FDA advisory committee members granted conflict of interest waivers should be required to disclose the companies to which they have financial ties, Bristol-Myers Squibb maintains in comments to FDA.

"In the interest of transparency, full disclosure of the name of the competitor, the competing product, the purpose of the grants provided by and the consultant agreements with the competitor, etc., should be made known to the public when a waiver of the conflict of interest has been granted," Bristol states.

BMS submitted comments on FDA's Feb. 1 draft guidance on disclosure of conflicts of interest for special government employees participating in product-specific advisory committees. The draft guidance requires disclosure of conflict of interest but not the name of the competitor (¹ 'The Tan Sheet' Feb. 4, 2002, In Brief).

[For full coverage of the guidance, visit ² www.FDAAdvisoryCommittee.com , a news and FDA meeting broadcast service from the publisher of "The Tan Sheet."]

In addition, Bristol says the sponsor of the product under review should provide a list of competing companies and products to committee members in advance of the meeting to avoid overlooked conflicts.

Public Citizen's Health Research Group suggests that FDA should furnish the list of competing companies and products beforehand to committee members.

"Although not stated in the guidance, the burden should be on the FDA to inform each advisory committee member, sufficiently in advance of the meeting, of the names of all companies with competing products - approved or in the pipeline - so a detailed financial conflict of interest response for each can be provided by the advisory committee member," HRG states.

For products that have not been marketed, "it may be legitimate not to disclose the name of the company and product but to have full disclosure of the financial conflict of interest," the group says.

Public Citizen also requests information on committee members who are excluded from a meeting or who resigned from serving on a committee due to conflict of interest. Disclosure of this information would reveal the level to which FDA goes to disqualify a committee member from serving, the organization asserts. Resignation of committee members due to conflict of interest is rare, but has occurred in the past, FDA said.

The consumer group recommends the period of disclosure be extended from one year to a minimum of two years. Bristol advises a span of at least three years since "the one-year period may artificially mask the true nature of the relationships" among committee members and companies.

Public Citizen also suggests conflict of interest disclosure should be available to the public at least two weeks prior to a committee meeting.

Under the FDA Modernization Act, FDA must inform the public of a waiver granted to a committee member. Currently, the agency announces waivers on the day of the meeting in a statement read by the committee's executive secretary.

HRG suggests conflict disclosures be made for all meetings, including non-product-specific sessions, because the topics may have general applicability.

In separate comments, Merck questions the definition of "product-specific meetings" because disclosure could still be necessary for non-product-specific meetings involving "discussion of guidances for a therapeutic class of drugs or advice for products treating specific diseases."

Committee members should have the same disclosure standards as clinical investigators, Merck notes. "It is illogical for [special government employees] on advisory committees to be held to more stringent financial disclosure standards."

"While [special government employees] on advisory committees may influence the timing of marketability of a product, their influence on the clinical data presented to them is not the same as that of clinical investigators," Merck states.

The draft guidance requires committee members to report interest in a publicly held company, consulting fees and contracts and grants "of any magnitude."

Clinical investigator disclosure requirements, set under a separate guidance, have different financial thresholds for stock holdings, consulting and research activity (³ Also see "OTC "Actual Use Studies" Subject To Financial Disclosure Requirements" - Pink Sheet, 1 November, 1999., p. 18).

Conflict of Interest Waiver Details For Cmte. Members Should Be Public – BMS

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