WASHINGTON — US Sen. Ron Johnson (R-WI) on Friday morning failed in a bid for quick action on a House-passed bill that he says would increase the access of terminally ill patients to experimental drugs.
Critics of the measure contend it would fall short of this aim and would also undermine federal regulators and hinder medical research.
Johnson took to the Senate floor after the chamber passed a massive spending package (HR 1625) shortly after midnight on Thursday. He asked for unanimous consent for the Senate to proceed to the immediate consideration of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 (HR 5247), which the House passed by a vote of 267 to 149 on March 21.
Senate Minority Leader Charles E. Schumer (D-NY) quickly rebuffed Johnson’s late-night bid, and assured his colleague that he intended to join him in efforts to help more people gain access to experimental therapies.
“We will work together to get something done and done quickly, because this is an important, important issue,” Schumer said on the Senate floor early Friday. “People that have terminal illnesses deserve every option and chance at survival.”
“The Right Thing to Do”
Schumer and Johnson differ, though, on the role of the US Food and Drug Administration (FDA) in these efforts.
Johnson said he is seeking to create a pathway to allow people who are dying or could face premature death to decide about taking unproven medicines rather than having a “faceless bureaucrat at the FDA make that decision.
“It makes so much sense to give those terminally ill patients the freedom to make these decisions themselves,” Johnson said.
He stressed that the experimental medicines in question would need to have cleared phase 1 testing, citing this as evidence of their safety and fitness for use without intense FDA monitoring. But critics of right-to-try measures note that phase 1 is an initial step largely meant to determine whether medicines are safe enough to advance in testing. Phase 1 studies are usually conducted in healthy volunteers, with medicines tested in about 20 to 80 people, according to the FDA’s website.
Thus, Schumer and many Democratic colleagues say they are intent on preserving the FDA’s role as a watchdog while working to encourage drugmakers to provide more people who are dying with access to experimental drugs outside of clinical trials. Rep. Frank Pallone Jr (D-NJ), for example, this week put forward a proposal intended to address concerns of drugmakers about allowing expanded use of unproven drugs. This proposal would build on the expanded access program that the FDA already has in place, Pallone said.
Johnson does have the ardent support of a Democratic colleague for his right-to-try legislation. Sen. Joe Donnelly (D-IN) was an original cosponsor of Johnson’s right-to-try bill (S 204), which the Senate passed last year by unanimous consent. Johnson on Friday reiterated his call that the House vote on that measure and clear it for President Donald J. Trump.
Joining Johnson in late-night Senate floor speeches, Donnelly said he’s “hopeful” that Congress will soon complete right-to-try legislation. “We will continue to work nonstop to get this done, because it’s the right thing to do,” Donnelly said.
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