FDA announced it is taking steps to improve how its advisory panels are conducted, in accordance with recommendations from the Institute of Medicine.
One guidance document lays out how conflicts of interest will be disclosed from now on. All panelists must now publicly disclose any interests for which FDA has granted them a waiver. Another guidance recommends that panels adopt simultaneous voting, announce voting results immediately, and record how each member voted in the public record. Operating procedures for the panels have also been formalized. And the agency’s advisory panel Web site has been reworked to make it more understandable to the public.
Also of interest, the agency posted a report from a consultant that outlines how difficult it is to find experts who are totally free from conflicts, and proves that panelists who have received conflict waivers are usually more qualified than panelists without them. This is a long-overdue response to the mainstream media belief that all conflicts are by definition wrong. Let us hope it gets the coverage it deserves.
– From MD&DI’s blog.
The Combination Products Coalition is conducting a survey about the need for guidance in the combination products area. The results will be shared with FDA’s Office of Combination Products and could impact its decisions about what guidances to work on next. The survey can be found here.
The deadline for completing the survey is Nov. 30. Respondents should be professionals working on combination products. Respondents will not be identifiable unless optional demographic information is given. One response per organization is requested, though collaboration is acceptable.
FDA has selected 15 people to serve on its new risk communication advisory panel. The purpose of the panel is to “advise FDA about how best to communicate to the public about the risks and benefits of FDA-regulated products so as to facilitate their optimal use,” according to an FDA release.
There is little doubt that FDA needs to do a better job with this. The agency and the media have both been guilty of overblowing minor problems, minimizing major ones, and otherwise addressing issues in a way that is out of proportion to their significance. Congress isn’t helping either — it used to virtually ignore FDA matters, now it sees any potential controversy as a chance for grandstanding and spotlight-hugging. But what kind of a consensus are 15 people going to be able to come to? There needs to be a focused sense of mission, and a strong set of procedures. Otherwise the panel will be little more than an excuse for FDA to claim it is doing something and for panel members to add to their resumes.
– From MD&DI’s blog.
