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Scott Gottlieb keeps FDA office hours while growing star power

The Wall Street Journal’s May 22 Health Forum at the Four Seasons Hotel in Washington D.C. will feature 22 speakers, including several CEOs for big pharmacy and giant insurance companies.

But in a full-page advertisement, which WSJ has been running at the expense of its paper and ink, the top billing goes to Food and Drug Administration Commissioner Scott Gottlieb.

Scott Gottlieb

Gottlieb will complete his first year as FDA Commissioner on May 11. He returned a year ago to head FDA, where he’d earlier served as deputy commissioner for Medical and Scientific Affairs. The 23rd FDA commissioner, Gottlieb was previously a practicing physician and clinical assistant professor at the New York University School of Medicine in Manhattan.

In addition to medicine, Gottlieb studied economics and was a Resident Fellow at the American Enterprise Institute. His history includes work on the Medicare drug benefit and medical records technology.

The WSJ Health Forum is not the only indication that Gottlieb likes a big stage. In January he attended the World Economic Forum in Davos, Switzerland.

He reported going to Davos on the FDA public calendar of “significant meetings” with people outside the executive branch of the federal government. Gottlieb reported, “healthcare professionals, government, academia, industry representatives, media and other registered guests” as among those he met in Davos.

Gottlieb was at FDA headquarters in Silver Spring, MD, during most of the first 11 weeks of 2018. And according to FDA’s public calendars, the two topics getting most of the commissioner’s attention were tobacco and opioids.

However, his public calendars continue to show Gottlieb is involved in all facets of FDA, including food safety.

In January Gottlieb had a series of meetings about menu labeling, discussing the controversial topic first with industry and consumers groups, and then separately with the National Restaurant Association. Just before he took over as commissioner, FDA extended the compliance date for menu labeling from May 5, 2017, to May 7this year.

The Affordable Care Act contains language calling for menu labeling. Federal menu labeling precludes state and local requirements, and restaurant chains like that.  In getting federal menu labeling underway, however, Gottlieb has to deal with less enthusiastic pizza restaurants, convenience stores, and the like. He met with those groups on Jan. 3

On Jan. 8, he invited in health and consumer groups, including representatives of the American Heart Association, Center for Science in the Public Interest, National Association of County and City Health Officials, and the American Diabetes Association.

On the same day, Gottlieb met with the NRA’s Cicely Simpson and Steve Danon. They are all-in for federal menu labeling because national restaurant chains do not want to deal with a maze of state and local regulations.

Dr. Stephen M. Ostroff

Dr. Stephen M. Ostroff, deputy commissioner for Foods and Veterinary Medicine, and other FDA staff attended the menu labeling meetings with Gottlieb.

While Gottlieb was at the economic forum in Switzerland, Ostroff addressed the Jan. 26 meeting of the Safe Food Coalition and the Make Our Food Safe Coalition in Washington D.C. He took several FDA staffers with him, according to the agency’s public calendar.

The FDA commissioner was back in time to address the National Association of State Departments of Agriculture’s Winter Policy Conference on the Food Safety Modernization Act (FSMA) and State and Local Collaboration and Partnerships. Ostroff and other FDA staffers also attended the policy conference. FDA contracts some FSMA activities out to state departments of agriculture.

Ostroff led a meeting on Feb. 20 involving FDA staff and federal officials from Mexico about fresh produce and Mexico’s National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA), which regulates the produce industry. Personnel from the Embassy of Mexico and SENASICA participated.

Ostroff also led a meeting, with the agenda simply stating “food safety,” with Mike Liewen of PepsiCo; Rob Mommsen and Shali Shalit-Shoval of Sabra Dipping Co. LLC; Don Zink of IEH Laboratories & Consulting Group; and Randy Russell and Tyson Redpath of The Russell Group. Several other FDA staffers attended the meeting.

Ostroff and three other FDA staffers traveled to Tokyo from March 4-7 to attend the Global Food Safety Conference. While in Japan, the FDA delegation met on the side with representatives of the Food Standards Agency of the United Kingdom and Food Standards Scotland.

Upon return, Ostroff and others from FDA met with representatives of the European Medicines Agency, European Commission for Food and Safety and Consumer Health, and the European Union about shellfish equivalence. The meeting was about the food safety systems recognition that might result in shellfish trade between the U.S. and Europe.

Gottlieb and Ostroff met on March 14 with Elizabeth Fawell, Gregory Pritchard, Matthew Carpenter, Maxine Blanck, Molly Fogarty, Rafaela Carvalho, Sarah Sunday, William Cooper, all apparently from Nestle, about the FSMA’s Intentional Adulteration Rule. Several others from FDA also attended.

Finally, on March 16, Ostroff attended a committee meeting of the U.S. Apple Association in Washington D.C. to talk about the FSMA.

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