Pew and the American Academy of Pediatrics Outline Principles for Over-the-Counter Drug Regulation Reform

Americans routinely turn to over-the-counter (OTC) drugs to treat a wide variety of ailments, from coughs to stomachaches. And they have a growing number of choices: The OTC market now includes more than 300,000¹ products, with annual sales of $32 billion.² But the framework for evaluating these medications, established in 1972,³ has not kept pace with scientific discovery, putting consumers at risk and slowing innovation of OTC drugs.

The Food and Drug Administration reviews the safety and effectiveness of active ingredients present in categories of OTC drugs, rather than individual products. Its findings are used to create monographs, which provide the “recipe” for the creation and labeling of products. If FDA seeks to update an existing monograph or create a new one based on scientific and medical determinations about a specific ingredient, it must follow a procedure that includes comment periods and reviews by many outside agencies. The White House Office of Management and Budget, for example, must determine cost implications. This complexity, combined with limited resources and restricted authority to mandate adequate data from manufacturers, makes it hard for FDA to keep up with scientific developments, address safety concerns, and accommodate innovation.

This cumbersome process has real-world implications. Until pending changes to monographs are finalized, any OTC drugs with ingredients that have been demonstrated to be unsafe or ineffective can legally remain on the market. In addition, any new scientific information about a product cannot be added quickly to the monograph. This process is further complicated by the fact that every proposed change to a monograph is a new regulation and therefore has to be evaluated for more than safety and effectiveness. It is clear that consumers and manufacturers need a more efficient FDA review process to ensure that the agency can act on up-to-date scientific information, encourage product innovation, and respond quickly to safety risks.

The undersigned medical associations and consumer interest organizations urge Congress to help streamline and modernize FDA’s OTC monograph system based on the core principles outlined below. The new law should:

1. Eliminate the rulemaking process for creating and updating monographs; FDA must have a more efficient mechanism for making changes.
2. Allow FDA to take swift action to address emerging safety issues regarding the use and misuse or abuse of OTC drugs.
3. Allow FDA to accommodate innovation in OTC drug products, permitting new uses, dosage forms, and other developments that have been demonstrated to be safe and effective.
4. Include an efficient mechanism for FDA to receive and compile data to make determinations on safety and effectiveness, including a means to obtain the data from industry within a reasonable time frame and a standardized procedure to facilitate data submission, collection, and analysis.
5. Establish FDA as the final arbiter of scientific evidence on the safety and effectiveness of ingredients and changes to monographs, as is true for prescription drugs and medical devices.
6. Ensure that FDA has adequate resources devoted to OTC oversight.

Incorporating these principles will make the monograph system more flexible, evidence-based, and responsive to emerging public health concerns. By addressing regulatory barriers, it will promote innovation by increasing access to improved drug formulations and dosage forms that are safe. Moreover, it will provide reassurance that the OTC drug regulatory system can respond rapidly to evolving science and new information on the safety and efficacy of nonprescription drugs. The monograph system was established more than 40 years ago, and it is time for meaningful reform.

These principles are supported by:

• American Academy of Allergy, Asthma & Immunology
• American Academy of Dermatology Association
• American Academy of Pediatrics
• American Public Health Association
• March of Dimes
• National Association of County and City Health Officials
• Society for Maternal-Fetal Medicine
• The Pew Charitable Trusts

Kirsten Moore directs Pew’s health care products project.

1. Food and Drug Administration, “Drug Applications for Over-the-Counter (OTC) Drugs,” accessed Dec. 19, 2016, http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/over-the-counterdrugs/default.htm.
2. “OTC Retail Sales 1964-2015,” Consumer Healthcare Products Association, accessed Nov. 18, 2016, http://www.chpa.org/PR_OTCRetailSales.aspx.
3. U.S. Department of Health and Human Services, Food and Drug Administration, “Procedures for Classification of Over-the-Counter Drugs,” 37 Fed. Reg. 9464 (May 11, 1972).