House vote nears on GOP bill easing use of unproven drugs

Key Democrat comes out against 'right to try' bill

Dozens of patient groups urged the House to reject "right to try" legislation - scheduled for a vote Tuesday - created to allow seriously ill patients to largely bypass the Food and Drug Administration to get access to experimental treatments. Since the Senate approved similar legislation last August, Republicans could revisit the legislation under rules that would require only a simple majority for passage, perhaps after reworking the measure.

The FDA's compassionate use program already approves experimental drugs for very sick patients, with a 99 percent approval rate for requests that it gets each year, Politico reported. "The right-to-try approach blames an innocent entity for access problems, and by pushing legislation that targets the FDA, those who advocate for right-to-try are not putting forth viable solutions to these problems".

If passed, the bill would have enabled terminally ill patients to access unapproved drugs if a doctor and the manufacturer of the medicine agreed.

Republicans say the "Right to Try" legislation gives hope to patients with fatal diseases and erects safeguards to protect them.

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. They also said the proposal was risky because it rolls back FDA oversight in the process.

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"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.

The agency would have to be notified after treatment begins, manufacturers would have to report if problems arose and drug makers and doctors would be broadly shielded from legal liability. The right-to-try legislation does not compel pharmaceutical firms to provide sought-after therapies.

"The only way forward is to work with companies and to find out what would make them willing to provide their experimental products to patients who wish to try them", said New York University bioethicist Alison Bateman House in Politico's report.

House Minority Leader Nancy Pelosi, D-Calif, speaks at the U.S. Capitol in Washington, D.C. on January 18.

More than 70 patient and research groups sent a letter of opposition Monday to House leaders saying the bill "would not increase access to promising therapies" and "is still less safe" that the FDA's existing process.


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