Alan Minsk Discusses FDA’s New Guidance Plan in Bloomberg Law

AGG Food & Drug practice chair Alan Minsk was quoted in an article published by Bloomberg Law on December 27, 2024, discussing how the Food and Drug Administration’s streamlined guidance practices will be received by the incoming presidential administration.

Combined with the recent overturn of the Chevron doctrine, which had empowered agency interpretations of ambiguous laws, FDA may be more hands-off when it comes to rule-making Alan explained.

“FDA notes that it issues more guidances than rules,” Alan said. “It was doing this pre-Chevron decision, and I think FDA, like many agencies, will continue to do this for fear of lawsuits if they issue final rules.”

Considering the handful of appointments President-elect Trump has made to lead agencies and his advisory team, the future of how FDA guidance and rules will be implemented is up in the air.

“It will be interesting to see direction from the higher-ups on ‘transparency’ and ‘get things done,’” Alan said. “FDA is trying to find a balance of transparency, which industry and the public want, and practical time and resource constraints. It clearly notes the value of public input, document availability and overall disclosure.”

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