Regenerative Medicine in the Trump Era

The second in a series of articles to help you deal with legislative and regulatory issues as President Trump and a new congress take hold. To view the series, visit Buchanan's 100 Days in a Minute.

Where We Are

Regenerative Medicine swept into 2017 on a propitious wave created in part by the enactment of the 21st Century Cures Act (the Act). The Act identified regenerative medicine as a regulatory category and codified a statutory mechanism for rapid review and approval when they address unmet medical needs. It also extended the rare pediatric disease priority voucher incentive program until September 2022, and added provisions to strengthen and enhance the nation’s readiness for biological threats by incentivizing the development and testing of vaccines and ensuring they can be added to the national stockpile in case of an attack. This wave was further powered by increasing public awareness of the potential benefits of cell and gene therapies created by social media and high-profile scientific breakthroughs.

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