President Biden Signs Bill Clearing The Way For Medical Cannabis Research

• Published date: 09 December 2022
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Cannabis & Hemp, Food and Drugs Law
• Law Firm: Arnold & Porter
• Author: Ms Kristine Blackwood, David J.M. Skillman, Bobby McMillin, Paul Howard, Evelina J. Norwinski, Scarlett Bickerton and Lucas Gorak

Although the cannabis plant has been popularly believed to have medicinal properties for centuries, if not millennia¹, evidence-based medical research on the health risks and potential therapeutic benefits of the plant has remained in the early stages in the 21st century.²

Federal prohibitions on the sale and use of cannabis took hold in the United States, along with negative associations with use of cannabis, in the early to middle part of the last century, culminating in the United States' ratification of the Single Convention on Narcotic Drugs in 1967 and passage of the Controlled Substances Act (CSA) in 1970. The CSA placed "marijuana"³ in Schedule I with drugs such as LSD and heroin deemed to have "no currently accepted medical use in treatment" in the United States, a high potential for abuse and a lack of accepted safety for use under medical supervision.⁴

Since California became the first state to legalize medical marijuana in 1996, interest in cannabis for medical and recreational use has grown steadily. Thirty-seven states now allow the medicinal use of cannabis and, with passage of ballot measures in Maryland and Missouri this November, twenty-one states and the District of Columbia have now legalized cannabis for adult recreational use. Nearly half of all Americans live where marijuana is legal to consume under the laws of their states and more than 5 million Americans have registered as medical marijuana patients.⁵ Recent polling conducted by Gallup indicates that a record-high 68 percent of Americans support marijuana legalization and that political support is robust across nearly all demographics.⁶

Given the significant implications of widespread use of cannabis for individual and population health, and the plant's potential for addressing unmet medical needs, research institutions, patient advocacy organizations, cannabis companies, and institutions of higher education have long urged Congress to clear the path for research on the safety and efficacy of cannabis and cannabis-based products.⁷ In a significant federal policy breakthrough, on December 2, 2022, President Biden signed into law the "Medical Marijuana and Cannabidiol Research Expansion Act, H.R. 8454," (the Cannabis Research Bill).

This bipartisan legislation is the first standalone cannabis reform bill to pass both the House and Senate, marking a significant milestone in the evolution of federal cannabis policy. While the new law does not change marijuana's status as a Schedule I substance, the legislation is intended to: 1) advance research on the potential risks and medical benefits of cannabis, cannabis products, and their synthetic equivalents by streamlining and clarifying the role of the Drug Enforcement Administration (DEA) in research; 2) expand sources of research-grade marijuana; 3) promote the commercial development of FDA-approved drugs derived from marijuana and CBD; and 4) ensure that physicians may discuss the potential risks and benefits of marijuana and CBD with their patients. Passage of the legislation, along with recent Executive Branch actions, promises to unlock the potential of medical cannabis. This Advisory describes the current landscape for clinical research involving cannabis and explains the changes effectuated by the new law.

Legislative History

The Cannabis Research Bill was introduced in July 2022 by Representatives Earl Blumenauer (D-OR) and Andy Harris, M.D. (R-MD), among other cosponsors.⁸ The legislation reflected a bipartisan, bicameral agreement resolving longstanding differences between research expansion proposals passed by the House and the Senate in the 117th Congress and considered by prior Congresses. Shortly after introduction, the House passed the compromise measure by a vote of 325 to 95. In the Senate, where Senators Dianne Feinstein (D-CA), Chuck Grassley (RA) and Brian Schatz (D-HI) introduced the companion bill, the measure passed by voice vote on November 16, 2022.

Current Requirements for Clinical Research

Researchers seeking to investigate the medical benefits and risks of cannabis have had to navigate a multi-step process involving three federal agencies, the US Food & Drug Administration (FDA), the DEA, and the National Institute on Drug Abuse (NIDA), as well as comply with requirements imposed by the state(s) in which the research is conducted.⁹ These federal processes govern scientific research protocols, security and controls to prevent diversion, and the source of the cannabis used in the research.

FDA Authorization

In the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress charged the FDA with ensuring that before a new drug is allowed to enter the US market, the drug must be shown through adequate and well-controlled clinical trials to be both safe and effective for its intended use. As with any new drug,¹⁰ the sponsor of a study involving cannabis or a cannabis-derived substance must submit an Investigative New Drug (IND) application to the FDA outlining protocols for the proposed study (e.g., certificates of analysis providing cannabinoid profile/purity and testing for contaminants; stability testing; and manufacturing procedures) and the qualifications of the investigators.¹¹ Investigative new drug sponsors also must provide assurances of informed consent and protection of the rights, safety, and welfare of the human subjects participating in the study.¹² In addition, for studies involving controlled substances, the sponsor must include protocols to ensure secure storage to prevent theft or diversion.¹³ The sponsor must also submit the clinical protocol to an institutional review board (IRB). The timeline for FDA's initial IND submission review is 30 days.¹⁴ If the clinical studies sufficiently establish safety and efficacy, the sponsor may then apply to FDA for formal approval to market the drug for the approved indication in the US.¹⁵

Supply Sources

Until recently, the United States relied exclusively on a single grower to produce marijuana for domestic research purposes. For nearly 50 years, the National Center for the Development of Natural Products at the University of...