The Freedom to Heal Act Opens a Door Few Patients Use

The Freedom to Heal Act would let doctors give MDMA and psilocybin under Right to Try. The Senate bill has been in the Judiciary Committee since December 4, 2025, and the House companion has no recorded markup either.

On April 18, 2026, the White House ordered the FDA and DEA to open a path for experimental psychedelics, including ibogaine, under that same 2018 law. Sen. Cory Booker, the New Jersey Democrat who wrote the Senate bill, called the order a step and then asked Congress to pass his statute, because an order cannot register a physician to handle Schedule I medicine.

S. 3346 Has Not Left the Judiciary Committee

Booker and Sen. Rand Paul, a Kentucky Republican, introduced S. 3346 as a CSA patch, not a rescheduling bill. Reps. Madeleine Dean (D-Pa.) and Nancy Mace (R-S.C.) filed H.R. 6434 the same day with a bipartisan original group that included Reps. Lou Correa, Ro Khanna, Ted Lieu, Dan Crenshaw, Jack Bergman, and Morgan Luttrell.

Booker’s office said the measure would create a narrow, DEA regulated system so physicians could administer Schedule I substances to Right to Try patients. Paul said doctors need “a clear, legal way to administer investigational therapies.” The text does not move MDMA or psilocybin off Schedule I, and it does not change the 2018 eligibility rules.

Congress.gov still lists the Senate bill as referred to the Committee on the Judiciary. Sen. Martin Heinrich, a New Mexico Democrat, signed on February 11, 2026. That is the last Senate action on the public record. The House file kept picking up names into March 27, 2026, then went quiet.

THE PUBLIC RECORD ON S. 3346

1. December 4, 2025: Booker and Paul introduce S. 3346; Dean and Mace introduce H.R. 6434 with six original House partners.
2. February 11, 2026: Heinrich is added as a Senate cosponsor.
3. March 27, 2026: The House companion records its last listed cosponsor add.
4. April 18, 2026: An executive order directs FDA and DEA to build a Right to Try path for experimental psychedelics, including ibogaine.
5. April 21, 2026: Booker says the order is progress and calls on the Senate to pass the Freedom to Heal Act.
6. June 30, 2026: Luttrell introduces H.R. 9559, the IBOGAINE Act, which copies special-registration language for Schedule I Right to Try drugs.

Three senators now stand on S. 3346. The IBOGAINE Act, referred to the House health subcommittee on July 17, 2026, is a tell: the CSA registration clause is already being pasted into a wider bill because the first one has not moved.

The 2018 Law Never Opened Schedule I

Federal Right to Try, signed May 30, 2018, lets some people with life-threatening conditions seek experimental drugs that have finished Phase 1, if they have exhausted approved options and cannot join a trial. Manufacturers still decide whether to ship. FDA’s job is mostly to collect annual summaries, not to approve each use.

The 2018 statute did not amend the Controlled Substances Act. The Veterans Mental Health Leadership Coalition, which helped write the 2025 bill, says that gap is why the DEA lacks a legal mechanism to register physicians to give Schedule I experimental drugs even when a patient already qualifies under Right to Try.

That is a real lock for MDMA, psilocybin, and 5-MeO-DMT, which the coalition lists as eligible investigational drugs with FDA Breakthrough Therapy designations. Breakthrough status is not approval. It is a queue jump for drugs that may beat current care in early data. The Freedom to Heal Act would tell the attorney general to register doctors to give those drugs in clinic settings, with limits on who can be treated, how much can be held, and how it must be stored.

It would not decide whether PTSD, addiction, or suicidal depression counts as “life-threatening” under the 2018 definition. Sponsors talk about veterans with PTSD and traumatic brain injury, cancer patients with end-of-life anxiety, and people with treatment-resistant suicidal depression. The statute they would leave in place is narrower than that brochure.

Right to Try Supplied 27 Drugs in Seven Years

If the political argument is that Right to Try is how America already gets experimental medicine to desperate patients, the FDA table is a cold read. Sponsors report drugs they supplied. The agency does not publish how many people received them.

RIGHT TO TRY DRUGS REPORTED TO FDA

The Right to Try annual reporting summary puts every one of those 27 products in the column for drugs whose clinical outcomes were not used in a marketing application. The two columns that would show FDA leaning on Right to Try data to judge safety sit at zero in every period.

Holly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania Perelman School of Medicine, has described reported use as a handful of cases. The Goldwater Institute, which pushed the state laws that came before the federal statute, says privacy rules keep it from tracking how many patients have used the federal path.

The older, quieter route still moves the volume. A Congressional Research Service review of fiscal 2010 through 2020 found FDA granted 16,258 of 16,380 expanded-access requests, or 99.3%. That program keeps FDA in the file. Right to Try was written to take FDA out. Psychedelic sponsors now want the version of the law that almost nobody uses, because it is the version that would also need a DEA badge.

An April Order Directed FDA and DEA to Move

The White House did not wait for Judiciary. On April 18, 2026, President Donald Trump signed an order that, in the accompanying fact sheet, told FDA and DEA to establish a pathway for eligible patients to access investigational psychedelic drugs, including ibogaine compounds, that are under FDA review and have met basic Right to Try safety tests.

WHAT THE APRIL 18 ORDER DIRECTED

• Review vouchers: FDA is told to give Commissioner’s National Priority Vouchers to appropriate psychedelic drugs that already hold Breakthrough Therapy designations for serious mental illness and meet voucher rules.
• Right to Try path: FDA and DEA are told to open access to experimental psychedelics, including ibogaine, for eligible patients under the 2018 law.
• State match money: HHS is told to put $50 million through ARPA-H toward matching state spending on psychedelic research for people with serious mental illness.
• Trial recruitment: HHS and FDA are told to work with the Department of Veterans Affairs and private clinics to get more patients into studies.
• Reschedule clock: The attorney general is told to start scheduling reviews when products finish Phase 3, so rescheduling can follow FDA approval where that is appropriate.

The White House built its case with its own figures: over 14 million U.S. adults have a serious mental illness, 8 million of them are on prescription medication, veteran suicides have run above 6,000 a year for over 20 years, and the veteran suicide rate is more than twice the non-veteran adult rate. It pointed to work at Stanford, Harvard, and Johns Hopkins, to a 2025 Texas ibogaine research consortium, and to the HALT Fentanyl Act, also from 2025, which changed how Schedule I research is cleared.

Booker treated the order as confirmation and as incomplete. Three days later he wrote that Congress still had to “meet the moment” and pass the Freedom to Heal Act.

This is a major step forward in confronting the mental health crisis devastating our nation.

An executive order to accelerate access to breakthrough psychedelic therapies for depression, anxiety, PTSD, and more offers something too many Americans have gone without for too long:…

— Sen. Cory Booker (@SenBooker) April 21, 2026

Matthew Buckley, a former TOPGUN adversary pilot who founded the No Fallen Heroes Foundation and said he was in the Oval Office for the signing, put the practical lag in plain terms after the ceremony: the VA, in his telling, is still years away from serving the medicine. An order can tell two agencies to invent a pathway. It cannot, by itself, amend the Controlled Substances Act that the DEA has cited as the reason it cannot register those physicians.

Gary Hess Went Looking After Doctors Went Quiet

Gary Hess, director of advocacy at the Veterans Mental Health Leadership Coalition, spent 11 years in the Marine Corps and later lived with severe PTSD. After standard care failed, he has said MDMA and ibogaine helped him reconnect with his mind and body. Doctors told him privately that they believed in the work and still would not discuss it on the record, because the institutions around them would not let them.

That is the human version of the CSA hole. The coalition says the barrier has already pushed thousands of eligible patients, including veterans, either out of the country or into underground sessions. Susan Ousterman’s son Tyler died of an overdose in 2020 after he could not get ibogaine in the United States. She now argues for legal access and still flags the next wall: even if the law changes, most people with addiction cannot pay.

Those two stories do not need a committee vote to stay true. People with cash and a passport already buy the treatment the bill would legalize at home. People without either still wait on a doctor who is afraid to talk, a sponsor who is afraid to ship, and a clinic that does not exist in the VA system.

Who Would Be Allowed to Administer the Drugs?

The bill would have the attorney general register physicians to give Schedule I experimental drugs to Right to Try patients in a clinical setting. It would not recertify psychiatrists, fund training, or require FDA or HHS to teach the work. Universities already run psychedelic courses. The agencies that would police a new registration have not joined them.

Melissa Lavasani, founder of the Psychedelic Medicine Coalition, has asked the question the statute leaves on the table: “How are physicians being educated and supported? At this point, there has very little public-facing medical education.” Columbia, UCLA, NYU, Yale, and Johns Hopkins have started programs. Lavasani notes that neither FDA nor HHS has taken part in those efforts.

She has also flagged a research conflict the bill does not resolve. Many psychedelic trials exclude people at high risk of suicide. An expanded-access law aimed at life-threatening mental illness would, if it ever ran, put some of those same patients in front of doctors who have never given the drug outside a protocol.

Regardless of the outcome of any individual application, the questions now facing the field are the ones MAPS was built to answer: how therapists are trained, how patient safety and outcomes are maximized, and whether the people most affected by trauma can access the treatments research has made possible.

Ismail Ali, J.D., Co-Executive Director, Multidisciplinary Association for Psychedelic Studies, August 10, 2026 statement

MAPS, founded in 1986 after MDMA was criminalized in 1985, says donors have given more than $150 million to its research and policy work. In July 2026, FDA issued final guidance on psychedelic clinical trials, covering design, safety, therapist-delivered care, and long-term follow-up. That document is about studies, not about a neighborhood psychiatrist with a new DEA number.

Drugmakers Still Control the Bottles

Brett Waters, executive director of Reason for Hope, has said companies developing psychedelics often resist compassionate use because a bad event in an unblinded patient could damage an FDA file. Right to Try cannot conscript them. The Freedom to Heal Act would not either. It would only make it legal for a willing doctor to handle a willing sponsor’s Schedule I stock.

The sponsor file that has defined this fight is already back at FDA. On August 9, 2024, the agency issued a complete response letter on MDMA-assisted therapy for PTSD, then sponsored by Lykos Therapeutics, and asked for more work on durability, safety characterization, and bias. On August 10, 2026, MAPS said Resilient Pharmaceuticals, the company formerly known as Lykos and as the MAPS Public Benefit Corporation, had resubmitted the application. Rick Doblin, MAPS’s founder, said the new file went in without a new Phase 3 study. MDMA is not approved. Psilocybin is not approved. Ibogaine is not approved.

So the legal picture in late 2026 is a stack of incomplete keys. The 2018 law exists and, through 2025, accounts for 27 reported drugs and no published patient census. The December 2025 bill would add the DEA registration the coalition says is missing, and it has not left committee. The April 2026 order tells FDA and DEA to build a path under the law they already have. Luttrell’s June bill copies the registration clause into an ibogaine package. None of those papers force a manufacturer to fill a vial, train a VA psychiatrist, or price a session for the families Ousterman is trying to represent.

Booker’s April 21 request for a vote still has no matching markup on the public docket. Hess’s doctors can keep believing in private. The people who can already afford a plane ticket do not need S. 3346 to find the medicine, and the people who cannot still need a bottle, a room, and someone allowed to stay in it.

Disclaimer: This article is news reporting on proposed federal legislation, agency data, and public statements. It is informational only and is not medical, legal, or treatment advice, and it is not a recommendation to seek or provide unapproved Schedule I drugs. Readers considering experimental care, Right to Try requests, or clinical-trial enrollment should consult a qualified physician and, for legal eligibility, a lawyer who knows FDA and DEA rules. Drug-approval status, bill language, and agency programs can change after the documents cited here were issued.