Professor Erika Lietzan was quoted at length today in an article published by the Regulatory Affairs Professional Society (RAPS) about the impact of President Trump’s January 30 “two-for-one” executive order on the U.S. Food and Drug Administration (FDA).
The executive order provides that whenever an agency promulgates a new regulation, it must identify at least two existing regulations to be repealed. Professor Lietzan practiced FDA law for 18 years and is ranked as one of the nation’s best lawyers in FDA law. She cited numerous FDA regulations that are on the books and not in force and that could be withdrawn over the next year.
Professor Lietzan, who teaches FDA regulation as well as administrative law, added that the order does not change FDA’s mandate from Congress. The agency will continue to implement the statute that Congress enacted, and there is no reason to think its interpretation of the statute or its regulatory policies would change, even if it withdrew regulations and guidance. The primary issue without regulations and guidance, she explained, would be lack of certainty for regulated industry and lack of transparency to the public about those interpretations and policies.