By Erik T. MacLaren, PhD
On May 11, 2017, Scott Gottlieb, MD, was sworn in as the 23rd Commissioner of Food and Drugs of the US Food and Drug Administration (FDA). Dr. Gottlieb previously served as Deputy Commissioner for Medical and Scientific Affairs at the FDA, and his background includes experience in medicine, medical policy, and public health advocacy. As the new FDA Commissioner, Dr. Gottlieb delivered his first speech to FDA staff on May 15, emphasizing patient and consumer protection as the core mission of the agency.1
In an address that also discussed the need for the agency to achieve operational efficiencies and the challenge of addressing the increase in opioid abuse, Dr. Gottlieb highlighted tobacco cessation, harm reduction, and youth smoking prevention as an area of great consequence for public health. He said that “among these and many other opportunities, there’s probably no single intervention or product we’re likely to create in the near future that can have as profound an impact on reducing illness and death from disease as our ability to increase the rate of decline in smoking.”
In remarks touching on the future of drug development, the Commissioner noted, “Congress gave us a clear mandate to be forward-leaning when it comes to how we’ll evaluate safety and efficacy in view of emerging scientific insight and better analytical tools,” and he identified the implementation of the 21st Century Cures Act as a priority. Both Dr. Gottlieb and Robert M. Califf, MD, the previous FDA Commissioner, have pointed to this legislation as a vehicle for greater regulatory clarity in the development of digital health technologies and for increased efficiency in clinical trials through changes in study design such as common control arms for trials of different drugs for the same indication.2,3
On the issue of high consumer prices for medications, the Commissioner suggested the FDA could take actions to indirectly reduce prices and to ensure that the generic drug process is not gamed at the expense of consumers. “We still need to be taking meaningful steps to get more low-cost alternatives to the market, to increase competition, and to give consumers more options,” he said. Dr. Gottlieb also indicated the need for action is even more urgent with the emergence of more complex drugs and biosimilars.
The Commissioner’s emphasis on efforts to prevent youth smoking, to help more smokers quit, and to produce scientific data to inform potential harm reduction strategies for those unwilling or unable to quit is of particular interest to the thoracic oncology community, and Dr. Gottlieb has continued to promote smoking prevention. In June 2017, he highlighted agency efforts in this area in a statement on the results of the 2016 National Youth Tobacco Survey.4 Dr. Gottlieb pointed to FDAfunded, science-based educational campaigns such as “The Real Cost” as effective tools to keep young people from smoking; 4,000 warning letters have been issued by the FDA to retailers since August 2016 for selling newly regulated tobacco products such as e-cigarettes, cigars, and hookah tobacco to minors. As an organization promoting not only the study of thoracic cancers but also patient education and cancer prevention efforts, the IASLC is uniquely suited to assist in the FDA’s drive to reduce the harms of smoking as an important step toward eliminating thoracic cancer. ✦
1. Gottlieb, S. Dr. Gottlieb’s first remarks to FDA staff. 2017 May 15. Available at: https://www. fda.gov/NewsEvents/Speeches/ucm558566.htm.
2. Gottlieb, S. Fostering medical innovation: A plan for digital health devices. FDA Voice. 2017 June 15. Available at: https://blogs.fda.gov/ fdavoice/index.php/2017/06/fostering-medicalinnovation- a-plan-for-digital-health-devices/.
3. Califf, M. 21st Century Cures Act: Making progress on shared goals for patients. FDA Voice. 2016 December 13. Available at: https:// blogs.fda.gov/fdavoice/index.php/2016/12/21stcentury- cures-act-making-progress-onshared- goals-for-patients/.
4. Gottlieb, S. Statement from FDA Commissioner Scott Gottlieb, MD, on the 2016 National Youth Tobacco Survey results. 2017 June 15. Available at: https://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/