President Donald Trump has nominated Scott Gottlieb, MD, a physician with broad experience in government service, health policy, and drug development, to be the commissioner of the US Food and Drug Administration (FDA).
The nominee matches up with Trump's vision — and that of Congressional Republicans — of a less regulated FDA that makes it easier for drug and device makers to get innovative products to market. However, his critics warn that an agency with Dr Gottlieb at the helm could be less committed to ensuring that those products are safe and effective, given his ties to the pharmaceutical industry and his penchant for deregulation.
Dr Gottlieb knows the FDA as both an insider and an outsider. He worked at the agency from 2003 to 2004 as senior adviser to the FDA commissioner and then its director of medical policy development, and from 2005 to 2007 as the agency's deputy commissioner for medical and scientific affairs. Between those FDA stints, he helped implement the Medicare Part D drug program as a senior advisor at the Centers for Medicare and Medicaid Services.
He now serves as a board director or advisor to a number of drug and medical device companies including GlaxoSmithKline, Glytec, and Tolero Pharmeceuticals. In other roles on the industry side of things, Dr Gottlieb is a managing director of TR Winston & Company, an investment banking firm that focuses on healthcare, and a venture partner in the venture capital firm New Enterprise Associates, which has a large footprint in healthcare.
The US Department of Health and Human Services currently receives his advice on digital medicine. In 2013, Dr Gottlieb was appointed to the department's Health Information Technology Policy Committee.
Trump's choice for FDA has bonafide conservative credentials. Dr Gottlieb is a resident fellow at the American Enterprise Institute, a conservative-leaning think-tank in Washington, DC. The former hospitalist shares his views as a contributor to Health Affairs, the Wall Street Journal, Forbes, and other publications.
Dr Gottlieb has said that the FDA needs to tolerate a little more uncertainty when it assesses the effectiveness of a new drug. The agency, he once said at a symposium on cancer cures, is paralyzed "by the risk that they will approve a drug on the basis of an observation of a benefit that isn't 100%...certain."
Likewise, he wrote in Forbes last year that the agency's premarket review of novel products such as gene and cell therapies can't ferret out all risks by itself, and that "the FDA needs to take a more active approach to risk mitigation once products gain market entry."
Rumors of Dr Gottlieb's nomination prompted the consumer watchdog group Public Citizen to call for his rejection by the Senate. Michael Carome, MD, director of the group's healthcare division, said in a news release that Dr Gottlieb has long been beholden to Big Pharma, so much so that, during his tenure as FDA deputy commissioner, he often had to recuse himself from key meetings and decisions.
Dr Carome also faulted him for "dangerous deregulatory approaches" to the review process for new medications for the sake of speeding them to the market place. "Gottlieb is willing to accept a greater degree of uncertainty about safety and effectiveness at the time of approval," Dr Carome said.
Dr Gottlieb's confirmation process begins with a hearing before the Republican-controlled Senate Health, Education, Labor and Pensions committee. That committee will then vote on whether or not to recommend confirmation by the full Senate.
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Cite this: Trump Nominates Scott Gottlieb, MD, to Head FDA - Medscape - Mar 10, 2017.