Current and acting FDA Commissioner Dr. Janet Woodcock must step down on November 15 as required by law. The Biden administration has been vetting several individuals to head the FDA in 2021. The front-runners for the position include prominent anti-vape official Dr. Joshua Sharfstein. Dr. Sharfstein was heavily discussed for the acting Commissioner position before Dr. Woodcock took the post on January 20, 2021. Dr. Laurie Glimcher, who is also the CEO of the Dana-Farber Cancer Institute, was also considered for the Commissioner role, as well as former FDA commissioner Dr. David Kessler. But currently, the favored nominee is Dr. Robert Califf. Dr. Califf served as FDA commissioner from 2016 to 2017.
Who is Dr. Califf and why is he currently the favored frontrunner?
Who Is Dr. Robert Califf?
Dr. Califf is a native of South Carolina. He was born in 1951 and attended Duke University, graduating in 1973 summa cum laude. He then went on to graduate from the Duke University School of Medicine in 1978, specializing in cardiology and internal medicine. He later returned to teach at the Duke University of Medicine, and was the founding director of the Duke Clinical Research Institute. Duke Clinical Research Institute is considered the world’s largest academic research organization, with 1,000 employees and a budget of $320 million, giving Dr. Califf the credentials to lead a large organization such as the FDA.
Dr. Califf is also known for his close ties with the pharmaceutical industry. From 2009 to 2015, Califf did paid consultant work with a large number of pharmaceutical companies, including Johnson & Johnson, Merck Sharp & Dohme, GlaxoSmithKline, AstraZeneca, Eli Lilly, Janssen Pharmaceutica, Sanofi-Aventis, among others. In 2015, he was appointed the Deputy Commissioner of the FDA’s Office of Medical Products and Tobacco, where his role was described as being “second in scope only to being commissioner” according to David Kroll, then a contributor to Forbes. Califf was then nominated in September 2015 for the post of FDA commissioner itself, and the Senate confirmed him by 89-4. Califf then stepped down in January 2017.
What Is Dr. Califf’s Stance On Vape?
Much of the criticism around Dr. Califf revolves around his close ties with the pharmaceutical industry. Two senators who opposed his FDA Commissioner nomination in 2016 included Sen. Bernie Sanders (I-VT) and Sen. Richard Blumenthal (D-CT). Sen. Joe Manchin (D-WV), who is considered to be a “swing vote” among Democrats, also opposed the nomination of Dr. Califf in 2016. With an evenly divided Senate and completely different political climate now dominated by the response to the COVID-19 pandemic, Califf’s nomination could face new challenges.
It is also worth noting that Dr. Califf was FDA commissioner at the time the Deeming Rule was passed in 2016. “With this rule, the FDA will be able to prevent misleading claims and provide consumers with information to help them better understand the risks,” he said when the rule was passed. The FDA is also under the purview of the Department of Health and Human Services (HHS), run by anti-vaping advocate Xavier Becerra. This could mean that the Biden administration could force even more regulations onto the vaping industry.
Dr. Califf also (incorrectly) linked EVALI to legitimate vaping products instead of illicit THC-containing products in 2019. AVA President Gregory Conley pointed out that Dr. Califf did this six weeks after the FDA and state health departments confirmed that illicit THC products were the cause of EVALI. This may raise questions related to the depth of Dr. Califf’s vaping knowledge. Aside from his previous stances on vaping, concerns exist regarding his ability to fairly regulate vaping products as FDA commissioner based upon the science presented.
In regards to regulating vaping products, Dr. Califf said, “The regulatory trifecta would be to: 1) require the tobacco industry to lower the amount of nicotine in its products to subaddictive levels (if nicotine can be dialed up using irradiation and selective breeding, it can also be dialed down, even if the law forbids regulation that reduces the level to zero); 2) ban over-the-counter vaping products; and 3) support prescription vaping so that the 30 million current tobacco users do not go through acute withdrawal all at the same time.”
While prescription vaping is being implemented in other jurisdictions, implementing this within the United States would require a substantial overhaul of the current regulations.
What This Means For Your Business
The change in FDA commissioner may not be immediate, as Biden must nominate a permanent commissioner before November 15. The timeline of handing over the reins to Dr. Califf (or whoever else becomes the new FDA commissioner) is unknown as of this writing, given that the Senate must hold confirmation hearings.
What you can do, however, is inform your customers about the upcoming FDA Commissioner changes. You can also offer support to your customers as they continue to reduce their nicotine consumption. Additionally, you should seek to provide various delivery options to customers if possible (especially in rural settings) to ensure that your customers are not left out when they need their alternative nicotine products.
That’s all for this edition of State of Vape. If you have any questions, comments, or concerns, please feel free to contact your eJuices.co account manager or sales representative. We’re looking forward to speaking with you and helping your business succeed.