FDA Commissioner Scott Gottlieb to step down in a month

Dive Brief:

FDA Commissioner Scott Gottlieb will resign effective in one month, HHS Secretary Alex Azar said in a statement Tuesday. The Washington Post first reported the news.
The regulator, who took office May 11, 2017, has been a relatively steady figure at the agency throughout President Donald Trump's tenure. He has garnered bipartisan support for balancing protection of public health while pushing efforts to encourage medical product development. Just two months ago, he tweeted he was not planning to leave.
Gottlieb has overseen FDA's reaction to a spate of criticism of its regulation of medical devices. The agency is in the process of trying to encourage manufacturers to utilize the De Novo pathway for new medical devices and lessen reliance on older 510(k) predicate devices.

Dive Insight:

Gottlieb’s efforts to oversee the pharmaceutical industry may be more high profile, but device safety and effectiveness has emerged in recent months as a contentious topic in its own right. Under his regime, FDA has made efforts to rejigger approval pathways, including the De Novo and 510(k) processes.

Approval standards have also been under a spotlight after a hard-hitting Netflix documentary and a series of investigative reports took aim at the agency and industry, putting FDA on defense.

During Gottlieb’s tenure, FDA’s Center for Devices and Radiological Health put out its Medical Device Safety Action Plan aimed at ramping up post-market surveillance, real-world data collection and cybersecurity efforts. Scrutiny of controversial devices like transvaginal mesh and breast implants, both the subject of FDA advisory committee meetings, also rose.

Gottlieb, who did a stint during the administration of President George W. Bush at the agency, also oversaw the ramping up of the FDA’s Pre-Cert Program. That effort seeks to update how the agency reviews software as a medical device amid the rise of wearables and other hybrid products. Nine companies including Apple, Fitbit and Johnson & Johnson are part of the pilot program.

Senior Democrats in Congress have expressed concern about FDA’s ability to maintain safety and hold companies that skirt the rules to account. Both lawmakers and industry have also called into question the legal authority of the agency to implement the idea.

On the device side, Gottlieb was largely seen as industry friendly. Public interest groups such as Public Citizen have complained the device approval process is still too lenient, especially compared to the drugs side.

"His tenure as commissioner was marked by regulatory decision-making regarding drugs and medical devices that tilted further in favor of industry’s financial interests rather than the interests of public health," Mike Carome, director of Public Citizen’s Health Research Group, said in a statement.

In his March 5 resignation letter, Gottlieb touted the record number of medical devices cleared in 2017 and 2018.

AdvaMed CEO Scott Whitaker praised Gottlieb’s service, saying he was committed to patient access to new treatments and diagnostics.

"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.