On Tuesday, Democrats in the US House of Representatives sank a GOP bid to use a legislative shortcut to pass a bill that Republican leaders say would make it easier for people with terminal diseases to access experimental therapies.
The House defeated the bill with a 259-140 vote. The vote failed to meet a high threshold set for so-called suspension bills. GOP leadership had opted to bring the bill to the floor under a suspension of usual rules for considering legislation. The measure thus needed the support of two thirds of members present and voting for passage, instead of a simple majority.
There was both bipartisan dissent and support for the House GOP's "right to try" measure, officially known as the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 (HR 5247). Thirty two Democrats voted for the bill, named after Wendler, who died of amyotrophic lateral sclerosis, and Mongiello, McLinn, and Bellina, who have terminal diseases. Two Republicans rejected it, and thirty one members didn't vote on the bill, according to the House clerks's tally.
To develop this ultimately unsuccessful bill, House GOP leaders on health policy issues, including Energy and Commerce Committee Chairman Greg Walden (R-OR), worked among themselves to revise a "right-to-try" measure (S.204) passed by the Senate last year. The Republicans seemingly surprised Democratic colleagues by moving for a suspension vote this week on the revised bill.
Rep. Frank Pallone Jr (D-NJ), the top Democrat on the Energy and Commerce Committee panel, which oversees the US Food and Drug Administration (FDA), said the bill should never have been put on the House floor, because it was formally introduced only on Tuesday. The Energy and Commerce Committee had not had a chance to review the bill, said Pallone, who objected to the substance of the measure as well as to the process used to try to pass it.
"By defeating this bill tonight, we protected patients and supported FDA's continued role in approving experimental treatments that may help save a patient's life," Pallone said in a statement.
Walden and Rep. Michael C. Burgess, MD (R-TX), the chairman of Energy and Commerce's health subcommittee, said in a statement after the vote that they were "disappointed" with the lack of support from Democratic colleagues.
"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," Walden and Burgess said in a joint statement. "This bill does just that, with more robust informed consent and real-time reporting, as well as requiring FDA notification of participation."
While President Donald J. Trump and Vice President Mike Pence aligned with certain patient groups in championing a drive to expand access to experimental medicines, many medical organizations fought against the House measure. The new House bill failed to ease the concerns of advocacy organizations such as the American Cancer Society Cancer Action Network (ACS CAN), which joined dozen of groups in seeking the measure's defeat.
The House GOP bill included changes to the Senate bill, such as requirements for more robust informed consent and more frequent reporting to the FDA, said ACS CAN and groups such as the American Society of Clinical Oncology in a March 12 letter to House lawmakers. Still, the groups concluded that the bill's proposed pathway for access to experimental drugs would be "less safe for our patients than the current expanded access process" used by the FDA.
"We're pleased patient concerns over this legislation were heard and reflected in [Tuesday's] vote on the 'Right to Try' legislation," said ACS CAN President Chris Hansen in a statement after the vote. "Preserving the Food and Drug Administration's ability to consult on drug dosing, scheduling, and administration among other important safety measures for which the agency is uniquely qualified is critical to protecting patients and their access to new therapies."
Further Action?
Congress appears likely to contend again with new calls to pass "right to try" legislation. Sen. Ron Johnson (R-WI), the sponsor of the Senate version of the "right-to-try" bill (S.204), said in a Tuesday tweet that he was "disappointed" with the failure of a bill that "would give the right to hope to so many terminally ill patients in America.
"I pledge to work tirelessly on behalf of patients and their families until right to try is signed into law," Johnson tweeted.
The Phoenix, Arizona–based Goldwater Institute, which works to limit the scope of government, has been building support for the concept of "right to try" laws on a local level. It wrote a model state law that has been adopted by at least 38 states. Yet, these laws have no real standing because the federal Food, Drug, and Cosmetic Act governs the use of medical therapies.
Still, Rep. Walden referred to the state laws frequently on the House floor on Tuesday as a marker for support for expanded access, as he sought to ward off Democratic criticism of his bill. Some of his GOP colleagues, including Rep. Joe Barton (R-TX), contended during the debate that patients facing death should be allowed to try toxic therapies even if there's only a remote chance that the therapies can help them.
"Perhaps false hope is better than none at all," Barton said.
That's a view with which many patient advocates disagree. Karuna Jaggar, executive director of Breast Cancer Action, said in a March 12 blog post that the FDA approves new treatments faster than any other developed country. And the agency quickly "approves 99 percent of compassionate use requests," Jaggar writes.
"Framing the issue as 'right to try' tugs at the heartstrings and suggests that the failures of medicine are not scientific, but rather regulatory," Jaggar writes. "It promises a quick fix for a problem that doesn't exist. The implication is that the cure is out there, but it's being kept from patients by government bureaucrats."
Medscape Medical News © 2018
Cite this: Democrats Defeat GOP Bid to Quickly Pass 'Right-to-Try' Bill - Medscape - Mar 14, 2018.
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