October 27, 2021

Volume XI, Number 300

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Commissioner Scott Gottlieb’s Priorities as Newly Approved FDA Commissioner

On May 9, 2017, Scott Gottlieb, M.D. was confirmed by the Senate as the new Commissioner of the Food and Drug Administration (“FDA”).  As Commissioner, he will be immediately responsible for shaping FDA policy on a number of current issues, including addressing and implementing several mandates stemming from the 21st Century Cures Act, (“Cures Act”), which was signed into law on December 13, 2016 with tremendous bipartisan support. The Cures Act contains over 200 sections that create new obligations for FDA; however, most pressing for Commissioner Gottlieb are three requirements that must be fulfilled within 180 days of the Cures Act’s passage (June 11th, 2017).

These requirements are:

  • Submission of a work plan to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives for any projects, which will use funding from the FDA Innovation Account created under Section 1002 of the Cures Act;

  • Development of “a plan to issue draft and final versions of one or more guidance documents, over a period of 5 years, regarding the collection of patient experience data, and the use of such data and related information in drug development” pursuant to Section 3002 of the Cures Act, which is codified at 21 U.S.C. 360bbb-8c; and

  •  Publication of “a list of reusable device types” pursuant to Section 3059 of the Cures Act, which is codified at 21 U.S.C. 360.

Commissioner Gottlieb has a long professional history in the pharmaceutical industry working in both the public and private sectors. His firsthand experience as a former Deputy Commissioner at the FDA provides him with unique insights into the internal workings of the administration. As a former consultant advising on FDA policies to the pharmaceutical industry, Commissioner Gottlieb is also familiar with recent issues and trends affecting the industry, many of which are addressed within the Cures Act.  Despite having only one month to organize and address the mandates of the three above-referenced sections of the Cures Act, we believe Commissioner Gottlieb will likely meet these deadlines based on his prior knowledge and experience.

We will continue to monitor and provide insight on Commissioner Gottlieb’s activity as FDA Commissioner, and the implementation of key Cures Act provisions as they develop.

©2021 Epstein Becker & Green, P.C. All rights reserved.National Law Review, Volume VII, Number 130
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About this Author

Bradley Davidsen, Epstein Becker Law Firm, Health Care Attorney
Associate

Mr. Davidsen is an Associate in the Health Care and Life Sciences practice, in the Chicago office of Epstein Becker Green.

Mr. Davidsen:

  • Advises clients on the research, development, and approval of pharmaceuticals, biologics, and medical devices

  • Develops clinical trial agreements, vendor agreements, informed consent documents, and related materials for clinical research sponsors, and negotiates agreements with clinical research institutions and...

312-499-1467
Elena Quattrone, Epstein Becker Law Firm, Health Care Attorney
Associate

ELENA M. QUATTRONE is an Associate in the Health Care and Life Sciences practice, in the New York office of Epstein Becker Green. 

Ms. Quattrone:

  • Assists health care clients in contracting for corporate formation, mergers, acquisitions, and various other business transactions

  • Advises clients on national and state-wide health care reform, including legislative and policy developments

  • Informs health care organizations about...

212-351-4685
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