Restrictions placed on FDA’s recruitment of advisory committee members, including limits on the number of waivers it may issue, would be removed under draft user fee legislation circulating in the House of Representatives.

Reform of the agency’s conflict of interest rules for advisory committees has been among the most debated issues of the user fee program reauthorization. Yet the discussion draft from the House Energy and Commerce Committee devoted only one sentence – 11 words – of the 205-page document to the subject.

Those words were powerful, however: “Chapter VII is amended by striking section 712 [of the Food, Drug and Cosmetic Act] (21 U.S.C. 379d-1).” No substitute language was included in the draft bill, which began circulating earlier this month.

That section, which was added as part of the last round of user fee renewal legislation in 2007, governs the advisory committee waiver process, including the caps placed on the number of waivers the agency may issue in a given year.

It also includes requirements that decisions about advisory committee members can only be made after reviewing financial disclosure forms and states that those with a financial conflict cannot participate.

Advisory committee members, presumably, would continue to be governed by the Ethics in Government Act of 1978, which deals with financial disclosures for government employees.

But FDA would have more freedom to structure its advisory committees nearly as it sees fit, under the discussion draft. The agency could issue as many waivers of financial conflicts as it chose.

The section that would be deleted also includes requirements that waivers and reasons for granting them must be disclosed publically before an advisory committee meeting. But FDA recently finalized guidance of its financial interest disclosure and conflict waiver policies, which indicate the agency would continue making them public.

The Ethics in Government Act also requires that financial disclosures be made public.

Will The Change Make A Difference?

It remains unclear whether the concerns expressed by several patient and advocacy groups about advisory committee problems would be solved by the deletion.

They have said repeatedly that FDA has become too rigid and is excluding valuable, and many times scarce, experts from the advisory panels. They argued the agency is avoiding potential conflicts rather than looking for the best experts Also see "PDUFA Word Association: Consumer Advocates Complain About Lack Of "Safety" In Commitment Letter" - Pink Sheet, 31 October, 2011..

Consumer groups, on the other hand, have argued against loosening the conflict of interest rules Also see "Conflict Of Interest Reform: With FDA Undecided, Consumer Groups Give Their Pitch" - Pink Sheet, 9 January, 2012..

Lifting the waiver caps likely will not significantly alter FDA’s selection policy in the short term because FDA uses few of the waivers it is allowed.

In FY 2011, the most recent data available on the FDA website, the agency granted 11 waivers out of 1,364 committee members who participated at meetings during that period. No waivers were issued during six of the 12 months of the fiscal year.

The provision may work out as the best move for FDA. It has said throughout the debate that it has not found any legislative solution that would significantly enhance its conflict of interest reviews.

Removing caps that have proven unnecessary may be the best amendment the agency could expect, given the desire by Congress to do something about the perceived problem.

Members of the Energy and Commerce Committee already have wondered publically whether removing the caps would solve the problem Also see "FDA Conflict Of Interest Policy May Be Biggest Conflict Of PDUFA Reauthorization" - Pink Sheet, 6 February, 2012..

Final Guidance Does Not Affect Screening Process

The agency also made it clear in the final disclosure guidance that it did not address the “screening process” it employs to select advisory committee members.

Not included in the discussion draft was any language that would increase the disclosure of advisory committee financial information that was used to determine whether a conflict existed.

The watchdog Project on Government Oversight called for increased disclosure related to advisory committee conflicts after it was revealed that several members of an advisory committee looking at the risks of drospirenone products like Yaz, Yasmin, Beyaz and Safyral had ties to Bayer HealthCare LLC and other manufacturers in the drug class Also see "Burgess Not Changing Conflict Of Interest Thinking Despite Flap Over Oral Contraceptive AC" - Pink Sheet, 23 January, 2012..

Ned Feder, a staff scientist at POGO, said the agency has not responded to the group’s disclosure requests or its calls to set aside the committee vote and hold another meeting.

The final guidance on disclosure of conflicts of interest and waivers for advisory committee members will continue to require disclosure of justifications when the agency issues a waiver as well as the financial ties that could be problematic.

The guidance also expands somewhat the amount of information about experts with financial stakes that will be released to the public.

FDA formalized the two disclosure forms it will use to release information about advisory committee members with ties to drug companies and other concerns that could potentially affect their judgment of an application.

Both have been in use for some time. The financial disclosure form, under the final guidance, will require those filling them out to include information about whether the financial interest is the sponsor of the drug in question, an industry competitor or another affected entity.

That is a change from the 2010 draft guidance, where only the company or institution and nature of the interest had to be identified.

Potential advisory committee members also have to give the amount of the potential financial interest, as well as the type, such as consulting fees or patent royalties.

Of the waivers issued to date, some have been extensive. Several were nearly three pages or more.

The guidance states that waiver documents would be drafted in such a way that “information protected from disclosure by statute or regulation does not appear” so they would “not typically require redaction.”

FDA still has been forced to redact portions of waiver forms on several occasions, including recently. A waiver issued for Alexander Vinks, a temporary voting member of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology’s March 14 meeting, included several redacted portions in the agency description of the facts on which the waiver was based.

Vinks apparently was providing consulting services and could have had a financial interest impacted by the meeting’s subject matter, according to the waiver form.

Deborah Armstrong, a voting member of the Oncologic Drugs Advisory Committee, also had information about a clinical trial her employer was involved with redacted in a waiver issued for a March 20 ODAC meeting.

Conflict Of Interest Rules Get Clean Sweep In House Draft User Fee Bill

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