FDA head resigns after clearing slew of drugs, fighting e-cigs

By | March 6, 2019

Scott Gottlieb, the U.S. Food and Drug Administration Commissioner, ending a tenure where he approved more drugs and pushed for sharp curbs on e-cigarettes.

Gottlieb earned a reputation as an attentive and media-savvy regulator in a Trump administration that’s taken a more hands-off approach in many other areas of oversight. A medical doctor, Gottlieb won over the agency’s staff and became a celebrated figure among pharmaceutical companies, biotechnology firms and medical device makers for moving swiftly to bring more innovative treatments to the marketplace.

As FDA chief, he also became a trusted adviser on prescription drug prices and other health issues to President Donald Trump, who said on Twitter on Tuesday afternoon that Gottlieb “will be greatly missed.”

Scott Gottlieb, MD

Scott Gottlieb, MD

A senior FDA official said Gottlieb’s resignation had been planned for some time and that he was leaving the administration on amicable terms. Gottlieb, 46, had grown tired from a long commute each week back and forth to Connecticut, according to the person, and he felt like he’d set in motion many of his goals on drug costs and e-cigarettes.

Another person familiar with his thinking said Gottlieb had also been frustrated by the government shutdown in December that shuttered many of the agency’s activities for about a month.

Trump said in a tweet that Gottlieb would leave “sometime next month.” He took over as FDA commissioner in May 2017.

Speeding up the drug-approval process had been one of Gottlieb’s top priorities from the start. The FDA approved 59 new novel medications in 2018, including highly anticipated drugs to treat migraines. That was a jump from the 22 such medications cleared in 2016 and 45 in 2015, the last two years of the Obama administration.

Gottlieb was also a key player in the Trump administration’s push to lower pharmaceutical costs. Those efforts focused on approving hundreds of new generic medications, as well as targeting industry tactics that he and others blamed for keeping prices high.

Gottlieb also targeted the growing youth use of e-cigarettes after it became apparent that an earlier move to ease restrictions on the industry backfired. Teen vaping skyrocketed last year, pushing the commissioner to propose limits on where flavored products could be sold. He has recently said he would finalize that proposal in the next few weeks.

In his resignation letter, Gottlieb trumpeted the FDA’s recent success in rolling out policies to address youth tobacco use and opioid addiction, and touted the brisk pace of new drug approvals by the agency. He said that the FDA had expanded access to lifesaving drugs for patients with terminal illness on his watch.

His efforts to help lower drug costs focused on easing generic drug approvals, particularly for copycats of treatments that didn’t have much competition previously. The FDA approved a record 971 generic drugs in the fiscal year ending September 30. That number totaled 937 in fiscal 2017 and 835 in fiscal 2016.

At the same time, the FDA conducted fewer surveillance inspections of drug manufacturers, dropping 11 percent in Fiscal 2018 from Fiscal 2017, a Bloomberg investigation found earlier this year. The inspections are meant to confirm medications are being made to meet U.S. standards, and many generic-drug manufacturers in recent years have been found not to include in official records quality checks that show drugs failed to meet U.S. standards.

He’s also overseen a massive recall of blood-pressure medications made in India and China that have been found to contain potentially cancer-causing chemicals. Just last week, seven months after the first so-called angiotensin II receptor blockers were recalled, the FDA announced a third potential carcinogen had shown up in additional ARBs. The House Energy and Commerce Committee has asked the FDA for a briefing on the inspection numbers and the drug recall.

Bloomberg News

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