Executive Health April 21, 2010, 16:00 EST

FDA to Broaden Disclosure on Advisers' Conflicts of Interest

Agency has faced criticism in the past over the issue

By Steven Reinberg
HealthDay Reporter

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WEDNESDAY, April 21 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday proposed new guidelines to help give the public more information on the experts the agency places on its all-important advisory committees, which help approve drugs and devices.

The FDA has in the past been criticized for allowing individuals with conflict of interests to serve on these panels. In some cases, prospective committee members with financial or other ties to a product under discussion can still receive special conflict-of-interest waivers that allow their participation on an advisory panel.

But on Wednesday the agency proposed new guidelines that, in its words, would "expand transparency and [public] disclosure" whenever one of these waivers are handed out.

FDA advisory committees provide the agency with advice on a wide range of topics, including drugs, medical devices and tobacco. They also provide key advice on regulatory decisions, such as product approvals and general policy matters. While the FDA is not bound to follow its committees' recommendations, it usually does.

"The primary goal of the advisory committee process is to bring high-quality input to FDA to inform our decision making," Jill Hartzler Warner, the FDA's acting associate commissioner for special medical programs, explained during a press conference Wednesday.

The new guidelines would expand the information disclosed to the public whenever the FDA grants a conflict-of-interest waiver, Warner said.

The FDA has 49 advisory committees with room for more than 600 members. Currently, there are over 200 vacancies on these committees, according to the agency.

Under the proposed guidelines, the FDA would disclose conflict-of-interest waivers before committee meetings, naming the company or institution and any financial interest advisers might have as well as the specific conflict of interest.

"In my view, it is clearly better for the agency in fulfilling its public health mission when advisers have no conflicts of interest," FDA Commissioner Dr. Margaret A. Hamburg wrote in a letter to senior agency officials. "FDA staff should search far and wide for experts who have the requisite knowledge without conflicts of interest. At the same time, however, I recognize the fact that many of the top authorities in specific areas may have conflicts of interest."

In the letter, Hamburg outlined three steps to consider before a conflict-of-interest waiver is given. These include:

Defining the nature of the conflict of interest before recommending giving a waiver. "Not all conflicts are created equal. For example, an academic researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than the researcher who conducts studies for the company directly," she wrote.
Weighing the kind of advice the committee is being asked for. "A waiver may be more appropriate for a meeting about a policy issue affecting a class of entities or products than for a meeting focusing on approval of a specific product," Hamburg explained.
Determining why expert advisers without conflicts could not be found and why the individual under scrutiny is needed.

"Conflict-of-interest waivers for scientific advisers have been controversial, however," Hamburg wrote. "If FDA is perceived to rely heavily on conflicted experts, then confidence in the agency's decision-making can be undermined."

More information

For more on the proposed guidelines, visit the U.S. Food and Drug Administration.

SOURCES: April 21, 2010, teleconference with Jill Hartzler Warner, J.D., acting associate commissioner for special medical programs, U.S. Food and Drug Administration; April 21, 2010, letter, Margaret A. Hamburg, M.D., commissioner, U.S. Food and Drug Administration