FDA Commissioner Scott Gottlieb Announces His Resignation

On March 5, Scott Gottlieb, M.D., announced he will be stepping down as Commissioner of FDA.  His resignation will become effective in about one month.  His two-year tenure, since May 2017, has been very productive.  Gottlieb spearheaded initiatives on a variety of complex issues, including generic drug pricing, electronic cigarettes, drug compounding, and the 510(k) program.  Secretary of HHS, Alex Azar, stated that Dr. Gottlieb “has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation.”

Dr. Gottlieb has also been a prolific tweeter throughout his time as Commissioner, frequently engaging directly with the public about the Agency’s actions.  At the FDA Law Blog, we have been particularly grateful for his tweets expressing appreciation of our article titles.

Though we do not yet know what the future holds for FDA in the post-Gottlieb era, we decided to look back at some of his noteworthy actions and accomplishments as described in our blog posts:

1. FDA Announces Various Initiatives to Increase Oversight of the Dietary Supplement Industry – February 15, 2019
2. Commissioner Gottlieb and CBER Director Marks Deliver “State of Cell and Gene Therapy” Joint Statement – January 30, 2019
3. C. Escher By Way of Generic Drug Pricing – January 18, 2019
4. International Plan of Mystery: ICH Guidelines for Generic Drugs – November 28, 2018
5. Possible Major Changes to 510(k) Program Ahead – November 26, 2018
6. Gottlieb to E-Cigarette Manufacturers: Reduce Youth Use or I Will END You – September 18, 2018
7. FDA Commissioner Gottlieb Indicates Modification of Requirement for “Added Sugar” Declaration on Pure Maple Syrup and Honey; Details are Forthcoming – Sweet! – September 17, 2018
8. Industry Submits Comments (Nearly 3000) and the Agency Listens: Revised Draft Standard MOU Addressing Section 503A’s Limits on Interstate Shipments of Compounded Medications – September 10, 2018
9. It Feels Like the First Time: FDA’s First Competitive Generic Therapy Approval – August 9, 2018
10. FDA Commissioner Gottlieb Emerges as a Champion for Patient Engagement in 2018; Patient-Centric Guidance Development, Rare Disease Listening Sessions, and the Benefit-Risk Framework – April 11, 2018
11. FDA Opens A Door For Consumer Genetic Tests – December 4, 2017
12. Commissioner Gottlieb’s Statement: “We Want You”… Seeking Able-Bodied Compounders to Register as Outsourcing Facilities Pursuant to FDCA Section 503B – October 4, 2017
13. FDA’s Hatch-Waxman Public Meeting and Progression of the Agency’s Drug Competition Action Plan – July 19, 2017
14. A Few More Steps in FDA’s Drug Competition Action Plan – June 27, 2017
15. FDA, Under New Leadership, Seeks More Comments on Rules Affecting Off-Label Communications – May 19, 2017