August 25, 2017

FDA Watchers: Gottlieb May Fly Under Trump Deregulatory Radar With Product-Specific Moves

From: Inside Health Policy | Special Report

Nicholas Florko


Bruce Levinson, senior vice president of regulatory intervention at the Center for Regulatory Effectiveness, told IHP he expects a lot of FDA’s important policy decisions will be occurring under the surface and outside of the formal rulemaking process — particularly given Trump’s Executive Order that mandates two regulations be scrapped for each new regulation.

“I get a sense there we have all this formalism…but the real decisions in all this regulatory changes are happening under the surface and they’re happening in different ways…And what I’m wondering at FDA is if we are going to see more product-specific, approval-specific, transaction-specific issues rather than these big broad conceptual rulemakings in areas such pharmaceuticals, medical devices and tobacco. I think that Commissioner Gottlieb and Director Zeller’s NEJM article on nicotine control points to the agency implementing a new regulatory paradigm,” Levinson told IHP.

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