Republican reset
How the Republican wave resets expectations for revamping FDA
The transition to Republican control in the Senate boosts the chances that the House Energy & Commerce Committee's 21st Century Cures initiative will result in legislation that is signed into law in 2015. In fact, the Republican wave resets the range of possible outcomes for the Cures legislation, making it much more likely it will include provisions aimed at fundamentally changing the regulation of drugs and devices and creating new incentives for innovation.
The new political alignment creates conditions favorable for enactment of substantial changes to the regulatory landscape that previously have been hammered out in PDUFA negotiations. These include new leadership in the Senate Health, Education, Labor and Pensions (HELP) and Finance committees, closer coordination between House and Senate leadership, and a push from GOP leadership to produce tangible evidence that they are capable of governing...