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 Gottlieb was well regarded by public health advocates and won
bipartisan support for his efforts to curb use of flavored
e-cigarettes by youths, speed approval times for cheap generic
medicines to increase competition and bring down drug prices, and
boost the use of cheaper versions of expensive biotech medicines
called biosimilars.
Unlike his predecessors, who said drug pricing was not the purview
of the FDA, Gottlieb waded into the intensifying debate about the
high cost of medicines for U.S. consumers and had the agency
actively looking into possible solutions.
"Scott's leadership inspired historic results from the FDA team,
which delivered record approvals of both innovative treatments and
affordable generic drugs, while advancing important policies to
confront opioid addiction, tobacco and youth e-cigarette use,"
Health and Human Services (HHS) Secretary Alex Azar said in a
statement.
Gottlieb, who said he wanted to spend more time with his wife and
three young children in Connecticut, was nominated by President
Donald Trump in part to aid in Trump's anti-regulation agenda. But
Gottlieb took an aggressive stance toward e-cigarette makers, such
as Juul Labs Inc.
On Monday, he confronted 15 retailers including Walgreens Boots
Alliance, Kroger Co and Walmart Inc, for illegally selling tobacco
products to children. In early February, the FDA pursued enforcement
actions against some Walgreen and Circle K locations.
But Gottlieb ran into fierce opposition from anti-regulation groups,
such as Americans for Tax Reform, and former FDA officials, who said
the agency's regulatory efforts would destroy thousands of jobs.
A coalition of these groups wrote Trump last month asking him to
"immediately halt the Food and Drug Administration's aggressive
regulatory assault" on e-cigarette businesses.
Following news of Gottlieb's resignation, the Nasdaq Biotechnology
Index turned negative.
It closed down 0.5 percent as shares of Amgen Inc erased gains and
Gilead Sciences Inc shares fell further.
“He made proposals that were unprecedented in their breadth, scope
and, if they were adopted, likely impact,” said Matthew Myers,
president of the Campaign for Tobacco-Free Kids. “But they were just
proposals."
Shares in British American Tobacco and Imperial Brands rose in early
London trade on Wednesday.
Gottlieb had signaled his intention to also go after menthol and
other flavored cigarette products, sending BATS and Imperial down
sharply at the time.
"He has been the driver of the menthol ban, and now the sector is
totally under-owned," said one London-based trader.
E-CIG 'EPIDEMIC'
Gottlieb's campaign against flavored e-cigarettes followed
preliminary federal data showing teenage use had surged by more than
75 percent since last year, which the FDA described as an
"epidemic."
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Under Gottlieb, the FDA proposed a ban on the sale of fruit- and
candy-flavored electronic cigarettes in convenience stores and gas
stations. The FDA also proposed stricter age-verification
requirements for online sales of e-cigarettes.
"Scott has helped us to lower drug prices, get a record number of
generic drugs approved and onto the market, and so many other
things. He and his talents will be greatly missed!" Trump said on
Twitter on Tuesday.
Trump picked Gottlieb to lead the agency in March 2017 and he was
confirmed by the Senate in May of that year.
The Washington Post first reported on Tuesday that Gottlieb planned
to resign.
"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," Gottlieb wrote in a note to FDA staff.
In his resignation letter, Gottlieb touted several agency
initiatives, including efforts to curb tobacco use, decrease the
rate of opioid addiction, speed up approval of generic drugs and
streamline the process to bring to market novel medical
technologies, such as gene therapy.
Gottlieb, 46, a conservative and former physician, was deputy FDA
commissioner under Republican President George W. Bush. Before
taking over at FDA, he was a healthcare investor and consultant who
sat on multiple company boards.
He surprised critics who worried about his ties to the
pharmaceutical industry by speaking out about rising drug prices and
drug company tactics to keep competitors off the market.
“In all my years of public service, I’ve never worked with a more
talented, forthright, and effective agency leader than Dr. Scott
Gottlieb," Republican Congressman Greg Walden said in a statement.
"He worked effectively with Congress to find solutions and to
improve the quality of life for all of us."
Gottlieb often touted that the agency had approved more than 1,000
generic drugs as evidence that it was helping to curb prescription
drug prices, a priority of Trump's administration.
Among those seen as possible successors, according to the Wall
Street Journal, are Norman Sharpless, director of the National
Cancer Institute, and Brett Giroir, assistant secretary at HHS.
Giroir has been the senior adviser to Azar for HHS efforts to fight
the opioid crisis.
In January, Gottlieb said in a tweet that he did not plan to leave
the agency after speculation that he was preparing to step down.
"We've got a lot of important policy we'll advance this year," he
wrote in the January tweet.
(Reporting by Yasmeen Abutaleb and Tim Ahmann; additional reporting
by Chris Kirkham in Los Angeles and Helen Reid in London; editing by
Eric Beech, Jonathan Oatis and Bill Berkrot)
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