FDA Losing Credibility With Public, Own Staff : Half of survey respondents in the agency said they did not think it was headed in the right direction.


It is easy to overlook the more subtle value that advisory committees can provide, said Dr. Gottlieb.

“The advice we are getting is not necessarily in many cases whether or not a drug can make it to market, but the contours of the approval, what the language should look like, what indications this drug should be approved for, should it be restricted, what is an appropriate postmarket monitoring plan,” he said.

Changes to the FDA Advisory Process

The FDA recently announced several steps it will take to codify the processes for bringing in expert voices and managing the agency's advisory committees.

“There are places where we can bring more consistency potentially to our processes. There are places where we can bring more transparency to the work we do. We know that and we feel that doing so is important to inspiring confidence in the process,” said Dr. Gottlieb.

Those changes are to include:

▸ Revamped advisory committee guidelines identifying more clearly the conditions under which conflict-of-interest waivers are to be granted.

▸ New guidance specifying when those waivers will be disclosed to the public and what information will be made available.

▸ New guidance specifying when briefing materials used by advisory committees will be made available to the public.

▸ Broader dissemination of advisory committee schedules through mailings to public groups and electronic notifications through FDA listservs and the Web site.

▸ A streamlined approach to the appointment of members to drug-related advisory committees.

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