Coalition’s comments to the FDA on User Fees for Over-the-Counter Drugs

Thank you for the opportunity to speak today.  My name is Paul Brown and I am speaking on behalf of 10 members of the Patient, Consumer, and Public Health Coalition.  Our informal coalition of nonprofit organizations represents the interests of patients, consumers, health-care professionals, scientists, and public health experts.

We support providing FDA with additional resources through the implementation of OTC user fees, so the agency can fulfill its mission of protecting the public from dangerous and ineffective OTC products.  Additional funding will help FDA to finalize the remaining OTC monographs, and allow patients and consumers to have confidence in the OTC products they use every day.

Since the OTC drug review process was established in 1972, FDA has struggled to complete the safety and efficacy evaluations of ingredients used in OTC drug products.  More than 40 years later, the monograph process still has not been completed for all ingredients and conditions of use.

As a result, many OTC products without a general recognition of safety and effectiveness (GRASE) determination continue to be marketed, leaving millions of American vulnerable to potentially unsafe products.

A staff of only 18 people cannot effectively regulate 800 active ingredients for over 1,400 different therapeutic uses. We are particularly concerned about how the current process limits FDA’s ability to require new warnings or other labeling changes to address emerging safety or effectiveness issues in a timely manner.

We strongly urge FDA to include funding in user fees to address emerging safety and effectiveness issues.  FDA needs resources to provide ongoing surveillance of marketed products and move quickly when safety signals arise.

This is especially important for products used by children. When the monographs were first developed in the 1970s, FDA lacked specific data on use in infants and children.  So, FDA did what was scientifically customary at the time and extrapolated the data by simply reducing adult doses by a percentage.

Our understanding of pediatric dosing has grown since then and, as a result, data from actual use in the pediatric population is preferred.  Many products continue to be given to infants and children without sufficient safety and effectiveness data. OTC user fees are needed to support the reexamination of the use of these products in children.

OTC product user fees should also support the development of product formulation standards. The monographs set forth the conditions under which a specific active ingredient used in a drug product is generally recognized as safe (GRAS) and generally recognized as effective (GRAE) and not misbranded.

The monographs, however, generally do not dictate what other non-active ingredients can be added, or other aspects of the formulation. For example, we know that many product formulation variables affect how much of a tablet’s medication dose is absorbed. The regulatory science behind generic drugs has shown us that excipients and manufacturing quality control must factor into the determination of a product’s safety and effectiveness. Therefore, we recommend development of standards for drug products, not just their ingredients; and we urge FDA to include funding for this in user fees. (As United States Pharmacopeia (USP) has recommended.)

A user fee system for OTC drugs will have to take into account the way OTC drugs come to market.  Since the monograph system is ingredient-based and not product-based and, since sponsors of monograph drugs are not required to obtain FDA approval prior to marketing, the fee structure will have important differences as compared to that used by the prescription drug programs.

We recommend that user fees be structured as a product listing fee based on a sliding scale proportionate to the complexity and reviewing resources required. We feel this mechanism would provide the agency with a stable and predictable source of funding for the OTC division.

We would avoid structuring the fee as a facility fee since it may have the unintended consequence of pushing sponsors to consolidate operations into as few facilities as possible. This could impact the supply chain and cause OTC drug shortages, if a facility is removed from operation.

In summary:

  • We support the establishment of a user fee program for OTC drugs so that all OTC monographs can be finalized.
  • We urge you to include funding in user fees to address emerging safety and effectiveness issues as well to reexamine use of certain OTC products in infants and children. Additional resources are critical to protect public health.

Thank you for your attention.

American Medical Student Association




National Center for Health Research

Our Bodies Ourselves

Quinolone Vigilance Foundation

The TMJ Association

Washington Advocates for Patient Safety


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