Despite the hubbub over the “right-to-try” law, a recent survey found that nearly half of drug makers indicated they would require regulators to review a decision to provide an experimental treatment to a person with a life-threatening disease.
Specifically, 13 of 29 drug companies indicated they want a relevant regulatory authority to review requests that are granted to such people. Of these, six specified they would ask the Food and Drug Administration to conduct a review and five stated they require a research ethics committee or institutional review board, according to a report from the Government Accountability Office.
The results show many drug makers still prefer to follow the mandate in the FDA expanded access program, which was created to provide a route for people with serious or life-threatening illnesses to request experimental treatments from the pharmaceutical industry. The program requires a physician to submit a request to a drug company, and for the FDA to sign off on providing a medicine.
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