The 21st Century Cures Act aims to reshape drug regulation and biomedical research.
Legislation that would streamline research and development at the US National Institutes of Health (NIH) and drug regulation at the Food and Drug Administration (FDA) is one step closer to becoming law.
The US House of Representatives approved a nearly 1,000-page bill — known as the 21st Century Cures Act — on 30 November. The Senate is expected to vote on the controversial US$6.3-billion measure as early as next week. Several senators have promised to fight the bill over worries that it will increase drug prices. But after President Barack Obama said on 29 November that he would sign the bill, analysts expect the Senate to pass it with few if any changes.
“Defeating a bill that helps kids a month before Christmas, even by DC standards that’s pretty Dickensian,” says Jennifer Zeitzer, director of legislative relations at the Federation of American Societies for Experimental Biology in Rockville, Maryland.
What is the purpose of the bill?
The act is intended to speed the translation of research findings into new therapies by eliminating some regulation and bureaucracy. Many of its 996 pages are devoted to altering regulatory practices at the FDA, and it provides $500 million for the FDA to apply incentives and enforce rules provided for in the law.
The bill would also create a research policy board within the White House to streamline research-grant proposals and policy. Among its tasks would be to coordinate research regulations between government funding agencies to make life simpler for researchers, and to review the controversial rules governing conflict-of-interest disclosures by NIH-funded researchers.
How much would it cost?
The bill would provide $500 million for the FDA to apply the changes. It would also authorize $4.8 billion over 10 years for three specific NIH research programmes: the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) initiative, the Precision Medicine Initiative and the Cancer Moonshot. These funds would be ‘mandatory spending’ — meaning that would be supported by a dedicated revenue stream outside of the annual process through which Congress parcels out government funding.
Why has it proven controversial?
Republican lawmakers had objected to the original bill’s provision of $10 billion in mandatory funds for the NIH — money over which Congress would have had little control. The current version compromises by halving this amount, and requiring that lawmakers sign off each year before the agency receives it.
And Democrats and some advocacy groups have challenged the act as being overly friendly to industry. They worry that provisions in the bill that would loosen requirements for things such as the size and length of clinical trials could endanger patients. One provision would allow companies to submit summaries of their trial results to the FDA rather than specific patient data. Advocacy groups such as Public Citizen in Washington DC worry that this will allow companies to hide problems and side effects from the agency.
Aaron Kesselheim, who studies health-care ethics at Brigham & Women’s Hospital in Boston, Massachusetts, says that the bill is more likely to endanger patients than to improve how the FDA functions. “The goal is not better, the goal is faster, and fast isn’t the problem,” he says.
For instance, the new bill expands companies’ ability to request expedited FDA review for certain therapies, including neglected tropical diseases such as Chagas, in exchange for developing needed therapies for children or countermeasures against biological and chemical warfare attacks. Kesselheim says that there is little evidence that such perks actually speed up drug development.
Where would the money come from?
Some of the funding would come from selling US government-held land that contains fossil-fuel reserves. The rest would be drawn from a programme established under the Affordable Care Act — the health-care reform law known as Obamacare that president-elect Donald Trump has vowed to repeal. Known as the Prevention and Public Health Fund, it provides roughly $1 billion to $2 billion each year to the CDC to support public-health programmes.
The agency has used this money to bolster spending on existing programmes such as tobacco prevention and environmental-health research. Georges Benjamin, executive director of the American Public Health Association in Washington DC, says that his organization no longer backs the bill, saying that the work that the CDC does with the money is necessary to public health.
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Reardon, S. US health-reform legislation clears big hurdle. Nature (2016). https://doi.org/10.1038/nature.2016.21088