Senate OTC Monograph Reform Bill Clears HELP For Floor Vote
Executive Summary
Senate HELP Committee approves an OTC monograph reform bill with two-year market exclusivity for some products. The bill also establishes a user fee program to pay for FDA's work and replaces public rulemakings currently required for any change with an administrative order process.
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The length of exclusivity periods is the only major difference between pending US House and Senate bills, both largely based on a proposal developed by FDA and drug industry representatives. Committees in both chambers are expected to vote on moving the bipartisan proposals to floor votes within two months.