Leadership Shake-Up: What’s Next for FDA?

Staff Report

Rumors of Gottlieb’s resignation surfaced in January 2019, leading to speculation that he was at odds with the current US administration and forced out like many other top officials over the last two years, which he had denied. The reason he gave for his resignation was that he wanted to spend more time with his family and the toll commuting between his family in Connecticut and his office in Washington had taken.

Before becoming FDA commissioner in May 2017, Gottlieb had been a top official at the agency during the George W. Bush administration and a partner at a venture capital fund. Despite criticism about his connections to and work for the pharmaceutical and biotech industries, Gottlieb was confirmed after promising to divest from several health care companies.

During Gottlieb’s tenure as commissioner,  FDA’s relationship with the industry had gone through drastic change. It seemed the agency was adopting a more open-minded stance in July 2017  when he delayed the compliance deadline for the regulation of e-cigarette products to 2022, acknowledging that e-cigarettes can help smokers transition from traditional tobacco products and allowing companies four years to apply for  FDA’s approval for their e-cigarette products, during which time the agency would also be able to study the effects of said devices more thoroughly. That all changed in 2018 when the agency adopted a decidedly less-friendly take on e-cigarettes, citing an increase in youth vaping as the reason.

In April 2018 Gottlieb announced the Youth Tobacco Prevention Plan to “stop youth use of, and access to, Juul and other e-cigarettes” as well as asking Juul to explain what the agency saw as “the explosive rise” of the device’s popularity with young people. In October 2018 FDA conducted a surprise inspection of Juul’s headquarters, followed by an announcement in November saying that it would limit the sale of most flavored, except menthol and mint, e-cigarette products in places without age-verification procedures.

Gottlieb and the FDA did not toughen up just on e-cigarettes, either. Last November the agency also announced that it would be proposing a ban on sales of menthol cigarettes, with Gottlieb quoted as saying, “It was a mistake for the agency to back away on menthol,” as well as on flavored cigars. Earlier in his tenure, Gottlieb had also put forward a policy to reduce the nicotine levels in cigarettes.

During his time as FDA commissioner, Gottlieb published roughly 175 commissioner statements and gave countless media interviews, helping raise FDA’s stature and influence.

Gottlieb will be returning to the American Enterprise Institute, a Washington-based conservative think tank, as a resident fellow on health policy studies. He plans to focus on drug prices and the “market failures” that are keeping them high, which include an insufficient number of products on the market to constrain prices and branded drug-makers gaming the system to keep generics off the market; underdeveloped markets for orphan drugs that preserve monopolies; and various rules and strictures in areas like Medicare Part B. Gottlieb had previously worked for AEI starting in 2002.

Norman “Ned” Sharpless, the director of the National Cancer Institute (NCI) was named acting FDA commissioner, effective April 5. A physician-scientist,  Sharpless, had previously run the Lineberger Comprehensive Cancer Center at the University of North Carolina (UNC) since January 2014 before taking over the NCI in October 2017.

Sharpless was a Morehead Scholar at UNC at Chapel Hill and received his undergraduate degree in mathematics. He later pursued his medical degree from the UNC School of Medicine, graduating with honors and distinction in 1993. He completed his internal medicine residency at the Massachusetts General Hospital and a hematology/oncology fellowship at Dana-Farber/Partners Cancer Care, both of Harvard Medical School in Boston. After two years on the faculty at Harvard Medical School, he joined the faculty of the UNC School of Medicine in the Departments of Medicine and Genetics in 2002 and became the Wellcome Professor of Cancer Research at UNC in 2012.

While news of Gottlieb’s resignation caused tobacco stocks to rise by about 2%, Sharpless’ appointment news a week later led to Philip Morris shares going down 0.3% and Altria shares fell 0.35%. British American Tobacco shares experienced a similar dip, but the stock remained up 0.3%.

Sharpless has been reported to be an enthusiastic supporter of Gottlieb’s aggressive push to increase tobacco and e-cigarette regulations. It remains to be seen, however, where the wind will blow for the industry – whether we can expect getting slapped with even heavier regulations without hearing what the industry has to say or whether the agency under Sharpless’ leadership will prove to be more even-handed.