On Tuesday, the Food and Drug Administration released preliminary guidance explaining how companies seeking to develop cannabis-based drugs can receive approval through the use of clinical trials. This new process, which is akin to a traditional drug review application that must be followed by all pharmaceutical companies, is, to date, only in place for products containing THC. Though long-promised, the FDA has yet to issue regulations concerning cannabidiol, or CBD.
The new draft guidance on cannabis from the FDA was issued just weeks after the White House reviewed the document.
“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis,” said FDA Principal Deputy Commissioner Amy Abernethy in a statement. “Recent legislative changes have also opened new opportunities for cannabis clinical research. As that body of research progresses and grows, the FDA is working to support drug development in this area.”
So far, the FDA’s preliminary guidance on cannabis is, according to their own language, “limited to the development of human drugs and does not cover other FDA-regulated products.” Within the document, federal officials have outlined things such as how researchers are permitted to obtain cannabis.
According to the new FDA regulations, the most significant change right now for researchers is allowing them access to higher quality hemp products. Previously, scientists were forced to rely on one single manufacturer of government-approved research cannabis —the University of Mississippi. Now, as long as the product meets federal guidelines, researchers can purchase it from better sources.
“This change gives sponsors and investigators of clinical studies new options that do not involve the [National Institute on Drug Abuse Drug Supply Program],” said the FDA in a statement.
The FDA has warned researchers that if the supply they use has a higher THC concentration than the federally-mandated 0.3 percent, they could be in breach of DEA regulations. They recommend that researchers consult with the agency.
“It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis,” said Abernethy in a statement. “The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds, are available to patients in need of appropriate medical therapy.”
The FDA has opened a 60-day comment period for stakeholders in regards to the new guidelines.
“The agency is committed to supporting the development of these new drugs through the investigational new drug, drug review and drug approval processes – and one key element of this support involves development of guidance, like this one,” said Abernethy in a statement.