Representative Fred Upton, Chairman of the House Energy & Commerce Committee, recently released a discussion draft of legislative language for the 21st Century Cures Initiative. This initiative attempts nothing less than to “boil the ocean” of regulations and incentives that govern medical innovation in the U.S. The 400-plus-page draft rolls up a number of previously proposed bills (including an updated version of Representative Marsha Blackburn’s SOFTWARE Act, discussed in a previous Health Alert).
A large share of the draft incorporates legislation designed to improve the incentives for inventing new medicines, or finding new uses for old medicines. This is important, because we are facing a crisis in pharmaceutical innovation.
One of these is the Dormant Therapies Act, put forward by Senator Orrin Hatch (R-UT) and Senator Michael Bennet (D-CO). This would give a “dormant therapy” 15 years of marketing exclusivity after approval by the Food and Drug Administration (FDA), significantly more than currently exists.
Read the entire column in Forbes.