ARTICLE | Politics & Policy

Academics' open letter opposes right-to-try bill

February 6, 2018 12:27 AM UTC

In an open letter to members of the U.S. House Energy and Commerce Committee, 336 academics called on the committee on Monday not to pass right-to-try legislation that would remove FDA from the initial authorization process for accessing unapproved therapies outside of a clinical trial. The letter was addressed to committee Chairman Rep. Greg Walden (R-Ore.) and committee ranking member Rep. Frank Pallone (D-N.J.).

In August, the Senate passed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017 (S. 204), which seeks to prohibit FDA from using safety or efficacy data associated with the use of an investigational drug administered outside of a clinical trial to “delay or adversely affect the review or approval of the drug.” Companion legislation, the Right to Try Act of 2017 (H.R. 878), is under review in the House...