FDA’s line of ‘thinking’ via draft guidances draws lawmakers’ attention

Members of the Senate Health, Education, Labor, and Pensions (HELP) Committee, including Senator Lamar Alexander (R-Tenn), asked the FDA to explain why draft guidances were not being revised, finalized, or withdrawn in a timely manner. In a letter expressing concern on the matter, the lawmakers asked the FDA to update information and provide answers to questions regarding (1) the length of time it took for each FDA center to finalize a draft guidance, previously reported as between 425 and 797 days; (2) the number of still-pending draft guidances published prior to December 31, 2013, previously reported as standing at 172; (3) current work plans to address draft guidance review; and (4) FDA staff training on the use of draft guidances in the absence of a final guidance document.

Although the senators applauded the implementation of easy-to-use navigation of guidance documents on the FDA website, the lawmakers stressed that it should be kept as up to date as possible. In the previous 12 months, the FDA took action to withdraw 47 guidance documents that it considered “outdated and unfinished.”

However, the lawmakers noted that industry members, including physicians and corporations, were concerned about the agency’s reliance on draft guidances to carry out regulatory responsibilities. As such, industry felt compelled to follow the draft guidances as if final, even if the most up-to-date information suggested an alternative path. The lawmakers noted that the FDA was periodically sending, as well as publicizing, “It has come to our attention” letters that relied upon new “thinking” only previously discussed in a draft guidance to raise concerns about a current regulated product.