BY DANIEL GAITAN | firstname.lastname@example.org
The House of Representatives passed a controversial bill to allow terminally ill patients to experiment with drugs not approved by the Food and Drug Administration.
The bill passed 267 to 149, with support from 35 Democrats and opposition from two Republicans. The so-called “Right to Try” bill now heads to the Senate, which passed a similar bill last year.
President Donald Trump has signaled he plans to sign the legislation when it reaches his desk.
Drug companies already allow some patients access to new drugs outside of clinical trials under a program known as compassionate use – as long as the FDA approves such requests.
Although the FDA approves the vast majority of compassionate use requests, sometimes companies refuse, fearing that negative results could be used against them by the government or patients injured by their products.
Supporters of “Right to Try” maintain it would make it far easier for seriously and terminally ill patients to access experimental treatments. These vulnerable patients are often unable to participate in clinical trials and have little chance of being cured.
Opponents are deeply concerned it would deter patients from seeking hospice care and give them false hope.
The bill’s passage came just days after four former FDA commissioners expressed deep concerns about such legislation.
Former Barack Obama FDA commissioners Robert Califf and Margaret Hamburg, and former George W. Bushcommissioners Mark McClellan and Andrew von Eschenbach said the bills would “erode protections” for the most vulnerable
“There is no evidence that either bill would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent that would erode protections for vulnerable patients,” the commissioners said in a joint statement to The Washington Post.