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Inside Health Policy – Stakeholders Pour Out Approval Of Gottlieb’s Leadership At FDA

Inside Health Policy – Stakeholders Pour Out Approval Of Gottlieb’s Leadership At FDA

Within hours of the announcement that FDA Commissioner Scott Gottlieb will be resigning from the agency in a month, an array of stakeholders sent out their near-universal applause of the commissioner’s leadership and policy initiatives.


Though representatives of industry spoke fondly of the outgoing agency chief, Michael Carome, director of the Health Research Group at Public Citizen, condemned Gottlieb for his connections to the pharmaceutical industry, said his decisions at the agency favored industry over public health, and bid him “Good riddance,” he wrote.


But Public Citizen’s criticism wasn’t shared by others. Those lauding Gottlieb’s accomplishments in his 23 months at FDA’s helm included House Energy & Commerce ranking Republican Greg Walden (OR), American Heart Association, Advanced Medical Technology Association, Friends of Cancer Research, Pharmaceutical Research and Manufacturers of America, Association for Accessible Medicines and many others.


Walden said the commissioner “worked effectively with Congress to find solutions and to improve the quality of life for all of us” and “gives public service a good name.”


Many industry-specific stakeholders praised Gottlieb’s efforts on initiatives rooted to their sectors. AdvaMed President and CEO Scott Whitaker applauded the commissioner’s support of using medical technology to combat the opioid crisis.


The Association for Accessible Medicines commended Gottlieb’s commitment to cracking down on brand drug makers’ anti-competitive behavior in the drug market.


PhRMA also lauded the commissioner’s work to encourage innovation in drug development and the advancement of novel technologies, such as gene therapies.


Consumer Healthcare Products Association President and CEO Scott Melville said Gottlieb’s tenure was marked by “tremendous progress” modernizing regulations for over-the-counter medicines and a start on doing the same for dietary supplements.


Despite Carome’s condemnation of Gottlieb, other patient groups approved of his tenure. Friend of Cancer Research’s founder and chairperson, Ellen Sigal, said the agency head “understands the politics & bureaucracy of Washington – and he knows how to make that system work to benefit patients.”


Peter Lurie, president of the Center for Science in the Public Interest and a former FDA associate commissioner for public health strategy and analysis, tweeted that Gottlieb “is getting out while the getting’s good. Perhaps the only Trump nominee we’ll actually miss.”


American Heart Association CEO Nancy Brown saluted the commissioner’s work to crack down on e-cigarette sales to minors and urged FDA to continue working on that and other areas, such as generic approvals and consumer education on nutrition information. Lisa Lacasse, president of the American Cancer Society Action Network, echoed praise of Gottlieb’s work on youth tobacco use.


Many FDA experts contacted by Inside Health Policy were surprised by the resignation announcement and wondered why it had occurred.


“I think everyone is a bit shocked,” said Jeffrey Shapiro, a director at the law firm Hyman, Phelps & McNamara. “He has been a proactive Commissioner and very involved in all areas of FDA responsibility. Like everyone else, we are waiting to learn why he is resigning.”


The Alliance for a Stronger FDA also praised Gottlieb’s work, but did not comment on what might have led to the departure.


Former FDA Commissioner and director of the Duke-Margolis Center for Health Policy Mark McClellan pointed out the strain of the job on the commissioner’s family life. Gottlieb’s family lives in Connecticut.


“I think he loves the job and cares deeply about the FDA and its mission,” McClellan wrote to IHP. “But it’s an always-on and very demanding job, and especially hard with a young family elsewhere.”


Gottlieb himself noted the toll of the job on his family life in a message he sent to his staff on Tuesday.


“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 and missing my wife and three young children,” he wrote.…