- The House Energy and Commerce Committee on Thursday gave unanimous approval (in an unusual 51-0 vote on such major legislation) to the landmark 21st Century Cures FDA reform bill after a full committee markup period.
- There were a number of changes made to the underlying bill (read our coverage of one of the most recent drafts before the final markup here). Most significantly, the bill passed out of committee on Thursday includes mandatory funding for the FDA (in addition to the $10 billion in mandatory for the NIH that was already in the bill).
- The FDA likely won't be satisfied with the funding amount, which is reportedly around $550 million. But all told, industry, federal agencies, and patient groups alike are likely to applaud the bill's progress, since it seeks to expedite the approval pathway and encourage drug development through incentives such as exclusivity (while incorporating patients into the regulatory process).
The 21st Century Cures initiative is sailing through Congress with notable bipartisan support. In fact, one committee member noted that Thursday's 51-0 vote marked the first time in just under three decades that such major legislation had been passed by the committee without a single detractor.
Given the bill's popularity, it seems extremely likely that it will pass the full House. What's less clear is its prospects in the Senate, although Sens. Richard Burr (R-NC) and Bill Cassidy (R-LA) have both indicated the upper chamber will take up the bill by the fall. The goal is to get a final bill to President Barack Obama's desk by the end of the year.
Stay tuned for our continuing coverage of 21st Century Cures as it continues to speed through Congress.