House Fails to Pass ‘Right-to-Try’ Bill
Posted 14 March 2018 | By Zachary Brennan, Regulatory Focus
House Democrats and two Republicans came together to defeat the Right-to-Try bill, dealing a blow to a bill supported by President Donald Trump, Vice President Mike Pence and House Speaker Paul Ryan.
The bill would have created an alternative pathway whereby patients with terminal illnesses could ask biopharma companies to access experimental treatments that have progressed past Phase I of the trial process.
Critics from academia and the pharmaceutical industry criticized the bill for trying to cut the US Food and Drug Administration (FDA) out of the process of overseeing terminally ill patients’ access to experimental treatments, which occurs under the agency’s expanded access program.
Rep. Frank Pallone (D-NJ) said in a statement after the vote: “By defeating this bill tonight, we protected patients and supported FDA’s continued role in approving experimental treatments that may help save a patient’s life. This bill should have never been on the House Floor in the first place since it was only introduced today and has never been reviewed or discussed by our Committee.”
James Nolan, CEO of InClinica, a contract research organization, also explained to Focus how the bill, had it been enacted, would have put smaller biopharma companies in a bind, particularly as many seek funding after Phase I trials and do not have the manpower to orchestrate requests for their experimental drugs outside of the trials being run.
Reporting requirements in the bill for companies would also have put pressure on companies to justify why certain patients were provided with experimental drugs while others might not have been, Nolan said.
“The issue is that this early in the process, [companies] could get bad information that’s not reliable bad information,” Nolan said.
The final vote was 259 yeas, 140 nays, which did not meet the two-thirds threshold to pass the bill. Reps. Patrick Meehan (R-PA) and Erik Paulsen (R-MN) were the two Republicans to vote against it.
House Majority Leader Kevin McCarthy (R-CA) said in a statement, “The House will not let this be the end.”