ABSTRACT
This is the era of evidence-based medicine, wherein the scientific method provides pharmaceutical companies with the methods to prove their nonprescription medications are both safe and effective. This chapter examines the interplay among over-the-counter (OTC) manufacturers, the regulatory Agencies, the profession of Pharmacy and those associated with it. The Reader will notice one underlying theme: Whenever there is a conflict between Public Health and profits, OTC manufacturers may act in their own self-interest, regardless of potential dangers to people who purchase their OTC products. At the height of the patent medicine scandal, millions of American citizens purchased worthless and dangerous remedies every day. How did this come about? The predatory manufacturers bear the primary responsibility, but much of the blame lies with the Proprietary Association (PA). During the prolonged struggle that led up to the 1938 Food, Drug, and Cosmetic Act, the PA vigorously attempted to protect the interests of the manufacturers rather than those of the consumer.
