Would have offered a necessary respite from overly cumbersome FDA rules…
(STAT) In a major blow to the effort to pass a federal “right-to-try” law, House Republicans failed to muster the votes to pass a key compromise measure Tuesday.
The legislation was rejected by a vote of 259-140.
The bill needed two-thirds majority to pass under suspension of rules.
The vote was an embarrassing defeat not only for House Republicans but for President Trump, who had called on Congress to quickly pass right-to-try legislation, and Vice President Mike Pence, a longtime supporter of the effort.
It was also a rare misstep from Speaker Paul Ryan, who like most congressional leaders almost never schedules votes on legislation without some certainty that the given measure has the support to pass.
The controversial “right-to-try” bill would offer a pathway for patients with a terminal disease to get around Food and Drug Administration rules to request an experimental treatment from a drug maker before the agency has approved it.
Supporters of the legislation, including the libertarian Goldwater Institute that first conceived of the pathway, say it would offer a necessary respite from what they say are overly cumbersome FDA rules.
Critics, however, including Minority Leader Nancy Pelosi of California, pointed out that the FDA already has a program in place to offer access to terminal patients, and the agency grants some 99 percent of all the requests it receives, often within a short time frame.
They also argued that without more FDA oversight of the use of experimental therapies, desperate patients could be vulnerable to bad actors or unsafe treatments.
Pelosi and Rep. Frank Pallone (N.J.), the ranking Democrat on the House Energy and Commerce Committee, spent Tuesday urging their colleagues to oppose the bill.
One key Democratic staffer even circulated an email highlighting the concerns that critics, including former FDA commissioners, had raised with the measure.
Thirty-two Democrats voted to support the bill; two Republicans opposed it.
“We are incredibly disappointed in our Democrat colleagues for not supporting this carefully crafted bill, delivering increased patient access to investigational drugs for those that have no other treatment options through the existing compassionate use program as well as a new alternative pathway,” said Energy and Commerce Committee Chairman Greg Walden (R-Ore.) and Health Subcommittee Chairman Michael C. Burgess, M.D. (R-Texas).
Asked by STAT why Republicans had brought the legislation under the “suspension of the rules” process, a Republican leadership aide said leaders had had no reason to believe Democrats would not support the measure.
It’s unclear what the next steps for the movement may be – if there are any.
The House could take up the measure anew, or a similar one, under the normal rules of the House, which are slower but only require a simple majority.
It is also possible Republican leadership could negotiate with their Democratic counterparts to include some or all of the bill’s provisions into an omnibus spending measure expected to be unveiled later this week.
House Majority Leader Kevin McCarthy of California vowed in a statement after the vote that “the House will not let this be the end.”
“We will try again, pass legislation, and bring hope to those whose only desire is the right to try to live,” he said.
Though the Senate passed its own version of the legislation unanimously last year, it did so because Sen. Ron Johnson (R-Wis.) demanded the consideration as a condition of his vote on a separate measure.
“It’s disappointing to see the House fail to pass commonsense legislation that would give the right to hope to so many terminally ill patients in America,” Johnson said in a statement released on Tuesday. “I pledge to work tirelessly on behalf of patients and their families until right to try is signed into law.”
Republished with permission from STAT via iCopyright license.