Washington-Watch
Scott Gottleib, MD: Company Man for FDA?
Policy experts say his ties to industry are an asset and liability
SAVESAVED
by Shannon Firth
Washington Correspondent, MedPage Today
March 13, 2017
WASHINGTON -- Scott Gottlieb, MD, is indeed President Trump's choice for FDA commissioner, according to a White House press statement, and he's getting mixed reviews from industry and policy experts.
Gottlieb is a partner at New Enterprise Associates, a venture capital fund with strong connections to the pharmaceutical industry; a resident fellow at the American Enterprise Institute, a conservative think tank; and a member of the Federal Health IT Policy Committee. He also served as FDA deputy commissioner under President George W. Bush from 2005 to 2007.
"In some ways for the Trump administration, he may be a rather traditional pick ... given some of the alternatives who had been floated,"said Caleb Alexander, MD, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, in a phone interview. Those alternatives included Jim O'Neill, a libertarian and a strong supporter of "progressive approval," or allowing drugs to be approved based on safety before their effectiveness has been established, according to Forbes.
Gottlieb's views on speeding up the review of generic products, and increasing generic competition, have been well-received, Alexander said, adding that Gottlieb's extensive industry experience is both "an asset and a liability." He noted one handicap that Gottlieb shared with Robert Califf, MD, the current commissioner.
"The depth of his expertise in tobacco and food is invariably going to lag behind his knowledge of medical products, and the FDA regulates all three," he noted.
'A Committed Reformer'
In an email to MedPage Today, Kip Piper, a healthcare reform consultant for Sellers Dorsey, called Gottlieb "an articulate advocate of increased patient access to innovative medical therapies and technologies," and "a committed reformer who can get the job done "
Piper and Gottlieb worked together as senior advisors to the administrator for the Centers for Medicare and Medicaid Services under President George W. Bush.
"Dr. Gottlieb's strong scientific base and understanding of programs, such as the breakthrough therapy designation and Oncology Center of Excellence, can help the FDA continue to streamline its processes," said Jeff Allen, PhD, president and CEO of Friends of Cancer Research. "Through his knowledge and experience, we have no doubt that Dr. Gottlieb will be the right person to ensure the FDA keeps pace with science and innovation without sacrificing the safety and efficacy gold standard established by the FDA."
In a survey of pharmaceutical executives from Mizuho Securities USA, given the choice of four potential candidates to run the FDA, including O'Neill, 72% chose Gottlieb, according to EndPoints News.
"Our industry applauds Dr. Gottlieb's commitment to innovation in medical technology and his recognition of its important role in providing the best care possible for patients, said Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed) in a press release. "Specifically, we look forward to working with Dr. Gottlieb and his team on the medical device user fee reauthorization in the coming weeks and months in our mutual pledge to continued patient access to life-changing technologies."
Stephen Ubl, president and CEO of PhRMA, lauded Gottlieb's experience, both as a physician and healthcare expert, in a press statement.
Complicit with Pharma?
Susan Wood, PhD, associate professor of health policy and management at the George Washington University Milken Institute School of Public Health in Washington, was less enthusiastic.
Any FDA commissioner must have the strength to stand up for the agency, and resist the "politicization" of its decisions, stressed Wood, a former FDA assistant commissioner for women's health, who was at the FDA at the same time as Gottlieb.
"It's widely known that he's very conservative; that he's been sympathetic, if not complicit, with the pharmaceutical industry over many years, and so that raises some concerns," she noted. Wood said she had two main questions about Gottlieb -- how would he withstand industry pressure, and how would he withstand political pressure?
As for access to reproductive products, including contraception or abortion medication, "the question is will he stand up to political pressure, not just on behalf of the FDA, [but] on behalf of people in the United States who depend on the FDA making its decisions based on science and on good medicine," Wood asked.
Diana Zuckerman, PhD, president of the National Center for Health Research, stated that Trump could have made a worse decision. "Gottlieb understands the agency and his goal will not be to destroy it," she pointed out.
However, because of Gottlieb's "enormous" conflicts of interest with industry, Zuckerman said she is not entirely comfortable with his selection.
She noted that the FDA of late has allowed drug approvals based on "skimpier research ... If Dr. Gottlieb continues [with] the FDA on this path of lowering standards, insurance companies will do what they've already started to do, which is to say, 'We're just not going to automatically cover FDA products, because too many of them are being approved without proof that they worked.'"
Consumer watchdog Public Citizen also expressed disappointment in the choice.
"When Gottlieb served as FDA deputy commissioner, he was recused from many key meetings and decisions due to his close relationship with industry. If the Senate does not reject Gottlieb, he will have to be recused from key decisions time and time again, otherwise there is no way to be sure he will put the public's health over industry profits," said Michael Carome, MD, director of Public Citizen's Health Research Group in a press statement.
Carome expressed concern that Gottlieb cares more about getting medications to market quickly, than he does about safety and efficacy. "Gottlieb's appointment would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients. The Senate must reject the nomination and demand a nominee who is better suited to protect public health," according to the statement.
The Senate is expected to schedule a hearing to discuss Gottlieb's nomination.
Next: House GOP's ACA Replacement Bill: What's In, What's Out?
