The House of Representatives failed to pass President Donald Trump's "right-to-try" bill March 13, which would allow terminally ill patients to seek drugs undergoing clinical trials and not yet fully approved by the Food and Drug Administration, according to The Washington Post.
Here are nine things to know.
1. The vote came after GOP lawmakers depicted the bill as severely ill patients' last chance at survival.
2. Democrats who opposed the bill said it would weaken FDA protections without addressing the obstacles to using drugs that have not received FDA approval. Republican backers brought up the measure under a suspension of the rules, which does not allow for amendments. Additionally, the measure needed approval from two-thirds of those present to pass.
3. The bill failed on a vote of 259 to 140.
4. The vote indicated the House "protected patients and supported the FDA's continued role in approving experimental treatments that may help save a patient's life," said Rep. Frank Pallone Jr., D-N.J., who opposed the bill.
5. "For months we sought to strike the right balance by allowing patients greater access to these unapproved treatments and therapies while also ensuring proper patient protections," Commerce Committee Chairman Greg Walden, R-Ore., and Health Subcommittee Chairman Michael Burgess, R-Texas, who backed the bill, said in a joint statement. "This bill does just that."
6. Over 75 patient groups, including the American Cancer Society Cancer Action Network, the American Lung Association and the Cystic Fibrosis Association, sent a letter March 12 to House leaders expressing concern about the bill. The groups argued the legislation "would not increase access to promising therapies" since it did not address the main obstacles of experimental drugs, including the cost of drugs and drugmaker restrictions on developing therapies that can be available outside of clinical trials.
7. Additionally, by bypassing FDA approval, the groups said the right-to-try bill would be "less safe" for patients than the FDA's expanded access program, which oversees the use of unapproved therapies outside of trials.
8. The House bill expanded liability protections to manufacturers and others who are taking part in either the right-to-try pathway or the FDA's expanded access program. Advocates of the bill said by simplifying and shortening the process for obtaining experimental drugs and by broadening the liability protection, the bill would have encouraged more patients, physicians and pharmaceutical firms to participate.
9. However, those who opposed the bill called it a "false hope" for critically ill patients. "The bill would have exposed vulnerable patients to risks of serious harm, including dying earlier and more painfully than they otherwise would have, without appropriate safeguards," Michael Carome, director of Public Citizen's Health Research Group, said in a statement.