ARTICLE | Politics, Policy & Law

The Promising Pathway Act is a cry for help

Congress is considering new evidentiary standards for life-threatening diseases, raising hopes and fears

November 2, 2023 4:48 PM UTC

Patients, biotechs, lawmakers and regulators agree that the pace of drug development for serious rare diseases is too slow, but there is disagreement over the best ways to increase the speed and volume of biomedical innovation.

A set of patient advocates and companies have convinced members of Congress that FDA’s approval standards are the rate-limiting factor, and that lowering barriers to approval will unleash life-saving innovation. Other patient groups, drug companies and FDA believe that maintaining current standards is essential for protecting patients from harm and for preventing the path to approval from becoming encumbered by ineffective drugs. ...