When Dr. Heidi Overton appears before the Senate health committee for her confirmation hearing to become FDA commissioner, senators should ask her a simple question: What should the FDA do when its own regulatory system leaves seriously ill patients with no safe way to obtain a medicine the agency already allows them to use?
Consider domperidone.
The drug treats nausea and impaired stomach motility. Canada, Britain and much of Europe approve it. The United States does not. Yet the FDA itself recognizes that some patients with severe gastrointestinal motility disorders who have failed standard therapies may benefit enough from domperidone to justify its risks. That is why the agency has permitted its use through expanded access.
Here comes the Catch-22.
The supplier serving that program stopped distributing domperidone after September 2025. Physicians can identify another supplier and submit a new expanded-access application. In other words, the regulatory door remains technically open, but patients and physicians must first find the medicine on the other side of it.
Meanwhile, beginning Oct. 22, changes in customs procedures for international mail subject to FDA requirements could make the informal alternative—patients obtaining domperidone from foreign pharmacies—more difficult. These are separate bureaucratic events. For patients, they converge into one very real problem.
Gastroparesis isn't an upset stomach. Patients can suffer relentless nausea and vomiting, lose weight, become dehydrated, require hospitalization and, in severe cases, depend on feeding tubes. Metoclopramide, the only FDA-approved drug specifically for gastroparesis, carries a boxed warning for a potentially irreversible movement disorder, and its label warns against treatment for longer than 12 weeks except in rare cases.
For patients who finally respond to domperidone after other therapies fail, losing access can mean losing the ability to eat and function. None of this means domperidone is risk-free. It isn't. The FDA's cardiac concerns are legitimate. Domperidone can prolong the QT interval and potentially trigger dangerous arrhythmias. Risk can increase with dose, age, electrolyte abnormalities and interacting medicines. But QT prolongation isn't a regulatory scarlet letter.
Azithromycin, ondansetron, citalopram, fluconazole and amiodarone are among the many medicines associated with QT prolongation. Their existence on the American market doesn't prove domperidone is safe. It proves something more important: risk must be weighed against benefit, not treated as the end of the conversation.
Can patients be screened for interacting medicines? Yes. Can electrolytes be checked? Yes. Can doses be controlled? Yes. Can ECGs be performed before and during treatment? Yes. Now consider the alternative: an unverified foreign website.
Forcing medicine outside supervised medical care doesn't eliminate risk. It eliminates many of the tools used to manage it—quality control, ECG monitoring, interaction screening and adverse-event reporting.
That isn't patient safety. It's risk avoidance masquerading as risk management.
Nobody is asking FDA to approve domperidone by administrative fiat. Approval requires a sponsor, a reliable manufacturer and evidence that benefits outweigh risks. Those standards shouldn't change. But patients shouldn't be abandoned while everyone waits for the perfect regulatory solution.
There is a practical bridge. FDA and Customs and Border Protection should provide clear, time-limited transition guidance for existing patients. FDA should help academic medical centers identify a good-manufacturing-practice supplier and establish a centralized, multi-patient expanded-access protocol, including ECGs, electrolyte and drug-interaction screening, dose controls and systematic adverse-event monitoring. And put every patient in a registry. Track symptoms, nutritional status, dose, duration, response and adverse events. Who benefits? At what dose? For how long? And at what risk? Turn access into evidence.
At the same time, FDA should encourage a qualified manufacturer to pursue approval of a quality-assured formulation. Expanded access should be a bridge, not a permanent substitute for drug development.
The larger issue Dr. Overton inherits, if confirmed, goes well beyond domperidone. FDA isn't in the zero-risk business. Almost every useful medicine carries risk. The agency's job is to understand it, put it in context and, when possible, manage it. Identifying risk is pharmacology. Managing it is regulation.
And the alternative to treatment isn't always perfect health. Sometimes it's malnutrition, hospitalization, feeding tubes and progressive disability. Counting the risks of treatment while discounting the risks of withholding it isn't benefit-risk analysis. It's bookkeeping with half the ledger missing.
Senators shouldn't ask Dr. Overton whether domperidone is a “good drug.” Commissioners shouldn't practice medicine by congressional testimony. They should ask whether an FDA under her leadership will solve regulatory problems rather than simply describe them.
Patients shouldn't have to choose between an unverified foreign website and no medicine at all.
A loading dock is no place to practice medicine.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest. Dr. Robert Goldberg is Vice President of Research Programs at the Center for Medicine in the Public Interest.
