The physician running the U.S. Food and Drug Administration stunned
tobacco companies when he said the agency had plans for rules to slash
cigarettes’ nicotine content. Maybe they should have seen something like
that coming.Scott Gottlieb has shaken things up in his 81 days
on the job. He’s proposed major policy shifts to ease regulations on
some companies, such as in the way generic-drug applications
are processed so that cheaper medicines can reach consumers faster. The
agency has taken other unprecedented steps to interpret some rules more
strictly, such as by requesting that a pharmaceutical company pull a powerful opioid pain medication off the market because of potential abuse.Scott GottliebPhotographer: Zach Gibson/Getty Images“I
was worried, given the rhetoric about regulation from the current
administration, that he would be held back, but he’s done really well,”
said Robert Califf, the last FDA commissioner under President Barack
Obama. Califf said his team, in fact, had looked into requiring lower
nicotine content in cigarettes, “but we couldn’t turn the corner.”
Gottlieb, 45, has gained an early reputation for moving
swiftly in an executive branch that has been bogged down by political
drama and a relatively slow pace in filling key posts across many
agencies. It’s not clear whether Gottlieb personally sought President
Donald Trump’s counsel before making the bombshell nicotine-reduction
announcement, which sent tobacco industry stocks tumbling, but the White
House supported the move.E-cigarette TradeoffWhile the
nicotine-cut revelation took the spotlight, the FDA said at the same
time that it would push back by five years, until 2022, a deadline for
electronic cigarettes to begin undergoing agency clearance. That harked
back to early concerns among some about Gottlieb, who served on the board of e-cigarette maker Kure Corp. and held a financial stake in it.During
his confirmation hearing, some Democrats questioned his ties to the
pharmaceutical industry; he had been an adviser to or on the boards of
companies including GlaxoSmithKline Plc and was a managing director at
T.R. Winston & Co., an investment bank that does deals in the
health-care sector. As commissioner, he said he would recuse himself for
a year from decisions involving companies to which he had financial or
other ties.Gottlieb has also been a venture capitalist, a fellow
at the American Enterprise Institute and an assistant professor at New
York University School. He was a deputy FDA commissioner under President
George W. Bush.When it comes to e-cigarettes, his view is that
for now, they should be freely available to people who can use them
to “transition them off of combustible cigarettes,” as he said at his
confirmation hearing.Early LegacyThe Campaign for Tobacco-Free Kids, which can be a tough critic,
praised the approach. “To Dr. Gottlieb’s credit, when he looked at the
issue, he realized that to be effective, the promotion of less-harmful
tobacco products must be paired with reduction in the use of the most
harmful products,” said Vince Willmore, a spokesman for the
organization.The tandem efforts could “become a major part of his legacy,” Willmore said.The
FDA’s Center for Tobacco Products, headed since 2013 by Mitch Zeller,
has studied the idea of forcing cigarette makers to reduce nicotine
content to below addictive levels. “A lot of people have been thinking
about this for a long time, including experts in the agency,” Gottlieb
said in an interview Friday.It wasn’t the first time he instituted a policy long promoted by the staff. The FDA moved
in June to ease approval of cancer treatments targeted at specific gene
mutations. Historically, the agency has sanctioned oncology drugs based
on what body part they treat, such as lung, breast or kidney. Rick
Pazdur, director of the FDA’s Oncology Center of Excellence, has been
advocating the gene approach for several years. Gottlieb has a personal
interest in cancer treatments, as a survivor of Hodgin lymphoma.In
an interview before the nicotine announcement, he said he inherited a
smooth-running ship, calling the FDA “a very efficient organization.”“So
I was able to take some early actions here. I have the benefit of
having the clear sense of what I wanted to do and also having known the
agency, so it’s easier to operate,” he said. “We have a pretty busy
agenda across a whole range of different areas.”
