GOP Senators Raise Concerns With FDA’s Draft Guidance Policies

Posted 06 May 2016 | By Zachary Brennan 

GOP Senators Raise Concerns With FDA’s Draft Guidance Policies

Four Republican senators sent a letter on Friday to US Food and Drug Administration (FDA) Commissioner Robert Califf with concerns over the agency’s inability to revise, finalize or withdraw draft guidance documents in a timely manner.

The concerns, which echoed comments made at a number of Congressional hearings with FDA officials, stem from industry and physician complaints over FDA’s use of draft guidance in carrying out regulatory responsibilities, particularly among those who “feel no choice but to follow draft guidances as if final, even if the most-up-to-date science would suggest an alternative path,” according to the letter.

The letter comes as FDA’s Center for Drug Evaluation and Research’s (CDER) 2016 guidance agenda, released in January, outlined an increased issuance of such guidance. A total of 102 guidance documents are set to be released this year, which is slightly higher than the 90 CDER planned to release in 2015, and shows a steady increase from the 70 documents planned for 2014 and the 60 guidances that were slated for 2013.

Republican Sens. Lamar Alexander (TN), Richard Burr (NC), Johnny Isakson (GA) and Orrin Hatch (UT) also are taking issue with the fact that on average, it takes FDA more than a year, and sometimes more than two years, to finalize draft guidance. In addition, FDA has been sending letters to industry with regard to “new thinking” by the agency that can only be found in draft guidance documents, the senators say.

And although the senators praised FDA for using a new, more transparent website to list newly-issued guidance documents, and the withdrawal last May of 47 “outdated and unfinished” documents, they also request that FDA provides more information on:

  • The median number of days it takes the agency to finalize draft guidance;
  • A list of guidance documents published before the end of 2015 that is still pending finalization;
  • Whether any future reviews have been planned for revising, withdrawing or finalizing other guidance documents;
  • How the agency is training FDA officials on the use of draft and final guidance; and
  • Whether a draft guidance document expresses the agency’s current thinking on a topic.


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