Bipartisan House Bill Revives Idea of Creating User Fee Program for OTC Drugs

Regulatory NewsRegulatory News | 20 March 2018 |  By 

Representatives from both sides of the aisle introduced a bill late Monday that would create a user fee system to better the US Food and Drug Administration’s (FDA) oversight and approval process for over-the-counter (OTC) drugs.

The bill seeks to update the current OTC monograph system, established in 1972, which has been slow and cumbersome for companies to update information on the safety of certain OTC medicines.  

In addition to bipartisan support, the Consumer Healthcare Products Association also backs the bill, noting that the current monograph system “has become cumbersome and, essentially, has ground to a halt. Today, it can take several years or more to update product labels with new safety information, approve new ingredients, or make other important changes for consumers. Moreover, the current system does not provide a mechanism for innovation.”

The House Energy & Commerce Committee in September 2017 discussed OTC monograph reforms and FDA Center for Drug Evaluation and Research Director Janet Woodcock stressed the lack of resources FDA currently has to deal with OTC monographs.

User Fees

Under the new bill’s text, which largely builds off previously introduced versions of the bill, each company that owns a facility identified as an OTC monograph drug facility would pay an annual fee beginning in FY 2019, and contract manufacturers would pay two-thirds of that annual fee.

OTC monograph order requests will also be divided in tiers, with those making Tier 1 OTC monograph order requests paying $500,000 and those making Tier 2 OTC monograph order requests paying $100,000. Fees would be due on the date of submission of the OTC monograph order request, the bill’s text says.

Text of the Draft Bill


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy