Republican Senators on the Committee on Health, Education, Labor, and Pensions (HELP) on May 6 sent a letter to the Food and Drug Administration (FDA) raising concerns that the Agency has been misusing draft guidances to make substantive policy changes. The letter from Lamar Alexander (R-TN), Richard Burr (R-NC), Johnny Isakson (R-GA) and Orrin G. Hatch (R-UT) explains that in the absence of finalized guidance, a draft guidance often is the only information that FDA review staff, patients, clinicians, and FDA-regulated entities have on the FDA’s current thinking on a particular issue. As a result, stakeholders feel compelled to adhere to the draft guidances, which become default FDA policy.

The letter expresses concerns that the FDA’s website does not differentiate between draft and final guidances and that draft guidances are not being revised, finalized or withdrawn in a timely manner. In addition, the Senators allege that the FDA issues guidances that do not reflect, or may be contrary to, recommendations and practices by the scientific community.

The Senators requested that the FDA respond to the following questions and requests:

  1. A list of all Level 1 Draft Guidances, including the date issued, and the timeline with which the FDA plans to withdraw, revise or finalize each document. Level 1 guidances “set forth the agency’s initial interpretations of new significant regulatory requirements; describe substantial changes in FDA’s earlier interpretation or policy; and deal with complex scientific or highly controversial issues.”
  2. An update on Agency-wide activities to implement the “best practices” to make the finalization of guidances more efficient and expeditious, as discussed in the 2011 report Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency.
  3. Has the FDA implemented the President’s Council of Advisors on Science and Technology recommendation to rely more on the biomedical community in help developing and revising guidances, and if so, could the FDA provide examples of specific guidances?
  4. How does the FDA ensure that its staff does not follow guidances still in draft form in the absence of any other policy or final guidance?
  5. What is the average amount of time in calendar days that the FDA has taken to finalize draft guidances in the last five years? What is the range?

On the same date that the Senators sent the letter to the FDA, the FDA’s Center for Devices and Radiological Health (CDRH) announced in the Federal Register a public workshop to be held on June 5 that will focus on CDRH’s guidance development process, guidance development best practices for the FDA, CDRH and CDRH stakeholders, and CDRH guidance priorities and priority development. Registration for the workshop closes on May 29. Stakeholders may submit comments to the FDA on the issues related to the workshop until July 7, 2014. 

AGG Insights: The Senate letter reflects on-going concerns by stakeholders that the FDA has been overusing guidances, particularly draft guidances, in the development and implementation of policy. This issue has profound implications for how the Agency communicates policy directions to the public and how the public interacts with the Agency in the future.