Scott Gottlieb: The FDA Commissioner America Needed
Dr. Scott Gottlieb announced his resignation as FDA Commissioner just a couple of weeks ago and will officially leave the agency in a just a matter of days. In his short time as the nation's foremost health and safety regulator he has tackled more than his fair share of challenges. Though critics initially feared Dr. Gottlieb's industry ties and libertarian beliefs would lead to massive deregulation, the last couple of years have seen just the opposite.
Commissioner Gottlieb set the tone on his first day, openly calling out the high price of prescriptions, the youth tobacco epidemic, and dangerous medical devices. He also hit the ground running as the most communicative and social media savvy FDA Commissioner in history. According to his Twitter history, Dr. Gottlieb averaged just over 6 original tweets per day from November 2018 to March 2019. He also released over 190 official statements on FDA.gov, a number almost 40 times higher than his predecessor released in a similar time period from 2016 to 2017.
In the last two years, the United States Food and Drug Administration has made great progress on a number of consumer safety concerns. We've pulled together the most notable accomplishments from Commissioner Gottlieb's tenure below.
Though e-cigarettes have made headlines for years over explosions and controversial marketing tactics seemingly aimed at children, the FDA did not have authority to regulate them until 2009. Even after gaining that authority, regulators initially chose to exercise "enforcement discretion," and did not impose real regulations until 2014. When Dr. Gottlieb took over, he quickly moved to extend regulatory deadlines previously imposed on e-cigarette and other tobacco product manufacturers.
The initial deadline extension seemed like a move toward relaxing e-cigarette oversight, but FDA actions since then have substantially increased regulations and enforcement actions concerning e-cigarette and vaping products.
- July 2017: Announcement of the Protecting American Families: Comprehensive Approach to Nicotine and Tobacco
- September 2017: Publication of A Nicotine-Focused Framework for Public Health
- December 2017: Launch of public education program designed to encourage adult smokers to quit
- April 2018: Citations to 40 retailers for youth sales of e-cigarette products
- May 2018: Warning letters to manufacturers marketing e-liquids using kid-friendly foods like cereal and candy
- July 2018: FDA regulatory plan to decrease tobacco-related disease and death by reducing nicotine in products to non-addictive levels
- Summer 2018: Official warning letters to 1,300+ retailers illegally selling e-cigarette products to minors
- August 2018: Products known for kid-friendly marketing tactics no longer available for sale
- September 2018: Official letters to five of the biggest electronic cigarette manufacturers requiring them to submit information regarding high teen usage rates
- September 2018: Unscheduled inspection of Juul Labs, Inc., the largest e-cigarette manufacturer
- September 2018: Launch of massive educational campaign to prevent youth adoption of vaping and tobacco products
- October 2018: Official letters to 21 e-cigarette manufacturers demanding proof of regulatory compliance for more than 40 vaping products
- November 2018: Proposal of new regulations for preventing youth access to flavored nicotine products and complete ban on menthol cigarettes
- February 2019: Attempted ban against major retailers for repeatedly selling tobacco products to teens despite warnings
- February 2019: Official letters to more than 40 retailers demanding proof of regulatory compliance for countless vaping products
- March 2019: List of national retailers repeatedly selling tobacco products to minors
- March 2019: Proposal of regulations to limit sale of all flavored tobacco products (except tobacco, mint, and menthol) to locations physically inaccessible to youths
Even after announcing his resignation, Dr. Gottlieb made several strongly worded statements regarding nicotine and tobacco products. In his most recent press release on the subject, he openly admitted the agency would rather restrict all access to tobacco and vaping products than see the teen vaping epidemic continue.
New Drug and Device Approvals
As part of the effort to decrease the cost of prescription drugs across the board, the FDA has updated approval processes related to new drugs and devices as well as generics. Under Dr. Gottlieb's leadership, the FDA approved a total of 105 new drugs, 58% of which treat rare diseases. This represented a substantial leap forward versus the same time period for his predecessor, which saw only 67 new drug approvals.
After the uproar over astronomical increases in the cost of the EpiPen, the first generic version was approved in record time. The generic now sells for about $100 without insurance, versus the now reduced $300 price of the name brand EpiPen two-pack, down from $600 in 2015.
In a public statement, Dr. Gottlieb recently encouraged drug manufacturers to take better advantage of the streamlined approval processes and new pathways made available during his tenure. He reminded manufacturers and consumers that swift approval and safety of new products are not mutually exclusive goals.
The Essure Female Sterilization Device
After learning about severe, unexpected side effects from the Essure birth control implant, the FDA increased surveillance of the product in several ways. While Dr. Gottlieb served as commissioner, the regulatory agency tightened controls on the device, restricting sales to patients who had formally signed an acknowledgment of the associated risks and benefits. Bayer, the manufacturer, was also required to complete extensive post-market surveillance studies of patients with the device.
Bayer pulled Essure from the market in December 2018, citing declining sales. Dr. Gottlieb released a statement reinforcing the need for continued post-market surveillance despite the product's removal from the market. He also emphasized his conversation with women affected by the device and reiterated the FDA's commitment to improving the way such devices are monitored.
The Essure device still faces thousands of lawsuits from consumers who say the manufacturer failed to warn them of the serious side effects that prompted increased FDA surveillance.
The FDA Without Gottlieb
Dr. Ned Sharpless, Director of the National Cancer Institute, is set to replace Dr. Gottlieb as FDA Commissioner. The Secretary of Health and Human Services, Alex Azar, has indicated the continuation of all current FDA initiatives and programs under the new commissioner. His public statements focused on continuing the improvements in drug approval times, regulatory processes, and controlling the rise of teen vaping.