The nation’s top food and drug regulator stepped up controls on e-cigarettes and unsafe medicines as well as advanced the Food Safety Modernization Act.
Scott Gottlieb announced on Tuesday that he’s stepping down as head of the U.S. Food and Drug Administration, effective next month.
Gottlieb, the 46-year-old, Westport, Conn.-based physician and venture capitalist, said he’s leaving the agency after two years as commissioner to spend more time with his family.
In a letter, he expressed his gratitude to the FDA staff for their work to protect public safety and health.
“There are many important efforts we undertook together, countless new policies we advanced and laws we enforced with vigor to protect consumers,” Gottlieb wrote.
“Over the coming weeks I’ll continue to work to cement more of these efforts, to secure our 2020 budget and to help transition the agency to new leadership,” he added.
President Trump tweeted on Tuesday that Gottlieb “has done an absolutely terrific job as commissioner of the FDA.”
The FDA, which operates within the Department of Health and Human Services, protects the public from unsafe human and veterinary drugs, vaccines, medical devices, food, cosmetics, dietary supplements, radiation-emitting products and tobacco.
While Gottlieb has been most recognized in the media for bringing regulatory attention to electronic cigarettes and other tobacco products, the agency in recent months also has undertaken efforts to strengthen the country’s security surrounding imported foods and pharmaceuticals.
The FDA recently proposed a new import food safety strategy that will build upon what the agency already has implemented through the 2016 FDA Food Safety Modernization Act (FSMA).
U.S. food imports from around the world have continued to increase during the past 15 years, with about 32 percent of fresh vegetables, 55 percent of fresh fruit and 94 percent of seafood consumed by Americans annually now imported. These imports originate in more than 200 countries from about 125,000 different food export facilities. This year alone, FDA expects the U.S. to import between 14 million and 15 million food shipments.
In February, the agency also launched a pilot program with the industry to develop an electronic system that will identify and trace certain drugs as they’re distributed within the U.S. Development of the pilot was authorized by the 2013 Drug Supply Chain Security Act (DSCSA). The legislation calls for completing the system by Nov. 27, 2023.
