Rep. Brian Fitzpatrick
The U.S. House of Representatives next week will vote on a version of a bipartisan bill U.S. Rep. Brian Fitzpatrick (R-PA) is helping push forward that would improve access to experimental treatments for patients with terminal diseases or conditions, according to a statement released by the congressman’s office.
“Every day millions of Americans and their families face the devastating reality of a terminal diagnosis. I am appreciative of House leadership’s commitment to have a vote on Right to Try. Patients with terminal illness have already waited too long,” Rep. Fitzpatrick said on May 17 following an early morning meeting with House leadership.
The House and U.S. Senate are trying to reconcile each chamber’s version of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, also known as the Right to Try Act.
The Right to Try Act of 2017, S. 204, specifically would permit certain unapproved, investigational drugs to be given to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs, according to the congressional record summary. S. 204 already has been approved in the U.S. Senate.
The Right to Try Act of 2018, H.R. 5247, which Rep. Fitzpatrick introduced on March 13, received House approval on March 21. Now both versions must be reconciled into one bill that can be presented to the president for his signature making it law.
“My constituent, Matt Bellina, and the thousands of Americans like him are running out of time,” said Rep. Fitzpatrick, co-chair of the ALS Caucus, referring to one of the faces of the Right to Try bill, a Pennsylvania resident, former U.S. Navy pilot and father of three who has ALS.
The proposed legislation also would require the manufacturer or sponsor of an eligible investigational drug to report annually to the Food and Drug Administration (FDA) on any use of the drug in accordance with the bill’s provisions, according to the summary, and the FDA would be required to post an annual summary report of such use on its website.
Additionally, the measure would limit the liability of a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill, the congressional record summary states.
Rep. Fitzpatrick had released a statement on May 16 demanding that S.204 be brought to the House floor for immediate consideration prior to his planned meeting with House leadership to appeal for action on the proposal. “Even with the amazing achievements in American medical research and development, access to potentially lifesaving treatment will come too late, or not at all,” he said.
The Right to Try Act, the congressman added, would give patients the freedom to try therapies “in situations where the benefits far outweigh the risks.”
Rep. Fitzpatrick noted that both chambers of Congress have demonstrated that the Right to Try Act can pass with bipartisan support and he urged the House “to immediately consider and vote” on the Senate measure.
“It’s time to send this bill to the President’s desk,” he said.