Freedom To Heal Act Gathers Support

Supporters of the Freedom To Heal Act met with the staff of some 80 lawmakers in the House and Senate this week to gain support for the bill, which would create a narrow, DEA-regulated system for physicians to administer Schedule I substances to patients with life-threatening conditions. 

The legislation was first introduced on December 4th by Senators Cory Booker (D-NJ) and Rand Paul (R-KY). U.S. Representatives Madeleine Dean (D-PA-04) and Nancy Mace (R-SC-01) have introduced companion legislation in the House.

According to a joint press release from the senators, Freedom to Heal would allow physicians licensed in the U.S.to submit an application to provide patients with Schedule I drugs that are deemed to be “eligible investigational drugs” or EIDs. 

To be considered an EID, a drug must have already gone through Phase 1 clinical trials. A number of psychedelic compounds, including MDMA, psilocybin, and LSD have already completed Phase 1 trials in the U.S. Drugs developed by pharmaceutical companies that are based on psychedelics such as psilocybin,  ibogaine, and DMT have already progressed into more advanced trials. 

Bridging Right To Try 

“Thousands of Americans, many of them veterans, are desperate for access to these therapies after exhausting all approved treatments in the United States.” Mr. Booker said in a prepared statement. “The Freedom To Heal Act is critical legislation that will remove unnecessary barriers and give physicians a pathway to legally administer these potentially lifesaving treatments.”

If passed in its current form, the Freedom To Heal Act would tweak the Controlled Substances Act to create a legal bridge between it and the federal Right To Try Act. Signed into law in 2018, Right To Try allows terminally ill people who have exhausted all conventional treatment options and cannot qualify for clinical trials to access experimental therapies not yet approved by the FDA. However, nearly all psychedelic drugs fall under Schedule I and are controlled by the DEA. 

“The Freedom To Heal Act would require the DEA to create a special registration for RTT access to psychedelic drugs that meet the requirements to be deemed an ‘eligible investigational drug,’ meaning the drug has completed a Phase I clinical trial and remains under investigation. The DEA could have created such a special category of registration on its own, and indeed, we urged it to do so in litigation, but it has refused to do so. This bill would require it to do so,” said Kathryn Tucker, Director of Advocacy for the National Psychedelics Association. 

A core argument behind the new bill is that many of the patients who qualify for Right To Try are ineligible to participate in the clinical trials for psychedelics. “As someone currently leading a clinical trial of psilocybin to treat veterans with PTSD, I know firsthand the significant number reaching out for help but who don’t qualify for our trial for various reasons,” says Dr. Lynnette Averill, an Associate Professor at Baylor College of Medicine and the Chief Science Officer for Reason for Hope, one of the bill’s leading backers. “Unfortunately, it is often those most in need who are excluded.”

Next Steps

The Senate Judiciary Committee of the House and Senate would be required to vote on Freedom to Heal in order for the bill to advance. Several sources who work with one or more of these bodies tell Lucid News that some lawmakers see Freedom To Heal as a repackaged version of the Breakthrough Therapies Act, a bill from three years ago that sought to expand the Right to Try. 

The Breakthrough Therapies Act sought to reduce the barriers to rescheduling drugs designated as breakthrough therapies and reclassifying them from Schedule 1 drugs with no accepted medical use to Schedule 2, which recognizes a medical use. Even after this legislation was reintroduced in 2023, it never received a vote in either the Senate or House Judiciary Committees. 

In late 2022, Arthur L. Caplan and Kenneth Moch, both members of the bioethics board at the NYU Grossman School of Medicine, co-authored an opinion in STAT  titled “Breakthrough Therapies Act: Good idea, wrong solution.” In their op-ed, the two argue that the greatest benefit to patients can only be accomplished through FDA approval and rigorously controlled clinical testing and declared the Right To Try process “utterly ill-conceived.” 

In their opinion piece, Caplan and Moch suggested allowing the FDA to review any Schedule I drug to ensure there is no abuse or misuse during the course of the clinical development process. “This would not be dissimilar to the existing Risk Evaluation and Mitigation Strategies process the FDA has already established for medications with serious safety concerns to help ensure that the benefits of a new medication outweigh its risks,” they wrote. 

Currently, Right To Try does not include any means for the DEA to review and register physicians seeking to work with Schedule I drugs, leading critics of the law to note its legal flaw – a source of symbolic power without any legal means to make change. According to sources familiar with the meetings held by advocates of the Freedom to Heal Act, many of the staffers and lawmakers advocates met with this week were unaware of this regulatory gap, including those who supported the original Right to Try Act. 

The recently passed HALT Fentanyl law creates a means for researchers to apply to the DEA directly for permission to work with Schedule I drugs. Supporters of Freedom to Heal believe that this successful piece of legislation offers supporters of Right To Try a way forward. 

“Following the passage of HALT Fentanyl, it made sense to take a more narrow targeted approach to specifically address the Schedule 1 barrier to Right To Try,” says Charlie Panfil, Vice President of the lobbying firm DB3. “While this was one of the goals [of the Breakthrough Therapies Act], the language is entirely different, as the Freedom To Heal Act creates a new DEA physician registration process solely for Right To Try purposes and does not include administrative rescheduling.” 

“It’s a very clear need. The system is clearly not working the way that it’s supposed to,” says Brett Waters, policy counsel for the Veterans Mental Health Leadership Coalition. “There has to be some flexibility to allow treatment for these patients, and we think it’s the right timing to address this very narrow common sense issue.”