President Joe Biden announced on Friday that he intends to nominate a new Food and Drug Administration (FDA) commissioner who has acknowledged the potential medical benefits of marijuana and says he actually prescribed a cannabinoid drug as a doctor.
Robert Califf, who previously served a short stint as the FDA head under the Obama administration, hasn’t been especially vocal about marijuana issues. But at a 2016 federally hosted research summit on cannabis, he recognized various therapeutic applications for the plant and its components and emphasized that the agency is interested in promoting research and development.
“We understand that people have identified a number of possible uses of marijuana and marijuana-derived products. For example, AIDS wasting, epilepsy, neuropathic pain, treatment of spasticity associated with multiple sclerosis, cancer and chemotherapy-induced nausea,” Califf said. “And I had the chance to prescribe some of this in my cardiology practice in people with extreme heart failure who get a wasting cachectic syndrome.”
Notably, he also said that while FDA had yet to find that botanical marijuana is “safe and effective for any indication,” that’s not to say there aren’t any good uses for it, and additional studies could shed light on the situation.
FDA’s position on cannabis is “not because we’ve had a ton of applications to look at,” he pointed out. “It’s because we haven’t gotten them into the pathway,” Califf said. “What this means is that no one has demonstrated to FDA that any such product is safe or effective for the treatment of any disease or condition. To change that we need studies conducted using marijuana to rigorously assess the safety and effectiveness of marijuana for medical use.”
Watch Califf discuss marijuana issues, around 5:03:00 into the video below:
“Then we need to get those studies submitted to FDA and a marketing application for review under the legal standard set out in the federal Drug and Cosmetic Act,” he said. “This assures that the drug product meets the statutory standards for approval.”
“This is what we really want and we actively encourage it and want to work with people to make this happen,” he added. “To do this, we know we need to facilitate the work of companies interested in appropriately bringing safe, effective and quality products to market, including scientifically based research concerning these medicinal uses.”
“We believe this process, which includes collaboration with other federal and state agencies, researchers and manufacturers working on issues related to the use of cannabidiol and other constituents of marijuana in the U.S. remains the best way to identify new treatments that are safe and effective for patients and to protect patients from products that are not what they purport to be.”
At the summit, Califf also noted that FDA has approved synthetic cannabis products like Marinol for the treatment of anorexia associated with AIDS and nausea related to chemotherapy treatment.
The approval of these substances “supports the point I made earlier that our decisions on the approval of any medicine relies on the science to determine the safety and effectiveness of new medicines. And it’s also consistent with the approach we’ll continue to take going forward in this area,” he said.
Overall, the remarks suggest that, if confirmed, it doesn’t seem that Califf wouldn’t be hostile toward attempts to explore the therapeutic potential of cannabis. But he does seem to defer to statutory processes within FDA that favor pharmaceutical approaches to these medicines that have so far kept marijuana in a tightly regulated drug category.
Separately, some vaping stakeholders have raised concerns about the prospective nominee, pointing to a 2019 op-ed he authored that advocated for a ban on flavored vape products as a way to mitigate the risks of the e-cigarette or vaping use-associated lung injury (EVALI) crisis.
“I believe that we should move to enact strict regulation to limit the harm done by vaping products, augmented by an aggressive public education program that is particularly aimed at vulnerable young people, but not excluding adults,” Califf wrote at the time.
However, he acknowledged that an “outright prohibition of vaping products seems impracticable on several grounds,” adding that the “regime of legal prohibition also dissuades people from seeking help with addiction for fear of stigma that might negatively affect future employment and social mobility.”
If Califf does become commissioner, he’ll have his work cut out for him on the cannabis front.
For example, industry stakeholders are eagerly awaiting action by the FDA to allow CBD to be marketed as a food item or dietary supplement. The agency has said that it is exploring regulatory pathways to allow for such cannabidiol commerce, but bipartisan lawmakers have introduced legislation this session to force a change.
FDA was mandated under appropriations legislation enacted in 2019 to provide an update on its regulatory approach to CBD, and it did so in March of last year. The update stated that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”
Another issue that FDA is focusing on concerns delta-8 THC products that are made through a synthetic process using hemp-derived CBD. The agency issued warnings to consumers about the potential risks of the cannabinoid in September.
FDA also recently announced that it plans to use Reddit and other “novel” data sources to gain a better understanding of public health issues surrounding use of CBD and other “emerging” marijuana derivatives like delta-8 THC.
With respect to broader marijuana policy, FDA would play a critical role in any moves to reschedule or deschedule cannabis. If a scheduling petition is accepted, the agency would need to assess the scientific, medical and public health implications before submitting that review to the Justice Department with its recommendations.
FDA Acting Commissioner Janet Woodcock, meanwhile, frustrated advocates earlier this year after dodging a congressman’s question about whether marijuana is more harmful than tobacco.
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Photo courtesy of Brian Shamblen.