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President Joe Biden announced Friday that he intends to appoint a new Commissioner for the Food and Drug Administration (FDA) who has recognized the potential medical benefits of marijuana and says he actually prescribed a cannabinoid drug as a doctor.
Robert Califf, who previously served briefly as FDA chief under the Obama administration, has not been particularly vocal about marijuana issues. However, at a research summit on cannabis organized by the federal government in 2016, he recognized various therapeutic uses for the plant and its components and emphasized that the agency was interested in promoting research and development.
“We know that people have identified a number of possible uses for marijuana and marijuana-derived products. For example, AIDS waste, epilepsy, neuropathic pain, treating spasticity related to multiple sclerosis, cancer, and chemotherapy-induced nausea, ”Califf said. “And I had the opportunity in my cardiology practice to prescribe some of it to people with extreme heart failure who have cachectic syndrome.”
Notably, he also said that while the FDA has not yet established that botanical marijuana is “safe and effective for every indication,” that doesn’t mean there aren’t any good uses for it, and additional studies may shed light on the situation.
The FDA’s position on cannabis is “not because we had a lot of applications to consider,” he said. “That’s because we didn’t get them off the ground,” Califf said. “This means that no one has shown the FDA that such a product is safe or effective for treating any disease or condition. To change that, we need marijuana studies to rigorously assess the safety and effectiveness of marijuana for medical use. “
Watch Califf discuss marijuana issues around 5:03:00 in the video below:
“Then we need to submit these studies to the FDA and submit a marketing proposal for review under the legal standards of the Federal Drugs and Cosmetics Act,” he said. “This ensures that the drug meets the legal approval standards.”
“This is what we really want and we actively promote it and want to work with people to make it happen,” he added. “To do this, we know that we need to facilitate the work of companies interested in bringing safe, effective and high-quality products to the market appropriately, including scientifically based research into these medical applications.”
“We believe this process, which involves working with other federal and state agencies, researchers, and manufacturers who address issues related to the use of cannabidiol and other marijuana ingredients in the United States, remains the best way to go is to identify new treatments that are safe and effective to protect patients and protect patients from products that are not what they say they are. “
At the summit, Califf also noted that the FDA has approved synthetic cannabis products such as Marinol for the treatment of anorexia-related AIDS and nausea-related chemotherapy.
The approval of these substances “supports the point I mentioned earlier that our decisions about approving a drug are based on science to determine the safety and effectiveness of new drugs. And it is also in line with the approach we will continue to take in this area, ”he said.
Overall, the comments suggest that if confirmed, Califf will not be hostile to attempts to explore the therapeutic potential of cannabis. But he appears to be submitting to legal processes within the FDA that favor pharmaceutical approaches to these drugs, which have previously kept marijuana in a tightly regulated drug category.
Regardless, some vaping stakeholders have raised concerns about the potential candidate, drawing attention to a 2019 comment he wrote calling for a ban on flavored vaping products to reduce the risks of the e-cigarette or the lung injury associated with vaping to mitigate (EVALI) crisis.
“I believe we should have strict regulation in place to limit the harm done by vaping products, complemented by an aggressive public education program aimed specifically at vulnerable young people but not excluding adults,” Califf wrote at the time .
He acknowledged, however, that “a total ban on vaping products seems impracticable for several reasons,” adding that the “legal ban regime also discourages people from seeking help with addiction for fear of stigma that negatively affects them.” future employment and social mobility ”.
If Califf becomes commissioner, he’ll have his work on the cannabis front for him.
For example, industry stakeholders are eagerly awaiting action by the FDA to enable CBD to be marketed as a food or dietary supplement. The agency has said it is exploring regulatory avenues to enable such cannabidiol trafficking, but bipartisan lawmakers passed laws at that meeting to force a change.
The FDA was tasked with providing an update on its regulatory approach to CBD under the 2019 granting legislation, and it did so in March last year. The update reads: “The FDA is currently considering issuing a risk-based enforcement policy that will provide more transparency and clarity about factors that the FDA intends to consider when prioritizing enforcement decisions.”
Another issue that the FDA is focusing on concerns Delta-8-THC products, which are made from hemp through a synthetic process using CBD. In September, the agency warned consumers about the potential risks of the cannabinoid.
The FDA also recently announced that it would use Reddit and other “novel” data sources to better understand the public health problems associated with the use of CBD and other “new” marijuana derivatives such as Delta-8 THC.
In terms of general marijuana policy, the FDA would play a pivotal role in any move to move or move cannabis. If a proposal for planning is accepted, the agency would need to assess the scientific, medical and public impact before forwarding this review and recommendations to the Department of Justice.
Acting FDA Commissioner Janet Woodcock frustrated proponents earlier this year after evading a congressman’s question about whether marijuana was more harmful than tobacco.
DEA increases production levels of psilocybin, MDMA and DMT again in the final quotas for 2021
Photo courtesy Brian Shamblen.
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