by Vince Sliwoski, Attorney at Harris Bricken
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 annually to the Food and Drug Administration (FDA) on any provision of a drug. And the FDA is required to post a summary of such use on its website.
To date, FDA has not been particularly helpful about the new law. This may be due to the fact that Right to Try was designed specifically “to diminish the FDA’s powers over people’s lives.” Or because Right to Try is similar to FDA’s existing expanded access program (often referred to as the “compassionate use” program). Or, it could be because FDA is sort of a drag about everything.
On July 24, 2020, the agency finally published a proposed rule to facilitate Right to Try reporting requirements (I’m not sure this was even necessary). Comments closed at the end of September. Because the reporting protocol is not yet final, it’s unclear how many patients have received drugs under Right to Try over the past few years, what drugs they have received, or how any of this is really working out for people. Things seem pretty slow overall.
In any case, it’s important to note that Right to Try does not encompass any drug or treatment under the sun. Eligible investigational drugs must: 1) have completed an FDA-approved Phase 1 clinical trial; 2) be in an active clinical trial intended to form the basis of an application for approval, or subject of an approval application; and 3) be in ongoing active development or production. As one might expect, Right to Try also limits the liability of “a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.”
Obviously, a big question here is which drugs qualify as eligible three prongs identified above. The answer to that will always be a question of timing, but our read is that psilocybin and MDMA preparations should currently qualify. The question for doctors and patients will be whether these drugs are worth a look in each case scenario, and beyond that, whether dealing with Right to Try or one of the state law analogues is worth it. A terminal patient wishing to try psilocybin in Oregon, for example, might be inclined to source a few stems and caps locally rather than try to obtain a distilled preparation from an FDA pharmaceutical applicant.
Let’s see how it all goes. We will otherwise continue to monitor federal and state right-to-try laws, along with other possible “safe harbors” for psychedelic drugs use, including everything from religious exemptions to state licensed service providers to broad decriminalization. Psilocybin in particular is being modeled on all of these paths today. It’s a very promising compound and we are definitely here for it.
Re-published with the permission of Harris Bricken and The Canna Law Blog