Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in "Pressure Builds on FDA to Overhaul Guidance Process."

Following is an excerpt:

The U.S. Food and Drug Administration is facing sharp criticism that it's become sluggish and secretive when developing highly consequential guidance used by drug and device makers, and regulators are showing signs that they're open to reform, attorneys say.

Much of the frustration is captured in a 400-page citizen petition that Epstein Becker Green attorney Bradley Merrill Thompson filed two years seeking a faster and more responsive guidance process. The petition is still pending, but Thompson said FDA staffers have agreed to sit down with him in October in hopes of drilling down to the core areas of concern.

“We sent in a ton of information, and the agency maybe isn’t sure what to do with all of it,” Thompson said. Although the FDA is constantly tweaking its approach, the last major overhaul came in 1997, when the agency — also in response to a petition from Thompson — introduced “good guidance practices” aimed at bringing order to what was then a less-structured system for making its expectations known. “As bad as the guidance process is today, it was much worse 20 years ago,” Thompson said. “Quite honestly, it was sort of chaos back then.”

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