Anyone who has been reading headlines has seen concerns raised by those on the Hill and among some consumer groups about the financial ties that exist between those who serve on Advisory Committees. The issue was raised a few years back in USA Today and continues to resonate.
The FDA has a procedure for screening advisors by having them reveal their ties to the industry through speaking fees, research grants and stock ownership. If a committee member is deemed to have ties that might bias an outlook, that committee member may be reduced to participation without a vote or recused entirely.
Yesterday, the FDA announced a new initiative to bolster existing guidelines. It is a good step, and hopefully a sign that the agency is finally taking criticisms to heart to the point that it is taking action. It should be part of a coordinated campaign that addresses an array of the issues the agency is facing. Time will tell.
The announcement outlines the following steps that the FDA is taking. It will:
- Issue a guidance identifying more clearly the conditions under which conflict of interest waivers are granted. Currently, for example, waivers can be granted to committee members under certain circumstances for participation in scientific endeavors related to the work of the committee, as well as for certain unrelated activities.
- Issue a guidance specifying when waivers of conflict of interest will be disclosed to the public and what information will be made available.
- Issue a guidance specifying when briefing materials used at advisory committee meetings will be made publicly available.
- Provide greater public dissemination of advisory committee schedules through increased mailings to public groups, and providing electronic notifications through an FDA advisory committee list serve and posting on the FDA web site.
- Implementation of a more streamlined approach to the appointment of members to the agency’s drug-related advisory committees.
The concerns raised by critics may be valid. On the other hand, there is a public health interest in ensuring that the people who sit on the Advisory Committees are people who are experienced in the type of research that pharmaceuticals undertake. It would not do to have a bunch of research naive scientists examining clinical trials who don’t understand their nuance. There is enough of that type of advice in government already.
For more specific information, you can read a speech by the FDA’s Dr. Scott Gottlieb and read an FDA comment on financial conflicts.