House passes 'Right to Try' bill for dying patients

The House passed a bill Tuesday that lets dying patients try medicines that haven’t won full regulatory approval, handing President Trump the bipartisan win he had demanded during his State of the Union speech this year.

Backers said the legislation could give hope to people in desperate situations, offering them the chance to try experimental treatments as long as they accept the risks.

“There’s no downside to this,” said Rep. Joe Barton, Texas Republican.

The bill passed 250-169, with about two dozen Democrats joining the GOP, and heads straight to Mr. Trump, after clearing the Senate last year.

Opponents said terminally ill patients may not be prepared for the implications of trying experimental therapies, including possibly dying earlier or more painfully.

The FDA already has an “expanded-access” program for terminally ill patients that approves nearly all requests, so cutting the agency out of the process would only invite trouble, they said.

“FDA oversight of access to experimental treatments exists for a reason — it protects patients from potential snake oil salesmen or from experimental treatments that might do more harm than good,” said Rep. Frank Pallone, New Jersey Democrat. “By removing FDA oversight, you are counting on physicians and manufacturers to serve as the gatekeeper and protector of patients. I simply don’t buy that that’s going to work.”

The bill took a circuitous path to Mr. Trump’s desk. The Senate passed the bill last year under unanimous consent, meaning no senator objected to the measure.

In March, House GOP leaders tried to pass an amended version of the Senate bill under a procedural process that requires two-thirds support. It fell short of that threshold, but the bill passed under normal procedures later on. Yet Senate Democrats indicated they would block the House bill if it came to their side of the Capitol.

Rep. Michael Burgess, Texas Republican, said he was “perplexed” by that decision, since the House bill was more narrowly written than the Senate bill that breezed through.

House GOP leaders decided the path of least resistance would be to bring up the Senate version that already passed, so Mr. Trump can get something now.

Sen. Joe Donnelly, an Indiana Democrat facing a tough re-election battle, trumpeted his role in authoring the bill. “I look forward to President Trump signing it into law as soon as possible,” he said.

Under the bill, the FDA would be notified if a patient tries a new treatment, and it would collect data on poor outcomes. But the agency would no longer have a supervisory role over people who use the bill’s “alternative pathway” to obtaining the treatments through their doctors and drug companies.

The bill doesn’t force companies to provide the treatments to those who request them, however.

Dozens of patient-advocacy groups opposed the bill. They said a bigger problem, which the bill doesn’t tackle, is pharmaceutical companies denying requests for access to drugs outside of their normal clinical trials.