Right to Know: Why the FDA Should Not Be Cut Out of Expanded Access Requests

By CHAPMAN, KLEIN and McFADYEN Over the past three years, the libertarian Goldwater Institute–led right to try (RTT) movement has had wind in its sails, propelling the passage of RTT laws in 38 states and counting. The movement, which aims to cut the FDA out of the process by which patients with serious or immediately life-threatening diseases without available therapies access investigational drugs and biologics, hit some choppier waters at the hearing held October 3rd by the Health Subcommittee of the House Energy & Commerce Committee. The House is considering passage of a federal RTT bill, and two potential options were presented at the hearing. S. 204, sponsored by Sen. Ron Johnson (R-Wis.), was passed by unanimous consent in the Senate on August 3. Another RTT bill, H.R. 1020, introduced by Representatives Morgan Griffith (R-Va.) and Dave Brat (R-Va.) in February, was also under consideration. Rep. Andy Biggs (R-Arizona), who in February introduced a third version of a federal RTT bill, H.R. 878, testified at the hearing. Senators Joe Donnelly (D-Ill.) and Johnson have urged the House to pass S.204 “as soon as possible” and “without amendment.” Making any changes to S.204 would require reconsideration of the new version by the Senate. Notably, FDA Commissioner Scott Gottlieb, appointed by President Trump, did recommend revisions to S.204. In his testimony to the committee, Dr. Gottlieb expressed concerns about the definition of “eligible patient” in S....
Source: The Health Care Blog - Category: Consumer Health News Authors: Tags: Uncategorized Source Type: blogs