Senate OTC Monograph Reform Bill Clears HELP For Floor Vote
This article was originally published in The Pink Sheet & The Rose Sheet
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.
Senate legislation to reform the US OTC monograph process mirrors the House draft proposed in January, including a two-year market exclusivity provision for some products. The Consumer Healthcare Products Association says it is working with legislators and is encouraged a reform bill will pass this year.
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