Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week, in “House Rules Chair Seeks to Limit Agency Use of Guidance Documents,” by David Lim. (Read the full version – subscription required.)
Following is an excerpt:
However, Brad Thompson, a medical device attorney with Epstein Becker & Green whose advocacy resulted in FDA’s good guidance practices, told Inside Health Policy the bulk of the legislation would have no impact on FDA because the agency is already “pretty far ahead other federal agencies,” due to good guidance practices being codified in the FDA Modernization Act of 1997. But one part of the bill that would affect FDA, Thompson said, is language requiring at least a high-level response from the agency to comments filed on economically significant guidance documents.
“That has been sorely missing at FDA. Even for the most important guidance documents, when the public submits comments, the agency may or may not make changes to the draft, but whatever they do they never explain their thought process on the impact of the comments,” Thompson said. “That leaves people wondering — if the agency disagreed — why did they disagree? That makes it highly unsatisfactory for folks who take the time to comment, but also frankly is very frustrating because the public makes some great arguments for change, the agency doesn’t change, and no one knows why. So I would wholeheartedly support that change.”