The House of Representatives has passed a “right to try” bill, after a previous failure earlier in the month. The bill now heads to the Senate, which passed its own “right to try” bill last year. The push for federal “right to try” legislation points to a larger trend towards more treatment choices for patients with serious conditions.
“Right to try” legislation allows terminally ill patients to have access to experimental medication as a form of treatment. Under the FDA’s expanded access program, patients with serious conditions can already access experimental drug treatments. With “right to try”, however, the experimental treatment needs to have passed Phase 1 FDA trials only, which is the earliest testing stage. It does not require final FDA approval. Under “right to try,” patients can choose treatments that otherwise would not be available. However, since experimental treatments are still in the early testing stages, it is risky for patients. On the other hand, if all goes well, patients can live longer. This has vital implications for patients who have exhausted all available treatment options.
The “right to try” movement started in 2014, when the Goldwater Institute drafted a policy for which state legislation would be based on. That year, Colorado became the first state to pass “right to try”. Since the passage of “right to try” in Texas in 2015, the Institute has put forward several real-life testimonies of patients who have benefited from the new law.
From a physician’s perspective, Dr. Ebrahim Delpassand’s story has been instructive. Dr. Delpassand is a nuclear medicine physician in Texas, who since the passage of the state’s “right to try” bill, has successfully treated, with experimental medication, more than 100 patients (as of 2017) that were terminally-diagnosed with neuroendocrine cancer.
Mark Angelo suffers from pancreatic neuroendocrine cancer. Mark would travel to Switzerland every three months to receive an investigational therapy, which the FDA had not approved for the United States. When this treatment became available in Texas under “right to try”, Mark was able to continue his treatment in Houston. Since December 2016, Mark’s condition has improved enough for him to only be required a six-month rather than a three-month follow-up to his treatment.
Last year, Pennsylvania became the 38th state to pass right to try legislation and the 6th state to do so in 2017. Last month, the Wisconsin state assembly passed a “right to try” bill that when signed by Governor Walker, will make Wisconsin the 39th state to pass such legislation. Legislation is also under consideration in Nebraska, Alaska, and Rhode Island.
Since states are passing their own laws, why the need for federal legislation? The main concern is that there aren’t enough drug manufacturers participating in “right to try” or expanded access programs. Under the FDA’s expanded access program, there is no clear guidance as to what happens with an experimental drug when an adverse event is reported. Specifically, what happens with the experimental drug if something bad happens to a patient after being treated with it and it is subsequently reported? Will the FDA require the manufacturer to stop the clinical trial of the drug in question or deny the drug’s approval because of the adverse event?
Advocates of “right to try” claim that this ambiguity is keeping drug manufacturers from participating in experimental drug treatment programs, which prevents patients from accessing potentially life-saving treatments. The House version prevents experimental drug treatments from being delayed or withdrawn from the FDA approval process, unless it is determined that the clinical outcome points to a safety concern in the drug.
Terminal illness raises the stakes when considering the speedy approval of a drug but the merits of doing so remain the same. “Right to try” expands the number of options available to terminally ill patients. The House and Senate must now reconcile their versions of “right to try” before it heads to the President’s desk for a signature. If the bill is passed and signed into law, it would be the pinnacle of the “right to try” movement.
Isai Chavez is a contributor to Economics 21.
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