Senate Passes OTC Drug Monograph Reform Bill

Regulatory NewsRegulatory News | 11 December 2019 |  By 

The US Senate on Tuesday voted 91-2 to pass a bill that would reform the way over-the-counter (OTC) drugs are regulated by introducing a user fee system similar to the ones for prescription drugs and medical devices.
Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN) called the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, “The most important new law affecting the safety, innovation and affordability of over-the-counter drugs since the 1970s.”
The Consumer Healthcare Products Association (CHPA) similarly applauded the bill’s passage: “Thanks to today’s decisive Senate action, our nation is one step closer to having a modern [OTC] regulatory framework that will better serve consumers and facilitate a new wave of innovation in OTC medicines.”
The bill, introduced by Sens. Johnny Isakson (R-GA), who’s resigning from the Senate at the end of the year, and Bob Casey (D-PA), aims to speed up the antiquated approval process for OTC drugs and would create an 18-month exclusivity period as an incentive for companies to bring innovative OTC products to market.
Under the bill, OTC drugmakers and contract manufacturers would be assessed annual facility fees beginning in FY2021. The bill would also create a two-tiered fee structure for OTC monograph order requests: $500,000 for Tier 1 requests and $100,000 for Tier 2 requests.
The bill now moves to the House, which passed similar provisions in its version of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 in January in a landslide 401-17 vote. That bill was sidelined after the Senate version, which lacked OTC monograph provisions, was passed in both chambers and signed into law on 24 June. A standalone OTC monograph bill was introduced in the House the same day but has yet to be taken up by a committee.
S. 2740, Press


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