I spoke with another attorney about the Oregonians’ vote last week to legalize psilocybin therapy here in the state. We discussed how licensed facilities will be out of service for a few more years and how people in the meantime will have to cope with general decriminalization under Measure 109 and, in certain cases, may be relied on the right to attempt access.
Public Law 115-176 (“Right to Try”) is a federal law enacted in 2018 that creates a unified system for terminal patients seeking access to trial treatment. It’s pretty restrictive. The right of experimentation was first introduced as state legislation, with similar laws in 41 states (the federal law does not contain any pre-emptive language). In particular, the right to experiment changes the Federal Law on Food, Drugs and Cosmetics.
to exempt from the provision of certain unauthorized investigational medicinal products to a terminally ill patient who has exhausted the approved treatment options and cannot take part in a clinical trial with the medicinal products, from certain requirements and restrictions under this Act and other laws.
In contrast to many predecessor states, no review by the Institutional Review Board is required. However, the right to experiment requires that the manufacturer or sponsor of an “approved investigational product” report to the Food and Drug Administration (FDA) annually on the provision of a drug. And the FDA must post a summary of this use on its website.
So far, the FDA has not been particularly helpful with the new law. This may be due to the fact that Right to Try was specifically designed to “reduce the FDA’s powers over people’s lives.” Or because Right to Try is similar to the FDA’s existing Advanced Access Program (often referred to as the “Compassionate Use” program). Or it could be that the FDA is putting some kind of resistance on anything.
Finally, on July 24, 2020, the agency published a rule proposal to simplify reporting requirements for the right to experiment (I’m not sure if this was even necessary). Comments closed at the end of September. Since the report log is not yet final, it is unclear how many patients have received drugs under the right to try in recent years, what drugs they have received, or how it really affects people. Things seem pretty slow overall.
In any case, it should be noted that Right to Try does not include any medication or treatments under the sun. Eligible investigational medicinal products must: 1) have completed an FDA-cleared Phase 1 clinical trial; 2) are in an active clinical trial that is intended to form the basis of an application for approval or that is the subject of an application for approval; and 3) are in active active development or production. As is to be expected, Right to Try also limits the liability of a “sponsor, manufacturer, prescriber or donor who provides or refuses an appropriate investigational drug to an eligible patient according to the invoice”.
Obviously, a big question here is which “candidate investigational drugs” qualify under the three prongs mentioned above. The answer to that will always be a matter of timing, but we read that psilocybin and MDMA supplements should qualify right now. The question for doctors and patients will be whether these drugs are worth a look in any case and, moreover, whether it is worth looking into the right to trial or one of the state analogues. For example, a terminal patient wishing to try psilocybin in Oregon might be inclined to source some stems and caps locally instead of trying to get a distilled supplement from an FDA drug registrar.
Let’s see how it all works. In the meantime, we will continue to oversee federal and state experimentation laws as well as other possible “safe havens” for psychedelic use, including everything from religious exceptions to government-licensed service providers to extensive decriminalization. Psilocybin in particular is modeled in all of these ways today. It’s a very promising connection and we’re definitely here for it.