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Alliance Offers Comments on FDA OTC Monograph User Fees

June 15, 2016   |   Alliance for Aging Research Team   |   FDA & Regulatory Policy, Medication Safety
Green pills spilling out of OTC medicine bottle.

Last Friday, on June 10, Vice President of Public Policy Cynthia Bens presented comments on behalf of the Alliance at a U.S. Food and Drug Administration public meeting focused on OTC monograph user fees.

Bens offered comments about the importance of over-the-counter (OTC) products in the care of older adults as well as the Alliance’s views on the creation of a new user fee program for monograph activities as they relate to OTC products.

Before sharing her comments, here’s a brief background on OTC monographs and why the FDA is considering a user fee program.

According to the FDA, an OTC drug monograph “describes the conditions of use under which active ingredients are considered generally recognized as safe and effective for inclusion in an OTC drug.” Through the FDA’s monograph program, active ingredients in thousands of OTC products have been approved as safe and effective for use by the public.

However, in order to keep pace with the substantial growth in the number of OTC products in the marketplace, the FDA has found it needs additional resources to modernize the OTC review process. Thus, it is considering the adoption of user fees to provide supplemental funding for the OTC monograph program. The June 10 meeting offered stakeholders the chance to share their remarks regarding the user fee program.

Now on to the Alliance’s remarks.

Bens noted that there are 100,000 OTC products on the market today, accounting for $32 billion in total sales. Older adults use OTC medications more than any other demographic group, accounting for 30 percent of all OTC medication use.

Bens added, “Many of the OTC non-prescription medications in routine use by seniors are monograph products. Despite the significant role OTC monograph products play in routine care, FDA’s review of ingredients included in and proposed for inclusion in OTC monographs is underfunded. With 30 FTEs and $8 million devoted to these FDA activities, a lack of funding has contributed to unfinished monographs and delayed labeling changes. We fear that this could have negative consequences for public health and safety.”

Bens then discussed the effectiveness of current user fees programs, citing MDUFA and PDUFA as examples, “The Alliance continues to engage in user fee discussions because we understand that user fees play an essential role in maintaining regulatory processes that efficiently deliver safe and effective products for people who need them. We are generally supportive of FDA’s desire to institute a user fee program for OTC monograph activities,” she said.

She closed by offering three recommendations:

  • The user fee program should be developed through monthly consultation with patient groups, consumer groups, and industry
  • The user fee program should not exceed the amount of appropriated resources devoted to the OTC monograph activities
  • Since the Alliance believes that user fees should not replace appropriated dollars or become a dominant funding source for the agency because they are targeted by nature and do not allow the FDA the flexibility to adapt to changing science, agency and industry should agree to a period of time to re-evaluate the need for the OTC user fee program

To read the Alliance’s remarks in their entirety, please go here.

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