The Washington Post reported on March 5, 2019 that Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., will leave his job “in about a month” to spend more time with his family.
He was picked to lead the agency in March 2017, and he was confirmed by the Senate a couple of months later.
Gottlieb, a former physician, was Deputy FDA Commissioner under President George W. Bush. Before taking the FDA reins, he was a healthcare investor and consultant who sat on multiple company boards.
Gottlieb was arguably one of the most respected and effective political appointees of the Trump Administration, receiving bipartisan praise from lawmakers on Capitol Hill. He was also well received by the media due to his constant presence on Twitter and voluminous communications regarding FDA activities.
The Commissioner’s primary job is to run the agency entrusted to “promote and protect” public health. How he fared in accomplishing those goals will not be known until long after he’s left his position. Daniel Carpenter, a Harvard University professor of government, reportedly said we may not know the full story of Gottlieb’s FDA legacy for a few years until the appointments he made and the draft rules that he fashioned are studied. “I think the jury is still out.”
Legacy
Gottlieb’s tenure will be largely remembered for dealing with the opioid crisis, regulating electronic cigarettes, challenging pharmaceutical drug pricing and guiding the agency through the longest U.S. government shutdown in history.
In his resignation letter to HHS (Health and Human Services) Secretary Alex Azar, Gottlieb named a list of accomplishments, including accelerating the approval of generic drugs and modernizing the process for handling novel gene and precision therapies to treat those with cancer and other diseases. He said the agency was “strong in moments of crisis,” including its work in Puerto Rico to remedy drug and medical device shortages after Hurricane Maria in 2017.
Last year, the agency approved a record 971 generic drugs. He also began posting lists of drugs that aren’t protected by patents, inviting applications from generic manufacturers, and sharply criticized brand-name companies for stifling generic competition.
Gottlieb made his strongest public statements on tobacco. With 480,000 Americans dying every year from smoking-related causes, he frequently said curbing tobacco use was the No. 1 way to improve public health. His comments caused some tobacco-control activists to say that he had potential to become the most important commissioner since David Kessler, who began efforts to regulate cigarettes as a drug in the 1990s.
Medical Devices on the Docket
But for medical device makers, his embrace of a major overhaul of the 510(k)-clearance program is likely to have the most lasting impact. Approximately 82% of all medical devices reach patients under that program.
As we reported last December, the device industry should get ready for “increased product complexity and risk aversion” from the FDA. It’s top regulators, said regulatory attorney Mark DuVal, “disdain” the 510(k) clearance program and are intent on sweeping changes.
On November 26, 2018, Gottlieb and Center for Device and Radiological Health (CDRH) Director, Jeff Shuren, M.D., announced plans to formally propose a major overhaul of the 510(k) process by eliminating the use of predicate devices older than 10 years and publishing a list of newly cleared devices which used older predicates.
Essentially, said DuVal, the FDA wants to publicly “shame” the makers of those devices.
“Don’t get me wrong,” DuVal told us after the resignation announcement, “Dr. Gottlieb didn’t do a bad job, but his focus was on very big-ticket items, like the opioid crisis, vaping by teens, and drug pricing. CDRH got very little attention. We had hoped that by being appointed by a regulatory reform-minded president, he would have reformed FDA’s inability to clear and approve devices in a reasonable time frame without a mountain of unnecessary data for some fairly innocuous devices.
“The problem with FDA is that when industry argues for a Least Burdensome approach as required by statute, FDA pays lip service to it, waves the banner of patient-safety to justify any and all data requests, and they are immunized from criticism.
“Reviewers today are hired as scientists, not regulatory affairs specialists. As a result, they turn every device into a science project and management goes along to get along. They get more and more granular. As a result, they mis-prioritize things by focusing an inordinate amount of resources on devices that don’t require the level of time and attention they give them.”
“The bottom line is Gottlieb had a chance to critically review CDRH’s performance and make it better, more timely, and less burdensome and he didn’t do it. In fact, the trend line is going horribly in the other direction. My hope is that the Trump Administration and the next Commissioner will devote time to reforming CDRH.”
