In AHLA’s Health Law Weekly, Attorneys Analyze Regulatory Considerations in Cannabis Research

A groundswell of states have adopted legislation endorsing varying degrees of marijuana legalization and decriminalization. As the trend towards cannabis legalization continues, learning more about the public health implications of marketed cannabis products takes on greater urgency.

In an American Health Law Association "Health Law Weekly" article, attorneys explain that complex regulatory paradigms govern research activities conducted with these substances. They note that researchers need to consider applicable regulatory obligations imposed by the U.S. Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and states and localities where research will occur before designing and implementing research protocols intended to study cannabis usage by human subjects. The authors explain that these regulatory regimes need to be considered even in cases in which the cannabis is acquired by study subjects through pathways that are legal under state law.

The authors observe that to the extent regulatory hurdles, designed for different purposes, inadvertently undermine the conduct of these types of research studies, researchers and public health agencies may wish to advocate for regulatory change that would exempt this research from certain regulatory obligations.

The article was authored by health care partner David Peloquin, and life sciences regulatory & compliance counsel Beth Weinman.