The “Right to Try” Psilocybin and New Drug Therapies

I was talking to another lawyer about last week’s vote by Oregonians to legalize psilocybin therapy here in the state. We discussed how licensed facilities won’t be up and running for a few more years, and how, in the meantime, people will have to make do with general decriminalization under Measure 109 and maybe, in certain cases, reliance on Right to Try access.

Public Law 115-176 (“Right to Try”) is a federal law enacted in 2018 that creates a uniform system for terminal patients seeking access to investigational treatments. It’s quite restrictive. Right to Try was first introduced as state legislation, with similar laws in 41 states (the federal law does not contain preemption language). Specifically, Right to Try amends the Federal Food, Drug, and Cosmetic Act,

to exempt, from specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs.

Unlike with many precursor state laws, no institutional review board review is required. However, Right to Try requires that the manufacturer or sponsor of an “eligible investigational drug” report

Read More Here…

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