Easier access to experimental trails promised
House lawmakers passed a “right-to-try” bill last week, clearing the path for President Donald J. Trump to sign it.
The bill is intended to make it easier for people with life-threatening conditions to access experimental treatments outside of clinical trials. Many advocacy groups argue the measure will erode needed protections and put patients at risk for harm from unproven and potentially unsafe therapies.
Passage of the bill is a victory for the Trump administration, as the president has been pressuring GOP lawmakers to send him a bill on the issue.
“FDA (U.S. Food and Drug Administration) is constantly striving to make improvements to its expanded access program. Some patients and their families, however, still have challenges accessing investigational treatments,” the White House had said in a Monday statement in support of the bill. The Trump administration “believes that treatment decisions for those facing terminal illnesses are best made by the patients with the support and guidance of their treating physicians.”
Critics have cited the bill as an attempt to undermine the authority of the FDA. The consumer watchdog group mentioned that four former FDA commissioners have asked lawmakers to drop their support of this bill.
SOURCE: Medscape