Fate Hazy for GOP Bill Helping Dying Patients Try New Drugs

Adjust Comment Print

While the bill's proponents insist patients who are already terminally ill have nothing to lose by trying experimental drugs, Democrats who voted against the bill were reluctant to undermine the FDA's role in approving such drugs.

Among Republicans, 227 voted for the measure, two against; among Democrats, it was 32-138.

"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", Pallone said in a statement, the Hill reported.

"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.

On Tuesday, House Democrats blocked a Republican bill that would have allowed people to access experimental drugs without going through the FDA.

"And by pushing legislation that targets the FDA, those who advocate for right-to-try are not putting forth viable solutions to these problems", House added.

"The last thing I want to do is give patients false hope and to put them at risk" by reducing the FDA's powers, said Rep.

Under the new bill, the FDA would be notified if a patient tries a new treatment, and it would collect data on poor outcomes.

Scott Gottlieb, FDA commissioner and a Trump appointee, told Congress in October that 70 percent of the experimental drugs his agency now lets seriously ill patients use are never approved.

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 bill, which was released Saturday by House Energy and Commerce Committee Chairman Greg Walden, R-Ore., and Health Subcommittee Chairman Michael C. Burgess, R-Texas, is similar to legislation passed by the Senate in August.

Alison Bateman House, a bioethicist at New York University, told Politicothat the "right-to-try approach blames an innocent entity for access problems".

More than 75 patient groups, including the American Cancer Society Cancer Action Network and the National Organization for Rare Disorders, opposed the measure in a letter to Congress. They say the more common hurdle is manufacturers, which often prefer to use their limited quantities of early-stage drugs for clinical trials needed to gain final FDA approval for wide-spread sales or worry that a setback could damage the product's marketability.