Five things to know about Trump’s FDA lead pick Gottlieb
4. Gottlieb will likely take measures to lower pharmaceutical costs, which Trump has listed as high on his agenda.
Having worked on the implementation of the FDA’s generic drug user fee program, Gottlieb has direct knowledge of how this process was intended to work. “With drug prices as a persistent hot topic, he can be expected to frame his drug review and approval reform wish list as a way to address drug prices and spur competition,” Harrison says. “This kind of reform focus also fits with his support for innovation in the healthcare space.”
Says Landmon, “I think that he will at least work to speed the approval of generic drugs in an effort to lower pharmaceutical prices. This goal is generally supported by both parties in Congress and has wide support in the public.”
5. Due to legislation, it could be difficult for Gottlieb to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements, and tobacco—which Trump has touted.
“Although Gottlieb can certainly take certain administrative actions at the margins to reduce the regulatory burdens on industries regulated by FDA, much of the oversight provided by FDA is governed by statute,” Landmon says. “To enact significant change, Gottlieb and the Trump administration would need to convince Congress to enact legislative changes, which may be difficult in today’s politically heated environment.”
Karen Appold is a medical writer in Lehigh Valley, Pennsylvania.