False start for 21st Century
Why the sum of 21st Century Cures draft provisions would paralyze FDA
Energy & Commerce Committee Chairman Fred Upton launched his 21st Century Cures initiative last May with the goal of coming up with government solutions to improve the climate for biomedical innovation. So far, it is failing to pass the bipartisan test, and a great deal of work remains to be done to craft legislation that would improve medical product development.
Not a single Democratic member of Congress endorsed a discussion draft of 21st Century Cures legislation released on Jan. 27, and President Obama declined Upton's invitation to mention the initiative in the State of the Union address. The lack of Democratic support is related to disagreements about substance and process. Democrats, especially ranking E&C member Frank Pallone (D-N.J.), felt they were not sufficiently included in the process of writing the draft...