The act creates faster, more flexible FDA drug and biologic review, new drug and device approval pathways, increases FDA funding, and reduces EHR administrative burdens.

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), which Congress passed with strong bipartisan support. The Act increases mechanisms for the US Food and Drug Administration (FDA) to expedite approval of novel drugs and devices, provides new incentives for developing such products, and directs the US Department of Health and Human Services (HHS) to decrease the administrative burden of electronic health records (EHRs) and increase EHR interoperability. The Act authorizes a number of new and revised approval pathways, and requires FDA to issue several new guidance documents to assist industry in developing new drugs, biologics and devices. Additionally, the Act contains a provision intended to expand the off-label promotion safe harbor for certain manufacturer communications of healthcare economic information to payors, as well as provisions narrowing FDA’s jurisdiction over medical software. The Act provides increased funding to the National Institutes of Health (NIH) and FDA to implement the Act’s provisions; however, the funding levels have been criticized by some as insufficient.