December 06, 2016 Practice Points

House Passes 21st Century Cures Act

Notably, the bill seeks to improve upon the federal regulatory structure regarding FDA approval and expediting the development of new drugs.

By J. Nicole Martin and Chris Raphaely

On November 30, 2016, the U.S. House of Representatives passed the 21st Century Cures Act by an overwhelming margin (392–26). The bill moves on to the Senate this week, where it is projected to pass as well. Notably, the bill seeks to improve upon the federal regulatory structure regarding Food and Drug Administration (FDA) approval and expediting the development of new drugs. Under the bill, FDA funding would increase by $500 million. The bill also provides for the authorization of new National Institutes of Health research-grant funding—in the billions—including funding for Vice President Biden’s “moonshot” to cure cancer. Importantly, a proposed provision regarding reporting under the Sunshine Act was removed from the bill. Specifically, the proposed provision would have exempted from the reporting requirements of the Sunshine Act payments from drug and device manufacturers to physicians for speaking at continuing –medical-education events and for contributing to medical textbooks or medical journals.


J. Nicole Martin and Chris Raphaely are with Cozen O’Connor in Philadelphia, Pennsylvania.


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