Opinion: Breakthrough Therapies Act: Good idea, wrong solution

The Breakthrough Therapies Act, recently proposed by Senators Rand Paul (R-Ky.) and Cory Booker (D-N.J.) as a way to expand access for therapeutic purposes to potentially beneficial but highly regulated Schedule I substances like psilocybin and LSD, has the right underlying idea but provides a solution that is wrong.

The act would automatically reclassify to Schedule II any experimental medicine designated by the Drug Enforcement Agency as a Schedule I controlled substance — defined as a drug “with no currently accepted medical use and a high potential for abuse” — that receives a Breakthrough Therapy Designation from the Food and Drug Administration.

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