FDA Issues New Draft Guidance for the “Appearance” of Conflicts of Interest

The U.S. Food and Drug Administration (FDA) issued draft guidance for the appearance of conflicts of interest with regard to serving on one of its expert advisory panels.

“Advisory committees provide independent, expert advice to the FDA on a range of issues affecting the public health,” authors of the document wrote. “To protect the credibility and integrity of advisory committee advice, the FDA screens advisory committee members for current financial interests that may create a recusal obligation under federal conflict of interest laws.” This new draft guidance covers “other interests and relationships that do not create a recusal obligation under federal conflict of interest laws but that may create the appearance that a member lacks impartiality, known as ‘appearance issues.’”

Some new conflicts of interest contained in the guidance include:

  • The panel member is a dean of a medical school at a large university, which receives a multi-year grant from the drug manufacturer whose product is under review. Regardless of whether the grant is related to the drug under review, “this is an interest or relationship that could cause a reasonable person to question the member’s impartiality.”
  • The panel member has a relative or someone living in the same household who has a relationship with a person or entity appearing before the panel.
  • Those enforcing the guidance may also look into past financial conflicts rather than just current conflicts.

Of note, the draft guidance does not address “intellectual bias,” used to describe a panel member who has a strong point of view about a medical product.

Source: U.S. FDA, “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees,” June 2016.