Multiple advocacy groups went straight to the top of a still undecided FDA to advocate against loosening conflict of interest rules for advisory committees.

The December meeting between FDA Commissioner Margaret Hamburg and members of the Patient, Consumer and Public Health Coalition allowed the advocates to express their concerns about what they perceive as FDA eagerness to modify the conflict of interest rules. The meeting also underscores the challenges FDA faces as it works with Congressional leaders intent on reform while the agency itself is uncertain how it wants to proceed.

The consumer groups are worried that allowing committee members with conflicts on panels could erode FDA’s decision-making process, but many patient groups, as well as some members of Congress, believe the system has become excessively rigid, excluding many of the scarce experts in some disease areas Also see "PDUFA Word Association: Consumer Advocates Complain About Lack Of "Safety" In Commitment Letter" - Pink Sheet, 31 October, 2011..

But FDA may be partially on the consumer groups’ side. The agency said it has “not yet identified any legislative changes that would significantly enhance” its review of conflicts of interest.

Changing minds on Capitol Hill may prove difficult. Several bills already are pending that would loosen or adjust the rules and the issue is expected to be addressed in the upcoming Prescription Drug User Fee Act reauthorization later this year.

It also is unclear whether a formal adjustment will cause real change. FDA is using few of the waivers already allotted that permit vital but potentially conflicted experts to serve on committees. And the panels’ vacancy rate is decreasing, indicating FDA apparently is finding more of the experts it wants.

We Didn’t Say Ease The Rules

The meeting with Hamburg, held Dec. 12, 2011, included seven groups, among them Consumers Union and the Union of Concerned Scientists, who wanted to talk with the commissioner about problems with the conflict of interest rules.

Diana Zuckerman, president of the National Research Center for Women and Families, who was among the advocates that met with Hamburg, said in an interview the groups will be working to defeat congressional efforts to change the rules again.

Zuckerman said after the 2007 FDA Amendments Act did not adequately strengthen the rules, she does not want them eased.

“We feel that there can be exceptions and there already are places for exceptions,” she said. “That does not mean every advisory committee is incomplete without people who developed the product or have a financial interest in it.”

The meeting was a follow-up to a letter the Patient, Consumer and Public Health Coalition sent to Hamburg Aug. 3, 2011, challenging her assertion in an interview that patient and consumer stakeholders felt the rules should be loosened.

The letter said conflicts disclosed and not disclosed continue to undermine the advice the committees provide.

“FDA must do more to manage potential conflicts in order to keep the public trust,” the coalition stated.

The coalition, which includes Zuckerman’s group, told Hamburg about perceived problems in the conflict of interest system, Zuckerman said.

That included FDA’s recruiting system for new panel members. Zuckerman said stakeholders also could do a better job referring people qualified for the positions.

“We believe there are a lot of people who could be very valuable to advisory committees who are not being included,” she said.

The group also told Hamburg intellectual conflict of interest decisions should be more consistent, Zuckerman said.

She said if those who make prominent statements about a drug’s risks will be excluded from advisory committees, researchers and others who make statements about the strengths of a drug candidate should be given similar treatment Also see "FDA Intellectual Bias Policy Takes Wolfe Off Contraceptives Safety Review" - Pink Sheet, 6 December, 2011..

Zuckerman said FDA officials at the meeting disagreed with some of the coalition’s opinions, but Hamburg told them she understood their concerns.

The agency said in a statement it likes some of the requirements that were included in FDAAA, such as public disclosure requirements to promote transparency. It also wants to continue discussions with congressional leaders on whether modifications are necessary.

FDA Not Using Its Waivers

The pending bills that address conflict of interest rules are based on the opposite perception of the consumer coalition: that the rules should be changed to allow more potentially valuable experts on the panels.

Rep. Michael Burgess, R-Texas, included a proposal in a massive medical device-focused reform package last fall that would require FDA to consider the type, nature and magnitude of financial interest when assessing a potential conflict. It also said no one factor will be considered dispositive.

Burgess said when he introduced the bill that too many people were being kept off the committees.

Sen. Amy Klobuchar, D-Minn., also included conflict of interest rule changes in a separate medical device reform bill that would strike much of the conflict of interest section to state that potential advisory committee members are subject to the Ethics in Government Act of 1978 and other related laws.

Burgess said his bill could be included in the PDUFA legislation, but that drug shortage mitigation efforts likely will drive any FDA reforms that are included in the bill Also see "Drug Shortage Bills Likely Drivers Of PDUFA Add-ons" - Pink Sheet, 29 November, 2011..

FDA already has the ability to allow financially conflicted members of advisory committees through its waiver process. The agency was directed in FDAAA to reduce the number of waivers it issued in each year of PDUFA IV, which will end in October.

FDA data indicate its monthly target for participating advisory committee members that had received waivers was less than 12.78%, a goal derived from fixed percentage reductions required from the pre-FDAAA baseline.

But the agency has never come close to missing the target, suggesting that legislation increasing the number of waivers permitted wouldn’t necessarily increase the number granted: FDA is currently granting far fewer than it can already. From October 2010 to June 2011, the most recent data posted on FDA-Track, the number of waivers was never more than 1%.

During that period, FDA granted six waivers. That is about 0.5% of the 1,053 advisory committee members who participated in meetings during that period.

Vacancy Rate Declines, But Above Target

While FDA has shown improvement in filling the number of openings, it has not met its targets, according to agency data.

The agency had a vacancy rate slightly more than 25% in October 2010 and decreased it to just less than 20% by June 2011, the most recent data available. However, it is still well short of its goal of 10%.

The number of total agency advisory committee positions remained steady at 608 during that period, while the number of openings fell from 155 in Oct. 2010 to 120 in June 2011, a more than 22% improvement.

Office of New Drugs Director John Jenkins admitted in late 2009, after the agency realized the full impact of FDAAA, that the conflict of interest rule changes may have gone too far. He said at that time some meetings were canceled because FDA could not find the needed experts.

But in 2010, the agency said the new rules were not having a large impact on its ability to fill the positions.

The agency released new guidance on advisory committee financial interest and waivers in April 2010 and said its goal was to reduce vacancies to 10%. The revision of previous guidance documents was expected to increase transparency and be relatively in line with conflict policies for academic journals Also see "FDA Working To Fill Advisory Panel Vacancies While Tightening Conflict-Of-Interest Rules" - Pink Sheet, 21 April, 2010..

Conflict Of Interest Reform: With FDA Undecided, Consumer Groups Give Their Pitch

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