Two lawmakers, longtime friends from opposing parties, found common ground on health care over the past 18 months as they developed a measure they hope will help cure disease.
WASHINGTON — By the standards of the modern Congress, Reps. Fred Upton, R-Mich., and Diana DeGette, D-Colo., have no business writing health-care legislation together.
Upton, the buttoned-up chairman of the powerful Energy and Commerce Committee, is one of the House Republicans’ go-to representatives on dismantling the Affordable Care Act. DeGette, a member of the Democratic leadership who leans left of center, counts herself among the central champions of the law.
But the two lawmakers, friends since they met in a prayer group nearly two decades ago, have spent the past 18 months developing a measure they hope will help cure disease.
“Every family is impacted by disease; they just are,” Upton said. “My wife has lupus, my dad has diabetes, my mom’s a cancer survivor. And I’m no different than anyone else.”
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On Friday, their bill — which would spur biomedical innovation, change the way federal health officials approve drugs and medical devices, and increase funding for the National Institutes of Health (NIH) — passed the House overwhelmingly, 344-77.
The compromise was so strong that lawmakers even agreed on a highly unusual way to pay for it: by ordering the Obama administration to sell enough oil from the nation’s strategic petroleum reserve to cover the cost. The reserve is supposed to be for national energy emergencies and has been tapped on occasion to soften price shocks; it is not meant to serve as a piggy bank.
The bill would give $8.75 billion to the NIH, which lawmakers believe has been starved, and $550 million to the Food and Drug Administration (FDA) in the next five years, a provision researchers said would help remedy shortfalls imposed by mandatory-spending limits.
The measure drew praise from many physician and patient groups, and criticism from some consumer advocates who said the changes threatened to lower safety standards. But it was also a rare bipartisan compromise, hard fought with intense disagreements, largely over the role of pharmaceutical companies.
A similar bill is under consideration in the Senate, where lawmakers hope to have legislation by the end of the year. “This is kind of a throwback to the way people used to do business around here,” DeGette said.
The impetus for the bill, 21st Century Cures, was what the drafters said was a plodding and outdated regulatory process at the FDA, the federal agency in charge of drug approvals. In announcing the legislation in April, Upton and DeGette called the federal drug- and device-approval process “the relic of another era.”
The agency countered that it approved drugs far faster than other developed countries and that about two-thirds of drugs approved in 2014 were accepted under expedited processes, assertions that researchers corroborated.
The FDA has strict standards for what kind of information is required for drug approvals. Most approvals are based on the outcomes of highly controlled clinical trials, considered the gold standard in science, though some consumer advocates say the agency has been under pressure in recent years to relax its standards.
The legislation contains numerous ways for FDA regulators to accelerate clinical trials of products, including allowing the use of data from case studies, patients’ experiences, other countries and medical journals.
Procedures would be streamlined for approving some new antibiotics and medical devices considered breakthrough technologies. Producers of existing drugs would get an extra six months of protection from competition if their drug is approved for use against rare diseases.
Some consumer groups and doctors said some provisions sacrificed sound science for speed and could be dangerous.
“There are parts of this bill that unnecessarily allow drugs and devices to be approved based on very limited data and unnecessarily accelerate products to market before we know enough about their safety and effectiveness,” Dr. Aaron Kesselheim, a Harvard University Medical School professor, said in an interview.
Kesselheim, who recently wrote an article criticizing the bill in The New England Journal of Medicine with Harvard colleague Dr. Jerry Avorn, said the legislation contained a “false assumption” that current FDA approval processes are too slow.
“What we have here is a Trojan horse,” said Avorn. “The elevator pitch is very appealing: ‘This is about getting crucial drugs to the American public sooner.’ But it is a vehicle for some regulatory changes that are really very worrisome.”