OTC Monograph Reform

July 25, 2017

By Mark Land, AAHP president
August 1, 2017

Self-medication is an important way in which American consumers treat many types of illnesses.

Over-the-counter (OTC) drugs often provide effective relief in a cost-effective and accessible manner and represent the first choice of treatment for many ailments. More than 80 therapeutic categories of OTC drugs exist and represent an estimated 500,000 products, including acne treatments, sunscreens, laxatives, toothpastes, and medications for eye care, first aid, and colds.

The particular advantages of OTC drug products include their relatively low cost and wide safety margins. Thus, regulatory agencies typically recognize that access to such products, which have proven to be largely safe in the hands of the consumer, require less regulatory oversight than products with more risks or shorter histories on the market.

This view is reflected in the reduced regulatory requirements for OTC products. The U.S. regulatory system for OTC products has a 40-year history of development. The review process was designed to evaluate the safety and efficacy of drugs by therapeutic group, rather than on a product-by-product basis.

Under this system, any OTC drug product produced in conformity to a monograph is allowed to be manufactured and sold in the United States without an individual product license. Although manufacturers have some discretion under a monograph in regard, for example, to inactive ingredients and product claims, many characteristics and requirements of a drug product are typically well defined in a final monograph. Once a monograph has been published, manufacturers are obligated to satisfy its requirements. However, when a monograph is incomplete, the picture is not so clear.

Many monographs remain incomplete after many decades. The uncertainty among manufacturers and marketers of products within these categories and sluggishness in the monograph revision process have handicapped both FDA and industry. FDA reports inadequate authority and dexterity to modify a monograph in the event of safety concerns. Industry cites lack of innovation potential within the current system.

In light of these concerns, industry and FDA have been working for more than two years to redesign the system and remove the obstacles inherent in the revision process. In an early pitch for more resources, FDA announced that it had fewer than 20 people dedicated to the review of OTC drug products. User fees and streamlined administrative procedures became the order of the day. After two years, industry and FDA came to agreement earlier this year.

Although initial legislative efforts were thwarted by financial concerns from adjacent industry associations, the outcome achieved is effective for both industry and FDA. More to come.

Although homeopathic medicines were specifically carved out of the draft legislation enabling OTC monograph reform, the monograph system is a vital touchstone for labelers and marketers of homeopathic drug products. What affects the OTC monograph system affects homeopathic drug products. See our feature article for more on OTC monograph reform.

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Posted in Compliance, Regulatory