Medical Device Industry Rattled by Gottlieb Resignation

Posted March 12, 2019

The medical device industry has been reeling since Scott Gottlieb, the commissioner of the Food and Drug Administration (FDA), unexpectedly announced his resignation last week. He will officially step down next month, and National Cancer Institute Director Norman “Ned” Sharpless will take the reins as acting commissioner.

News of Gottlieb's departure left "biotech and pharma executives, who largely adored Gottlieb, nervous at best and frightened at worst,” wrote StatNews. “Likewise, healthcare investors.”

Gottlieb’s nearly two years of service were marked by the FDA’s partnering with industry to help advance new technologies, ongoing efforts to streamline medical device regulation, and modernizing the agency’s processes.

Biotech stocks sank following the announcement, as the industry faces an “uncharted regulatory landscape, with no idea which Gottlieb initiatives will survive his exit,” according to a report by FiercePharma. Many of the FDA’s announced initiatives to streamline medical device approvals and fast track innovative new devices are still in progress.

Gottlieb’s exit was also a “potential blow to Silicon Valley,” according to CNBC, as initiatives such as the Digital Health Software Precertification (Pre-Cert) Program and others were seen as a way for technology companies to enter the digital health space with faster approval of low-risk technologies. Pre-Cert is currently in the pilot phase.

"Scott did a lot culturally to make the agency easier to work with," Bob Kocher, a partner at venture capital firm Venrock, told CNBC. "I think he'll be missed by many in the tech industry, including the startups."

In his resignation letter, Gottlieb cited “historic” approvals of novel medical devices (a record 108 last year) in addition to efforts to “modernize the development process for novel medical technologies,” such as a new premarket approval pathway for “breakthrough devices” and an updated 510(k) process.

In addition to Gottlieb’s work with medical devices, he also advanced policies to reduce generic drug prices, curb opioid addiction, and fight tobacco use—efforts that won him widespread approval.  Scott Whitaker, president and CEO of the medical device trade association AdvaMed, thanked Gottlieb for his work to help patients received “the latest treatments, diagnostics, and cures.”

“During his tenure as FDA commissioner, Dr. Gottlieb has been a tireless advocate for improved patient care and for promoting innovative solutions to our most pressing health challenges, including greater use of medtech to combat the opioid crises,” Whitaker said in a statement.

The uncertainly facing the medical device and biotech industries may not be over anytime soon. Gottlieb’s permanent successor is likely to face a long Senate confirmation process. In a contentious political climate, it’s possible that the interim director would remain in place into 2020, according to StatNews.

During this period, Jeff Shuren, who has been director of the FDA’s Center for Devices and Radiological Health for nearly a decade, is expected to provide continuity and a steady hand for the medical device industry, according to MedTech Dive. Gottlieb largely delegated device decision making to Shuren, a career official, and the “true impact of Gottlieb’s exit” will be felt by the medical device industry if his successor changes that structure.

According to a Washington Post report, Gottlieb, 46, decided to leave the FDA to spend more time with his family, including his three young daughters. He commuted to the job in White Oak, MD, from his home in Connecticut.