FDA Commissioner Scott Gottlieb Resigns, Citing Family Commitments

Image source: BioSpace

VCBeat has learned that Scott Gottlieb, head of the U.S. Food and Drug Administration (FDA), resigned on March 5, 2019.

According to The Washington Post, which first reported the news, Gottlieb will leave the regulatory agency in about a month. The Post stated that Gottlieb wishes to spend more time with his family. Currently 46 years old, Gottlieb is the father of three children: nine-year-old twins and a five-year-old. He needs to commute weekly to Connecticut.

Since taking office in May 2017, Gottlieb has actively supported the approval of new brand-name drugs and generic drugs. In addition, he has focused on addressing multiple public health issues, including the opioid epidemic sweeping across China and smoking.

According to The Washington Post, Gottlieb’s resignation caught the White House by surprise. He was favored by the Trump administration and hired for his proactive stance on reshaping federal regulatory agencies.

Alex Azar, Secretary of the U.S. Department of Health and Human Services, stated that he was proud of the work Gottlieb accomplished during his two-year tenure as head of the FDA. Azar described him as a vigorous advocate for American patients and an enthusiastic driver of innovation. In a statement, Azar noted that Gottlieb’s leadership had delivered historic results, providing “record approvals of innovative therapies and affordable generic drugs.”

Since taking the helm at the U.S. Food and Drug Administration, Gottlieb has consistently used his Twitter account to brief the public on various initiatives he has undertaken and to keep the public informed during the FDA shutdown earlier this year.

Last month, Gottlieb outlined new measures the FDA plans to take to address the opioid crisis. Gottlieb stated that the FDA has shifted its stance on the opioid crisis and will adopt a more proactive approach to regulatory actions. In his statement, Gottlieb pointed out that the FDA’s practice of waiting for “accumulating evidence of harm” has triggered a crisis of trust in communities across China, although the crisis is not always apparent.

Also in February, Gottlieb outlined a new pathway to accelerate the review of generic drug applications. This initiative underscores the FDA’s efforts to increase competition and lower drug prices. Gottlieb stated that the agency has been taking steps to support “downward pressure” on drug pricing, meaning it aims to leverage increased generic competition to influence market dynamics. He noted that many brand-name drugs on the market lack generic competition, which can keep prices high and “ultimately harm American patients.” The FDA is working to reduce barriers to generic drug development and lower the costs associated with bringing generics to market, thereby expanding treatment options for patients.

During his tenure, Gottlieb also supported the development of biosimilars for the U.S. market and cracked down on unapproved plasma-based anti-aging treatments.

Prior to his recent tenure as FDA Commissioner, Gottlieb had a long-standing career in public health policy. From 2003 to 2004, he served as a senior advisor to the FDA Commissioner and subsequently as the agency’s Director of Medical Policy Development. In 2004, Gottlieb became a senior advisor at the Centers for Medicare & Medicaid Services. He then served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs from 2005 to 2007. In addition to his work in public health, Gottlieb has acted as a consultant for companies such as Novo Nordisk, GlaxoSmithKline, and Daiichi Sankyo. Before becoming FDA Commissioner, he was a venture partner at New Enterprise Associates and a resident fellow at the American Enterprise Institute, a conservative think tank.

With Gottlieb stepping down as Commissioner, the focus now shifts to who will succeed him. Although it is premature to speculate, several names have emerged as potential White House appointees for the role, including Jim O’Neill. He has previously called for FDA reforms, such as approving drugs that have been proven safe but not yet demonstrated effective.