The House March 21 passed the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act (H.R. 5247), on a largely party-line vote of 267-149. This was the second time the legislation had been brought to the floor for a vote, after House Republicans last week failed to garner the necessary two-thirds majority to advance the bill under suspension of the rules [see Washington Highlights, Mar. 16].
The legislation, authored by Rep. Brian Fitzpatrick (R-Pa.), would create a secondary pathway for accessing investigational therapies outside of clinical trials which would remove Food and Drug Administration (FDA) approval and consultation.
The bill now moves to the Senate, which passed a version of the bill (S.204) in August 2017 authored by Sen. Ron Johnson (R-Wisc.), who threatened to hold up a reauthorization of FDA user fee programs until the Senate voted on his legislation. Sen. Johnson March 23 sought unanimous consent to adopt the House bill shortly after the Senate voted on the fiscal year 2018 omnibus (see related story), but at least one senator objected to approving the bill under the expedited procedure.
The AAMC has joined 85 organizations in a community letter in opposing the legislation, stating that it does not address the primary barriers for access to therapies and removes important safety measures available under the FDA’s current expanded access program.