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FDA Chief Resigns After Clearing Slew of Drugs, Wrestling E-Cigs

Anna Edney and Margaret Talev
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FDA Chief Resigns After Clearing Slew of Drugs, Wrestling E-Cigs

(Bloomberg) -- U.S. Food and Drug Administration Commissioner Scott Gottlieb is resigning, ending a tenure where he approved a flood of drugs and pushed for sharp curbs on e-cigarettes to halt what he called an epidemic of youth use.

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.”

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 that Gottlieb had also been frustrated by the government shutdown that in December 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 of his time heading the agency. 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.

The departure of Gottlieb, an adroit user of social media who like the president likes to communicate directly with the public, reverberated in the stock market. Shares of smaller, innovative drug companies, who have benefited from Gottlieb’s efforts to modernize the approval process for novel therapies, slipped, with the Nasdaq Biotechnology Index ending the day down 0.5 percent.

Vaping Rules

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. He’s also called out retailers including gas stations and pharmacies found to have sold tobacco to minors.

In 2017, Gottlieb announced plans to potentially set nicotine levels in cigarettes to nonaddictive levels, but details haven’t been released and the effort appears to have been overtaken by e-cigarettes.

“If fully implemented, those key measures would significantly improve the health of our nation and reduce cancer death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in a statement. “These proposals must move forward despite the commissioner’s departure.”

Tobacco-company stocks briefly jumped after Gottlieb’s departure was reported, a sign that some investors see Gottlieb’s departure as a possible opening for a more relaxed regulatory regime. Altria Group Inc., which has a large stake in vaping company Juul Labs Inc., gained as much as 2.7 percent in afternoon trading in New York.

“Despite the e-cigarette panic, he still could have undertaken his stated goal of educating Americans on the truth about nicotine,” said Greg Conley, president of American Vaping Association, a group that advocates for e-cigarettes. “He failed in that mission.”

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 Sept. 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.

Health and Human Services Secretary Alex Azar praised Gottlieb as “an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation” in an emailed statement. Azar lauded Gottlieb’s record on drug approvals, opioids and tobacco.

--With assistance from Ellen Huet.

To contact the reporters on this story: Anna Edney in Washington at aedney@bloomberg.net;Margaret Talev in Washington at mtalev@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett

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