Schatz, Hatch, Tillis, Coons Introduce Bipartisan Legislation to Make it Easier for Researchers to Study the Medical Value of Marijuana

WASHINGTON – Today, U.S. Senators Brian Schatz (D-Hawai‘i), Orrin Hatch (R-Utah), Thom Tillis (R-N.C.), and Chris Coons (D-Del.) will introduce the Marijuana Effective Drug Studies (MEDS) Act of 2016, bipartisan legislation that would make it easier for researchers to study the medical effectiveness and safety of marijuana. Similar legislation is being introduced in the U.S. House of Representatives by Reps. Andy Harris (R-Md.), Earl Blumenauer (D-Ore.), H. Morgan Griffith (R-Va.), and Sam Farr (D-Calif.).

“The medical community agrees that we need more research to learn about marijuana’s potential health benefits, but our federal laws today are standing in the way of that inquiry,” said Senator Schatz.  “The MEDS Act will remove excessive barriers that make it difficult for researchers to study the effectiveness and safety of marijuana, and hopefully, give patients more treatment options.”

“While many patients have high hopes for the medical benefits of marijuana, further clinical research is needed to inform the decisions of policy makers regarding access to marijuana,” said Senator Hatch.  “This bill makes targeted changes to the Controlled Substances Act to address specific barriers that encumber medical researchers requesting approval of marijuana research protocols or seeking plant strains for clinical studies.  This joint legislative effort between the House and Senate will eliminate redundancies in the regulatory process and enable needed research to better understand the potential medical uses of marijuana.”

“When it comes to our nation’s efforts to cure diseases and improve the quality of life for people suffering from ailments, burdensome government regulations shouldn’t be an impediment to legitimate and responsible medical research,” said Senator Tillis.  “The MEDS Act is a commonsense, bipartisan effort to remove unnecessary barriers that will give scientists the ability to study the biochemical processes, impact, dosing, risks and possible benefits of cannabidiol and other components of the marijuana plant.”

“When it comes to Americans’ health and well-being, our public policy should be based on scientific research – not outdated assumptions,” said Senator Coons. “Dozens of states across the country, including my home state of Delaware, have shown that medical marijuana laws can be implemented safely and effectively. With more and more states across the country considering similar policies — an evolution backed by changing public opinion — federal barriers to conducting medical research simply make no sense. When it comes to public health and safety, the federal government should be promoting policies that seek new information and understanding – not standing in the way of science.”

Medical marijuana is legal in 25 states and the District of Columbia and shows promise for treating a wide-range of diseases and disorders. However, there is a lack of research evaluating the benefits and risks of marijuana as a possible medication, in large part because of federal barriers that block valuable scientific and clinical research. As a result, millions of Americans are utilizing a drug for medical purposes without scientific guidance with regards to its effectiveness, safety, dosing, route of administration, or standards for quality control. The MEDS Act promotes scientific research and mitigates a significant public health risk by doing the following:

• Enabling more research on marijuana by creating a faster, more streamlined process for obtaining Drug Enforcement Administration (DEA) approval to conduct research, including the ability to amend and supplement research proposals without reapplying. Under current law, researchers who want to conduct research on marijuana must interface with several federal agencies and engage in a complex application process that can take a year or much longer to complete for each study and must start from scratch if they make any changes to their research proposal.
• Eliminating the burdensome requirement of some DEA field offices that marijuana be kept in bolted safes – a requirement not possible in many research and clinical settings – and codifies current DEA regulations that allow marijuana to be stored in securely locked, substantially constructed cabinets.
• Requiring the licensing of marijuana manufacturers for the purpose of valid scientific and clinical research and drug development.  It also establishes manufacturing licenses for the commercial production of FDA-approved medical marijuana products.

The MEDS Act is supported by the American Medical Association, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Society of Addiction Medicine, American Preventive Medical Association, American Pain Society, American Society of Anesthesiologists, American Academy of Pain Medicine, Smart Approaches to Marijuana, Child Neurology Foundation, Child Neurology Society, and Society for Adolescent Health and Medicine.

“Children suffering from uncontrolled seizures are often debilitated by their severity and frequency; the seizures can occur up to hundreds of times a day in some cases,”  said Benard P. Dreyer, MD, FAAP, president of the American Academy of Pediatrics. “These children deserve medicines that are safe, effective, and can improve their quality of life. Recently, parents of some of these children have started seeking relief by turning to unapproved marijuana-derived therapies, but we don’t yet know if these treatments work for children, in part because unnecessary federal regulations have slowed medical research from easily advancing. The MEDS Act will ease these regulations to enable medical research into how these medicines work for children. The bill will also make sure any such therapies are safe by regulating them appropriately through the Food and Drug Administration. The American Academy of Pediatrics thanks Sen. Schatz for his leadership on this important issue and looks forward to working with Congress to advance the bill.”

“We welcome this bill as a way to encourage legitimate research on components of marijuana for medical use, as part of the process through which all FDA-approved medications must pass,” said Kevin Sabet, president of Smart Approaches to Marijuana (SAM). “Though smoked raw marijuana is not medicine, the plant's components should be studied so those in need can access any therapeutic benefits while knowing dosage, side effects, and contraindications. All medications should go through the scientific process and accessed through legitimate doctors—and the MEDS Act will get us there faster.”

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