Right to Try vs. Access to Prescription Peptides
In the US, access to certain peptides has been expanded by federal regulators, with the announcement that several popular peptides would be placed on the FDA “whitelist.” That means that they can be lawfully prescribed by physicians and dispensed by licensed compounding pharmacies; it does not mean that it is legal to make or sell them outside of that framework. The push and pull for wider availability for new treatments on one end vs. strict safety regulation on the other isn’t new. What is new is expanded application of what are called Right to Try laws in longevity medicine.
How Compassionate Use and Right to Try Laws Work
This struggle of regulatory responsibility for public safety against the right to make personal choices has been around since before the FDA existed. Recognizing a need for exceptions in special circumstances, statutes were enacted many years ago intended to strike a reasonable balance: Experimental drugs not yet approved could be made available outside of clinical trials for patients with incurable life-threatening diseases by applying for an exemption under a program called compassionate use. Formalized in 1987 during the AIDS epidemic, this expanded access program has worked well, with some 99% of applications being approved. In 2018, Congress updated the process with the Right to Try Act, but the drug must still have an investigational new drug application and clinical trial program in place. Several states have now passed laws seeking to facilitate a wider use of Right to Try as it moves to longevity medicine and broader use cases.
Montana’s Approach to Experimental Treatments
One place that seems to be doing it right is Montana. It wasn’t the first state to pass Right to Try, but in 2023 they enabled the creation of privately owned Experimental Treatment Review Boards (ETRBs) to consider approvals for treatments, along with state-licensed Experimental Treatment Centers. Normally, expanded access requires a nod from the FDA, and there is no guarantee that they will not intervene, but right now there seems to be little interest in enforcement.
A significant difference is that the state board will consider the treatment, not just the patient. I hope it works because unfettered access to everything by anyone will result in people being harmed or worse. There are already well-documented deaths from peptides, and those are just the ones we know about because no one is keeping track. The Montana program requires that any treatments considered for approval must have completed phase 1 safety trials, have a documented safety profile, and a comprehensive informed consent process. I believe that this is how we advance the specialty of longevity medicine.
The Risks of Expanding Access to Experimental Treatments
Others are testing the limits of Right to Try. A company called Mitrix Bio recently announced the formation of clinics in California, Texas, and Florida to provide mitochondrial transplantation after a phase 1 trial of only 3 subjects. But at least they have that. Peptides like BPC-157, CJC-1295, and others are unlikely to enter a formal approval process, for the simple reason that they are not patented, and so no one is willing to invest the millions of dollars it would take to do a proper clinical trial. The result is a situation where there is incomplete information about safety, optimal dosing, formulation, and outcomes. The way I see it, that is all the more reason why they should be used under medical supervision.
Contact Us To Learn More About Accessing Prescription Peptides
For more information on the right to try vs. access to prescription peptides, contact Phase Plastic Surgery & Longevity.
