FDA Commissioner Margaret Hamburg’s willingness to explore changes in conflict-of-interest policies for advisory committee members, coupled with a push for reforms by industry and lawmakers, suggests a relaxation of current screening requirements could become an easy add-on to the Prescription Drug User Fee Act reauthorizing legislation in 2012.

During a July 25 talk to the consumer advocacy group Public Citizen, Hamburg said she is open to regulatory and legislative changes that would make it easier for FDA to recruit outsiders with the level of expertise needed to give the agency sound advice.

The agency has been aggressive in screening for conflicts of interest in recent years, coming in well below the annual waiver cap created by FDAAA.

“I look at it as a complicated issue,” Hamburg said of difficulties the agency has had in recruiting non-conflicted experts to serve on its advisory committees.

“It’s one where I think we can’t have a static policy. … We need to keep looking at it with the goal of making sure that we have the right scientific expertise to make decisions unfettered by other distorting conflicts and that our goal is to best serve patients.”

Evolving Limits

The FDA Amendments Act of 2007, which encompassed the last PDUFA reauthorization measure, tightened limits on conflict-of-interest waivers for advisory committee members. It placed an annual cap on the percentage of waivers granted across the agency and required a determination that the individual receiving the waiver offered the committee “essential expertise.”

The agency’s internal guidelines for conflict-of-interest screening have evolved in the wake of FDAAA. In an August 2008 final guidance document, the agency relaxed voting eligibility requirements introduced in a 2007 draft document (Also see "Advisory Committee Policy Allows Members With Financial Conflicts To Vote" - Pink Sheet, 11 August, 2008.).

In April 2010 the agency issued another draft guidance on public disclosure that proposed requiring potential panelists to identify the source of any financial conflicts (Also see "FDA Working To Fill Advisory Panel Vacancies While Tightening Conflict-Of-Interest Rules" - Pink Sheet, 21 April, 2010.).

The agency has been aggressive in screening for conflicts of interest in recent years, coming in well below the annual waiver cap created by FDAAA.

In fiscal 2010, FDA was allowed to grant waivers for up to 13% of all committee members. However, the actual percentage of waivers granted was just 1.1%, Advisory Committee Oversight and Management Staff Director Michael Ortwerth told a recent CBI conference on advisory committee preparation.

Yet the waivers that were granted reflect the struggles FDA has had in recruiting individuals with relevant subject matter expertise (see related story, Also see "FDA Advisory Committee Waivers Reflect Recruitment Challenges" - Pink Sheet, 1 August, 2011.).

Hamburg said she has heard the complaints from many sectors about the difficulty in finding knowledgeable experts to sit on committees.

“The concern about the limits on FDA use of experts is a concern that isn’t limited to any one stakeholder group,” said Hamburg, who began meeting with various organizations shortly after joining the agency in 2009.

“I was a little bit surprised but I heard from virtually every stakeholder group spontaneously that this was a concern of theirs.”

Industry and patient groups also have formally asked for changes, submitting requests to the docket FDA opened on streamlining regulations (see related story, Also see "FDA Gains No Impartiality Benefit From Conflict-Of-Interest Policy, Advocates Say" - Pink Sheet, 1 August, 2011.").

Changes Would Involve Congress

Hamburg suggested, however, that FDA was unlikely to initiate policy changes on its own.

“Any changes that would happen would no doubt be done both in concert with Congress and would be done through an open notice-and-comment … process where we could get input from all stakeholders,” she said.

Industry and some members of Congress already are chomping at the bit to relax conflict-of-interest rules.

The Biotechnology Industry Organization’s reform proposals for FDA include expanding access to external scientific experts, in part by easing conflict-of-interest rules for advisory committee members.

BIO is not pushing its package of regulatory reforms for inclusion in the PDUFA V reauthorization, instead preferring a clean agreement (Also see "BIO’s "Big Ideas" For FDA Reform Are Too Big For PDUFA" - Pink Sheet, 4 July, 2011.).

However, a recent House Energy and Commerce Committee Subcommittee on Health hearing on the user fee reauthorization provided a forum for Rep. Michael Burgess, R-Texas, to complain about the FDAAA limits on waivers (Also see "Women's Right To Choose Avastin Debated During House PDUFA Hearing" - Pink Sheet, 11 July, 2011.).

Burgess also questioned the absence of a breast cancer specialist from the panel convened to consider the Center for Drug Evaluation and Research’s proposal to revoke the metastatic breast cancer claim for Genentech’s Avastin.

Only six of the Oncologic Drugs Advisory Committee’s 14 members participated in the two-day Avastin hearing last month, along with one temporary voting member. Four other ODAC members were recused for conflicts and four were unable to attend (Also see "Less Than Half Of ODAC Members Will Participate In Avastin Hearing" - Pink Sheet, 23 June, 2011.).

Speaking with reporters after her talk at Public Citizen, Hamburg said there is a “renewed sense of interest” in conflict-of-interest screening procedures, partly because the PDUFA reauthorization process provides an opportunity for public discussion among those with strong views on the subject.

Not surprisingly, Public Citizen opposes any effort to relax conflict-of-interest screening procedures. “Every area where you see the connection, financial interests always tilt the way people evaluate whether it’s drugs or anything else,” Public Citizen President Robert Weissman told Hamburg. “I think the record at FDA is you need stronger protection rather than less.”

By Sue Sutter

Conflict-Of-Interest Policy Relaxation For FDA Cmtes. Could Be Easy PDUFA Add-on

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