The Senate approved the 21st Century Cures Act, a wide-ranging bill that authorizes $1.8 billion over seven years for cancer research as well as $500 million over the next decade for FDA to streamline drug and device approval processes.
The bill, which passed by a vote of 94-5 on Dec. 7, authorizes $4.976 billion for the NIH Innovation Account over 10 years. This money would fund Vice President Joe Biden’s National Cancer Moonshot Initiative, the Precision Medicine and BRAIN Initiatives, and regenerative stem cell research.
In a direct endorsement of Biden’s moonshot efforts, the first item in the nearly 1,000-page bill is named “Beau Biden Cancer Moonshot and NIH Innovation Projects,” an indication that the funds for cancer research are to be used for moonshot priorities.
NIH and NCI are “extremely fortunate” that support for research in Congress is bipartisan, said NCI Acting Director Doug Lowy at a joint meeting of the National Cancer Advisory Board and the Board of Scientific Advisors.
“I want to point out that [the Cures Act] includes Blue Ribbon Panel recommendations, but it says specifically, ‘Research that has the potential to transform the scientific field that has inherently higher risk and that seeks to address major challenges associated with cancer.’ This actually is quite broad,” Lowy said at the meeting Dec. 6.
The House version of the bill didn’t mention the moonshot (The Cancer Letter, Dec. 2).
“We want to recognize and thank Majority Leader Mitch McConnell (R-Ky.) and Minority Leader Harry Reid (D-Nev.) for co-sponsoring an amendment that renamed the cancer portion of the bill after Vice President Joe Biden’s son, Beau Biden, who passed away from brain cancer in May 2015,” Nancy Davidson, president of the American Association for Cancer Research and director of the University of Pittsburgh Cancer Institute and AACR CEO Margaret Foti said in a joint statement.
The Beau Biden amendment appeared to be a surprise to Joe Biden, said M.K. Holohan Quattrocchi, director of the NCI Office of Government and Congressional Relations.
“The vice president was a very well-liked senator,” Quattrocchi said at the advisory board meeting Dec. 6. “When the procedure vote was over and he was leaving the chamber, he told reporters that he was going to run for president in 2020. One reporter said, ‘You know, we’re going to run with that.’
“He said, ‘Go ahead.’ I don’t know if that was just the emotion of the moment or if he’s serious. He [had] a tissue in his hand, one of the clerks had snuck up some tissues to him.”
President Barack Obama is expected to sign the legislation, despite opposition from consumer advocacy groups and a number of lawmakers, who said the bill fails to protect patients from harmful medical devices and will weaken FDA regulations in order to accelerate approval for drugs and devices (The Cancer Letter, Dec. 2).
Immediate Funding for NCI, FDA in CR
The Senate approval comes two days before the current continuing resolution expires Dec. 9. The House passed a second CR on Thursday that would keep the federal government funded through
April 28, 2017.
The GOP leadership decided to extend the CR into April—instead of March—after dropping the initial fiscal 2017 appropriations bills to tailor spending to Trump and Republican priorities (The Cancer Letter, Nov. 18).
The CR would also accommodate what lawmakers anticipate to be a packed legislative schedule in the first 100 days of president-elect Donald Trump’s administration. This includes confirmation of presidential appointees and Supreme Court nominees.
The CR would extend funding for most federal agencies at a rate of operations that is 0.1901 percent below FY 2016 levels. According to a summary by the House Committee on Appropriations, the CR “maintains the current budget cap level of $1.07 trillion put into place under the Budget Control Act of 2011.” The stopgap measure would allow appropriators to complete work on the FY 2017 spending bills in the 115th Congress.
In a move lauded by cancer groups, the CR provides the full $352 million made available to NIH in FY 2017 through the Innovation Account established in the Cures Act. Under the Cures Act, the funding will be transferred to the NIH director for the following initiatives in FY 2017:
• $300 million for cancer research;
• $40 million for the Precision Medicine Initiative;
• $10 million for the BRAIN Initiative; and
• $2 million for clinical research in regenerative medicine.
The CR also allocates $20 million from the FDA Innovation Account in FY 2017.
At the joint NCAB-BSA meeting Dec. 6, Lowy thanked board members for urging Congress to direct moonshot funds to the institute (The Cancer Letter, Dec. 2).
“I can’t thank you enough. The BSA has been instrumental in giving us advice, especially about RFAs—for example, today you’ll be hearing about the results with the SPORE program—and the NCAB has been really instrumental in at least two different ways in very recent past,” Lowy said at the meeting. “One is with the Blue Ribbon Panel report, when we presented it initially, there were a number of important comments that were made by the NCAB and the report was modified in accordance with those comments.
“A second very important part is that, at the initiative of the board, the board talked about the 21st Century Cures and the cancer research part of that, and advocating for that funding, if it is made, for it to go to the NCI.”
Capitol Hill insiders say they expect the $300 million in cancer research funds to be fully channeled to NCI through the NIH director.
Of that amount, $15 million may be allocated to the FDA Oncology Center of Excellence, a moonshot initiative led by Richard Pazdur, director of the agency’s Office of Hematology and Oncology Products (The Cancer Letter, July 1).
“The NCI, under [Acting] Director Doug Lowy’s clear leadership, has laid out a well-defined path for making the Vice President’s Moonshot vision a reality,” said Chris Hansen, president of the American Cancer Society Cancer Action Network. “With the legislation and the funding now in place Moonshot can move forward and accelerate the pace of progress against this disease.
“The Senate’s passage of Cures represents a significant victory for cancer patients and their families nationwide. The additional funding set aside in this bill would enable NIH and NCI to begin implementing many of the National Cancer Moonshot Initiative’s recommendations for accelerating cancer research,” Hansen said in a statement Dec. 7. “These expert recommendations range from improved data sharing—so researchers can see patterns and possibilities across studies and cancers more quickly—to increased focus on emerging and promising treatments, like immunotherapy where the body’s own immune system is harnessed against cancer. Now is the time to re-invest in cancer research and capitalize on so many new and potentially life-saving developments in diagnostic tests and treatments for this disease.”
Cures Bill Had Bipartisan Support
The Cures Act is a bipartisan achievement that focuses on helping patients, said Ellen Sigal, chair and founder of Friends of Cancer Research.
“This monumental victory for patients could not have been done without the collaborative efforts of so many in the science and advocacy community over the past couple of years, and especially not without Vice President Biden’s fortitude and determination,” Sigal said to The Cancer Letter. “We are thrilled that the act includes many provisions Friends of Cancer Research has been instrumental in developing, including the establishment of the FDA Oncology Center of Excellence.”
The bill will spur development and delivery of promising new treatments for patients, said Daniel Hayes, president of the American Society of Clinical Oncology.
“The remarkable bipartisan, bicameral support for the 21st Century Cures Act proves that congressional lawmakers are serious about the need for scientific research, effective care-delivery, and the removal of barriers to scientific progress,” Hayes said in a statement. “We thank Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) for their persistent effort and leadership in advancing this legislation in the Senate.”
The Cures Act invests in precision medicine and builds toward a future where patients are treated with precise, individualized care, said Jonathan Hirsch, president of Syapse, a company that licenses informatics software for integration of oncology data from electronic health records with genomic data.
“The continued funding of the Cancer Moonshot and Precision Medicine Initiative illustrates our government’s commitment to fight cancer and support medical innovation,” said Hirsch, whose company was highlighted by Biden and the moonshot (The Cancer Letter, July 1). “Most importantly, it ensures timely access to lifesaving therapies by encouraging the use of real-world evidence for drug approvals. The Cures Act leaves us optimistic about the future of medicine in America, where patients are treated with precise, individualized care. Syapse is dedicated to the goals embodied in the Cures Act through developing and delivering software to improve care, reduce costs and improve the patient experience through precision medicine.”
The approval of the Cures Act represents more than two years of information gathering, collaboration and a commitment from stakeholders across the research enterprise to accelerating medical progress, said Mary Woolley, president and CEO of Research!America.
“The bill is a crucial step towards removing barriers to innovation, securing funding for major initiatives like the cancer moonshot and streamlining drug development to ensure more patients benefit more quickly from lifesaving therapies and devices,” Woolley said in a statement. “Regretfully, the Prevention and Public Health Fund will be reduced to offset the costs of the Cures Act which will inevitably impact efforts to address health threats.
“But we should be reminded that the Cures Act will incorporate the patient voice in the regulatory decision-making process, among other important provisions, and provide resources to help those impacted by mental illness and the opioid epidemic.”