BioCentury
ARTICLE | Politics & Policy

House to vote on Senate's right-to-try bill

May 17, 2018 11:22 PM UTC

House Majority Leader Kevin McCarthy (R-Calif.) said the House of Representatives will vote next week on a right-to-try bill (S. 204) passed by the Senate last August that seeks to authorize using investigational treatments for terminally ill patients.

S. 204 is intended to prevent FDA from overriding state right-to-try laws by providing an alternative pathway alongside existing FDA expanded access polices. Unlike state RTT laws, S. 204 would bar FDA from considering adverse safety or efficacy information outcomes revealed from RTT use to “delay or otherwise adversely impact review or approval” of that product. The bill would not compel companies to provide patients with access to eligible RTT products, but does require companies that choose to participate to report annual summaries on their use and any adverse events for publication by FDA...