29 Jul U.S. fails, again, to approve new suppliers of marijuana fo…
WASHINGTON — Forgive us if you read our stories on this topic from 2017 and 2018, but here it comes again: Another year has passed since the Drug Enforcement Administration said it was open to approving more suppliers of marijuana for scientific research, and another year has passed without an application being approved.
The lag has increasingly frustrated scientists, advocates, and members of Congress from both parties who argue that expanding research into marijuana could lead to new medicines and help identify what health risks use presents.
It’s also created an odd juxtaposition, as the availability of and interest in marijuana surges in other ways. A growing number of states have legalized marijuana for medical and, in some cases, recreational purposes. Consumer products made from cannabidiol — a component of marijuana that can also be derived from hemp — are flooding wellness shops, cafes, and beauty stores in ever increasing varieties. And last year, the Food and Drug Administration approved the country’s first prescription drug derived from marijuana, a cannabidiol product called Epidiolex that treats types of epilepsy.
“My understanding was that if we went through the process to be federally compliant, we would be treated fairly and have an objective evaluation,” said George Hodgin, CEO of Biopharmaceutical Research Company, a California-based group that applied for a license to grow marijuana to supply it to scientists in early 2017. “Since then it’s become apparent that there have been no evaluations that I’m aware of, despite years of promises and congressional outrage.”
Hodgin described the years of waiting as a form of “bureaucratic purgatory.”
Despite what is happening in states, marijuana remains illegal at the federal level and is considered a Schedule I substance, meaning the government views it as having a high potential for abuse and no medical benefits. To study marijuana, scientists have to go through a rigorous review and can only get a supply from the University of Mississippi, which has had the lone contract with the National Institute on Drug Abuse to grow marijuana for research for years.
In August 2016, the DEA, at the same time as it extended marijuana’s Schedule I designation, said it would consider granting additional licenses for suppliers. Scientists and advocates celebrated the announcement, saying it paved the way for more research into marijuana and the possibility of studying more strains than Mississippi could offer. (Mississippi scientists say their supply is of sufficient quality and variety.)
Some two dozen applicants sought approval in the first year. But so far, no new licenses have been granted.
“We are still working through the process and those applications remain under review,” DEA spokeswoman Katherine Pfaff wrote in an email.
NIDA — which is part of the National Institutes of Health — said in a statement that “there has been no major increase in the level of demand for cannabis by researchers in recent years,” even as the number of researchers who have received marijuana from NIDA has increased over the past decade, up from nine in 2010 to 21 in 2017 and 20 in 2018.
The agency said it had increased the variety of marijuana available due to researcher demand, including strains with high levels of cannabidiol, or CBD, which is an increasingly popular consumer product and which scientists are investigating for its therapeutic potential.
The inaction on the applications has drawn congressional scrutiny and forged some unlikely partnerships among lawmakers.
In a letter to the DEA and Justice Department in May, more than two dozen House members urged the agencies to “act on one of the 26 pending applications to grow cannabis for research purposes.” The lead signatories were Reps. Eric Swalwell of California, the onetime Democratic presidential candidate, and Matt Gaetz of Florida, a Republican and close ally of President Trump.
And this month, a bipartisan group of House makers introduced a bill to ease the registration process for researchers wanting to study marijuana and to open the door to private suppliers of marijuana for research.
(Drug research generally couples lawmakers oddly. Earlier this year, Gaetz and Democratic Rep. Alexandria Ocasio-Cortez of New York were two of the lawmakers backing an ultimately unsuccessful push to ease restrictions on research into medical applications of psychedelic drugs.)
By last month, one of the applicants to grow marijuana, the Arizona-based Scottsdale Research Institute, grew so frustrated with the DEA that it asked a federal court to demand the agency move on the applications. The petition described the marijuana received from Mississippi as “sub-par,” particularly for clinical trials.
“At this juncture, nothing short of a writ from this Court compelling the agency to act will stop the ongoing harm caused by DEA’s unlawful and unreasonable delay,” the petition says.
The DEA said it could not comment on the litigation, and the agency has not yet filed a response to the claim, court records show.
Earlier in the Trump administration, some advocates pointed to then-Attorney General Jeff Sessions’ anti-marijuana views as a reason behind what they perceived to be stalling on granting additional licenses. But even with Sessions’ resignation in November, applicants say they still haven’t heard updates.
At a Senate hearing in April with Sessions’ successor, Attorney General William Barr, Sen. Brian Schatz (D-Hawaii) noted that Sessions a year earlier had said that the agency would approve additional suppliers of marijuana for research.
“I’ve sent two follow-up letters,” Schatz said. “Where are we on this?”
“I have been pushing very hard over the last few weeks to get that process underway,” Barr said. “I think we’re going to move forward on it. I think it’s very important to get those additional suppliers.”