FDA To Set Guidelines for Advisory Panel Members
FDA on Monday is expected to announce details of an ongoing effort to create public guidelines for addressing potential conflicts of interest on agency advisory panels, the New York Times reports. Advisory panels' recommendations on whether to approve experimental drugs usually are followed by FDA.
The new rules, which are being debated internally, would codify the agency process of granting waivers that allow experts with certain types of financial ties to drug makers to serve on advisory panels. The current waiver process "is mysterious to outsiders and confusing even to insiders," the Times reports.
Agency officials said the new rules would "make it all but impossible" for experts who receive money from pharmaceutical companies' marketing departments to serve on the panels, the Times reports. However, other restrictions might be loosened. For example, the new rules could end a waiver requirement for experts whose financial ties to drug companies involve only grants made to their universities, officials said.
The new rules, once finalized, will have to go through a public comment period.
Scott Gottlieb, deputy commissioner for medical and scientific affairs at FDA, said, "We need to be far more transparent," adding, "A lot of the judgments we make in granting waivers are case by case and not codified anywhere" (Harris, New York Times, 7/24).
Gottlieb said it would not be practical to eliminate all experts from panels who have financial ties to drug companies, a step that has been called for by some lawmakers and FDA critics. Gottlieb said that under such restrictions, the agency "probably couldn't recruit department chairmen," adding, "It would hinder us from recruiting all but junior faculty members" (Bridges, AP/Houston Chronicle, 7/23).
Robert Temple, director of FDA's Office of Medical Policy, said some experts in the past have been excluded from advisory panels because they had served on industry-sponsored drug-safety monitoring boards that check study results and ensure the safety of patients. "Those are the very best people, and they are anything but patsies," Temple said.
Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, said, "The idea that all the bright people in the medical world are working for the industry is just not right" (New York Times, 7/24).
Rep. Maurice Hinchey (D-N.Y.), a critic of FDA's waiver process, said it is "absolutely untrue" that experts could not be found without financial ties to the drug industry. Hinchey said any reform short of "eliminat[ing] the conflict" would be a "charade" (AP/Houston Chronicle, 7/23).