The Food and Drug Administration (FDA) is releasing new draft guidelines that are meant to streamline approvals for generic oral CBD medications.
In a notice published in the Federal Register on Wednesday, the agency said it is soliciting public feedback on its guidance to researchers who are interested in submitting abbreviated new drug applications (ANDAs) for CBD solutions.
To expedite the approval process, FDA said applicants can request a waiver of an in vivo bioequivalence study if they meet certain requirements. This guidance comes two years after the agency approved the brand-name CBD-based epilepsy medication Epidiolex from GW Pharmaceuticals.
Going forward, if a drug company wants to produce generic versions of that 100 mg/mL cannabidiol solution, they could follow specific rules to skip the in vivo bioequivalence study step if the draft guidance is finalized. The drug would have to be derived from Cannabis sativa L, contain no more than 0.1 percent THC and have “no inactive ingredient or other change in formulation from the [reference listed drug] that may significantly affect systemic availability.”
Researchers must use “appropriate analytical methods” such as macroscopic or microscopic analysis or DNA bar-coding methods to determine that the solution is being made from cannabis sativa.
“Due to the many cultivars within this species, identification and authentication of plant species should be conducted at the cultivar(s) level if the potential cultivar(s) will be used as a natural source of the [botanical raw material],” FDA said.
Further, when collecting that raw cannabis, the agency said applicants must follow “established good agricultural and collection practices (GACP) procedures to minimize variations in BRM and eventually ensure the batch-to-batch consistency of the drug substance.”
A public comment period on FDA’s draft guidance will last until November 23. FDA also recently closed a comment period on separate draft guidance on developing cannabis-derived medications. However, three other federal agencies are currently accepting input on a variety of other proposed cannabis- and drug-related regulations.
While this latest document isn’t the separate comprehensive CBD guidance that advocates and industry stakeholders have been waiting for, it’s another example of how the scientific landscape around cannabis is changing, with a federal agency helping to facilitate the production of cannabidiol-based drugs.
Separately, FDA announced on Tuesday that it will be hosting a public meeting in November to discuss gender and sex differences in the effects of CBD and other cannabinoids.
The agency also recently held a meeting to help inform cannabis researchers and cultivators about opportunities to protect their proprietary information and promote studies into the plant.
It also recently submitted draft guidance on CBD enforcement to the White House Office of Management and Budget—a long-anticipated move that comes after hemp legalization.
The agency was mandated under appropriations legislation enacted late last year to provide an update on its regulatory approach to CBD, and it did so in March. The update stated that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”
FDA has been using enforcement discretion for CBD in the years since hemp became legal.
The agency has continued to issue warnings to cannabis businesses in certain cases—such as instances in which companies claimed CBD could treat or cure coronavirus—and provide public notices about recalls.
In July, FDA also submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.
Also that month, a congressional spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”
The agency is also actively looking to award a contract to help study CBD as the agency develops regulations for products containing the non-intoxicating cannabinoid.
Despite the hardline rhetoric of a vocal minority of prohibitionists, support for cannabis reform is growing in every corner of the country. There is arguably no surer sign of this than the fact that the Republican party in one of the country's most conservative states just officially endorsed the decriminalization of cannabis.
At this weekend's Texas Republican party convention, state delegates voted to approve several additions to their official platform, including support for decriminalization of low-level marijuana possession charges, as well as expanding the state's medical marijuana program. The party has also declared its support for legal hemp and recommended that the federal government change the legal classification of cannabis.
"We support a change in the law to make it a civil, and not a criminal, offense for legal adults only to possess one ounce or less of marijuana for personal use, punishable by a fine of up to $100, but without jail time," the party's new platform states, according to Forbes. Anyone busted with two or fewer ounces of weed in the Lone Star state can currently face up to six months in jail and a $2,000 fine.
"Having the conversation here at the convention, that's going to help us keep up the momentum that we've earned over the last several years," Heather Fazio, coalition coordinator for Texans for Responsible Marijuana Policy, said to Westword. "Having the position of decriminalizing the possession of small amounts of marijuana as an official plank in the Republican Party of Texas platform is going to help us tremendously with earning the support of lawmakers."
State lawmakers already passed a "cite and release" policy for cannabis possession and other crimes back in 2007, but the law allows individual jurisdictions to choose whether or not to implement the policy, and only a small number of cities have chosen to do so. Even in jurisdictions that have chosen to do so, the policy has done little to stop the disproportionate enforcement of cannabis laws against minorities, as individuals are still assigned court dates, and anyone who misses these dates is subject to being jailed.
The GOP has also endorsed the expansion of the state's Compassionate Use Act, an extremely limited medical cannabis program that only allows patients with intractable epilepsy to use CBD-based treatments. Last year, lawmakers proposed a bill to expand the state's MMJ program, but were unable to push the bills through before the end of the legislative session. The Republican platform now officially supports legislation allowing doctors to "determine the appropriate use of cannabis to certified patients," Forbes reports.
Texas Republicans have also officially voiced their support for the federal reclassification of cannabis. The drug is currently classified as a Schedule I drug under the Controlled Substances Act, a category reserved for dangerous drugs with no medical value. The party has recommended that cannabis be moved to Schedule II, where it will coexist with drugs that are considered dangerous but medically necessary, like methadone or oxycodone.
"What this demonstrates is that even the most conservative Texans among us are starting to look at new approaches to cannabis and starting to educate themselves about the fact that prohibition has failed," Fazio told Westword. "This is a medicine for many people." Fazio's organization, along with numerous other advocacy groups like NORML and the Marijuana Policy Project, have been fighting to drum up support for cannabis reform in the Lone Star state for years now, and the Republican party's official endorsement of these new policies is a testament to their success.