President Joe Biden announced Friday that he intends to nominate a new Food and Drug Administration (FDA) commissioner who has recognized the potential medical benefits of marijuana, and says he has already prescribed a cannabis drug as a doctor.
Robert Califf, who previously served for a short time as the head of the Food and Drug Administration under the Obama administration, hasn’t been particularly vocal about marijuana issues. But at a 2016 federal government-hosted research summit on cannabis, he learned about the many therapeutic applications of the plant and its components and emphasized that the agency was interested in promoting research and development.
“We understand that people have identified a number of possible uses for marijuana and marijuana-derived products. For example, wasting due to AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, cancer, and nausea caused by chemotherapy.” I had the opportunity to describe Some of this is in my cardiology practice in people with severe heart failure who have cerebral wasting syndrome.”
It’s also worth noting that while the FDA hasn’t found plant-based marijuana “safe and effective for any indication,” that doesn’t mean there aren’t any good uses for it, and additional studies could shed light on the situation.
He noted that the FDA’s position on cannabis “is not because we have a lot of applications to consider.” “That’s because we didn’t put them in the way,” Califf said. “What this means is that no one has proven to the Food and Drug Administration that any such product is safe or effective for treating any disease or condition. To change that we need studies conducted using marijuana to rigorously evaluate the safety and efficacy of marijuana for medical use.”
Watch Calif discuss marijuana issues, around 5:03:00 in the video below:
“Then we need to submit these studies to the Food and Drug Administration and a marketing request for review under the legal standard set forth in the Federal Drugs and Cosmetics Act,” he said. “This ensures that the medicinal product meets the legal criteria for approval.”
“This is what we really want and actively encourage and we want to work with people to make that happen,” he added. “To do this, we know we need to facilitate the work of companies interested in bringing to market safe, effective, and high-quality products, including scientific research related to 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 marijuana ingredients in the United States, remains the best way to identify safe and effective new treatments for patients and to protect patients from products that are not what they claim.”
At the summit, Califf also noted that the US Food and Drug Administration has approved synthetic cannabis products like Marinol to treat AIDS-related anorexia and chemotherapy-related nausea.
The approval of these substances “supports the point I made earlier that our decisions about approving any drug are based on science to determine the safety and efficacy of new drugs. It is also consistent with the approach we will continue to take moving forward in this area.
Overall, the observations indicate that, if confirmed, it does not appear that Calif would not be hostile to attempts to explore the therapeutic potential of cannabis. But he appears to acquiesce in legal processes within the FDA that favor pharmaceutical methods for these drugs that have so far kept marijuana in a tightly regulated drug class.
Separately, some vaping stakeholders have lift Concerns about the potential candidate, citing a 2019 article he wrote that called for a ban on flavored e-cigarette products as a way to mitigate the risks of e-cigarettes or the vaping-related lung injury crisis (EVALI).
“I think we should move to enact strict regulation to reduce the harm from e-cigarette products, backed by a rigorous public education program that specifically targets vulnerable youth, but does not exclude adults,” Califf books in time.
However, he acknowledged that “an outright ban on vaping seems impractical for many reasons,” adding that “the legal ban system also discourages people from seeking help with addiction for fear of stigma that may negatively impact employment and social mobility in the future.”
If Calif becomes a commissioner, his work on the cannabis front will cease.
For example, industry stakeholders are eagerly awaiting action by the FDA to allow CBD to be marketed as a food ingredient or dietary supplement. The agency said it is exploring regulatory pathways to allow such trade in cannabidiol, But lawmakers from both parties Legislation introduced this course to enforce change.
The US Food and Drug Administration is mandated by the Appropriations Act enacted in 2019 to Provide an update on its regulatory approach to the CBDAnd I did it in March of last year. The update stated that “the FDA is currently evaluating the issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding the factors that the FDA intends to consider when prioritizing enforcement decisions.”
Another issue the FDA is focusing on concerns Delta-8 products that are manufactured through a synthetic process using hemp derived from CBD. The agency has issued warnings to consumers about Potential dangers of cannabis in September.
The Food and Drug Administration also recently announced that it plans to Using Reddit and other ‘new’ data sources To gain a better understanding of the public health issues surrounding the use of CBD and other “emerging” marijuana derivatives such as delta-8 THC.
In terms of broader marijuana policy, the Food and Drug Administration will play a critical role in any moves to reschedule or deschedule cannabis. If the appointment petition is accepted, the agency will need to assess the scientific, medical, and public health implications before submitting that review to the Department of Justice with its recommendations.