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January 05, 2017

New “21st Century Cures” LegislationSpeed and Ease vs Science

Author Affiliations
  • 1Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
JAMA. Published online January 5, 2017. doi:10.1001/jama.2016.20640

The 21st Century Cures Act was signed into law in December 2016. Praised by its advocates as a means of speeding drug development, the act covers several areas, but the provisions related to the US Food and Drug Administration (FDA) will be among the most problematic and potentially important. An earlier version was passed with a wide margin by the House of Representatives in July 2015; it contained sweeping measures to permit manufacturers to submit less rigorous data to the FDA for approval of drugs and devices, and it recommended annual increases to the National Institutes of Health (NIH) budget of approximately 3% per year for 3 years as well as approximately $8.75 billion over 5 years in additional support.1 Further progress on the bill stalled for about a year until it was taken up again in the congressional session after the recent election.

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