By Joseph Walker and Thomas M. Burton
The U.S. Senate voted Tuesday in a 57-42 mostly party-line vote
to confirm Scott Gottlieb as the new commissioner of the Food and
Drug Administration.
Dr. Gottlieb, 44, a veteran health-care investor and physician,
is well known to many drug-industry executives. He worked for years
as a consultant to companies including GlaxoSmithKline PLC and
Vertex Pharmaceuticals Inc., spoke frequently at health-care and
investor conferences, and wrote hundreds of essays and op-eds,
often advocating for the FDA to approve drugs more quickly and
loosen regulations on off-label marketing.
He is also steeped in the details of regulatory approval of
drugs and medical devices, having previously served as deputy FDA
commissioner under the George W. Bush administration.
Dr. Gottlieb favors free-market strategies to bring down drug
costs, including by increasing the rate of generic-drug approvals
at the FDA. He has also questioned the wisdom of allowing U.S.
consumers to import brand-name drugs from countries like Canada,
where they cost less, in part because of safety concerns -- a
viewpoint shared by drugmakers.
"He agrees with the basic concept of the pharmaceutical
industry: the need to have drugs come to market quickly, viewing
the bureaucracy as necessary but [it] can get in the way of
innovation," said Ronny Gal, a stock analyst at Sanford C.
Bernstein & Co.
Company officials say they expect Dr. Gottlieb to push the FDA
to accelerate its adoption of more flexible approaches to
evaluating new drugs and clinical trials. And his experience at the
agency should help him garner support from rank-and-file staff to
implement his agenda, executives say.
He "sounds like a progressive person who wants to get things
done," Eli Lilly & Co. Chief Executive David Ricks said in an
interview. "He's got experience in the agency already. He's a
doctor and a cancer survivor. Sounds to me like he has a balanced
perspective." Dr. Gottlieb had Hodgkin lymphoma and is cancer-free
now.
His work in recent years as a venture capitalist, making
hundreds of thousands of dollars from medical companies in
consulting and speaking fees, had given pause to Democrats in the
Senate.
Sen. Patty Murray (D., Wash.), the ranking Democrat on the
Senate health committee, said she opposed Dr. Gottlieb because of
his "unprecedented industry ties" and what she regards as his
"inability to withstand industry pressure."
Dr. Gottlieb has said he would recuse himself for one year from
FDA decisions on more than 20 companies where he has potential
conflicts of interest. "I understand how important impartiality of
this agency is," Dr. Gottlieb said at his Senate confirmation
hearing in April. "I don't want to do anything in my conduct to
reduce people's confidence in the agency's mission."
Dr. Gottlieb earned at least $645,000 from drug companies and
trade groups from the beginning of 2016 through the first two
months of 2017, according to his disclosure statements.
He served for seven years on a GlaxoSmithKline board that
manages the company's research and development investments,
providing "a valuable perspective on the U.S. health-care and payer
environment," said a GSK spokeswoman. As FDA commissioner, Dr.
Gottlieb "will help ensure that the FDA maintains its focus on
innovation and protecting public health by expeditiously approving
safe and effective new treatments for patients," she said.
Dr. Gottlieb has also been supportive of loosening FDA
restrictions on off-label marketing, where companies advertise drug
uses that haven't been cleared by the agency. He has advocated
allowing companies to distribute such information to doctors as
long as it is truthful and not misleading.
There are numerous alternatives to "FDA's current regime --
which virtually bans off-label promotion -- that would promote
FDA's public health goals even better than the current regime
does," Dr. Gottlieb wrote in expert testimony in 2015 on behalf of
Amarin Corp., in a lawsuit the company filed against the FDA over
its off-label marketing policies. Dr. Gottlieb was paid $600 per
hour for his work on the case, he wrote in his testimony.
Like other of President Donald Trump's nominees, Dr. Gottlieb
has been critical of the agency he is nominated to oversee. He
wrote in a 2012 essay that the FDA has a "harmful culture" that
mistrusts doctors to prescribe drugs appropriately, leading
officials to have "an excessive desire for certainty" that new
medicines are safe and effective before they are approved, he
wrote.
The FDA has several methods for accelerating approvals, such as
granting conditional approval if studies show the drug is
"reasonably likely" to help patients live longer or have other
benefits. Some FDA divisions have embraced the faster methods, but
other divisions are still very "rigid," said Ron Cohen, chief
executive of Acorda Therapeutics Inc. "Even if you bring them
evidence of benefit to patients, it's still an uphill climb."
Dr. Gottlieb said in April that he would create "consistency to
how different parts of the FDA" use their powers.
Some researchers question how much further the FDA can go in
speeding up drug approvals without lowering its standards. More
than two-thirds of drug approvals last year were completed under
"priority review," where the FDA makes an approval decision within
six months instead of the standard 10 months, according to the
FDA.
"The FDA is already one of the fastest regulatory agencies in
the world, " says Aaron Kesselheim, an associate professor of
medicine at Harvard Medical School. "Faster for faster's sake is
not wise."
--Peter Loftus contributed to this article.
Write to Joseph Walker at joseph.walker@wsj.com and Thomas M.
Burton at tom.burton@wsj.com
(END) Dow Jones Newswires
May 09, 2017 18:05 ET (22:05 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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