House Sends Right-to-Try Bill to Senate After 267-149 Vote

The House of Representatives Wednesday night passed the right-to-try bill by a vote of 267-149, sending it to the Senate. HR 5247, "Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018," was passed largely along party lines.

“With the House’s passage, we’re one step closer in delivering for patients with no other treatment options who are desperately seeking the right to try investigational treatments and therapies,” said Energy and Commerce Committee Chairman Greg Walden, R-Oregon, and Health Subcommittee Chairman Michael C. Burgess, MD, R-Texas, in a statement after the vote.

Supporters of the bill will say it will create an alternative pathway for patients who do not qualify for a clinical trial. They also point to improvements made to protect patients since the bill was first introduced last year.

The bill failed its first House vote March 13, but Republicans had vowed to bring it back to the floor for a vote under different rules.

During the floor debate on the bill, Representative Frank Pallone, D-New Jersey, the ranking member of Energy and Commerce, noted the continued opposition to the bill by major patient advocacy organizations.

He also noted opposition to the bill from 4 former FDA commissioners: Robert Califf, MD, and Margaret Hamburg, MD, who were commissioners during the Obama administration, and Mark McClellan, MD, PhD, and Andrew von Eschenbach, MD, who served under President George W. Bush.

Opponents of the bill are concerned that it removes the FDA from the process, and that it jeopardizes the safety of vulnerable patients.

Earlier this month, The American Journal of Managed Care^® (AJMC^®) spoke with Marjorie A. Speers, PhD, executive director of the WCG Foundation, a public charity that works to ensure experimental medicines to very ill patients under the FDA's current expanded access and compassionate use programs. Speers has previously participated on a panel on this subject at AJMC^®'s Patient-Centered Oncology Care^® meeting in Philadelphia, Pennsylvania.

Speers told AJMC^® she did not think the bill added much beyond the FDA's current expanded access program.