A? week after a bill aimed at giving terminally ill patients another way to access experimental medical treatments fell short of passing the U.S. House, federal lawmakers tried again.
The late-Wednesday vote on a measure described as offering those patients a “right to try” treatments not yet approved by federal regulators was approved on a vote of 267-149, with 32 Democrats joining all but two Republicans in support.
The legislation co-sponsored by U.S. Rep. Brian Fitzpatrick, a Bucks County Republican, would create guidelines on which patients can seek out drugs that are still in the federal Food and Drug Administration’s approval pipeline.
It also includes provisions on giving patients get the information they need about the risks and liability protections for drug manufacturers.
Supporters say the proposal would aid those who otherwise may not live until a life-saving treatment is approved and becomes available. While the FDA already has a process for accessing experimental treatments on a case-by-case basis, that path has been criticized as too cumbersome to navigate.
“It gives them the option of trying to save their life,” Fitzpatrick said on the House floor Wednesday.
One of his constituents, Matt Bellina, a 34-year-old Navy veteran battling ALS, has lobbied for the bill, saying it would open up treatment options that are blocked for him. Bellina and his family came to D.C. last week for the unsuccessful vote.
But the “right-to-try” measure also has drawn criticism from medical ethicists and patients groups, such as the American Lung Association and the Cystic Fibrosis Association, which say it would sidestep the FDA’s regulatory mission and hinder the agency’s ability to ensure patients are accessing safe treatments.
The legislation “creates a dangerous back-door for modern-day snake oil salesmen, a back-door around the FDA approval process,” said U.S. Rep. Jan Schakowsky, D-Ill.
Opponents argue that the FDA’s current alternative process for accessing those treatments — known as expanded access, or compassionate use — should be used and improved, citing its high approval of requests.
They also have expressed skepticism that the bill would ensure that more drug companies offer access to their yet-unapproved treatments, describing that as a more significant current roadblock than the FDA.
FDA Commissioner Scott Gottlieb had asked lawmakers to narrow who is eligible for the treatment-access option. The updated House bill was changed to include patients with a disease or condition with a “reasonable likelihood that death will occur within a matter of months.”
That revised legislation was then brought up for an expedited vote last week, using a process that required support from two-thirds of lawmakers in order to head to the U.S. Senate. More than a majority of the House passed the bill, but not enough for approval.
The legislation has drawn support from President Donald Trump, who called for its approval in his State of the Union address earlier this year.
It now goes to the U.S. Senate, which passed similar legislation last fall.