OTC Monograph Reform Ticks Forward With Passage of House Bill

Regulatory NewsRegulatory News | 17 July 2018 |  By 

The US House of Representatives on Monday voted to pass a bill to reform the over-the-counter (OTC) monograph process by creating a user fee program to speed FDA's reviews of OTC monographs.

The bipartisan bill, known as the Over-the-Counter Monograph Safety, Innovation and Reform Act of 2018 (H.R. 5333), cleared the House by voice vote.

Under the bill, FDA would collect fees from companies that own facilities identified as OTC monograph drug facilities. Contract manufacturers that produce OTC monograph products would also be required to pay two-thirds of the facility fee.

The bill also would create a two-tiered fee structure for OTC monograph orders. Tier 2 requests, which cover certain changes to existing monographs, would be subject to a $100,000 fee, while all other requests fall under Tier 1 and are subject to a $500,000 fee.

Specifically, Tier 2 requests would cover changes such as reordering existing information in the drug facts label of an existing OTC monograph drug; adding information to the "other information" section of the drug facts label; modifications to the directions for use; or changes to ingredient nomenclature to align with nomenclature developed by a standards-setting organization.

In May, the Congressional Budget Office (CBO) estimated that FDA would collect nearly $150 million in fees under the user fee program laid out in the bill over the five-year period from 2019-2023.

Energy and Commerce Committee Chair Greg Walden (R-OR) and Health Subcommittee Chair Michael Burgess (R-TX) called the vote an "important victory" and urged the Senate to pass its version of the bill, S. 2315.

Consumer Healthcare Products Association (CHPA) President Scott Melville also applauded the vote and said he hopes to see legislation enacted by the end of the year.



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