New rules on medical marijuana research could play into Pennsylvania legislative process

Last week the U.S. Drug Enforcement Administration relaxed regulations on medical marijuana research, with potential implications for approval of laws in Pennsylvania.

Loosening regulations on medical marijuana research should streamline the process for researchers conducting FDA-approved clinical trials on cannabidiol, or CBD, an extract of the marijuana plant, according to a news release from the DEA.

While good news for researchers, who have the potential to provide more information on its uses, the change in research protocols could affect the timetable for approving legislation to legalize medical marijuana for certain illnesses.

Pennsylvania’s medical marijuana bill was approved by the Senate last year and is currently being amended in the House.

This November, a House committee voted 25-8 in favor of the bill, but a full House vote is still pending.

State physician weighs in

The Pennsylvania Medical Society has consistently opposed the medical marijuana bill, but supports more research.

The society feels Pennsylvania lawmakers should hold off approving any legislation until more research takes place, which is likely to happen more easily under the newly loosened regulations, according to a statement released by Scott Shapiro, president of PAMED and a practicing cardiologist in Montgomery County.

“Legalization advocates and patients alike want to use marijuana for a number of illnesses and conditions despite incomplete and limited FDA research on its safety and efficacy,” Shapiro said in a statement. 

What the changes mean

The new regulations allow researchers to obtain a waiver if they want to modify their studies by obtaining more CBD.

The waiver requirement removes a step from the approval process. Previously, the process for obtaining additional CBD could be lengthy.

Researchers who wanted to access more CBD had to provide a written request explaining the modification to their research, which caused a potential delay.

The modification request had to be approved by both the DEA and the FDA.

As it stands, CBD-based clinical trials take place under an FDA Investigational New Drug Application and require a DEA research registration.

The DEA regulates the handling of all controlled substances, including those used by researchers in studies. The FDA approves drugs for medical use in the U.S.

Marijuana is currently classified as a Schedule I controlled substance because it contains tetrahydrocannabinol (THC), a psychoactive ingredient.

Schedule 1 drugs are defined as “drugs with no currently accepted medical use and a high potential for abuse.”

CBD is made up of less than one percent THC and has shown potential medical value, according to the DEA.  

Medical marijuana is legal in some form in almost half of the United States.

Lenay Ruhl

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