Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published January 1998

OUR VIEW

OTCness: Then and Now

Labeling of OTC drugs has undergone a significant evolution since the patent-medicine era.

R. William Soller
Senior vice president and director of science and technology
Nonprescription Drug Manufacturers Association

Years ago, I could have obtained a free sample of Dr. Wurst's Catarrh Remedy for self-treating asthma, consumption, and other lung-related conditions, simply by writing to the newspaper that advertised the product. Without scientifically based indications, directions, and warnings, Dr. Wurst's remedy provided a questionable benefit with significant risk. Fortunately, today's OTC medicine labels are comprehensive as a result of an evolution in "OTCness."

In the patent-medicine era, OTCness meant the widespread availability of well-advertised medications that often had questionable safety and efficacy. Through defining legislation and regulations—such as the Federal Food, Drug, and Cosmetic (FD&C) Act of 1906 and its 1938 and 1962 amendments, the 1972 OTC Review, and the good manufacturing practices regulation of 1978—OTCness has evolved to a higher standard. As I define it, OTCness is:

The widespread availability of safe, effective, and clearly labeled nonprescription medicines designed for responsible self-care by the consumer and manufactured and advertised pursuant to all applicable laws, regulations, and voluntary industry codes affecting manufacturing, packaging, labeling, distribution, and promotion.

This definition holds industry and government to the highest standard of professionalism in all aspects of R&D, regulatory and legal affairs, production, distribution, marketing, and sales. Manufacturers are challenged to do the right thing the first time, consistent with ethical approaches to the delivery of high-quality finished pharmaceuticals that are labeled correctly and appropriately for safe and effective use.

As the pharmaceutical industry became more highly regulated and science was placed at the cornerstone of OTCness, label information became more comprehensive and consumer friendly. This is in contrast to the patent-medicine era, during which the underlying science was tenuous and claims were fashioned using abstruse medical jargon to give the impression of medical credibility. With good science as the foundation of OTCness, label language is now a simpler and more meaningful communication with consumers.

The evolution of OTCness to its current definition explicitly demands that consumers play a responsible role in self-medication, which involves reading the label, using the product as directed, and seeking more information from a health professional when needed.

Today consumers can confidently purchase OTC medicines at competitive prices, read the labels, use these medicines for safe and effective relief of common ailments, and avoid expensive, time-consuming, and unnecessary physician visits. For this reason, we can be thankful for the dedicated professionalism of industry, government, and the retail marketplace that created OTCness as we know it today.

For more information about the Nonprescription Drug Manufacturers Association, call 202/429-9260.