FDA Guidance: Regulations Under a Mask?


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 me 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.”

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

“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.

Read my full article here.

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