Down-scheduling marijuana, even if approved by multiple federal agencies, may not be easily accepted by Congress.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Rep. Andy Harris, R-MD, chairman of the House Appropriations Subcommittee on Agriculture, Rural Development and the FDA, as well as a doctor, said he had “serious concerns” about the FDA’s recommendation that marijuana be moved from Schedule I to Schedule III of the Controlled Substances Act.
FDA Commissioner Robert Califf appeared before the subcommittee on 18 April to discuss the agency’s fiscal year 2025 budget request. The nearly two-hour session included a large number of questions about the FDA's oversight of illegal vaping products from China and menthol in cigarettes, but committee members also posed several questions related to drug shortages, supply chain issues and inspections, as well as marijuana policy.
Harris' questions stemmed from an August 2023 memo where the FDA said that after assessing all available preclinical, clinical and epidemiological data, it recommended that marijuana be reclassified to Schedule III.
Schedule I drugs have a high abuse potential and no accepted medical use. Schedule III drugs are classified as having a potential for abuse less than drugs or other substances in Schedules I and II, as well as a currently accepted medical use in treatment, and moderate or low physical dependence that may result from their use, states the memo, which was forwarded to the Drug Enforcement Administration.
If the DEA decides to reschedule marijuana, it would be easier and cheaper for scientists and sponsors to study the drug for medical use. (Also see "Prescription Marijuana? FDA Rescheduling Memo Sets Stage To Test Whether There’s A Viable Market" - Pink Sheet, 14 February, 2024.)
“It seems the FDA ignored several important factors when considering marijuana’s potential for abuse and harm to public health.” – Rep. Andy Harris
However, Harris made clear he does not think that would be an appropriate regulatory decision.
“It seems the FDA ignored several important factors when considering marijuana’s potential for abuse and harm to public health, including but not limited to daily marijuana use, health damage caused by traffic fatalities due to individuals driving under the influence of marijuana, and the impact of marijuana on pregnant women and children,” Harris said.
Furthermore, marijuana’s chemistry is not known and reproducible, and there is potential that combustibles in smoked marijuana may cause cancer, he said.
Harris asked if Califf was aware that National Institute on Drug Abuse Director Nora Volkow was “adamantly opposed to making marijuana more broadly available?”
“I'm aware of her opinions, yes,” Califf said.
“Good, because I would hope that we think that she is like the expert in the country on it, and I would hope you would have taken that into consideration, but I suspect you took it in very minor consideration having come up with that recommendation to reschedule marijuana,” Harris said. “I just think it's a dangerous move and very uncharacteristic of the FDA, which deals with drugs.”
In a cover letter forwarding the FDA’s recommendation to the DEA, HHS Assistant Secretary for Health Rachel Levine said NIDA concurred with the FDA's recommendation.
NIDA told the Pink Sheet that the HHS recommendation to reschedule marijuana is currently undergoing DEA review, and the National Institutes of Health does not comment on pending decisions. However, researchers continue to face multiple challenges and barriers in conducting cannabis research, including regulatory, supply and methodological factors, NIDA said, adding that Volkow described these challenges in congressional testimony on cannabis in 2020.
Animal Testing
The subcommittee’s ranking member, Sanford Bishop, D-GA, asked about the FDA’s progress in establishing alternatives to animal testing.
The 2022 Food and Drug Omnibus Reform Act encouraged the use of alternatives to animal studies and described other types of tests that could be used to support an investigational new drug application, such as cell-based assays, organ chips and microphysiological systems, computer modeling, and other nonhuman or human biology-based test methods, such as bioprinting.
“We're a long way right now from substituting animals when we go to give a drug to a human being for the first time.” – FDA’s Robert Califf
The FDA’s FY 2024 appropriations included $1.5m to reduce animal testing through alternative methods. (Also see "Congress Gives US FDA Austere Budget But Seeks Boosts On Inspections, IT, And ALS Activities" - Pink Sheet, 5 March, 2024.)
“I think the modeling effort is moving along, both extrapolating from in silico models, organs on a chip, all that into humans, and also totally virtual AI,” Califf said. “But we're a long way right now from substituting animals when we go to give a drug to a human being for the first time.”
Given that most drugs that enter Phase I testing do not make it to market because of unexpected toxicity, “we don't want to be giving drugs to children or adults with serious disease without having proper testing done beforehand,” Califf said. “So we're working on it. It's a big focus of our Office of Chief Scientist and our Arkansas National Center for Toxicologic Research.”
Califf also opined on the need for less off-label prescribing of attention deficit/hyperactivity drugs, which are in shortage. (Also see "ADHD Drugs: FDA Commissioner Blames Inappropriate Prescribing For Shortages" - Pink Sheet, 22 April, 2024.)
