Gottlieb to leave top post at FDA

He’ll be missed, president states

In this Wednesday, April 5, 2017, file photo, Dr. Scott Gottlieb speaks during his confirmation hearing before a Senate committee, in Washington, as President Donald Trump's nominee to head the Food and Drug Administration.  Gottlieb is stepping down after nearly two years leading the agency’s response to a host of public health challenges, including the opioid epidemic, rising drug prices and underage vaping.
In this Wednesday, April 5, 2017, file photo, Dr. Scott Gottlieb speaks during his confirmation hearing before a Senate committee, in Washington, as President Donald Trump's nominee to head the Food and Drug Administration. Gottlieb is stepping down after nearly two years leading the agency’s response to a host of public health challenges, including the opioid epidemic, rising drug prices and underage vaping.

U.S. Food and Drug Administration Commissioner Scott Gottlieb is resigning, ending a tenure during which 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 President Donald Trump's administration, which has taken a more hands-off approach in many other areas of oversight. A 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 take more innovative treatments to the marketplace.

As FDA chief, he also became an adviser to Trump on prescription-drug prices and other health issues. The president said in a Twitter post 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 that 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 leading the agency. The FDA approved 59 new 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.

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 likes to communicate directly with the public, reverberated in the stock market. Shares of smaller, innovative drug companies, which 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.

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 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 the e-cigarette issue.

"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."

Information for this article was contributed by Ellen Huet of Bloomberg News.

Business on 03/06/2019

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