ARTICLE | Politics, Policy & Law

One more vote

How 21st Century Cures Act paves a path for real but modest regulatory innovation

December 3, 2016 1:43 AM UTC

Last week’s vote by the House of Representatives to pass the 21st Century Cures Act sets the stage for a Senate stamp of approval in the coming week, potentially making it the last major piece of legislation President Barack Obama will sign. If a handful of opponents manage to scuttle the Senate vote - which isn’t likely - all the provisions related to FDA and drug development will be reconsidered next year for inclusion in legislation accompanying user fee reauthorization bills.

The final version of the Cures bill is the result of the formula BioCentury posited in March 2015: “Start with a large number of policy options, subtract any that don’t appeal to Republicans, remove any that Democrats adamantly oppose, delete any that industry hates, and kill or revamp those that FDA says it cannot live with.”...