Scott Gottlieb, a practicing physician and resident fellow at the American Enterprise Institute, is President Donald J. Trump’s pick to be the 23rd commissioner of the Food and Drug Administration.
He was FDA’s deputy commissioners for medical and scientific affairs from 2005 to 2007.
Dr. Gottlieb is one of the nation’s foremost voices for “changing the FDA’s culture.” His views on issues are easy enough to find as he’s been putting them out there for AEI and in national periodicals for the past decade.
“The FDA’s cumbersome (drug) approval process has been a long time in the making, but its effects are by now clear to patients, physicians, and drug makers, Gottlieb wrote in the journal National Affairs in 2012. “This has made them increasingly evident to politicians, too. One would expect that this growing awareness would prompt lawmakers to seek some remedy, and they have — but legislative fixes will succeed only if they are rooted in a proper understanding of the problem.”
Everything Gottlieb has written will now be copied and circulated as part of his Senate confirmation, but those charged with researching his record are going to find his experience involves drugs and medical devices not food safety.
It’s not unusual for FDA Commissioners to devote most of the their own official time to drugs and medical devices, and leave food safety to a deputy. Margaret Hamburg became FDA commissioner from being in charge of public health in the Big Apple- a hands on food safety job. Yet she was content to turn food safety over to a deputy. Hamburg was drawn to the conferences and international travel on the drug and medical device side of FDA’s house.
If confirmed, Gottlieb will succeed Robert Califf, who was FDA Commissioner for just short of a year. He’s a famous cardiologist who also had most interest in the drug and medical device lines.
Stephen Ostroff, deputy Commissioner for Foods and Veterinary Medicine, is serving in his second stint as Acting FDA Commissioner. He is expected to go back to food and animal health if and when Gottlieb gets confirmed.
With Gottlieb not having apparent interest or experience in food safety, the confirmation hearing will likely find some Senators wanting to explore Trump administration plans for funding food safety inspections, especially as it relates to the enforcement of the Food Safety Modernization Act (FSMA).
The FSMA signed into law by President Obama in January 2011 went through five years of rule making to reach the point where it can be used to prevent foodborne illnesses, not just respond to them.