- On April 30, 2014, Rep. Fred Upton (R-MI), chair of the House Energy & Commerce Committee, along with Rep. Diana DeGette (D-CO), launched a multi-pronged, multi-year program known as the 21st Century Cure Initiative.
- The broad focus of the very complex bill is to provide incentives for innovation to spur development of drugs for unmet medical needs. Therefore, the bill includes provisions on issues such as periods of exclusivity and reforming the regulatory approval process to make it easier and faster.
- Now, as the Senate Committee on Health, Education, Labor and Pensions (HELP) Committee prepares to release a draft of its Innovations for Healthier Americans Act, the climate has changed dramatically in light of the major focus on reining in drug prices.
Previous iterations of the 21st Century Cure Act, and its related provisions, were generous towards pharma with longer periods of exclusivity built in, support for R&D, easier approval pathways and other pro-pharma features. What a difference 18 months makes. Now, as the HELP Committee attempts to move one piece of the bill forward, it is being met with resistance on all sides. The money just isn't there, nor is the political will.