The U.S. House of Representatives today approved a bill intended to advance basic research and drug development, in part by giving the NIH $8.75 billion in additional funds over the next five federal fiscal years, and the FDA, $550 million.
The 21st Century Cures Act (HR 6), creates a dedicated “Innovation Fund” from which the NIH would receive $1.75 billion, and the FDA $110 million, each of the next five years. The bill also offers several incentives to speed up R&D, including clinical trials, and gain faster approvals for new drugs.
“Increased funding for the National Institutes of Health and the Food and Drug Administration will support the important work of these agencies in finding and advancing solutions to diseases that continually try to outsmart us,” Mary Woolley, president and CEO of research advocacy group Research!America, said in a statement. “We urge the Senate to embrace this opportunity to transform medical innovation, and bring about the kind of progress that helps our nation and its people thrive.
The legislation also facilitates broader use of central institutional review boards for multi-institution trials. It also requires FDA to promote greater use of patient experience data in regulatory decision making; advance precision medicine by issuing and updating guidance; and support public-private efforts by industry, research institutions, and patient groups to speed up clinical trials through alternative clinical trial designs, biomarkers, and surrogate endpoints.
NIH would be required to establish a national pediatric research network; submit a report to Congress on programs for young emerging scientists at the agency; create a “capstone” grant program to support “outstanding” scientists funded by the agency; and remove the ban on the National Center for Advancing Translational Sciences (NCATS) conducting or funding Phase II and III clinical trials.
Also in the bill is a one-time, six month extension of exclusivity periods and patent protection for an already-approved drug if the drug’s sponsor obtains approval of a new indication for a rare disease or condition.
21st Century Cures passed the House by a bipartisan margin of 344 to 77, reflecting growing support among Republicans and Democrats for funding basic research. That support—reflected in the crafting of the bill led by House Energy and Commerce Committee Chairman Fred Upton (R-MI) and a ranking member, Rep. Diana DeGette (D-CO)—has emerged despite ongoing partisan squabbling over federal spending.
Support for research funding was strong enough to withstand an amendment proposed by Rep. Dave Brat (R-VA) that would have changed the status of the bill’s additional NIH funding from mandatory to discretionary. That amendment and others were voted down by the House 281-141 before the chamber ultimately approved 21st Century Cures.
However, supporters of 21st Century Cures emphasized that the additional spending was offset through funding cuts—namely changes to Medicare and Medicaid entitlement rules projected to trim $500 million over the next decade, and $7 billion the following decade, from budget deficits.
Congress is still subject to the Budget Control Act of 2011, which forces Washington to either cut at least $1.2 trillion in spending over 10 years, or implement across-the-board budget cuts or “sequestration.”
“We strongly urge elimination of the discretionary spending caps to allow Congress the freedom to fund those programs appropriately—like the NIH—that have been identified as clear bipartisan priorities,” Benjamin Corb, public affairs director of the American Society for Biochemistry and Molecular Biology, said in a statement.
The bill advances to the U.S. Senate, where Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander (R-TN) told National Journal he hoped to have a bill by Thanksgiving.