What does Right to Try Mean for Psychedelics?

In 2018, the Senate and President Trump passed the Right to Try Act. It allowed patients to access experimental treatments outside of clinical trials. Yet since then, few patients have used the Right-to-Try pathway. Why have few people used, or even heard of, the Right to Try Act? Who can access treatment through this act? And what does Right to Try mean for psychedelics?

Psychedelic Support is all about equitable, legal psychedelic treatment. We’re looking forward to widespread access, but for now, people can still get psychedelics through clinical trials, expanded access, and potentially Right to Try. Let’s discover what Right to Try is and what it means for psychedelic medicine.

What Is Right to Try?

Right to Try refers to a patient’s right to access treatments that the FDA doesn’t fully approve [1].

But this right doesn’t apply to everyone. It only applies to patients who have been diagnosed with a terminal disease and/or have exhausted FDA-approved treatments. It’s also not for patients who can access a clinical trial.

Right to Try laws are meant to help people get access to medications that have already shown to be helpful but that haven’t been rigorously tested. Let’s get into how they came about.

The History of Right to Try Laws

Right to Try laws amend the Food, Drug, and Cosmetic Act of 1938. This act came after a wave of dangerous, untested products poisoned and killed people in 1937. After one medication killed hundreds of patients, it spurned outrage over federal consumer protections [2].

Intended to protect people from dangerous medical devices, this act helped the Food and Drug Administration (FDA) restrict which products could be on the market. It forced companies to be more truthful in claims made about their products. It also made it illegal to market devices and drugs that were proven to be dangerous to consumers [2].

The Food, Drug, and Cosmetic Act still guides the FDA approval process for new pharmaceuticals. It now takes an extensive approval process before any new medications are allowed to enter the market.

Here’s a brief synopsis of the FDA’s requirements for approval:

Discovery and Development: This includes the initial hypothesis and discovery of a drug and its effects. Then companies gather evidence for how it’s absorbed, its mechanism of action, benefits, dosage, and more. This may include lab and animal testing [3].

Preclinical Research: This phase determines a drug’s safety. To do this, companies may test on small groups of people. This phase typically includes in vivo testing, which uses living subjects. It also uses in vitro testing, which is in test tubes [4].

Clinical Research: During this phase, several clinical trials include larger samples of people. This helps researchers gather more data on safety and shows how it interacts with the human body [5].

FDA Review & Approval: Once a company has established good evidence for safety and efficacy, they submit their data to the FDA for review. This New Drug Application includes labeling, safety updates, drug abuse information and directions for drug use. The FDA reviews this information, and decides whether to approve the substance for the market [6].

*This step is where drugs are specified for one diagnosis. When we talk about “off-label” uses, we’re saying that the FDA hasn’t approved that drug for that diagnosis. For instance, ketamine is approved as an anesthetic, but it’s used off-label as a treatment for depression.

Post-Market Safety Monitoring: The real picture of a medication’s safety comes in the months and years after approval. Once larger groups of people can access the drug, more data on safety and efficacy help the FDA add caution or usage information, if necessary.

The approval process protects patients, but it also means that helpful treatments can take years before people can access them.

During approval, patients can sometimes access treatments before approval through preclinical and clinical trials. Yet these aren’t accessible to everyone. They’re often location-specific or require patients to meet specific requirements.

Clinical trials can be especially prohibitive for patients with terminal illnesses. The application process can take months, and there’s a chance that patients won’t receive the experimental drug at all. In theory, Right to Try laws help these patients get treatments more easily.

While the FDA approval process works to ensure safety for large groups of people, Right to Try laws depend on doctor discretion. Its proponents argue that regulatory bodies shouldn’t be involved in personal treatment decisions between patients and doctors. Its critics worry that Right to Try will lead to patient safety issues and undermine FDA approval.

Since Right to Try bypasses the FDA, patients have to pay for whatever therapies they access through the Act. It’s up to distributors what any experimental substance will cost, and insurance won’t cover whatever that cost is. This potential expense may severely limit who can use the Right to Try pathway.

The FDA has long allowed access to pre-approval drugs under their Expanded Access Program. This helps patients receive experimental treatments outside of clinical trials. Yet the FDA’s pathway for access is murky, and Right to Try bypasses FDA permission for patients.

The first Right to Try law was passed in Colorado in 2014. Between then and 2018, 40 other states passed similar legislation. Now, it’s nationwide. At the end of May 2018, The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act passed into federal law.

This move strengthened Right to Try so that patients in every state could access experimental substances. But what are these experimental drugs?

What Substances Fall Under Right to Try?

Right to Try doesn’t apply to all experimental substances. Drugs and substances have to meet these standards before patients can access them under Right to Try:

The substance must have shown preliminary safety. The drug must already be in clinical trials, meaning it must have already gone through steps 1 and 2 for FDA approval.
The substances must be in ongoing research without any safety holds or discontinuations.
The FDA doesn’t require pharmaceutical companies to provide access to their experimental substances. Therefore, it needs to be available through a sponsor or manufacturer.

These requirements limit the substances people can access through Right to Try laws. But is it still possible to access psychedelics under Right to Try?

Can You Apply Right to Try to Psychedelics?

Yes and no. While Right to Try ideally would allow access to psychedelics, it doesn’t make them federally legal.

Substances like MDMA, psilocybin, and LSD could provide unparalleled relief for anxiety and depression resulting from a terminal illness [7]. Yet as far as we know, no one has been able to access psychedelics under Right to Try.

Right to Try makes no mention of allowing access to substances that fall under the Controlled Substances Act. The DEA maintains that psilocybin’s use, even under the circumstances of Right to Try, is illegal. Doctors who invoke Right to Try for their patients could be punished under the Controlled Substances act, losing their medical license and even facing jail time.

In March of 2021, a suit was filed against the DEA over their refusal to accommodate Right to Try. Dr. Sunil Aggarwal and the Advanced Integrative Medical Science Institute (AIMS) argued that they had the right to treat terminally ill patients to the best of their abilities and that the DEA was hampering treatment. The DEA still refused approval.

In January of 2022, Oregon senators circulated a Dear Colleague letter urging the DEA to allow access to psychedelics under Right to Try. The DEA had no comment. For now, the Right to Try pathway to psychedelics remains closed.

Right to Try and the Future of Psychedelic Medicine

As it stands, Right to Try isn’t strong enough to grant access to people who need psychedelics. We hope that the DEA will see the overwhelmingly positive data around psychedelics and give compassionate use to patients at end of life.

Psychedelics have granted relief to people in palliative care and have shown few side effects. We hope the mounting evidence for psychedelics will turn the tide toward DEA descheduling and FDA approval. That way, patients won’t have to go through the Right to Try process at all.

Clinical trials are going on all over the world right now to move the needle towards approval for psychedelics. Many trials need participants to widen the data for psychedelic safety and efficacy.

If you’re interested in enrolling in a psychedelic clinical trial, take a look at our resources. We’ve got a map of trials and an outline of the trial process, so you know what to expect. Contact a study site on our map to get started and contribute to the evolving field of psychedelic medicine.

References

Commissioner, O. of the. (2020, January 14). Right to try. U.S. Food and Drug Administration. Retrieved June 15, 2022, from https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try
Commissioner, O. of the. (2018, March 28). How did the Federal Food, Drug, and Cosmetic Act come about? U.S. Food and Drug Administration. Retrieved June 15, 2022, from https://www.fda.gov/about-fda/fda-basics/how-did-federal-food-drug-and-cosmetic-act-come-about
Commissioner, O. of the. (2018, January 4). Step 1: Discovery and Development. U.S. Food and Drug Administration. Retrieved June 15, 2022, from https://www.fda.gov/patients/drug-development-process/step-1-discovery-and-development
Commissioner, O. of the. (2018, January 14). Step 2: Preclinical research. U.S. Food and Drug Administration. Retrieved June 15, 2022, from https://www.fda.gov/patients/drug-development-process/step-2-preclinical-research
Commissioner, O. of the. (2018, January 4). Step 3: Clinical research. U.S. Food and Drug Administration. Retrieved June 15, 2022, from https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
Commissioner, O. of the. (2018, January 4). Step 4: FDA Drug Review. U.S. Food and Drug Administration. Retrieved June 15, 2022, from https://www.fda.gov/patients/drug-development-process/step-4-fda-drug-review#:~:text=If%20a%20drug%20developer%20has,application%20to%20market%20the%20drug.
Rosenbaum, D., Boyle, A. B., Rosenblum, A. M., Ziai, S., Chasen, M. R., & Med, M. P. (2019). Psychedelics for psychological and existential distress in palliative and cancer care. Current oncology (Toronto, Ont.), 26(4), 225–226. https://doi.org/10.3747/co.26.5009