FDA Says Path to Cannabis Product Approval Involves Clinical Trials
The US Food and Drug Administration released on Tuesday preliminary directives on clinical research related to cannabis, highlighting how companies seeking approval for drugs containing cannabis or its derivatives should follow the traditional drug review and approval process involving clinical trials.
The FDA, the agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, as well as medical devices. The agency is also responsible for the safety and security of our country's food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products. Tuesday's guidelines outline how to conduct federally approved research for drug development, specifying steps such as where researchers are allowed to obtain cannabis and stressing the need to ensure consistency between information. on quality considerations and recommendations for calculating tetrahydrocannabinol (THC) levels. The draft guidance also introduces key regulatory concepts of the FDA to stakeholders who may be less familiar with the FDA and its authorities.
Will CBD have to wait?
The agency is still working on the rules for products containing the cannabis ingredient CBD, the well-being properties of which are widely recognized, but which are not supported by research. Many companies are keen to market foods, drinks, and dietary supplements that contain CBD.
Since the adoption of the Farm Bill of 2018, CBD has existed in a kind of regulatory vagueness. While the bill legalized hemp, it did not legalize CBD, but instead moved the application of the substance from the Drug Enforcement Administration to the FDA. Because the FDA approved a drug that contains the ingredient, GW Pharmaceuticals PLC's GWPH, -1,53% Epidiolex, a treatment for severe forms of childhood epilepsy, it told the companies they couldn't do not add it to food or drink or make health claims for its use in topicals.
The following quote is attributed to the Senior Assistant Commissioner of the FDA, Amy Abernethy MD, Ph.D:
“A range of stakeholders have expressed interest in the development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened up new possibilities for clinical cannabis research. As this body of research progresses and expands, the FDA strives to support drug development in this area. It is essential that the FDA continue to do what it can to support the science needed to develop new drugs from cannabis. The FDA believes that the drug approval process is the best way to ensure that new, safe and effective drugs, including any drug containing cannabis or compounds derived from cannabis, are available to patients in need of therapy. appropriate medical.
The regulator is working on creating a framework for companies who want to launch CBD products and bring them to market, but has warned that given its drug status, it may require clinical trials. In November, he warned that CBD could cause liver damage and other damage to the human body. The agency has cracked down on some companies, mostly for making unsubstantiated health claims.
- The change gives sponsors and 93 clinical study researchers new options that do not involve NIDA's drug supply program, according to the guidelines.
- The FDA is also advising researchers that too high a concentration of THC could put them in violation of DEA rules and recommends that they consult the agency on the requirements.
- Researchers who submit a research request for a cannabis-based drug will be required to provide quantitative data on the percentage of THC in their product, as well as detailed descriptions of the testing methods.
- The FDA is opening a 60-day public comment period to allow stakeholders to comment on the guidelines.
The FDA recently submitted a CBD product testing report to Congress, which found that many products do not contain the amount of CBD stated on the label, and in some cases do not contain it at all.