FDA Responds to Conflict of Interest Uproar

Posted 18 January 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) responded to critics of an FDA advisory board decision on Tuesday, saying that critics of the decision exhibited a "lack of understanding about our selection and evaluation process, as well as federally mandated limitations on the type on information [FDA] can share" with the public.

Utilizing the new FDA Voice blog, Jill Hartzler, acting associate commissioner for special medical programs, sought to clarify the agency's conflict of interest policies and the work the agency does to root out potential sources of bias. FDA will not allow participants with financial interests or the "appearance" of conflicts of interest unless a waiver is granted by FDA, which is then posted to FDA's website.

If there is no need for a waiver, "the information submitted by the committee members is considered confidential ," and FDA is legally precluded from releasing the information.

Hertzler said that she wanted to "specifically address recent reports related to the 8 December advisory committee meeting" that have resulted in some controversy for the agency.

The Wall Street Journal reported last week that an advisory committee convened to assess the safety of birth controls products containing drospirenone-containing oral contraceptives-including the Bayer products Yaz and Yasmin-had three members on the panel that had conflicts of interest that had not been disclosed to the public. A fourth member of the committee, Public Citizen's Sidney Wolfe, was pulled from the committee for "intellectual conflict of interest" after criticizing the products in advance of the meeting.

Wolfe eventually served as a non-voting member of the committee, which concluded in a 15-11 vote that the products had a favorable risk-benefit ratio, and 21-5 in favor of labeling changes to indicate a higher likelihood of blood clots as a result of taking the products.

"Based on our review of the members' reported financial interests, we did not identify any financial interests that would have precluded their participation," said Hertzler. However, Hertzler noted that both she and FDA Commissioner Margaret Hamburg "desire to create a more consistent and transparent process for disclosing conflict of interest waivers granted by the agency." The agency is working with the Institute of Medicine (IOM) on best practices to handle potential conflicts of interest.

Hertzler further noted that waivers granted by the agency have fallen from 15% of all meeting participants in FY2007 to just 1% in FY2011.

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