A leading House Democrat announced his opposition Monday to a Republican bill making it easier for some terminally ill patients to try experimental drugs, clouding the measure's fate.
Continue Reading Below
Republicans are hoping for House approval Tuesday, seven months after a similar package cleared the Senate. The "Right to Try" bill gained added momentum after President Donald Trump called for its passage in January's State of the Union address.
Under the bill, if a doctor and drug maker agree to let a patient with life-threatening ailments try an experimental treatment, the federal Food and Drug Administration would no longer need to consent. The FDA would have to be notified of the decision and of any problems that occur.
New Jersey Rep. Frank Pallone, top Democrat on the House Energy and Commerce Committee, said the measure is risky, unneeded and "provides false hope to patients."
He also noted that the bill doesn't require drug makers to provide these treatments to patients, which is often where stumbling blocks can occur. Companies sometimes prefer using what they've produced for clinical trials needed for final FDA approval, or worry that a problem could hurt the drug's marketing prospects.
A recent study by the Government Accountability Office, Congress' investigative agency, found the FDA currently approves 99 percent of such requests, often within hours.
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 Oregon and Michael Burgess of Texas, another top panel Republican.
Pallone's stance is important because GOP leaders want to rush the legislation through the House using a process, normally reserved for uncontroversial measures, that could require a two-thirds majority. If all Republicans vote yes, they'd need the backing of at least 50 Democrats.
House Minority Leader Nancy Pelosi, D-Calif., hadn't taken a public position on the bill by late Monday afternoon. Republicans released the latest version of their proposal Saturday.
More than 40 patients' groups have expressed opposition to the measure, saying it would "likely do more harm than good." PhRMA, the trade group representing major drug companies, has taken no public stance.