March 13, 2017

Meet the doctor Trump just picked to head FDA

Daily Briefing

    President Trump on Friday announced his intent to nominate Scott Gottlieb, a physician and former deputy commissioner at FDA, to lead the agency, according to an emailed statement from the White House.

    Industry executives praised Gottlieb's nomination, but some consumer advocates raised concerns about his financial ties to drugmakers. If confirmed by the Senate, Gottlieb would be responsible for implementing Trump's plan to scale back regulations at FDA, which oversees safety and product approvals for everything from prescription drugs and medical devices to tobacco, food, and cosmetics.

    About Gottlieb

    Gottlieb has a business and medical background. He completed a degree in economics at Wesleyan University in 1994 and in 1999 graduated from the Mount Sinai School of Medicine, after which he completed his residency in internal medicine at Mount Sinai Medical Center.

    Gottlieb served in several FDA roles during former President George W. Bush's administration, including former FDA deputy commissioner for medical and scientific affairs. Since leaving FDA, Gottlieb has been a public commentator on drug policy and has advocated for easing FDA's approval requirements to help lower prescription drug costs.

    Gottlieb also worked at CMS, where he helped implement the Medicare Part D program.

    Currently, Gottlieb is a resident fellow at the conservative think tank the American Enterprise Institute and a partner at New Enterprise Associates, one of the world's largest venture capital funds with investments in the health care services, life sciences, and medical technology industries. He also serves as a board member for several small drug and biotech companies and is an adviser to GlaxoSmithKline, Reuters reports. Gottlieb between 2013 and 2015 received more than $400,000 in payments from pharmaceutical companies, according to CMS' Open Payments database, the New York Times reports.

    How FDA could change

    While Gottlieb is not expected to completely overhaul FDA, Reuters reports that he could significantly change the agency if he is confirmed.

    Trump on several occasions has publicly stated his desire to cut regulations and speed up drug approvals at FDA. According to Reuters, Gottlieb likely will prioritize streamlining the approval process for generic versions of complex medications. Gottlieb in the past has said he believes the agency is ill-equipped to readily approve such products and has advocated for new standards.

    Among other things, Gottlieb would be tasked with implementing provisions in the 21st Century Cures Act, which includes $500 million over the next 10 years for FDA to accelerate its drug and medical device approval processes. Among other things, the law instructs FDA to consider the use of "real world evidence"—such as anecdotal data, observational studies, and patient reports—to support new drug applications.

    Reaction

    Pharmaceutical industry executives and experts largely praised Trump's selection.

    Stephen Ubl, a spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA), in a statement praised Gottlieb's "extensive experience as a physician and breadth of health care knowledge," adding that PhRMA "looks forward to working with Gottlieb in his new role and engaging with him and [FDA] as they seek to modernize the drug discovery and review process."

    Leonard Schleifer—founder, president, and CEO of Regeneron Pharmaceuticals—said, "I think [Gottlieb] is science-based, he's patient-focused, he's got strong management skills and he's intellectually tough, so he will use all of that to make sure FDA and industry are all acting in the interests of patients."

    Report: FDA failed to track many drug safety issues 

    Some patient advocacy groups also welcomed Gottlieb nomination. Ellen Sigal, founder of Friends of Cancer Research, said Gottlieb "has firsthand experience at the FDA and as a physician that has treated patients understands the breadth of work that needs to be achieved on their behalf."

    However, others, such as Public Citizen's Health Research Group, criticized Gottlieb's financial ties to the industry, saying they present a conflict of interest. Michael Carome, the group's director, said Gottlieb "has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry." Carome added that if Gottlieb is confirmed, Gottlieb would "have to be recused from key decisions time and time again."

    Daniel Carpenter, a professor at Harvard University who studies FDA, said, if confirmed, Gottlieb "would be the most interest-conflicted commissioner in American history, by far." He added, "These are not relationships whose influence just disappears once he resigns from a corporate board. The Senate should scrutinize the conflicts of interest carefully" (Clarke, Reuters, 3/10; Thomas, New York Times, 3/10; Edney/Langreth, Bloomberg, 3/10; McGinley/Johnson, "To Your Health," Washington Post, 3/10).

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