Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Law Health Law & Business, in “FDA Warned of Removing Guidance Comment Period in Proposed Plan,” by Nyah Phengsitthy. (Read the full version – subscription required.)
Following is an excerpt:
The FDA’s consideration of a plan to eliminate public comment periods before implementing agency guidance sits on shaky ground with industry groups and legal experts, who say the move undermines public feedback. …
Potential Legal Setbacks
The FDA skipping over a comment period prior to guidance implementation also violates its own statute, said Bradley Merrill Thompson, a medical device and industry attorney for Epstein Becker Green. …
“They’re supposed to listen to what the public has to say and make any changes that the public makes a good case for. They can ignore all the comments if they disagree with them, but if they agree with them, they’re supposed to make adjustments to the guidance document,” Thompson said. “They completely bypass that legal requirement when they put it out there in draft form with no real intention to even update it for a long time.”
Thompson said the legal challenge here wouldn’t be against the guidance document or its content, but rather against the FDA for failing to follow guidance regulation.
