Senate HELP Committee Asks FDA to Explain its Use of Draft Guidances

May 7, 2014

By Jeffrey N. Wasserstein

We have previously noted that FDA has increasingly regulated through issuance of guidance documents – rather than through notice-and-comment rulemaking as required by the Administrative Procedure Act.  The U.S. Senate Committee on Health, Education, Labor, and Pensions (the Senate HELP Committee) has also taken note of it, albeit without the flair and occasional snark our readers have come to expect from the FDA Law Blog!
Earlier this week, Senator Lamar Alexander (R-TN), the ranking member of the Senate HELP Committee, along with Senators Richard Burr (R-NC), Johnny Isakson (R-GA), and Orrin Hatch (R-UT), sent a letter to FDA Commissioner Margaret Hamburg “to express significant concern about [FDA’s] use of draft guidances to make substantive policy changes.”  The letter notes that draft guidances are becoming default FDA policy, notwithstanding that they are issued for comment purposes only.  Moreover, draft guidances are not revised, finalized, or withdrawn in a timely manner.  Although the letter doesn’t mention it specifically, we note that some guidances (see, e.g., here) have been kicking around in draft form since the last century.  The letter also notes that these guidances often do not take into account – or even worse, conflict with – the views of the scientific community.  As we’ve noted in the past, this would be solved with notice-and-comment rulemaking.  

The letter requests FDA to respond to the following information requests and questions:

1. A list of all Level I Draft Guidances, including the date issued, and the timeline with which you plan to withdraw, revise, or finalize each guidance.

2. An update on Agency-wide activities to implement the “best practices” to make the finalization of guidance more efficient and expeditious, as discussed in the 2011 report Food and Drug Administration Report on Good Guidance Practices:  Improving Efficiency and Transparency.

3. Have you 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 you provide examples of specific guidances?

4. For the guidances still in draft form, how do you ensure your staff does not follow the guidance 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?

Now that the Senate has had its interest piqued by this issue, will it ultimately change FDA’s penchant for issuing draft guidance documents instead of taking the harder (yet ultimately more beneficial) step of implementing substantive policy changes through notice-and-comment rulemaking?  Time will tell, but we’re not overly optimistic.

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