Last night, the House of Representatives passed a federal “right-to-try” bill, after a failed attempt last week. The bill, which has been backed by Goldwater Institute research, would allow terminal patients to try out drugs that are not fully approved, but have passed phase one of the FDA’s approval process and been deemed safe enough to enter patient trials. Thirty-eight states, including nine of the ten most populous, already have right-to-try laws on the books, and the passage of federal legislation would expand it to the remaining states.
A similar FDA “Expanded Access” program exists, to allow terminally ill patients access to investigational medicine, and emergency requests for them are almost always accepted. However, this bill would address the extreme cases — that is to say, the option to take drugs that have not yet reached that stage for patients who have no other option. The point of the program is to provide hope, even if it is a long shot, for patients on whom other treatments have not worked. Patients who qualify for clinical trials will lose access to those drugs once the trial is over — even if the treatment worked on them.
Critics such as Steven Joffe of UPenn’s medical school have suggested that the lack of FDA permission means that patients would be moving blindly and rushing to fly-by-night clinics, but “right-to-try” is already the law in the vast majority of the country and this does not seem to have happened. Taking drugs that are early in their approval process is not a best-case scenario . . . but neither is terminal illness. It is worth letting patients and their doctors make a decision that, even if it’s a long shot, offers the chance for recovery.