Prescription Marijuana? FDA Rescheduling Memo Sets Stage To Test Whether There’s A Viable Market

Rise in state-legalized marijuana helped pushed FDA to recommend more lenient regulation of the substance, easing pathway to prescription drug approval, but those same state markets may pose a challenge for commercialization of an Rx botanical if DEA follows through on rescheduling.

marijuana spilling out of prescription pill bottle on prescription pad
FDA-approved marijuana could soon be a reality in the US. Will anyone want to buy it? • Source: Shutterstock

A US Food and Drug Administration-approved botanical marijuana product could be available in the future if the Drug Enforcement Administration follows through on FDA’s recent recommendation to regulate the drug more loosely. But after decades of insistence by the federal government that marijuana lacks any accepted medical use, this change in course may come too late for the pharmaceutical industry to capture the economic windfalls.

Key Takeaways
  • Trade secret protections, not patents, provide protection for companies working on botanical medical marijuana products, but they’ll have to convince the public their “recipes” are worth going the Rx-drug route if DEA follows FDA’s new rescheduling recommendation.

  • Pain, anorexia, and nausea and vomiting are indications with some credible scientific support (but not NDA-level support yet), per FDA

FDA largely relied on individual US states recent experience with marijuana to make a crucial determination needed for rescheduling: that

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