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# 5 Challenges for FDA Commissioner-nominee Scott Gottlieb
- URL: https://www.fdaweb.com/5-challenges-for-fda-commissioner-nominee-scott-gottlieb/
- Published: 2017-04-18T12:00:00.000Z
- Updated: 2026-09-14T22:18:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138474

Faculty members at the Harvard Kennedy School and Washington University School of Law says FDA commissioner-nominee **Scott Gottlieb** will face five major challenges at the agency once he is confirmed. Writing in a *New England Journal of Medicine* [Perspective](http://www.nejm.org/doi/full/10.1056/NEJMp1703979?ref=fdaweb.com), the two list the challenges as:

- deciding what evidence should be required before a drug can be deemed safe and effective;
- working with industry throughout the research and development process;
- coping with pressure on drug pricing;
- making difficult policy choices under the 21st Century Cures Act; and
- addressing concerns about a lack of agency transparency.

“These are just a few issues facing the next FDA commissioner,” the two write, “and they do not address the agency’s broad regulatory authority over food products or new challenges including confronting the application of old statutes to new problems, such as the regulation of mobile health apps, surgical devices using software, or pills with sensors giving physicians feedback on patient adherence. All these challenges require a strongly resourced FDA working at the cutting edge of regulatory science. A commissioner who is able to advocate for such a vision, which includes less dependence on industry funding, will bring the agency into the 21st century.”