Medicine

House vote nears on GOP bill easing use of unproven drugs

House vote nears on GOP bill easing use of unproven drugs

Senate Bill 135 received unanimous approval by the House on Monday and is headed to Gov. Tom Wolf for his signature. As the Senate has already passed a similar bill, proponents of right-to-try could push legislation through under rules that would only require them to get a majority.

Sen. Mario Scavello (R-Monroe/Northampton) said his proposal would greatly decrease the chances of leaving deceased animals unrecovered.

Critics of the bill say that it casts the FDA as a roadblock to people getting treatment with unapproved medicines.

The House of Representatives has rejected a bill that would have cut the FDA out of the process for clearing terminally ill patients to access experimental medicine.

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.

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.

"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 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.

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

The Pennsylvania legislature has given final approval to a bill that would allow hunters to use leashed dogs to track big game that has been legally harvested or wounded.

Under the new bill, the FDA would be notified if a patient tries a new treatment, and it would collect data on poor outcomes. The House bill, taking a step in that direction, says patients would be eligible if they are likely to die in a "matter of months" or have a disease that would result in "significant irreversible morbidity that is likely to lead to severely premature death".

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. Manufacturers would still not be required to provide their pharmaceuticals.

Dozens of patient-advocacy groups opposed the bill in a letter to House Speaker Paul D. Ryan and Minority Leader Nancy Pelosi this week.