Even before the “right-to try” law passed, the FDA created an expanded access program to give patients with serious or life-threatening illnesses the chance to request experimental treatments from pharmaceutical companies, according to STAT. The program required a physician to submit a request to a drug company and then the FDA would sign off on giving the patient the medicine.
The “right to try” law, passed last year in response to complaints that the FDA program was overly complex, gives patients with life-threatening conditions the opportunity to access these experimental treatments without FDA authorization.
However, the study found that many drugmakers still seek FDA approval on these patient requests. In fact, out of the 29 drug companies surveyed in the GAO report, 13 said they will still ask a regulatory authority to review decisions to provide experimental treatments to patients. Six of those said they would ask the FDA specifically to conduct the review and five said they would require a research ethics committee or institutional review board to review the request.
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