FDA Defends Guidances in Letter to Republican Senators

The FDA is defending the pace at which it develops guidance in response to senate criticisms.

The agency has published 172 draft guidances that are more than a year old and have not been finalized — including 77 from CDER and 10 from CBER. On average it takes CDER 710 days to finalize draft guidances and CBER 743 days, the FDA says.

The agency produced the data in a letter to Sen. Lamar Alexander (R-Tenn.) to refute claims by Alexander and three of his Republican colleagues that the agency is too slow and that draft guidance often becomes default agency policy.

In the March 9 letter, FDA Associate Commissioner for Legislation Thomas Kraus said all centers at the FDA comply with the laws that govern guidance development, and he rejected the idea that the agency treats draft guidance in the same way it would final guidance.

Kraus also rejected the lawmakers’ claim that the FDA doesn’t differentiate clearly between draft and final guidance, noting that each draft guidance is prominently marked as a draft and carries a notice that it will represent official FDA position “when finalized.”

However, Kraus did say the FDA is looking for ways to shorten the guidance development process.

The Senate HELP Committee, which leveled the criticisms of the FDA in May of last year, did not respond to requests for comment. Read the letter at www.fdanews.com/03-11-15-HELPletter.pdf. — Lena Freund