Senators Question FDA’s Use of Draft Guidance

U.S. Sens. Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.), and Orrin Hatch (R-Utah) have sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg expressing “significant concern” about the agency’s use of draft guidance to, in their view, make “substantive policy changes.”

Noting that draft guidance is “increasingly becoming default FDA policy” although it is issued for comment purposes only, the letter expresses a number of concerns, including that (i) FDA’s website does not differentiate between draft and final guidance; (ii) draft guidance is not revised, finalized or withdrawn in a timely manner; and (iii) the agency issues guidance that “does not take into account, or may even conflict with, the scientific community.”

Specifically, the senators request that FDA provide a list of all Level I draft guidances, including the date issued and the timeline on which the agency plans to withdraw, revise or finalize each guidance, and an update on agency-wide activities to implement best practices to expedite guidance finalization. They also ask (i) whether FDA has implemented the president’s Council of Advisors on Science and Technology recommendation to rely more on the biomedical community to help develop and revise guidances, and if so, whether the agency can provide examples of specific guidances; (ii) how FDA ensures that staff does not follow guidances still in draft form in the absence of any other policy or final guidance; and (iii) what the average amount of time in calendar days FDA took to finalize draft guidances was during the last five years.

Issue 524