committees. The House voted 218-210 to pass an amendment offered by Rep. Maurice Hinchey (D-NY) to the FDA/USDA appropriations bill, prohibiting any expenditure of funds for advisory committees that waive conflict-of-interest provisions. FDA uses advisory committees of outside scientists to advise the agency on the safety and effectiveness of drugs and medical devices. Scientists on these panels have frequently been found to have ties to the makers of the drugs and medical devices under review by the advisory committees. For instance, 10 of the 32 scientists on FDA's COX-2 advisory panel had ties to manufacturers of the drugs. Because the amendment is limited to advisory committees, it would not apply to the Drug Safety Oversight Board.
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