WASHINGTON — A bill that would make sweeping changes to the medical research field passed the U.S. House on Wednesday, getting U.S. Rep. Diana DeGette of Denver that much closer to securing a win for her top legislative priority.
The 392-26 vote was a larger margin than the 344-77 vote that backed a 2015 version of the bill, but came as some Senate Democrats and progressive groups raised concerns over whether the measure does too much to help drug and medical-device companies.
Every member of Colorado’s U.S. House delegation, except for Rep. Ken Buck, R-Windsor, supported the 21st Century Cures Act.
Backers of the bill said they were hopeful they would send the measure to President Barack Obama — who wants to see it passed — before Congress ends its current term.
“This is a watershed moment in this country for bio-medical research,” said DeGette, who championed the bill with U.S. Rep. Fred Upton, R-Mich. “With this bill, we bring hope to millions of patents who suffer from cancer, Alzheimer’s, diabetes and a host of other ailments.”
The next step is the Senate, where liberal lawmakers such as Bernie Sanders, Dick Durbin and Elizabeth Warren have raised concerns about whether the bill would overly weaken standards for the approval of drugs and other therapies in an effort to more quickly get them in the hands of patients.
“This bill isn’t about doing what the American people want,” Warren said. “This bill is about doing what drug companies and (political) donors want.”
Buck said Wednesday he opposed the bill due to its cost. “It spends too much money. It’s that simple,” he said.
Kaiser Health News this week reported that the $6.3 billion measure was one of the most heavily lobbied pieces of legislation this Congress, with more than 1,400 lobbyists involved in trying to influence the bill’s language, which runs roughly 1,000 pages.
In this 2016 election cycle, health professionals and the pharmaceutical industry were the two biggest contributors to DeGette’s campaign – giving a combined $275,180, according to the Center of Responsive Politics, a nonpartisan watchdog.
Michael Carome, of the consumer-rights group Public Citizen, said the current version would require that the U.S. Food and Drug Administration develop a program that would make it easier for pharmaceutical companies to get approval to repurpose old drugs to treat new afflictions — such as using a drug for lung cancer to treat breast cancer, he said.
“That’s a troubling provision,” he said. “It further erodes the standards of approving drugs.”
Still, Carome said legislators had removed two troubling items.
No longer will the bill help drug companies extend the exclusivity of some medications to treat rare afflictions — and in the process delay the rollout of cheaper, generic drugs.
Also cut was a section that would have weakened the reporting requirements of gifts that medical companies give to doctors. Lawmakers such as U.S. Sen. Chuck Grassley, R-Iowa, had threatened to block the bill if that clause wasn’t removed.
U.S. Sen. Michael Bennet did not say Wednesday whether he planned to support the bill, although the Colorado Democrat had been involved in earlier efforts on the Senate side to fast-track new drugs to treat antibiotic-resistant bacteria.
“Michael is reviewing the bill and encouraged by the efforts to address antibiotic-resistant superbugs, safely speed up the FDA approval process to save lives, and provide clarity for health care mobile app developers,” said Laurie Cipriano, a Bennet spokeswoman, in a statement.
Whatever Democratic effort exists to stop the bill in the Senate could be stymied by the White House, which strongly backed its passage this week.
In addition to the bill’s push to make it easier for medical researchers to collaborate, it also takes steps to address the opioid drug epidemic and to jumpstart a “moonshot” effort to cure cancer — a major priority for Vice President Joe Biden.
The $1.8 billion moonshot plan “aims to accelerate research efforts and make new therapies available to more patients, while also improving our ability to prevent cancer and detect it at an early stage,” administration officials said in their analysis of the bill.
