Two Years and Done: FDA Commissioner Gottlieb To Resign

Xconomy National — 

Two months after insisting on Twitter that he wasn’t going anywhere, Food and Drug Administration Commissioner Scott Gottlieb announced his resignation today. He leaves a record of health and medical regulation that was more active than critics who spoke out against his nomination in early 2017 might have expected.

Gottlieb’s remit extended beyond drugs, of course, to food safety and tobacco regulation, and his legacy may well rest in his efforts to curtail teenage vaping and smoking.

Ashish Jha, director of the Harvard Global Health Institute, said on Twitter that Gottlieb’s resignation was “terrible news for public health” and called the commissioner “a ray of sunshine—advocating for vaccines, smarter drug policy, more generics, tackling vaping and tobacco.”

His short tenure, just under two years, is also marked by significant change in the drug world, including the rapid advances of cell and gene therapies. The first approved gene therapy in the U.S., a treatment for a rare form of genetic blindness, was OK’d on his watch, and his agency worked to create and clarify the regulatory framework that governs cutting-edge medicines.

He also began pushing recently for a new economic solution to the frightening lack of antibiotic drug development, even as “superbugs” resistant to current antibiotics continue to spread. “He particularly understands the development and economic challenges faced by companies innovating new antibiotics, including the need for alternative reimbursement models,” said Mike Dudley, president and CEO of San Diego antibiotics developer Qpex Biopharma.

In a resignation letter, Gottlieb did not offer a reason for his departure. It has been widely reported that Gottlieb, 46, commuted from his home in Westport, CT, to the nation’s capital. He and his wife have three young children.

Gottlieb, a trained physician, has worn several hats the past couple decades, including that of a biotech venture capitalist. He was also a high-ranking FDA official in the George W. Bush administration. His investment work made him a poor choice to oversee the life science industry, critics said at the time of his nomination.

The FDA does not have the same power to affect drug prices as the agency overseeing Medicare, but early in his tenure Gottlieb nonetheless pushed for changes to ameliorate the issue, such as the removal of obstacles—often put in place by big drug makers—that prevent generic and “biosimilar” drugs from coming to market. In 2018, a record number of generics were approved. Biosimilars, which offer cheaper versions of expensive protein-based drugs, have had far less traction in the US.

At the same time, the agency built upon Obama-era reforms and sped the pace of branded drug approvals, which also hit a record high last year. But fears of widespread deregulation, stoked by Gottlieb’s own writing in previous years during his stint at a conservative think tank, and by President Donald Trump’s remarks in early 2017 about cutting 75 to 80 percent of FDA rules, have not come to pass.

Under Gottlieb, the FDA has put heat on spurious stem-cell clinics and moved to stem the opioid crisis, a plight which, Gottlieb acknowledged, past FDA approvals of painkillers helped fuel.

Gottlieb has also pushed back against the antivaccine movement, which has gained momentum under the Trump administration with encouragement from the president himself.

In the wake of recent measles outbreaks, Gottlieb criticized state exemptions for mandatory childhood vaccines. And during his nomination hearing, he said: “This has been one of the most exhaustively studied questions in scientific history. We need to… come to the conclusion that there is no causal link between vaccination and autism. We’ve invested, and Congress has invested, enormous resources in studying this question.”

Gottlieb will step down next month.