- The Washington Times - Tuesday, March 13, 2018

Democrats blocked a bill Tuesday that would have let dying patients try medicines that haven’t won full regulatory approval, saying they worry about cutting the federal government out of oversight.

The “right-to-try” bill, which President Trump had called for in his State of the Union speech this year, had strong bipartisan support — but it still fell shy of the two-thirds majority needed to pass under the fast-track rules the GOP set for the bill.

Republican leaders decried Democrats’ roadblock and vowed to force another vote soon.

“The House will not let this be the end. We will try again, pass legislation, and bring hope to those whose only desire is the right to try to live,” said House Majority Leader Kevin McCarthy.

Still, the stumble was an embarrassment for GOP leaders who pushed the bill at the behest of Mr. Trump. A federal right-to-try bill is also a top priority for Vice President Mike Pence, who approved a state version while governor of Indiana.

Supporters say patients who’ve exhausted other treatment options or don’t qualify for clinical trials deserve the chance to obtain drugs that made it through first-phase safety testing at the Food and Drug Administration, without interference from the government.

“For too many families, access to these life-saving treatments will come too late or not at all,” said Rep. Brian Fitzpatrick, Pennsylvania Republican.

Dozens of states have passed their own measures on a bipartisan basis.

Key patient groups and senior Democrats pushed back, however, saying the FDA already has an “expanded-access” program for terminally ill patients that approves nearly all requests.

They said it was wrong to give patients a new workaround, saying they feared desperate families would falsely see new hope.

“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,” said Rep. Frank Pallone, New Jersey Democrat.

Under the new 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.

Holly Fernandez Lynch, a bioethics expert at the University of Pennsylvania, said the FDA acts as clearinghouse for useful information across companies, so cutting them out of the request process could be harmful.

“FDA provides helpful information about dosing, or safety monitoring, or something that should be disclosed,” she said.

The bill does, however, include a useful transparency measure, she said.

Companies would be required to post, online, how many treatment requests they get and whether patients fared poorly, so terminally ill patients should have a sense of whether it’s worth requesting a medicine from the supplier.

It’s slightly different than a version that passed the Senate under unanimous consent, meaning no senator objected to the measure. The House plan narrows the scope of eligible patients to those who are likely to die “within a matter of months” or have a disease that would lead to “significant irreversible morbidity that is likely to lead to severely premature death.”

The latest version beefs up consent requirements for patients and liability protections for doctors and manufacturers, after right-to-try advocates said too many companies were shying away from participation.

The Senate will have to take up and approve the amended House bill before it can reach Mr. Trump’s desk, though it’s unclear if and when it might get through the lower chamber.

Dozens of patient-advocacy groups opposed the bill in a letter to House Speaker Paul D. Ryan and Minority Leader Nancy Pelosi this week. They said the bigger problem, which the bill doesn’t tackle, is pharmaceutical companies shooting down requests for access to drugs outside of their normal clinical trials.


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