Democrats Refuse To Pass Bill Designed To Help Terminally-Ill Patients

The House failed to pass a bill Tuesday backed by President Donald Trump that would give terminally ill patients the right to seek drugs that remain in a clinical trial phase and are not yet fully approved by the Food and Drug Administration

The legislation failed on a vote of 259 to 140.

The Senate approved a similar bill last summer.

Democrats say the measure would achieve little since the federal Food and Drug Administration already approves almost all requests it receives for an existing program that lets patients use unproven treatments.

The measure strikes a balance between safety and providing "hopeful news for patients desperately seeking the right way to try" experimental treatments, said Energy and Commerce Chairman Greg Walden of OR and Michael Burgess of Texas, another top panel Republican. Vice President Mike Pence also signed a "right to try" law when he was governor of Indiana.

Energy and Commerce Committee ranking member Frank Pallone Jr., D-N.J., announced his opposition to the House bill Monday, saying it gives patients "false hope" and puts them at risk by removing the FDA from overseeing use of experimental treatments.

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.

The Institute blamed the legislation's failure on "scare tactics, falsehoods and innuendo".

A recent study by the Government Accountability Office, Congress' investigative agency, found the FDA now approves 99 percent of such requests, often within hours.

"Rather than rush to pass a bill that was hastily unveiled over the weekend without careful consideration or bipartisan consensus, we should work together to find a sensible path forward that protects patients and upholds FDA's approval process while ensuring patients, with no other recourse, have access to investigational therapies", he said. But drug companies often balk at providing experimental drugs outside of clinical trials.

"This is a right-to-ask bill, not a right-to-try bill", said Holly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania's Perelman School of Medicine.

The House bill does include some changes from the Senate legislation that are created to assuage concerns raised by critics and by FDA Commissioner Scott Gottlieb.

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.

The House Energy and Commerce Committee also last week defined eligible patients as those with "a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death".

The House bill broadens liability protections to manufacturers and others who are taking part either in the right-to-try pathway or in the expanded-access program. "We applaud the House members who voted against the seriously flawed False Hope legislation, which would have created a risky, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective", said Michael Carome, director of Public Citizen's Health Research Group, said in a statement.

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