OTC Monograph Bill Has Energy And Commerce Date, CDER Director's Hope
This article was originally published in The Pink Sheet & The Rose Sheet
US House is catching up with Senate on OTC monograph legislation, with a committee markup expected in the next few days.
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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.
Senate HELP Committee unanimously advances bill that would also boost FDA's power over unit dose packaging and improve inspection of international mail facilities.
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.