- Food and Drug Administration Commissioner Scott Gottlieb will leave the agency in one month, tendering his resignation in a March 5 letter to Health and Human Services Secretary Alex Azar. The Washington Post first reported the news.
- During his nearly two-year tenure as head of the FDA, Gottlieb brought a focus on increasing market competition for prescription drugs, particularly through record-high levels of generic drug approvals. Gottlieb also sought to modernize the agency's regulatory frameworks, a push which came with questions on whether the agency was appropriately balancing a desire to clear new medicines with long-standing standards on safety and efficacy.
- Gottlieb's time as commissioner, however, was defined by his response to major public health crises as much as it was by his work on pharmaceuticals. An opioid overdose epidemic that has caused tens of thousands of American deaths, as well as rising concerns over youth addiction to electronic cigarettes, tested the agency and gave urgency to its broader mission.
Gottlieb became FDA Commissioner at a critical time, taking office as the agency faced pressing questions on prescription opioids and rising prices for pharmaceuticals.
While he won Senate confirmation largely along partisan lines in 2017, Gottlieb quickly won plaudits from lawmakers, easing concerns he would oversee a deregulatory agenda that would weaken the FDA's oversight.
A former deputy FDA commissioner under President George W. Bush, Gottlieb also secured support from industry through his efforts to adopt a more flexible approach to drug approvals and overhaul the agency more broadly.
His resignation comes as a surprise, coming two months after he tweeted that he had no plans to leave the agency after rumors circulated he might depart.
In a note tweeted by the FDA's official Twitter account, though, Gottlieb cited family as the principal reason behind his decision.
"There's perhaps nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and three young children," the commissioner wrote.
Under his leadership, the FDA approved record numbers of generic drugs as well as novel medicines in both 2017 and 2018. And while drug pricing is largely outside of the agency's legal purview, Gottlieb broke from his predecessors by taking an more outspoken approach to the issue, calling out drugmakers for "Kabuki drug pricing" and anti-competitive "shenanigans."
Under Gottlieb, the FDA published a list of branded drugs with no generic competition and disclosed which drugmakers were potentially impeding development of copycats by withholding drug samples.
"It's a loss," said David Mitchell, head of the advocacy group Patients for Affordable Drugs. "Scott Gottlieb has been a standout on drug prices, but he's also been a really good FDA Commissioner."
Anger over pharmaceutical pricing reached new heights while Gottlieb was in office, spurred by earlier scandals over sharp increases for drugs like Turing Pharmaceuticals' Daraprim and Mylan's EpiPen.
The FDA doesn't regulate prices and has limited tools to address market abuses involving patents, for example. Still, Gottlieb used his position as head of the agency which controls which drugs make it to market to "name and shame" drugmakers for practices that limited competition.
"He had near unanimous support and approval from what one can tell," said Walid Gellad, head of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. "I see this is a big loss for the administration's efforts to address drug pricing," he added.
While Gottlieb enjoyed support from many corners, his efforts to speed medicines to market and use tools like surrogate endpoints and real world data in drug reviews also brought concerns. Several approvals, such as for the ultra-strong opioid Dsuvia, were criticized, and the agency under Gottlieb reversed previous demands for additional clinical data on drugs from Eli Lilly, Amicus and TherapeuticsMD.
Large-scale recalls of generic heart drugs containing contaminated active ingredients have raised additional questions of how well the FDA has been able to maintain oversight as it waves through more generic drugs.
While commissioner, Gottlieb also oversaw the agency during the recent 35-day government shutdown, which he characterized as "one of the most significant operational challenges in FDA's recent history." During the funding lapse, the FDA had to shutter large parts of its regulatory activities, although it was able to continue review of some drugs covered by user fee agreements.