The process for studying the potential medical benefits of marijuana became more streamlined on Tuesday, when the U.S. Department of Health and Human Services eliminated a controversial requirement for Public Health Service review of non-federally funded research protocols involving marijuana.
Historically, in addition to the standard FDA and Drug Enforcement Administration approvals needed for research using Schedule I drugs, researchers conducting trials with marijuana were required to receive approval through a National Institute on Drug Abuse/Public Health Service protocol review process. Last year, echoing researchers and activists, a bipartisan group of congressmen petitioned HHS to eliminate the process, asserting that it was hampering important research.
On Tuesday, in a Federal Register notice, HHS stated that the additional step was no longer required for non-federally funded research. HHS acknowledged that PHS review overlapped in several important ways with FDA’s Investigational New Drug process. The FDA’s IND review process considers whether the research design includes good clinical and laboratory practices, whether pivotal clinical trials to support the marketing of proposed drug products are adequate and well-controlled, and the therapeutic benefits and risks to study subjects, favoring dosage forms that would provide measured and consistent dosing to patients as well as reduced exposure to potentially harmful constituents. HHS concluded that FDA’s review was sufficient; PHS review is not necessary to support the conduct of scientifically-sound studies into the potential therapeutic uses of marijuana. HHS anticipates that the elimination of the requirement will streamline the application and approval processes for cannabis research. Federally-funded research will continue to require NIH review and approval.
Medical uses for marijuana and cannabis products have received significant attention in the media and drawn the attention of the public and researchers. Although classified as a Schedule I Narcotic under the federal Controlled Substances Act, medical marijuana is currently legalized in 23 states and D.C., and other states have approved specific uses of cannabidiol, or CBD, a compound found in cannabis that has shown promise in treating certain diseases such as epilepsy. But FDA and many medical professionals have called for more thorough testing of marijuana and cannabis to determine its safety and efficacy for treating a variety of ailments. Indeed, on the same day as the Federal Register notice, the Journal of the American Medical Association released several articles focusing on medical marijuana and emphasizing the need to conduct additional, high-quality studies of its purported benefits.