New FDA Advisory Committee Rules

The New York Times reported yesterday that the FDA will announce this week an effort to write guidelines detailing the kind of industry ties that are permitted for those who serve on its powerful advisory boards. The new rules, which are being debated internally and will have to go through a public comment period, are an effort to codify how the agency grants “waivers,” which allow experts with financial ties to drug makers to serve on the boards. The agency has almost complete discretion in granting waivers in a process that is mysterious to outsiders and confusing even to insiders.

If you have ever attended or reviewed a transcript of one of these FDA advisory board meetings, you can see they set forth all conflicts at the beginning of the meeting. It is incredible, typically every advisory board member has multiple conflicts on the drug they are asked to evaluate and consider for safety. This was permitted by informal waivers that could be granted for reasons that were never made clear to the general public. Accordingly, the FDA had absolute discretion in granting waivers. There is no question that the FDA must do a better job of keeping its advisory boards free from the pharmaceutical industry’s financial influence.

The rumors circulating on these new rules sound like they will be a great improvement. Reportedly, the FDA would make it virtually impossible for experts who get money from drug makers’ marketing departments to serve on FDA advisory boards.

The rules would also loosen other restrictions. Experts with ties to pharmaceutical companies through their academic institution may no longer need a waiver.

This is a difficult issue. Certainly, if a drug manufacturer is pouring a lot of money into your university, it may increase the expert’s power and authority within the university, leading to financial and other intangible gain. But there are very few academic experts engaged in research who do not have significant ties to the pharmaceutical industry. So it is a difficult balancing test. I’m not sure that these rules will solve the problem, but it is good to know the FDA is at least acknowledging the problem and looking for creative solutions.

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