FDA Issues New Rules For Advisory Committees

The changes involve conflicts of interest and waivers for panel members; advisory committee voting procedures; the timing of committee briefing materials to be released and the procedures for deciding when an advisory committee meeting should be held. The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. Here is a summary, and you can look here to read the individual guidances.

The most contentious issue has to do with concern over conflicts involving committee members, a hot-button topic that regularly embroils the FDA (see this item earlier today). The FDA has long argued finding experts without financial conflicts is arduous, if not impossible, because many top-flight physicians and academics serve as industry consultants.

To answer the criticism, the FDA has these new rules: For starters, if an individual, his or her spouse, or minor child has potentially conflicting financial interests totaling more than $50,000, he or she would not be allowed to participate in that meeting.

Second, the guidance specifies four scenarios where a conflict is significant and FDA does not intend to issue a waiver, even if the potential personal conflict is below $50,000. (For example, if the advisor is the principal investigator of a clinical trial of a product about which the committee will be providing advice, the advisor will not be allowed to participate in that meeting.) Third, before a waiver is issued, the FDA will require a showing that the waiver is necessary to ensure the committee has “essential expertise.” Fourth, as now required by law, the FDA will limit the number of waivers granted.

[Our thought: $50,000 is still a lot of money. Disagree? Ask someone who thinks $4 for a gallon of gas is too much. We recognize there is no perfect situation, but the threshhold remains stubbornly high.]

Source: Pharmalot

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