Right-To-Try Legislation Must Change Language To Narrow Spectrum Of Patients, Gottlieb Says

US FDA commissioner tells House hearing that the Senate's legislation in its current form could undermine the intent of addressing terminally ill patients.

Capitol House

The Senate's right-to-try legislation should be narrowed to specify patients who are "terminally ill" as a criterion for experimental drug eligibility from its current language of "a life-threatening disease or condition," US FDA Commissioner Scott Gottlieb urges lawmakers.

Testifying before the House Energy and Commerce Subcommittee on Health Oct. 3, Gottlieb cautioned that Sen. Ron Johnson's (R-Wisc.) right-to-try...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA

More from Agency Leadership

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

Swissmedic Appoints Trivigno As New Agency Head From 2026

 

Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.