The House of Representatives has approved a revised version of the 21st Century Cures Act, a comprehensive $6.3 billion health care reform measure that would fund the National Cancer Moonshot Initiative and amend FDA standards for regulating drugs and devices.
The bill, which passed by a vote of 392-26 on Nov. 30, includes:
$4.8 billion in additional funding for NIH over the next 10 years, including $1.8 billion for the moonshot and cancer research over the next seven years,
$500 million for FDA over nine years, beginning in fiscal 2018, and
$1 billion in the first two years for grants to states to supplement opioid abuse prevention and treatment activities.
If passed by the Senate and signed into law, the bill likely ensures the continuation of Vice President Joe Biden’s moonshot into the new administration.
The House bill isn’t entirely favorable to cancer groups. In a provision that irks many key players in oncology, the Cures Act lumps the new moonshot cancer research dollars under “NIH Innovation Projects” that would be “authorized to be appropriated from the Account to the Director of NIH.”
In recent months, amid reported efforts by NIH to claim these funds, cancer groups repeatedly urged Congress to direct new funds to the NCI budget. It remains to be seen how the Senate version of the bill will handle the controversy. See related story here.
“21st Century Cures is the innovation game-changer that patients, their loved ones, and the nation’s researchers and scientists so desperately need,” said Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.), co-authors of the bill. “The White House has expressed its enthusiastic endorsement of this critical legislation.”
The House passed the initial version of the bill in July 2015, but the measure stalled in the Senate. The Senate is now expected to consider the new 996-page legislation next week.
Biomedical research and cancer groups have been supportive of the bill since its inception in 2014, advocating for increased funding for NIH, NCI, and FDA. On Nov. 3, One Voice Against Cancer, a coalition of nearly 50 cancer-related organizations, urged Congress to pass the Cures Act to support the moonshot.
“With the passage of the Cures bill by such a significant majority in the house, this signals to the Senate how important this bill is to the millions of patients and their caregivers across the country,” Ellen Sigal, chair and founder of Friends of Cancer Research.
“By passing this bill next week, the Senate can assure the White House’s visionary Cancer Moonshot, led by Vice President Joe Biden, is executed fully,” Sigal said to The Cancer Letter. “The bill takes an important step to further implement the [FDA] Oncology Center of Excellence, which will make a difference for cancer patients and serve as a model for more patient-focused regulation in the future.”
In addition to providing support for the moonshot, the legislation includes funding for the Precision Medicine and BRAIN Initiatives, and empowers FDA’s ability to competitively recruit scientists and regulatory experts.
“Pay-fors” to cover the offsets of the Cures Act include proceeds from selling part of the Strategic Petroleum Reserve and dollars redirected from future increases in the Prevention and Public Health Fund.
According to the Association of American Cancer Institutes, if the funds are not used for the bill’s provisions, the PPHF dollars could revert to the federal treasury if the Affordable Care Act is repealed in the 115th Congress.
“We welcome the increased federal investment in cancer research,” AACI President Stanton Gerson said in a statement. “Investing in the NIH and NCI not only plays a vital role in addressing cancer incidence, but it also contributes to curbing the overall costs associated with cancer.”
Warren v. Pharma
Advocates, lobbyists, and Capitol Hill insiders predict that the bill will pass, despite vocal opposition from Sen. Elizabeth Warren (D-Mass.), Sen. Bernie Sanders (D-Vt.), and several patient groups, who say that the bill benefits pharmaceutical companies at the expense of patient safety.
“Months ago, Senate Democrats said any so-called ‘cures’ legislation must have a significant investment in medical research,” Warren said in a Senate floor speech Nov. 28. “And that’s why Senate Republicans publicly committed to doing exactly that. But now they have reneged on that promise and let Big Pharma hijack the Cures bill. This final deal has only a tiny fig leaf of funding, for NIH and for the opioid crisis.
“Why bother with a fig leaf in the Cures bill? Why pretend to give any money to NIH or opioids? Because this funding is political cover for huge giveaways to giant drug companies.”
The Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization said the bill benefits patients and the next generation of medical innovation.
“The legislation includes pro-patient, science-based reforms which enhance the competitive market for biopharmaceuticals and drive greater efficiency in drug development,” Stephen Ubl, CEO of PhRMA, said in a statement. “It also increases FDA’s regulatory capabilities to foster the timely review and approval of new treatments for patients.”
James Greenwood, president and CEO of BIO, said that “the legislation advances important patient-centered policies that can speed the pace of drug development, while authorizing essential funding for scientific discovery and the promotion of biomedical advancements that can help transform healthcare for patients with the promise of next generation modern medicines.”
The bill does not amend the longstanding policy of prohibiting manufacturers from engaging in off-label communication with patients, physicians, and payers, industry insiders say. PhRMA and BIO are seeking a limited modification to those constraints, arguing that payers make coverage decisions up to 18 months in advance (The Cancer Letter, Nov. 18).
Proponents of this change say the House version of the bill clarifies existing law—Section 114 of the FDA Modernization Act of 1997—allowing drug companies to share health care economic information only for products with approved indications.
Critics: Harmful Provisions, Inadequate Protections
Opponents of the Cures Act say that the bill weakens FDA standards. For instance, the legislation requires the agency to consider “real world evidence” in drug approval regulation, as opposed to sole reliance on randomized clinical trials.
Thirteen organizations, including the Center for American Progress and Public Citizen, a patient safety advocacy group, urged Congressional leaders to delay approval of the Cures Act.
“While the Cures Act’s funding for the National Institutes of Health is a priority for many, it is critical that any legislation making changes to drug policies take steps to rein in the cost of prescription drugs,” the groups wrote in a letter Oct. 26. “We have several concerns about the legislation’s provisions to speed FDA approval based on limited information and to extend exclusivity periods for certain drugs. Such provisions may undermine the agency’s ability to ensure the safety and quality of products and could reduce access to prescription drugs.”
An updated list of Cures provisions that Public Citizen deems to harmful to patients can be found here.
“The bill has been sold erroneously as a commonsense, bipartisan compromise that enables scientific innovation and medical breakthroughs for America,” said Michael Carome, director of Public Citizen’s Health Research Group. “But in reality, the legislation includes a grab bag of goodies for Big Pharma and medical device companies that would undermine requirements for ensuring safe and effective drugs and medical devices.
“Moreover, many House members were persuaded to support the bill, despite the many harmful provisions, in exchange for promises of increased funding for NIH,” Carome said in a statement Nov. 30. “But there is no guarantee that this funding will be appropriated by Congress in future years. Permanently weakening FDA in exchange for tenuous promises of increased NIH funding is a bad deal for patients. We urge the Senate to reject this legislation.”
The Cures Act doesn’t protect patients from harm caused by medical devices, said Rep. Mike Fitzpatrick (R-Pa.), who voted against the bill Nov. 30.
“I agree with many measures in this bill. It provides funding for cancer research at the NIH, grants money to states to fight opioid abuse, helps individuals and families in mental health crisis and improves the FDA’s review of life-saving drugs for patients,” Fitzpatrick said in a statement Nov. 30. “However, I voted against the bill because it fails to protect patients against dangerous medical devices.”
Fitzpatrick made a final and unsuccessful effort to amend the Cures Act to include his proposed Medical Device Guardians Act, which would require physicians to report adverse events.
Fitzpatrick’s advocacy on the issue is largely based on controversies over harm to patients stemming from Essure, a female contraceptive device, and power morcellation, a surgical procedure known to spread undetected uterine cancer (The Cancer Letter, How Medical Devices Do Harm).
“For two years, I’ve sought medical device reform in Congress to raise awareness and advance legislation that protected patients and altered FDA processes and procedures to allow for maximum innovation and safety,” Fitzpatrick said. “Congress ignored the patients harmed by faulty, dangerous medical devices and what is more disappointing—we were denied a hearing.”
Research, Cancer Groups: Pass the Bill
The $4.8 billion for NIH and $500 million for FDA will help spur advances in cancer prevention, detection, diagnosis, treatment, and quality of life of patients, said Daniel Hayes, president of the American Society of Clinical Oncology.
“ASCO is particularly pleased that the bill takes a step forward in addressing the interoperability of electronic health records and that the legislation puts restrictions on intentional information blocking,” Hayes said in a statement Nov. 30. “These much-needed improvements will make it easier to coordinate patient care across a variety of medical providers—and advance important efforts on big data and precision medicine.
“Big data initiatives, such as ASCO’s own CancerLinQ, rely on the ability to share massive amounts of clinical data from large groups of cancer patients that provide treatment insights and improve decision-making in a clinical setting. Increased interoperability of EHRs will make it possible for physicians to better coordinate patient care, reduce unnecessary and redundant cost, and allow these big data initiatives to be more successful.”
By providing funding to NIH, specifically for Vice President Joe Biden’s Cancer Moonshot, Congress can ensure progress in cutting-edge cancer research, said Chris Hansen, president of the American Cancer Society Cancer Action Network.
“Today’s House vote is just the first step, however, toward making this funding and its potential promise a reality,” Hansen said in a statement. “Never before have we been so close to making so much progress in such a short amount of time against this disease. Now is the time for action.
“On behalf of all those touched by cancer, we urge the Senate to quickly take up and pass Cures and for appropriators to allocate the requisite funding in the upcoming continuing resolution.”
The moonshot resulted in a robust and comprehensive list of innovative proposals for transforming cancer prevention and treatment, said Nancy Davidson, president of the American Association for Cancer Research and director of the University of Pittsburgh Cancer Institute, and AACR CEO Margaret Foti.
“Cures is critical because it establishes an NIH Innovation Account, through which $1.8 billion in supplemental funding over seven years is designated for cancer research, and specifically for the National Cancer Moonshot Initiative,” Davidson and Foti said in a statement. “This targeted, multi-year funding will help support the 10 cutting-edge scientific recommendations identified by the National Cancer Moonshot Initiative Blue Ribbon Panel for realizing Vice President Joe Biden’s goal of achieving a decade’s worth of progress in the next five years.
“House passage of this legislation is only the first step forward. We urge the Senate to also pass the bill.”
The Cures Act enables patients to be more involved in the drug development process and provides incentives for young researchers to succeed, said Research!America President and CEO Mary Woolley.
“We are grateful that members of Congress from both sides of the aisle persevered until they found a common path to faster medical progress, and that they coupled the 21st Century Cures Act with initiatives to combat the opioid crisis and help patients facing mental illness,” Woolley said in a statement. “We are disappointed that policymakers chose to redirect future increases in the Prevention and Public Health Fund to help offset the cost of this legislation, since that fund is a strategic investment in its own right.
“Nonetheless, we believe this bill richly deserves the bipartisan support it enjoys, and we urge the Senate to pass and the President to sign it. Finding solutions for deadly and debilitating health threats and combating insidious public health threats should be a dual imperative for our nation, and this legislation could well usher in an era of unprecedented progress on both fronts.”