Marijuana and drug policy reform groups are sounding the alarm about a bipartisan cannabis research bill that they say could inadvertently undermine state marijuana programs and patient access.
In a letter sent to Senate Majority Leader Chuck Schumer (D-NY) on Tuesday, the Global Alliance for Cannabis Commerce (GACC) and Law Enforcement Action Partnership (LEAP) said they support streamlining marijuana research, but the House-passed bill that’s now pending a final vote in the Senate would create more problems than it would solve.
Specifically, the organizations are arguing that the Medical Marijuana and Cannabidiol Research Expansion Act “does not expand research into existing cannabis medicines and only permits research for the purpose of a pharmaceutical New Drug Application (NDA) by large pharmaceutical companies.”
Current law already allows cannabis to be researched as a potential pharmaceutical, the letter says, pointing out that there are two marijuana-based Food and Drug Administration- (FDA) approved drugs on the market: Syndros and Epidiolex.
The legislation therefore aims to solve “a problem that simply does not exist.”
“The Act fails to address the real issues,” the letter says. “The barriers to research exist in obtaining existing market products for approval in non-drug pathways (such as dietary supplements, food additives, and other FDCA pathways); in obtaining existing products for health and safety testing across state lines to ensure consistency of products; in using human subjects in testing highways safety, motor skill, and other studies to determine more exactly intoxicating levels and effects.”
“These flaws cause the Act to have substantial and dire unintended consequences for the existing medical cannabis, industrial hemp, and dietary supplement industries. By disallowing existing product manufacturers from researching dietary supplement or other FDCA pathway use, Congress would only increase the ease of which the large pharmaceutical interests can file preclusive drug patents over existing products, akin to generics or dietary supplements, that are state-regulated and available nationwide.”
As fortune would have it for the groups, Senate consideration of the bill was delayed last week following an objection to a unanimous consent vote that was raised by Sen. John Cornyn (R-TX).
But GACC and LEAP are asking for the vote to be postponed indefinitely.
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Besides potentially upending existing state cannabis markets, the legislation could “substantially undermine the regulatory, social equity, agricultural, labor, and small business regimes in each state that are set up to promote public health, safety, and minority entrepreneurship,” the letter argues.
“Finally, the outcome would result in the diversion of pain management patients using medical cannabis back into opioid-based treatment and likely increase opioid-related mortalities,” it continues.
“Additionally, Title III unnecessarily complicates and narrows the existing, longstanding interpretations of criminal law and doctor-patient relationships under the First Amendment and Controlled Substances Act, and potentially interferes with a 20-year-old nationwide injunction addressing the issue. Doctors and medical professionals may currently discuss the benefits and risks of marijuana with their patients free from fear of criminal prosecution under the Controlled Substances Act, concurrent with the First Amendment. That discussion is governed by state medical practice law and tort, not the Controlled Substances Act.”
If the legislation is enacted into law, that “opens the door to prosecution of large swaths of First Amendment-protected activity under an expansive, novel interpretation of the Controlled Substances Act’s criminal reach,” the groups said.
They reiterated that they’re not opposed to promoting marijuana research and have supported previous, more expansive proposals. But while sponsors might have had the right intentions, GACC and LEAP said the measure would “work to substantially harm cannabis research reform.”
Reps. Earl Blumenauer (D-OR) and Andy Harris (R-MD) sponsored the measure in the House, which is substantively identical to a separate Senate bill from Sens. Dianne Feinstein (D-CA), Brian Schatz (D-HI) and Chuck Grassley (R-IA) that previously cleared that chamber.
Just last week, researchers and other advocates associated with the prohibitionist organization Smart Approaches To Marijuana (SAM) sent a different letter to Schumer, imploring him to bring the research measure to a vote.
Under the legislation, the U.S. attorney general would be given a 60-day deadline to either approve a given application or request supplemental information from the marijuana research applicant. It would also create a more efficient pathway for researchers who request larger quantities of cannabis.
Further, the bill would encourage the Food and Drug Administration (FDA) to develop cannabis-derived medicines. One way it proposed doing so is by allowing accredited medical and osteopathic schools, practitioners, research institutions, and manufacturers with a Schedule I registration to cultivate their own cannabis for research purposes.
The Drug Enforcement Administration (DEA) would get a mandate to approve applications to be manufacturers of marijuana-derived, FDA-approved drugs under the bill. Manufacturers would also be allowed to import cannabis materials to facilitate research into the plant’s therapeutic potential.
Another section would require the Department of Health and Human Services (HHS) to look at the health benefits and risks of marijuana as well as policies that are inhibiting research into cannabis that’s grown in legal states and provide recommendations on overcoming those barriers.
The bill further states that it “shall not be a violation of the Controlled Substances Act for a State-licensed physician to discuss” the risk and benefits of marijuana and cannabis-derived products with patients.
A Congressional Budget Office (CBO) analysis published in August found that the proposal would reduce direct spending by less than $500,000 and would have a “negligible net change in the deficit.”
Both the House and Senate passed earlier versions of their separate but similar cannabis research bills in late 2020, but nothing ended up getting to then-President Donald Trump’s desk by the end of the last Congress.
Congressional researchers separately released a report in March that details the challenges posed by ongoing federal prohibition and the options that lawmakers have available to address them.
DEA has taken steps in recent years to approve new cultivators of marijuana to be used in studies, and the National Institute on Drug Abuse (NIDA) recently published a solicitation for applications from those authorized growers as it looks for new contractors to supply the agency with cannabis for research purposes.
Meanwhile, large-scale infrastructure legislation that was signed by Biden in November contains provisions aimed at allowing researchers to study the actual marijuana that consumers are purchasing from state-legal businesses instead of having to use only government-grown cannabis.
NIDA’s Volkow told Marijuana Moment last year that scientists have been unnecessarily limited in the source of cannabis they’re permitted to study—and it makes sense to enact a policy change that expands their access to products available in state-legal markets.
Separately, a bipartisan duo of congressional lawmakers filed a bill in July to set a federal marijuana research agenda and create a designation for universities to carry out cannabis studies with federal grant money.
The legislation from Reps. Scott Peters (D-CA) and Dave Joyce (R-OH) is titled the “Developing and Nationalizing Key Cannabis Research Act.” The bill text doesn’t abbreviate the title, so it’s not clear if the intent was to play into cannabis consumer nomenclature with the introduction of the DANK Cannabis Research Act.
Meanwhile, the now-passed bipartisan, bicameral research bill was introduced on the same day that a long-awaited Senate marijuana legalization bill was finally filed—more than a year after a draft version was first released by Senate Majority Leader Chuck Schumer (D-NY) and fellow sponsors.
The prospects of that wide-ranging legislation making it through the Senate with a 60-vote threshold are dubious, however, and so Schumer has been working with bicameral and bipartisan offices to develop a package of incremental cannabis reforms that’s expected to be filed in the lame duck session.
That so-called SAFE Plus bill is expected to contain marijuana banking protections and other modest proposals on expungements, veterans’ medical cannabis access and more.
Rep. Ed Perlmutter (D-CO), the House sponsor of the standalone marijuana banking bill, said he recently spoke with Schumer at an event at the White House and discussed the need to enact the bipartisan reform this session.
President Joe Biden might be against adult-use legalization, but he campaigned on other incremental reforms like decriminalization, rescheduling and letting states set their own cannabis policies. He’s expressed interest in the medical potential of marijuana and has advocated for more research, so it’s likely that he would sign the bipartisan bill if it’s ultimately sent to his desk.
Read the new letter from GACC and LEAP on the marijuana research bill below: