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Right to Try Versus Clinical Trials

A US senator has called for the addition of a "right-to-try" provision to the US Food and Drug Administration funding bill, but Kelly McBride Folkers, a medical ethicist at New York University School of Medicine, argues at Stat News that such legislation "threatens the integrity of clinical trials."

She notes that the FDA Reauthorization Act has to be passed by Congress to allow the agency to collect user fees from companies that submit products for review. These fees cover some 70 percent of the budget for the FDA Center for Drug Evaluation and Research. But, Senator Ron Johnson (R-Wisc.) says he'll hold the bill up unless it includes "right to try" language in it, according to the Washington Examiner. He argues that terminally ill patients should have wider access to experimental treatments.

Folkers says that "[d]espite its benevolent intention," the provision would harm clinical trials as patients would seek experimental treatments outside that framework and slow the regulatory approval process for drugs. She further adds that patients that don't qualify for trials can already seek access to experimental treatments through compassionate use clauses.

"We need the FDA to ensure the effectiveness and safety of new drugs, and right to try undermines this process," Folkers says. "And the agency certainly can't work effectively if it is cut out of the process altogether."