The Food and Drug Administration (FDA) released a draft guidance on the development of cannabis-based drugs on Tuesday.
This occurs weeks after the White House completed its review of the document, clearing its way for public release.
The FDA is still in the process of developing regulations that could allow CBD to be marketed as a food or dietary supplement, but in the meantime it has worked to create these new research guidelines for drug manufacturing.
Much of the guidance, which is “limited to human drug development and does not cover other FDA-regulated products,” covers the basics of conducting federally authorized research for drug development purposes, such as location where researchers can obtain cannabis and the importance of demonstrating the ability to “constantly manufacture a quality product”.
“A variety of stakeholders have expressed interest in the development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for clinical cannabis research, ”said FDA Deputy Chief Commissioner Amy Abernethy in a press release. “As that body of research progresses and grows, the FDA is working to support drug development in this area.”
The main legislative change he referred to is the 2018 Agricultural Bill, which legalized hemp at the federal level and its derivatives, such as CBD.
For researchers, that reform means they are no longer subject to certain restrictions that exist for marijuana. For example, the FDA noted in the new document that as long as a manufacturer produces hemp products that meet the federal definition of containing no more than 0.3 percent THC, scientists can use that for studies rather than relying on only marijuana manufacturer licensed by the nation’s government. The University of Mississippi.
“This change offers clinical trial sponsors and researchers new options that do not involve [National Institute on Drug Abuse Drug Supply Program]”The FDA wrote.
The FDA has issued a draft guidance describing the agency’s current thinking on various topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. https://t.co/nncAluuUSZ pic.twitter.com/hv4EEcAZkF
– Media Affairs (@FDAMedia) July 21, 2020
Because excessive concentrations of THC could make hemp illegal under federal law, the FDA devoted a section to testing standards for hemp-derived products.
“Sponsors and researchers proposing drug development activities involving controlled substances should consult with [Drug Enforcement Administration] on applicable requirements, “he said.” Sponsors and researchers may find it useful to calculate the level of delta-9 THC in their proposed investigational pharmaceutical product early in the development process to get an idea of the potential control status of their product. ” .
“Regardless of whether cannabis or a compound derived from cannabis meets the definition of hemp, sponsors and applicants should work with trusted laboratories for analytical testing,” he continued.
Applicants for a new investigational drug must submit information to the FDA that includes “quantitative data, such as a laboratory certificate of analysis” on the THC content and “detailed descriptions of the test methods used to assess the delta level -9 THC “. They should also provide “quantitative data regarding the phytochemicals that are present in your proposed product, including but not limited to cannabinoids, terpenes, and flavonoids.”
“Many sponsors initiating clinical research for drugs containing cannabis and cannabis-derived compounds may be unclear or unfamiliar with the quality expectations of applicable drugs,” the FDA said.
The agency discussed how to calculate the dry weight for hemp is unique in that it should be based on “calculating the percentage of THC delta-9 in the composition of the formulation with the amount of water removed, including any water that may be contained in the excipients. ” “It is unclear if that standard would be onerous for hemp growers, but it is the case that many farmers have already complained about stringent THC testing policies under the guidance of the US Department of Agriculture.
The new FDA guide provides a step-by-step overview of how to assess THC in dry weight in a way that meets its standards.
“We recommend that you consult with the DEA regarding the status of cannabis control or materials or products derived from cannabis that are under development,” the document states. “We note that intermediates or drugs that contain more than 0.3 percent THC delta-9 by dry weight, even if the starting materials meet the definition of hemp, can no longer meet the definition of hemp and can be considered a Schedule I controlled substance. “
“We invite the public to comment on this recommended approach,” the agency said in a Federal Register notice accompanying the new draft guidance. “Additionally, the FDA invites public comment on appropriate manufacturing controls on materials that cross below 0.3 percent THC delta-9 by the dry weight threshold during the production of a drug that contains cannabis or derived compounds. of cannabis. “
A 60-day public comment period will be opened for interested parties to evaluate the proposed research guidelines. At the same time, the agency has a separate indefinitely open comment period for information on the safety and efficacy of CBD.
The FDA emphasized that guidance documents like this “do not establish legally enforceable responsibilities.”
“Instead,” he said, “the guidelines describe the Agency’s current thinking on an issue and should be considered only as recommendations, unless specific regulatory or legal requirements are cited.”
The agency said the researchers should also take into account other past non-cannabis-specific guidance on botanical drug development and raised several other considerations.
“Cannabis is governed by the same regulatory standards as any other botanical raw material, botanical pharmaceutical, or botanical pharmaceutical,” the guide states. To that end, researchers should do things like chemical fingerprints to ensure consistency and testing for residual pesticides. The FDA also noted that any medication that requires a device such as an inhaler falls into its own category with its own requirements.
Furthermore, researchers should “carefully consider the selection of a container closure system.”
The agency also emphasized that “a natural compound isolated from a botanical source would be expected to have a different impurity profile than the corresponding synthetically produced cannabis-related compound, and impurities for the natural compound should be controlled accordingly” rather than “synthetic monochemical active pharmaceutical ingredients. “
Advocates, industry representatives, regulators, healthcare professionals, and opponents of marijuana legalization stood before the FDA last year at a landmark public hearing to share their perspectives on how best to approach CBD regulation. .
“It is critical that the FDA continue to do what we can to support the science necessary to develop new drugs from cannabis,” said the agency’s Abernethy. “The FDA believes that the drug approval process represents the best way to ensure that new safe and effective drugs, including drugs containing cannabis or cannabis-derived compounds, are available to patients who need adequate medical therapy.”
“The agency is committed to supporting the development of these new drugs through the new drug research, drug review and drug approval processes, and a key element of this support involves developing guidance, like this one,” he said. .
The FDA also recently released a report to Congress on the state of the CBD market, and the document outlines studies the agency has conducted on the content and quality of the cannabis-derived products it has tested in the past six years.
Also this month, an FDA spending bill was launched that includes a provision that provides “funds to develop a framework to regulate CBD products.”
Read the draft of the FDA’s guide to cannabis research below:
FDA Cannabis Research Guide … by Marijuana Moment on Scribd
Justice Department Requires Marijuana Documents From California Officials In Federal Court Filing
Photo courtesy of Philip Steffan.
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