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# Woodcock Supports Reforms to OTC Monograph Program
- URL: https://www.fdaweb.com/woodcock-supports-reforms-to-otc-monograph-program/
- Published: 2017-09-13T12:00:00.000Z
- Updated: 2026-09-14T22:49:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139619

CDER director **Janet Woodcock** told a House Energy and Commerce Health Subcommittee hearing 9/13 that the current monograph system for over-the-counter (OTC) drug products is outdated and reforms are needed to “improve the timeliness of review activities, spur innovation on behalf of consumers, and enable the agency to better respond to urgent safety issues.” The hearing reviewed draft legislation, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017, which is sponsored by representatives **Bob Latta** (R-OR), **Diana DeGette** (D-CO), **Mike Burgess** (R-TX), **Brett Guthrie** (R-KY), and **Gene Green** (D-TX). During testimony, Woodcock signaled the agency’s support for the legislation, and offered staff for technical assistance.

“This bipartisan proposal establishes the OTC Monograph User Fee Program and makes a number of meaningful modifications to the monograph process,” [**said subcommittee chairman Burgess**](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTcwOTEzLjc4MTAxNzIxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDkxMy43ODEwMTcyMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2OTMzMzUzJmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ0YXJnZXRpZD0mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&102&&&https://energycommerce.house.gov/wp-content/uploads/2017/09/9.13.17-M.-Burgess-OTC%5FHealth.pdf&ref=fdaweb.com). “The goal is to create a system that is more flexible and more efficient, and reflects the scientific innovations so that patients and consumers have greater access to better and safer OTC drug products.”

Woodcock testified that the OTC user fee program would start at $22 million in Year 1 and gradually increase to $34 million by Year 4\. OTC manufacturers would pay an annual facility fee under the proposal, and there would be an additional fee each time a sponsor submits an OTC Monograph Order Request, which is similar to an NDA under the drug user fee program.

Additionally, the OTC user fee program would involve developing a new information technology (IT) platform. “FDA would work with industry to develop specifications for a public-facing IT dashboard, and would establish a fully functioning IT platform for OTC drug monograph review within five years of the program,” she said, adding that all monograph submissions would be required to be electronically submitted to make the program as efficient as possible.