1 February 2017 - With an executive order and comments from President Donald Trump yesterday calling for a massive overhaul of US FDA regulations, legal experts and former FDA officials are offering some practical and creative ways the agency could clean house.

And before this dive into what FDA might or even could do following the signing of this executive order it is important to remember a constant refrain from all experts Focus spoke with: FDA codifies statutes passed by Congress and many deal with processes that make clarifications for industry.

Erika Lietzan, an associate professor of law at the University of Missouri School of Law and former associate general counsel of industry group PhRMA, told Focus via email: “The Executive Order does not – could not – change the agency’s mandate from Congress. In addition, I don’t see why the agency’s interpretations of the statute or its regulatory policy would change. If the agency had to remove its NDA [new drug application] regulations, for instance, that doesn’t change the fact that under the FDCA [Federal Food, Drug, and Cosmetic Act] a new drug cannot be introduced into interstate commerce without an approved new drug application that is held to the statutory safety and effectiveness standard.”

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