Republican Senators Press FDA on Use of Draft Guidances

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May 6 — A group of Senate Republicans pressed the FDA May 6 for information on why draft guidance documents take so long to become final.

The lawmakers also said they've heard concerns about whether policies in draft guidances are being used in some enforcement letters sent to FDA-regulated companies.

However, Congress isn't going to be able to fix this problem until lawmakers appreciate the peculiarities of the guidance system and what drives the development of the documents within the Food and Drug Administration, Bradley Merrill Thompson, a device and combination product attorney at Epstein Becker & Green PC in Washington, told Bloomberg BNA May 6.

The lawmakers said physicians and drug and medical device makers have no choice but to follow draft guidances as if they are final documents, even if the most recent science suggests an alternative path. In their letter, Sens. Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.) and Orrin Hatch (R-Utah) asked FDA Commissioner Robert Califf for answers about the agency's guidance policies. Alexander serves as the Health, Education, Labor, and Pensions Committee chairman, which oversees the FDA, and Hatch serves as the Finance Committee chairman.

FDA guidance documents are meant to show the agency's current thinking on a particular topic. However, some FDA guidance documents languish in draft form for years, or even decades. This makes it difficult to know whether the agency remains committed to the policies outlined in old draft documents.

In May 2015, the FDA pulled 47 draft guidance documents on various topics related to drugs, devices and blood products. The oldest document to be pulled was from 1988 (13 PLIR 662, 5/8/15).


The senators pushed Califf for detailed information about how long the agency takes to make a draft guidance final. The lawmakers said the agency in 2015 said that it takes an average of between 425 days and 797 days to make a draft a final document, depending on which part of the agency is responsible.

The senators also asked which draft documents were published before Dec. 31, 2015, and are still pending, and for information on agency staff training on developing and using guidance documents.

In addition, they asked Califf to describe any plans to require agency staff to systemically review guidances and withdraw, revise or finalize those outstanding documents in a timely matter.

Two years ago, the same senators wrote the agency to express their concerns regarding the use of draft guidances to make substantive policy changes (12 PLIR 706, 5/16/14), and the FDA responded in a March 2015 letter.

The senators also asked the FDA to clarify a statement it puts into draft guidances that says the document “will represent the Agency's current thinking only ‘when finalized.'” Califf should describe whether a draft guidance that hasn't been finalized should be construed as expressing the FDA's current thinking on a particular topic, the senators' letter said.

Attorney's Take

At its core, the guidance issue is really about money, Thompson said. “Guidance costs money to develop. Through the user fee discussions, FDA is held accountable for meeting certain user fee related objectives, and so the money typically goes to meeting those objectives.” The industry-paid user fees help fund agency operations, such as drug and device reviews.

This dynamic means that ultimately, the guidance development process suffers because of the internal budget wars at the FDA and unless someone has a particularly strong reason for wanting a particular guidance out and finalized, it won't happen, Thompson told Bloomberg BNA.

Furthermore, making a guidance final rarely helps the FDA, according to Thompson. “Once in a while, FDA will want to finalize the guidance because they want to ensure greater uniformity in how the FDA staff act in a certain area. And once in a while FDA will finalize guidance because it reflects” a brand-new requirement, he added.

However, Thompson told Bloomberg BNA most of the time guidance simply communicates what FDA staff already think. “On its face, even when finalized, guidance is not binding,” which is why, given internal budget battles at the FDA, guidance typically suffers at the agency.

Thompson said ultimately, Congress can't resolve “this problem until they appreciate that FDA has typically no incentive to finalize guidance, because final guidance is no more useful to the agency than draft guidance.”

New System Needed

The senators said they've heard concerns that the agency is sending “untitled” or “it has come to our attention” letters, which aren't warning letters, to companies that refer to the “new `thinking' only seen in draft guidance.”

As for enforcement issues surrounding the agency treating draft guidances as final documents, Thompson told Bloomberg BNA “it would be the height of insanity to expect FDA to do anything other than what a draft guidance says, because the essence of writing a guidance as to codify what FDA thinks today about how a given statute and regulations should be interpreted.”

Thompson said that when there's no final document, “all they have is their current interpretation and that happens to be found in draft guidance. Of course, the longer draft guidance stays draft, it's possible that the FDA's thinking will evolve, which in some ways is even worse because industry assumes the draft guidance is still current when in fact it's not.”

Thompson called for changes to the guidance process, saying there has to be a better way. “I'm talking with a group of manufacturers about proposing some sort of supplemental process at FDA where the agency can answer more mundane questions quickly, and through a narrower pronouncement than the typical guidance document,” he told Bloomberg BNA.

The thought is, under this proposed system, the FDA would have less reason to avoid such narrow guidance, and indeed it would be far less costly for FDA to develop, Thompson added.

To contact the reporter on this story: Michael D. Williamson in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

The senators' most current letter is at

The senators' 2014 letter is at

The FDA's 2015 response to the 2014 letter is at

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