New FDA Guidance Seeks To Prevent Advisory Committee Conflicts of Interest

Federal drug regulators have issued new draft guidance for advisory committees, on how to prevent the appearance of impropriety and undue influence, and new draft guidance for staff members on accepting gifts. 

The draft guidance for gifts to the FDA (PDF) and potential conflicts of interest for FDA advisory committee members (PDF) were published in the federal register on June 29.

FDA advisory committees are panels of experts from a variety of disciplines who provide the agency with non-binding recommendations on drugs, medical devices, and other health policies. While the FDA is not required to follow the committees’ recommendations, they usually have a significant effect on the FDA’s final policy decisions.

Concerns about potential conflicts of interest and undue influence from manufacturers have existed for years, as the advisory committee members often have other jobs and work for other interested parties, such as pharmaceutical companies and activist groups. Many work as consultants or work extensively with one company or another’s products, leading to criticism for the FDA over failure to put these conflicts under closer scrutiny in the past.

Currently, the FDA screens advisory members and will disqualify them from working on certain issues based on whether their current financial interests create potential conflict or create an appearance that the members will lack impartiality, known as “appearance issues.”

“This draft guidance addresses FDA’s process for evaluating whether an advisory committee member has potentially disqualifying interests or relationships that fall into the second category of interest: appearance issues,” the advisory member guidance states. “It also describes FDA’s process for determining whether to authorize a member with an appearance issue to participate in the advisory committee meeting.”

The guidance details the screening procedure and what circumstances may give the appearance of impropriety. The FDA is accepting public comment on this guidance until September 27

FDA Staff Gifts Guidance

The draft guidance regarding gifts to FDA staff notes that the FDA has authority to accept unlimited gifts and donations, however it lays out instances where such gifts should be refused. The agency has opened the guidance to public comments, which are due by September 12.

“FDA will consider gifts from all sources on a case-by-case basis using a balancing test, described in the draft guidance,” the agency’s federal register notice indicates. “While any person may offer a gift, there are five reasons we should reject a gift without additional evaluation.”

Those reasons are:

• The donor tries to impose conditions on the gift that are illegal, contrary to public policy, or the FDA’s policies, or generally accepted public standards
• The donor requests some special privilege, concession or other benefit in exchange for the gift.
• The gift comes from a debarred entity
• The gift affects a different authority or financial mechanism
• The total costs associated with accepting the gift are higher than the cost of simply purchasing a similar item.

Even if a gift is accepted, the draft guidance indicates that it should be subject to further review under a balancing test. This test assesses whether the gift provides a benefit to the FDA’s public health mission that outweighs any real or apparent risks, as well as conflicts of interest.