Cannabis advocacy groups are warning lawmakers that a bipartisan cannabis research bill could cause problems for state medical cannabis programs.
The U.S. House of Representatives passed the Medical Marijuana and Cannabidiol Research Expansion Act in July with bipartisan support. The bill would streamline the registration process for researchers looking to study cannabis with permission from the Department of Justice (DOJ). The Drug Enforcement Administration (DEA) would be tasked with maintaining a registry of companies producing cannabis for drug researchers as well as the researchers themselves.
The bill would also allow accredited medical schools, practitioners, research institutions and manufacturers with Schedule I registration to cultivate cannabis for research purposes.
Last week Global Alliance for Cannabis Commerce (GACC) and Law Enforcement Action Partnership (LEAP)—two pro-cannabis advocacy groups—sent a letter to to Senate Majority Leader Chuck Schumer (D-NY) calling for the bill to be removed from the Senate agenda. The groups say that although they support more cannabis research in general, the bill will only end up benefiting pharmaceutical companies while harming private cannabis producers.
“The 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,” wrote the advocates. “Under current law, there are no barriers to research of cannabis and cannabis extracts for the purposes of an NDA aside from the controls that any pharmaceutical drug manufacturer must put on any Schedule I substance.”
As the letter points out, pharmaceutical companies have already produced FDA-approved cannabis-derived drugs without need of the Medical Marijuana and Cannabidiol Research Expansion Act. Epidiolex—a drug for treating rare forms of epilepsy in children—was approved in 2018, and Syndros—a drug that treats cachexia, nausea and vomiting in AIDS and cancer patients—was approved in 2019.
The advocate groups explained that the bill does not address the barriers that block researchers from being able to study state-regulated cannabis products that are actually being purchased and used by consumers. They call on Schumer to drop the bill because it only appears to open new pathways to research while in reality, those pathways are already there.
“It solves a problem that simply does not exist.”
Worse still, the group say the bill will lock out existing cannabis companies. “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.”
Making it easier for pharmaceutical companies to create cannabis-derived drugs could also have negative effects on cannabis legalization in the future.
The active ingredient of Epidiolex is CBD, a nonpsychoactive cannabinoid found in cannabis. The chemical was made legal by the 2018 Farm Bill as long as it is derived from hemp (cannabis containing less than 0.3 percent THC by dry weight). A cottage industry has grown up around the cannabinoid, which people use to treat a host of ailments. But FDA approval of Epidiolex made it illegal for companies to sell CBD-infused products over the counter, jeopardizing the entire industry.
It isn’t hard to imagine what would happen to the current medical and adult-use cannabis industries if a pharmaceutical company were to develop a THC-derived drug.
Stopping the bill could prove troublesome as it’s popular with both major political parties as well as advocates on either side of the legalization battle.
Last month prohibitionist advocacy group Smart Approaches To Marijuana (SAM) pressed Schumer to move forward with a vote on the bill, noting that further research will illuminate the health effects of cannabis.
“This bill would streamline the process for research necessary to improve our understanding of marijuana and its effects on the human brain and body,” wrote the group. “As existing research already shows, there are myriad potential harms and benefits to marijuana and its various compounds. But we need to have a greater understanding of exactly how marijuana affects its consumers.”
The Medical Marijuana and Cannabidiol Research Expansion Act streamlined aspects of other House and Senate research bills while dropping the controversial provision to allow researchers to access cannabis sold in state-approved dispensaries. By combining measures that have been approved by both Republicans and Democrats, it’s positioned to become the first standalone cannabis reform bill to ever make it to the president’s desk.
Even if the GACC and LEAP are right about the bill’s unforeseen consequences, lawmakers may be unresponsive to their message in light of the historical significance of seeing a bipartisan cannabis bill passed. Experts say the bill has a high likelihood of passing in the Senate.
If the advocacy groups are successful in convincing Schumer to drop the bill, they will owe much to Sen. John Cornyn (R-TX) who halted the bill’s progress when it was up for expedited Senate consideration in late September. Cornyn did not comment on his objection to moving the bill forward, but he has called for more research into cannabis in the past. He is also staunchly opposed to cannabis reform.
“I’m a member of the Senate Drug Caucus and we’ve had hearings from experts who said we just don’t know the answers to a lot of these questions, and the concentration of THC in cannabis today is not what it was just 20 or 40 years ago,” Cornyn said during an interview in April with CNS News.
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