Last week now former FDA Commissioner Scott Gottlieb made the rounds on Capitol Hill. The expressed purpose of his testimony was the agency’s FY2020 budget. Given these hearings occurred on the eve of Gottlieb’s departure, they became more of a discussion about the future direction of the agency in the absence of the much-admired outgoing commissioner.
(As an aside, Gottlieb was a bright spot in federal politics. A forceful combination of intelligence, competence and the necessary political skills made him very effective, resulting in a robust record of accomplishments. His record will be hard to match)
Testimony and the accompanying Q&A centered on three major priorities of the FDA:
- FDA’s policy conundrum on tobacco use
- Continued efforts to limit spread of opioid addiction
- Development of policy framework for the regulation of CBD products.
Tobacco Use. Regulating tobacco use has presented the FDA with a challenge. On the one hand, e-cigarettes and pod-based products provide a pathway for adults to reduce their dependency on nicotine while avoiding the harms caused by combustible cigarettes. On the other hand, e-cigarettes, especially when used with flavored pods, are an attractive gateway to nicotine addiction in youths.
After falling for years, tobacco use among high school students increased 27.1% year over year in 2018, according to the National Youth Tobacco Survey results released in February. Among middle school students, the increase was 7.2 %..
The FDA has taken steps to stem the tide of youth tobacco use with heighted age verification requirements. However, the commissioner indicated that if the 2019 survey produces similar or greater use of tobacco products by youths, the FDA plans to demand market withdrawal of pod-based products, especially the flavored variety. The 2019 survey results should be available for the FDA’s decision making in the summer. The agency has also undertaken research projects into the safety of pod-based tobacco products and their relationship to seizures.
Along those lines, the Commissioner had strong word for Altria and JUUL.
“I can’t say that I walked away from my meeting with [MO and JUUL] with clear insight into why they would send me a 15 page letter that they believed the pod-based products are so concerning [for] stoking this youth epidemic and the flavored products in particular are so problematic that they are going to voluntarily withdraw their entire portfolio from the market pending either a successful PMTA application or otherwise the abatement of the youth addiction crisis then several months later make an investment to expand market access to the flavored pod-based products that happens to be the top selling product with adolescents. Those two don’t seem to square with me.”
Moving the tobacco use agenda forward on Gottlieb's absence appears assured with a number of research and regulatory steps underway at the time of his departure.
Opioid Epidemic. The agency is and will continue to be focused on revisions to guidance for approval of opioids. They will be taking more of an indications-based approach to ensure the prescription matches the need for pain relief. For example, post-surgical pain should be addressed with a very limited supply of short-acting opioids like Percocet or Vicodin not a long-lasting alternative.
The FDA will also be more focused on approval of opioids using comparative effectiveness standards. Drugs that improve pain control while limiting opportunities for use and non-opioid alternative are being encouraged under new guidance.
However, Gottlieb pointed out that the opioid epidemic is increasingly fueled by illicit drugs. Where addiction previously started with a medical encounter, now illicit drugs are playing a larger role. Fentanyl, often masquerading as Vicodin, imported illegally from China and India is presenting a greater challenge for managing and reversing the epidemic.
Like tobacco use, addressing the opioid epidemic forcefully also appears to be a safe agenda item despite Gottlieb's departure.
Cannabis Regulation. Cannabis regulation presents the FDA with another pretzel problem. As Gottlieb testified, CBD is considered a drug as it is an active ingredient in GWPH’s Epidiolex. However, the 2018 Farm Bill de-scheduled industrial hemp while putting the FDA firmly in charge of its regulation.
Gottlieb testified that he has taken those action to mean that Congress wanted a regulatory framework for CBD. He suggested that the high level working group announced last week would begin work, with public input, and offer legislative recommendations. One possible path will be an approval process for low concentrations of CBD as a food additive while higher concentrations would remain in the drug approval pathway.
In the meantime, the FDA will continue enforcing “unfounded” health and medical claims associated with the sale of CBD products. In a particularly interesting exchange (1:08:26) with Dr. Andy Harris (R-MD), Gottlieb was asked what “founded” claims were, aside from addressing pediatric seizure disorders as Epidiolex does. The Commissioner agreed with Rep. Harris that there were no other “founded” claims for CBD use.
The FDA Commissioner also highlighted some of the risks he saw to use of CBD such as liver injury and the unknown effects of cumulative use.
This exchange and others is an indication of just how difficult it will be to thread the needle in developing a regulatory framework for CBD which is considered a drug by the FDA but one which Congress wants regulated some other way some of the time. With scant scientific evidence to rely on and a mixed political bag of support, it is not hard to imagin this regulatory item foundering in the near term and until strong appointed leadership takes the help.
Call with questions.
Emily Evans
Managing Director – Health Policy
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