Senate passes ‘right-to-try’ bill which critics call ‘deceptive’ to terminal patients

The U.S. Senate unanimously passed a bill on Aug. 3 which would allow terminally ill patients the “right to try” experimental treatments that haven’t yet been approved by the Food and Drug Administration (FDA), but critics say it gives patients false hope without allowing for federal oversight.

The idea isn’t a new one, as 37 states have passed similar laws. The legislation, sponsored by Sen. Ron Johnson, R-Wisconsin, was supported by Vice President Mike Pence as well as groups like the libertarian Goldwater Institute, which authored a letter to senators signed by 18 other organizations, including patient advocacy groups.

“Right to Try is only for patients whose doctors have determined are facing a life-threatening illness, who have exhausted all available treatments, and who cannot participate in a clinical trial,” they wrote. “This law is aimed at helping a narrow set of patients who have truly run out of options, but who might be helped by a treatment that is helping people in clinical trials.”

Patients with serious diseases, ranging from advanced cancer to muscular dystrophy, would be able to request access to unapproved treatments directly from pharmaceutical companies, outside of the FDA’s own compassionate use program. According to the advocacy groups, only treatments which completed the first phase of FDA trials and are still working towards full approval would be available. Changes from Johnson’s previous version of the bill would require drug companies to report adverse events to the FDA, though the agency wouldn’t be able to use that data alone to end a trial or deny approval of a treatment.

Pharmaceutical companies would not be required to make the treatments patients request available, however, leading critics of the proposals to label them “right-to-ask.” According to POLITICO, the Goldwater Institute offered only one example of a doctor utilizing a state right-to-try law on behalf of a patient, and the treatment they sought was already being made available through the FDA’s compassionate use program.

“This bill is inherently deceptive,” Alison Bateman-House, PhD, MPH, a professor of medical ethics at a New York University’s Langone Medcal Center, said to POLITICO. “What [patients] have a right to (and did long before this bill) is to ask drug companies for permission to use their experimental drugs outside of clinical trials. If the drug company says no, both before and after this legislation, that's the final word: neither the FDA nor the courts have to power to make companies provide access to their experimental drugs-in-development.”

All that changes in Johnson’s bill, Bateman-House said, is removing the oversight of a federal agency from the process. To Johnson, however, the bill offers an alternative, quicker pathway to treatments for terminally ill patients.

“These are real people facing their mortality with no hope,” he said to the New York Times.