The U.S. Food and Drug Administration (FDA) recently released a draft guidance on developing cannabis-based drugs. These guidelines come weeks after the White House announced it had completed reviewing the draft guidance.
In December 2018, Congress passed the 2018 Farm Bill (1), which was a groundbreaking piece of legislation that legalized the sale and cultivation of industrial hemp and its derivatives after decades of prohibition. For quite some time, lawmakers, advocates, and stakeholders have pressed the U.S. Food and Drug Administration (FDA) to create a regulation structure to assist the industry. Recently, the FDA did just that by releasing a draft guidance on developing cannabis-based drugs (2).
These FDA guidelines come weeks after the White House announced it had completed reviewing the draft guidance (3). The new document (2) mentions that the guidance is “limited to the development of human drugs and does not cover other FDA regulated products.” The draft documentation is meant to provide an outline for drug manufacturing. The agency is currently still working on developing guidelines that will allow cannabidiol (CBD) to be marketed and sold as a food item or supplement. CBD has increased in popularity in recent years because of its potential for treating medical conditions.
“A range of stakeholders have expressed interest in the development of drugs that contain cannabis and other compounds found in cannabis. 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,” said FDA Principal Deputy Commissioner Amy Abernethy (4).
Some of the legislative changes Abernathy is referring to is the 2018 Farm Bill, legalizing industrial hemp with less than 0.3% tetrahydrocannabinol (THC). Researchers are now able to use industrial hemp from any source as long as it doesn’t exceed the allowed THC limit and not limiting them to use from the University of Mississippi, which is the country’s only federally authorized cannabis manufacturer.
In the new draft guidance, there is an emphasis on THC testing, mentioning that investigators and sponsors may find it beneficial to calculate the level of delta-9 THC early in the development process of their proposed investigational drug product so that they can gain better insight into the potential control status. The document also provides step-by-step guidance on how to test for THC on a dry weight basis according to the FDA’s standards (4).
The FDA is receptive to the public and has opened a 60-day comment period for stakeholders to display any opinions on the proposed research guidelines.