Posted on Thursday, May 11 2017 at 8:34 pm by hlt

New FDA Commissioner Scott Gottlieb, M.D. Sworn in Today

By Carolina M. Wirth

As many of you know, Scott Gottlieb, M.D. was confirmed by the Senate (57 to 42) on Tuesday, May 9, 2017, to serve as the 23rd Commissioner of the Food and Drug Administration (FDA or agency).   Today, he was officially sworn in as Commissioner and begins the task of leading the FDA.

drscottgottlieblHere are a few facts about the FDA’s new Commissioner:[i]

  • Dr. Gottlieb is a physician, medical policy expert, and public health advocate.
  • He previously served as FDA’s Deputy Commissioner for Medical Scientific Affairs and as Senior Advisor to the FDA Commissioner.
  • He worked on the implementation of the Medicare drug benefit when he served as a Senior Advisor to the Administration of the Centers for Medicare and Medicaid Services.
  • He was appointed by the Senate in 2013 to serve on the Federal Health Information Technology Policy Committee, which advises the Department of Health and Human Services on Healthcare Information Technology.

With more than half of fiscal year 2017 in the books, now that FDA has a Commissioner, both industry and the public await to see how he will direct the agency on a variety of issues, including the implementation of the 21st Century Cures Act, a law that was signed by President Obama on December 13, 2016.  The 21st Century Cures Act, a bipartisan bill, is focused, among other things, on advancing medical product innovation and ensuring that patients have quicker access to drugs and medical devices.[ii]  In the food area, there have been many requests for the agency to delay the compliance date for the Nutrition Facts label that go in to effect on July 2018 (or July 2019 for businesses with less than $10 million in annual food sales).  During his confirmation hearings, Dr. Gottlieb had indicated that he “would favor delay of the Nutrition Facts updates to line up with whenever the U.S. Department of Agriculture’s upcoming rule requiring disclosure of ingredients from genetically modified [or GMOs] takes effect.[iii]”  It may be that now, FDA will be able to make a final decision on this issue with the compliance deadline a little over a year away.

[i] See FDA’s Meet Scott Gottlieb, M.D., Commissioner of Food and Drugs, available at, https://www.fda.gov/AboutFDA/CentersOffices/ucm557569.htm.

[ii] See FDA Voice, 21st Century Cures Act:  Making Progress on Shared Goals for Patients, available at, https://blogs.fda.gov/fdavoice/index.php/2016/12/21st-century-cures-act-making-progress-on-shared-goals-for-patients/.

[iii] See Food Industry Urges Delay of Nutrition Facts Label, available at https://cspinet.org/news/food-industry-urges-delay-nutrition-facts-label-20170405.




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