Washington — The U.S. House is poised to vote Wednesday on a revamped $6 billion package to speed up the drug and medical device approval process, boost cancer and Alzheimer’s research, and increase funding for the National Institutes of Health and the Food and Drug Administration.
The bill, known as the 21st Century Cures Act, includes mental health programs, $1 billion in state grants to help fight opioid addition and abuse, and a scaled-down $4.8 billion for the NIH over 10 years.
Rep. Fred Upton, R-St. Joseph, a key package architect, calls it a “once in a generation” chance to help researchers change the way disease is treated. The original bill passed the House in July 2015 with bipartisan support, 344-77.
The legislation includes $1.8 billion in cancer research funding for Vice President Joe Biden’s cancer “moonshot.”
“We look forward to swift and favorable consideration of the 21st Century Cures Act in both the House and Senate,” Upton said in a joint statement with Sen. Lamar Alexander of the Senate’s Committee on Health, Education, Labor and Pensions. “America’s patients are waiting on us and we will deliver #CuresNow.”
The Obama White House said Tuesday it “strongly supports passage” of the bipartisan legislation, adding that it “offers advances in health that far outweigh” any concerns.
“The Administration is committed to taking immediate action to lay the groundwork to ensure that the funds in the bill would be disbursed quickly and effectively so we can begin to address these important public health challenges,” the White House said in a statement.
The package is paid for in part by selling excess crude oil from the Strategic Petroleum Reserve but mostly by cutting $3.5 billion from the Prevention and Public Health Fund from Obamacare.
AdvaMed, a trade group for medical-device makers, praised the creation of a broad category of “breakthrough” devices that would receive expedited review if there are no approved alternative treatments for patients.
But critics are unhappy the legislation doesn’t include controls for drug pricing and worry that easing drug and device approvals could compromise patient safety.
The initial bill guaranteed a decade of mandatory funding for the NIH, but now it will be left up to congressional appropriators each year.
Democratic Sen. Elizabeth Warren of Massachusetts noted that federal spending on medical research has been cut 20 percent in the last 12 years, when adjusted for inflation.
“This final deal has only a tiny fig leaf of funding, for NIH and for the opioid crisis. And most of that fig leaf isn’t even real,” Warren said Monday on the Senate floor. “Most of the money won’t really be there unless future congresses passes future bills in future years to spend those dollars.”
Diane Zuckerman, president of the National Center for Health Research, said studies — including one she just published in the Journal of the American Medical Association — have found that cancer drugs approved through the FDA’s expedited process don’t necessarily help patients live longer and are almost never proven to improve their quality of life.
Upton’s bill “is pushing even more in that direction,” Zuckerman said. “You have a bill that purports to help patients and find cures, but you see from the research that lowering the standard does the opposite.”
Zuckerman said the legislation also has good provisions, but she’d rather Congress scrap the draft and try again later.
The consumer group Public Citizen says the bill would weaken FDA standards for the type of evidence needed for drugmakers to get approval for new medical uses. The legislation calls for the FDA to evaluate the potential use of “real world evidence,” such as patient registries, observational studies and claims.
“It’s a much lower standard of evidence than a controlled, randomized clinical trial. It’s more subject to bias and to manipulation of the data to make the case that a drug is safe and effective for another use,” said Michael A. Carome, the group’s director of health research.
Republican Sen. Chuck Grassley of Iowa has objected to a section that would weaken reporting requirements for industry payments to doctors under the Physician Payment Sunshine Act by exempting indirect payments for speaking fees and payments for medical education such as textbooks.
“Watering down sunshine provisions is counter productive and goes against the trend in health care to have more transparency, not less,” said Grassley, who said he’d block Cures’ progress in the Senate unless the provision is removed.
Senate Majority Leader Mitch McConnell has said the Senate will take up the package in December after the House acts on it.