Lawmakers began the US FDA user fee reauthorization legislative process with the clean bill many desire, although it likely will not end up that way.
The House Energy and Commerce and Senate Health, Education, Labor and Pensions committees jointly released the first discussion draft of user fee legislation on April 14
The only non-user fee language would reauthorize exclusivity related to drugs with single enantiomers, pediatric humanitarian device exemptions and device consortia, as well as the