As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter (OTC, also known as nonprescription) drug products. In June of 2016, the Agency held a public meeting to solicit stakeholder feedback on its ideas. Since that time the proposal to develop an OTC Monograph User Fee Program has matured and it is generating considerable steam. However, FDA cannot implement such a program to assess user fees against members of private industry unless and until it has statutory authorization from Congress to do so.

As the Agency explains it, “A user fee program for nonprescription monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph.” General partisan gridlock in D.C. notwithstanding, it appears likely that Congress may enact the legislation necessary to create this new User Fee Program during its current session (2017-18). This post updates legislative and FDA activities in this area since our introductory discussion in 2016. Continue Reading OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the Agency’s monograph system.  Agency leader Dr. Janet Woodcock wrote last week in Health Affairs that FDA’s “current system of OTC review is simply too sluggish to promote OTC modernization.”  Many of the OTC monograph reviews initiated in the 1970’s are far from complete, and there is little expectation that FDA will be finalizing anything soon, in light of the minimal funding and support the OTC program receives in comparison to other parts of the Agency.

User fee programs currently exist to help fund the Agency’s review and policy-development activities for prescription drugs, biologics, medical devices, generic drugs, and even some aspects of food inspectional programs.  Will the OTC drug industry become subject to user fees and, if so, what will they look like?  Although certainly no one is expecting a $2.5 million application fee like what is required for a new prescription drug, it will be a difficult balance for regulators to meet all of the Agency’s stated goals – to ensure stable revenue from year to year; to have fees paid by industry members who benefit from the OTC monograph program and to have them pay only a “fair share”; and to have sufficient fees collected to cover the intended services, without the program costs becoming unreasonable.

A webcast of the June 10th meeting, along with FDA’s presentations and other background information, can be accessed through the meeting page here.  Interested stakeholders can respond to the Agency’s specific questions or submit more general comments on the OTC drug monograph development process to Docket FDA-2016-N-0192 before it closes on July 10th.