Newly identified problems with the apparent conflicts of interest of FDA advisory committee members have not dissuaded the sponsor of legislation that would reform the rules.

However, the negative publicity may give more ammunition to advocacy groups pushing the agency to resist any loosening of the standards.

“The rules don’t make any sense,” Burgess said. “That’s the problem.”

Rep. Michael Burgess, R-Texas, said his thinking on the issue has not changed, despite revelations about several members of a joint meeting of the Reproductive Health Drugs and Drug Safety and Risk Management advisory committees having financial ties to Bayer HealthCare LLC and other manufacturers of drospirenone products such as Yaz, Yasmin, Beyaz and Safyral.

The Dec. 8 meeting was scheduled to discuss oral contraceptives containing drospirenone amid concerns about a risk of blood clots.

Burgess said in a Jan. 18 interview he did not have a problem with those committee members mentioned in an article in the medical journal BMJ because they disclosed their financial relationships to FDA. He said it is important for the committees to have members with knowledge of the products.

Burgess said the issue has not changed his thinking that the conflict of interest rules should be changed.

“The rules don’t make any sense,” he said. “That’s the problem.”

Burgess has proposed legislation that would change the conflict of interest rules to allow more flexibility by requiring FDA to assess the type, nature and magnitude of a financial interest when considering a potential conflict and that no one factor would be dispositive.

After filing the bill, he said the agency needs more flexibility because too many people are being excluded from participation Also see "PDUFA Word Association: Consumer Advocates Complain About Lack Of "Safety" In Commitment Letter" - Pink Sheet, 31 October, 2011..

Should FDA Release All Disclosure Documents?

The Jan. 10 BMJ article, citing court documents, said at least four advisory committee members at the joint meeting, including its acting chair, had financial ties to Bayer and other manufacturers of drospirenone and another committee member agreed to but did not actually conduct research for the company. The article also said the committee members were paid consultants or speakers for Bayer and other drospirenone manufacturers.

The committee voted 15-11 that the benefits outweighed the risks but said labeling does not reflect the products’ risk-benefit profile ([A#00111219007]).

The authors raised questions about FDA’s conflict of interest review process and the Project on Government Oversight called for the agency to make policy changes and release all financial disclosure forms on its website. The group also wants FDA to set aside the advisory committee vote and convene another meeting to consider the issue.

The watchdog said in a letter to Commissioner Margaret Hamburg that “judgment call should not be made by FDA officials behind permanently closed doors.”

Burgess said he has not talked to anyone at FDA about why financial disclosure forms are not released and indicated it may not be necessary to add a provision to his bill to make financial disclosure forms public.

“I don’t see that as being an impediment,” he said.

FDA chose not to issue any waivers for the meeting, which are intended to allow conflicted members to participate if their input is deemed essential.

An agency decision to prevent Sidney Wolfe, director of Public Citizen’s Health Research Group and a member of the Drug Safety and Risk Management Advisory Committee, from voting because of an intellectual conflict of interest generated controversy before the meeting convened Also see "FDA Intellectual Bias Policy Takes Wolfe Off Contraceptives Safety Review" - Pink Sheet, 6 December, 2011..

FDA referred questions about FDA’s handling of the issue to a blog post on the agency’s website. In it, Jill Hartzler Warner, acting associate commissioner for special medical programs, said the agency “did not identify any financial interests that would have precluded their participation.”

Fuel To Defeat The Reform Bill

Advocates against loosening the conflict of interest rules could use this issue as ammunition to keep Burgess’ proposal from being enacted.

Diana Zuckerman, president of the National Research Center for Women and Families, said in a Jan. 19 interview there already was interest among some members of Congress about the issue. She also said criticism over the advisory committee meeting most likely will create more interest and slow efforts to make changes.

Zuckerman further pointed out that releasing all financial disclosure forms would not necessarily prevent bias from creeping onto advisory committees.

Several advocates, including Zuckerman, recently met with Hamburg and other FDA staff to encourage the agency not to change the rules. They argued plenty of non-conflicted experts are available but are not being recruited, and allowing more conflicted advisory committee members would hurt FDA’s decision-making process.

Patient groups, however, have said the rules are too rigid and in some disease areas exclude most of the handful of experts available Also see "PDUFA Word Association: Consumer Advocates Complain About Lack Of "Safety" In Commitment Letter" - Pink Sheet, 31 October, 2011..

FDA said it has not found a legislative solution that would enhance its conflict review process Also see "Conflict Of Interest Reform: With FDA Undecided, Consumer Groups Give Their Pitch" - Pink Sheet, 9 January, 2012..

Burgess said his bill could be added to legislation reauthorizing the Prescription Drug User Fee Act and creating user fees for generic drugs and biosimilars. Sen. Amy Klobuchar, D-Minn., also included conflict of interest rule changes in a pending medical device reform bill.

Negotiated agreements with industry for the three user fees were recently delivered to Congress Also see "Biosimilar, Generic and Rx User Fees Rely On Different Adjusters For Needed Appropriations" - Pink Sheet, 23 January, 2012..

Burgess Not Changing Conflict Of Interest Thinking Despite Flap Over Oral Contraceptive AC

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