Committee Approves Bill to Boost NIH Funding

A bill aimed at boosting federal funding for biomedical research and streamlining the drug approval process has been introduced into the U.S. House of Representatives after being unanimously approved in committee.

The 21st Century Cures Act would increase annual funding for the NIH by 3%, or $1.5 billion total over the next 3 years, and provide an additional $10 billion spread over 5 years for an Innovation Fund to support promising research initiatives focused on precision medicine. The bill would also boost FDA funding by $550 million spread over 5 years and instruct the agency to expand the scope of the data it uses during the drug approval process.^*

“For many years, we have been going through an incredibly exciting time in cancer research, yet the funding has not kept up with the scientific opportunity,” says George Weiner, MD, director of the Holden Comprehensive Cancer Center at the University of Iowa in Iowa City and president of the Association of American Cancer Institutes. “We're very excited about the bill, and the fact that it was developed in a bipartisan manner is very encouraging.”

The bill would also make deidentified data from NIH-supported clinical trials more available to biomedical researchers. The provision is in line with earlier proposals by the NIH calling for researchers to publish results from early-phase trials and those involving unapproved drugs.

“The scientific community and the public expect data generated with federal funds will be shared to enable further insights to be gained, to help enhance the quality of research, to increase transparency in federal research spending, and to improve the return on investment in research,” said Kathy Hudson, PhD, NIH deputy director for science, outreach, and policy, in testimony before the Committee on Energy and Commerce.

Although the bill's provisions to increase funding for research and drug development have met with widespread support, proposed changes to the drug approval process have sparked some controversy. A recent commentary in The New England Journal of Medicine, for example, takes issue with the bill's directive that the FDA develop criteria for considering nontraditional data sources—including observational studies and patient registries—instead of large, randomized clinical trials when reviewing new uses for existing drugs (N Engl J Med 2015;372:2473–5).

“Although such data can provide important information about drug utilization and safety once a medication is in use, there is considerable evidence that these approaches are not as rigorous or valid as randomized trials in assessing efficacy,” wrote Jerry Avorn, MD, and Aaron Kesselheim, MD, JD, MPH, both of Harvard Medical School and Brigham and Women's Hospital in Boston, MA.

The bill would also encourage the FDA to rely more on biomarkers rather than clinical endpoints in assessing drug efficacy, the researchers said, a strategy that can be faster and cheaper but not always accurate in predicting patient outcomes.

FDA officials have expressed concern over insufficient funding in the bill, which may force the agency to generate more revenue through user fees or shift funding away from other priorities.

“A total of $550 million was added to accomplish certain activities called for in the bill,” said Stephen Ostroff, MD, acting commissioner of the FDA, at a meeting of the Alliance for a Stronger FDA. “But it is not enough. The biggest concern I have is ending up with yet another unfunded, or partially funded, mandate.”

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