FDA Guidance: Regulations in Disguise?

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By Mike Stankiewicz

The FDA’s over-reliance on guidance documents is undercutting traditional notice-and-comment rulemaking and hurting industry, one advocacy group warns.

The Washington Legal Foundation, a free-market advocacy group and think tank, is charging that the Food and Drug Administration is leaning too heavily on guidance documents in lieu of regulations, undercutting the Administrative Procedure Act and causing excessive burdens on affected industries. The group said the FDA has released more than 2,000 guidance documents and draft documents, far too many for industry to keep track of.

“The reason for this trend is obvious: Formal rulemaking can be quite cumbersome, and FDA would prefer, when possible, to avoid the time and expense involved,” the group wrote to the FDA in response to a comment request.

William Garvin, a Washington-based life sciences attorney at Buchanan Ingersoll & Rooney PC, told Bloomberg Law Dec. 11 that the FDA might be pushing guidance-based requirements too far.

“It gives the agency flexibility to change their position if the situation changes,” he said. “So in general, the use of guidances is an important tool for the FDA that can be subject to abuse.”

Comment Request

The group’s letter is in relation to a comment request by the FDA that aims to identify regulations and administrative requirements that could be modified or cut to reduce burden. The comment deadline was recently extended to Feb. 5.

It is hard to determine the FDA’s endgame for the request, Stephanie Philbin of Goodwin Procter LLP in Washington told Bloomberg Law Dec. 12.

“We will see some changes coming out of this effort, but what the extent and depth of the changes are to be determined,” she said. Philbin, a counsel in the firm’s FDA group, is a Bloomberg Law advisory board member.

The Washington Legal Foundation also argued that cutting the use of guidance documents could be an important step in complying with the White House’s deregulation mandate.

In January, President Donald Trump signed Executive Order 13,771 which requires that for every new federal regulation issued, at least two pre-existing regulations must be identified for elimination and be completely offset, resulting in a zero net increase in regulatory costs. The group said guidance documents fall under the broad definition of “regulation.”

The executive order defines “regulation” as “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

Over-Reliance on Guidance

Garvin said that by regulating policy through guidance and warning letters, the FDA can have its cake and eat it too because guidance cannot be reviewed by the courts.

Guidance documents “are not considered final agency action and so that is the main problem because you cannot generally sue FDA on issues where they have not made a final determination,” he said.

Garvin said the trend of overusing guidance started in the early 2000s and has increased every year.

“Now I think it is something that FDA realizes is advantageous and less burdensome, so it is the preferred method of dealing with many regulatory issues,” he said.

To contact the reporter on this story: Mike Stankiewicz in Washington at mstankiewicz@bloomberglaw.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bloomberglaw.com

For More Information

The Washington Legal Foundation's letter is at http://src.bna.com/uTR.

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