On Aug. 3, the United States Senate approved a "right-to-try" (RTT) bill by unanimous consent, a process by which the Senate suspends its traditional rules so that legislation with broad support can pass without each Senator voting individually. The bill would authorize the use of unapproved drug therapies by terminally ill patients, who have exhausted other treatment options and are unable to participate in ongoing clinical trials, as long as the drugs have been tested in Phase I clinical trials and are continuing in further Food and Drug Administration (FDA) research. A physician must certify that the patient is not eligible for a clinical trial with the drug, but there no requirements for physician participation.
The legislation includes provisions that would require FDA to receive safety reports on events that occur in right-to-try situations and forbid drug manufacturers from charging patients more than the cost to produce the medicines. The bill would also require manufacturers to submit reports on patient use, allow FDA to use outcomes data in certain instances, and require written informed consent—though that consent does not have to be approved by an institutional review board. It also includes a provision that would protect prescribers from liability expect in cases of willful misconduct or gross negligence.
The House of Representatives is in August recess, but may take up the bill in September.
Earlier this year, ASCO issued a position statement on access to investigational drugs. The society supports FDA’s expanded access program, but ASCO does not support right-to-try legislation. As currently envisioned and enacted, these laws will interfere with already-streamlined and effective protocols, potentially putting patients at high risk for unclear benefit.
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