A bipartisan group of House members introduced a bill on Wednesday that would eliminate barriers to research into medical cannabis.
Reps. Earl Blumenauer (D-OR), Andy Harris (R-MD), Zoe Lofgren (D-CA), Morgan Griffith (R-VA), Debbie Dingell (D-MI) and Rob Bishop (R-UT) are sponsoring the legislation.
The bill would accomplish two goals: First, it would establish a “less cumbersome registration process” for researchers interested in studying marijuana by “reducing approval wait times, costly security measures, and additional, unnecessary layers of protocol review,” according to a summary.
Second, it would allow certified scientists to obtain research-grade cannabis from private manufacturers. That could resolve an issue identified by researchers and lawmakers, who complain that marijuana produced at the only existing federally authorized facility at the University of Mississippi is difficult to access and is chemically closer to hemp than cannabis available on the commercial market.
“[Forty-seven] states have legalized some form of cannabis, yet the federal government is still getting in the way of further progress on the potential for research,” Blumenauer said in a press release. “We owe it to patients and their families to allow for the research physicians need to understand marijuana’s benefits and risks and determine proper use and dosage.”
Harris, a vocal opponent of cannabis legalization who was the lead sponsor of previous versions of the research-focused bill in prior Congresses under Republican control, said that as a physician, he “cannot stress enough how critical this legislation is to the scientific community.”
“Our drug policy was never intended to act as an impediment to conducting legitimate medical research. If we are going to label marijuana as medicine, we need to conduct the same rigorous scientific research on efficacy and safety that every other FDA-approved treatment undergoes. This legislation will facilitate that research by removing the unnecessary administrative barriers that deter qualified researchers from thoroughly studying medical marijuana.”
Today I and Reps. Blumenauer, Lofgren, Griffith, Dingell, and Bishop introduced the Medical Marijuana Research Act of 2019:https://t.co/NCqZoZTCau
— Rep. Andy Harris, MD (@RepAndyHarrisMD) July 17, 2019
“At first glance, it may seem like a strange partnership—one of the most vocal critics of the ever-advancing tide of cannabis legalization and one of legalization’s most ardent advocates—co-sponsoring a cannabis bill together,” Blumenauer and Harris, who rarely agree on cannabis issues, wrote in an op-ed they coauthored about the new legislation. “Dig a bit deeper into the debate, however, and our odd couple makes a bit more sense. We may come from different sides of the issue, but we can agree on one thing—the federal government should not stand in the way of legitimate, scientific medical cannabis research.”
“While we may disagree about the medical value of cannabis and the various state efforts to legalize cannabis, it is beyond dispute that the barriers to cannabis research inhibit this nation’s ability to both thoroughly evaluate the benefits and risks associated with increased cannabis use and craft responsible policy governing such use,” they wrote.
It is beyond dispute that the barriers to marijuana research inhibit this nation’s ability to both thoroughly evaluate the benefits and risks associated with increased marijuana use and craft responsible policy governing such use. @repblumenauer https://t.co/U17f4Nb4t2
— Rep. Andy Harris, MD (@RepAndyHarrisMD) July 18, 2019
Besides the sponsors, supporters of the legislation include prohibitionist group Smart Approaches to Marijuana (SAM), the American Psychological Association, Marijuana Policy Project and the American Academy of Neurology.
SAM President Kevin Sabet said in a statement that the organization hopes “Congress will move swiftly to pass it and reduce barriers to researching marijuana to produce new FDA-approved medicines.”
The bill’s aims are similar to those of a separate piece of bipartisan marijuana research legislation that was filed in the Senate last month.
Sens. Dianne Feinstein (D-CA), Brian Schatz (D-HI) and Chuck Grassley (R-IA) introduced that proposal, which aims to expedite the application process for researchers who want to study cannabis and promote the development of FDA-approved drugs derived from marijuana.
“There is evidence of marijuana’s potential medicinal benefits in treating conditions including cancer, epilepsy, and glaucoma,” Griffith said. “In order to move forward in evaluating the medicinal value of medical marijuana and determining its accompanying side effects, it is critical that we remove barriers to research.”
“To that end, I am pleased to join in reintroducing this bipartisan legislation,” he said. “The Medical Marijuana Research Act constitutes common sense legislation that could open the door to treatment that can substantially improve the quality of patient care.”
Read text of the new House marijuana research bill below:
Feds Send Warning Letter To Another CBD Company Over Medical Claims
The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent a warning letter to a Florida-based CBD company on Tuesday, alleging that the business made several unsanctioned claims about the therapeutic benefits of their products.
The federal agencies accused Rooted Apothecary of unlawfully asserting that their cannabidiol products could treat symptoms of conditions such as ADHD, Parkinson’s disease, ear aches, ADHD and autism. Those claims appeared on the company’s website and social media accounts, they said.
Certain products appeared to be marketed as dietary supplements, which FDA currently prohibits as it works to develop an alternative regulatory scheme for CBD.
“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance,” Acting FDA Commissioner Ned Sharpless said in a press release. “We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions.”
FDA and FTC have issued a joint warning letter to a company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease, among other conditions/diseases. https://t.co/tsn4SBiGzH pic.twitter.com/sG3wyURMDS
— Dr. Ned Sharpless (@FDACommissioner) October 22, 2019
We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements.
— Dr. Ned Sharpless (@FDACommissioner) October 22, 2019
“We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements,” he said. “As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority.”
FTC’s complaint with the company is that it violated a law that requires businesses that advertise medical claims about their products to have “competent and reliable scientific evidence” to back them up, which could include human clinical trials. Making or exaggerating such claims through “a product name, website name, metatags, or other means” without proper evidence is also prohibited.
FTC and @US_FDA warn Florida company marketing CBD products about claims related to treating autism, ADHD, Parkinson’s, Alzheimer’s, and other medical conditions: https://t.co/cAbxPPcxk8 pic.twitter.com/GdlttyBgxv
— FTC (@FTC) October 22, 2019
Rooted Apothecary must respond to the agencies within 15 working days to explain what steps it’s taking to resolve the issues. If the company fails to do so, it is subject to legal action, including the possible seizure of its products or an injunction. It may also have to compensate customers.
FDA emphasized that CBD products—other than the prescription medication Epidiolex, for the treatment of intractable epilepsy—are not currently allowed. But it also reiterated that the agency is in the process of developing rules that could allow for the lawful marketing of the compound.
In April, FDA sent warning letters to three other CBD companies that it said was making unauthorized claims about the medical benefits of their products. FTC also submitted warning letters to three separate CBD companies for allegedly advertising misleading statements about their products last month.
These letters are examples of the agency’s use of enforcement discretion. Former FDA Commissioner Scott Gottlieb, who recently suggested that the federal government should be involved in regulating state marijuana programs, clarified in March that the agency is only going after companies that make especially misleading claims about their products.
Senate Majority Leader Mitch McConnell (R-KY), who championed a provision of the 2018 Farm Bill federally legalizing hemp and its derivatives, has urged FDA to clear a path for the lawful marketing of CBD products by using enforcement discretion while it develops an interim final rule. A bipartisan group of lawmakers made a similar request in a letter sent to the agency last month.
“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” FDA Principal Deputy Commissioner Amy Abernethy said.
FDA’s working quickly to further clarify our regulatory approach for products with cannabis/cannabis-derivatives like CBD while using all available resources to monitor the marketplace & protect public health by taking action as needed against companies. https://t.co/HB9IhG2qud
— Dr. Amy Abernethy (@DrAbernethyFDA) October 22, 2019
We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence. We plan to provide an update on our progress in this area in the near future.
— Dr. Amy Abernethy (@DrAbernethyFDA) October 22, 2019
“We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products,” she said. “We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.”
Photo courtesy of Kimzy Nanney.
GOP Senator Links Medical Marijuana Claims To Tobacco Industry Advertisements
Sen. John Cornyn (R-TX) said on Tuesday that claims about the therapeutic potential of marijuana remind him of decades-old tobacco industry advertisements asserting that the product had medical benefits.
In a speech on the Senate floor, Cornyn discussed a hearing that the International Narcotics Control Caucus, which he co-chairs, will hold on Wednesday to explore the public health impacts of cannabis. He said it was especially important to hear from experts about the subject as more states legalize marijuana and members of Congress, as well as Democratic presidential candidates, push to end federal prohibition.
Senate Hearing To Focus On Marijuana And Health This Week – https://t.co/aPZczm3X75
— Senator John Cornyn (@JohnCornyn) October 21, 2019
The senator made clear he’s skeptical about marijuana’s health benefits.
“There’s no shortage of people who claim that marijuana has endless health benefits and can help patients struggling from everything from epilepsy to anxiety to cancer treatments,” he said. “This reminds me of some of the advertising we saw from the tobacco industry years ago where they actually claimed public health benefits from smoking tobacco, which we know as a matter of fact were false and that tobacco contains nicotine, an addictive drug, and is implicated with cancers of different kinds.”
“We’re hearing a lot of the same happy talk with regard to marijuana and none of the facts that we need to understand about the public health impact of marijuana use,” he said.
While Cornyn recognized there’s significant support for cannabis reform, he said that ” for the number of voices in support of legalization, there are even more unanswered questions about both the short- and long-term public health effects.”
He expressed concern about increased levels of THC concentration in cannabis products and stated that it’s “true that for some people that marijuana can indeed be addictive.”
“There’s simply a lack of scientific evidence to determine the link between marijuana and various health risks, and that’s something I would think Congress and the American people would want to know before we proceed further down this path,” Cornyn said. “We don’t know enough about how this could impair cognitive function or capacity or increase the risk of mental illness or perhaps serve as a gateway for other drugs that are even more damaging to the health of a young person.”
The senator made similar remarks during a conversation with a former White House drug czar in August. He said it was important to address the public health impacts of cannabis before moving forward with legislation that would protect banks that service marijuana businesses from being penalized by federal regulators.
“With increasing use and a growing number of states giving the green light for marijuana use, we need better answers,” he said.
The surgeon general and the director of the National Institute on Drug Abuse, along with several academics, are scheduled to testify at Wednesday’s hearing.
Photo courtesy of C-SPAN.
Michael J. Fox Parkinson’s Foundation Urges Congress To Pass Three Marijuana Research Bills
A leading advocacy group that’s dedicated to finding treatment options for Parkinson’s disease is backing three pieces of marijuana research legislation in Congress.
The Michael J. Fox Foundation (MJFF)—named after the actor, who has Parkinson’s and established the nonprofit—said last week that lifting barriers to cannabis research, including rescheduling the plant under the Controlled Substances Act (CSA), is necessary to promote studies verifying marijuana’s potential therapeutic benefit for conditions such as Parkinson’s patients.
“The MJFF supports increased access to cannabis for medical research. Congress has begun to recognize this need, and there are several bills in the U.S. House and Senate designed to remove barriers that impede safe and legal access to cannabis by medical researchers,” the foundation said on its website. “The MJFF public policy team is tracking these bills and working to educate members of Congress and their staff on their importance to the Parkinson’s community.”
MJFF said it’s in favor of three marijuana bills, which would accomplish the following:
—Require the Justice Department to approve additional manufacturers for research-grade cannabis.
—Protect research institutions that conduct studies on marijuana.
—Authorize the U.S. Department of Veterans Affairs (VA) to inform patients about opportunities to participate in federally authorized cannabis studies.
—Require VA to conduct studies into the therapeutic potential of marijuana in the treatment of various conditions that commonly afflict veterans such as chronic pain and post-traumatic stress disorder.
—Reschedule marijuana from Schedule I to Schedule III under the CSA.
—Free up universities to conduct studies on cannabis by removing certain regulatory requirements.
In a letter to the Senate sponsor of that last piece of legislation, Sen. Dick Durbin (D-IL), in June, the foundation stated that marijuana’s current classification under federal law and the inadequate quality of cannabis grown at the only federally authorized manufacturing facility has meant that “researchers do not have the proper materials to conduct the necessary research.”
The foundation noted that it has submitted comments to the Food and Drug Administration arguing in favor of rescheduling in 2018 and 2019. It also applauded the Drug Enforcement Administration for announcing that it would take steps to approve additional federal cannabis farms for research.
“Current policies hinder comprehensive medical research on cannabis, making it difficult to generate the evidence needed for clear recommendations,” Andrew Koemeter-Cox, MJFF’s associate director of research programs, said. “This is especially problematic when some products may be unsafe for human use and have the potential for adverse interactions with other medications.”
Ted Thompson, the nonprofit’s senior vice president of public policy, said that removing barriers to research “is one way in which Congress can help scientific researchers determine what the benefits of medical cannabis might be for Parkinson’s disease.”
“Our role on the public policy team is to work with Congress and the administration to ensure there is access and funding for research and care initiatives that can benefit people living with Parkinson’s and, right now, that includes access to medical cannabis for research,” he said.
Photo courtesy of Brian Shamblen.