OTC Monograph User Fee Absent From Updated FDARA Bill

A revised FDA user fee package set to face a House vote Wednesday afternoon under suspension of the rules largely combines the marked up House and Senate bills, and leaves out legislation crafted by industry and FDA to create an over-the-counter monograph user fee program . The updated user fee bill also maintains an amendment added by the House expressing a sense of Congress urging the HHS secretary to take administrative actions to lower drug costs. Certain provisions...