Four United States senators sent a letter to United States Food and Drug Administration (FDA) Commissioner Robert Califf with concerns over the agency’s apparent inability to revise, finalize, or withdraw draft guidance documents in a timely manner. The letter notes that on average, it takes between 425 and 797 days to finalize a draft guidance.
The comments echo comments that have been made at various Congressional hearings with myriad FDA officials, and stem from industry and physician complaints over the agency’s use of draft guidance in carrying out regulatory responsibilities, particularly among those who “feel no choice but to follow draft guidances as if final, even if the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.”
The letter comes a few months after the FDA’s Center for Drug Evaluation and Research’s (CDER) 2016 guidance agenda. The agenda outlined an increase in issuance of such guidance, with a total of 102 guidance documents set to be released this year. The number of planned guidance documents issued shows a steady incline: from 60 in 2013, 70 in 2014, and 90 in 2015.
The four senators, Lamar Alexander, Richard Burr, Johnny Isakson, and Orrin Hatch, take issue with the fact that on average, it takes the FDA over a year (sometimes over two years) to finalize draft guidance. Additionally, the FDA has been sending letters to industry with regard to “new thinking” by the agency that can only be found in draft guidance documents.
However, the senators did praise the FDA for using a new, more transparent website to list newly-issued guidance documents and for the withdrawal of forty-seven “outdated and unfinished” documents last May.
The bulk of the letter focused on requests by the senators, including an update on the stat that it takes between 425 and 797 days to finalize a draft guidance.
The letter also requests an updated list that identifies each draft guidance document that was published before December 31, 2015, and still is pending; an update on the plan for each Center and Office that “are continuing to work on their plan for which guidances will be withdrawn, reissued, or finalized;” whether or not the Agency plans to require Centers and Offices to systematically review guidances and withdraw, revise, or finalize those outstanding documents in a timely manner.
The letter also reiterated some concerns about how the Agency ensures that staff do not follow the guidance in the absence of any other policy or final guidance. The Agency has previously indicated that it provides initial and ongoing training for employees about how to develop and use guidance documents. The Senators asked for a “detailed description of who conducts these trainings, how frequently they occur, and the content and forum of the trainings. Please also provide copies of all training materials, including notes from presenters, slides or videos, and any review of the effectiveness of such training by the FDA or a contractor.”
In a March 2015 response, the FDA stated that staff may sometimes reach the same results as proposed in a draft guidance when applying statutes and regulations, explaining that “[a] draft guidance reflects FDA current thinking, and thus also usually reflects its current interpretation of the statute and regulations.” However, the Senators are a little concerned that when the FDA publishes a draft guidance, it includes a statement that the draft guidance document will represent the Agency’s current thinking only “when finalized.” The letter requests clarification as to whether a draft guidance which has not been finalized should be construed as expressing the FDA’s current thinking.
The FDA has not yet responded to this letter. When the senators sent a similar letter in May 2014, the Agency took almost an entire year to respond, writing back in March 2015.