Switching from Prescription to over the Counter

Under the federal laws governing the U.S. Food and Drug Administration (FDA) oversight of drugs, any drug that can safely be used by consumers without physician management should be available without a prescription. In 1951, the Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act established criteria for prescription and over-the-counter drugs. Habit-forming drugs listed in the statute are limited to prescription sale, as are drugs that must be administered, or their effects monitored, by a health professional.

Certain classes of drugs (e.g., toxic chemotherapy agents) are unlikely candidates for over-the-counter sale for obvious reasons. But drug makers, health insurers, and patient advocates are asking the FDA to consider allowing an increasingly wide variety of medications for over-the-counter sale. Their motives for seeking a switch vary almost as much as the drugs themselves, and the issues involved are growing more complex as the boundaries of the over-the-counter realm expand.

In 1972, the FDA began the ambitious task of evaluating all drug products sold over the counter. Seventeen expert panels reviewed 20 000 reports and other documents on the safety and efficacy of more than 700 ingredients (

). The FDA then published a series of monographs that established standards for allowable ingredients and appropriate labeling for over-the-counter drugs. The panels also recommended 40 prescription drugs or dosage strengths for transfer to over-the-counter status.

Drugs may be changed from prescription to over-the-counter sale through several administrative mechanisms. Drugs can gain over-the-counter status if one of the FDA monographs describes their ingredients as safe and effective for a specified indication. Switches on many drugs—including analgesics, antihistamines, decongestants, sleep aids, antipruritics, and vaginal antifungal preparations—have used this mechanism over the past 2 decades. Second, the FDA evaluates requests to switch drugs to over-the-counter sale on a case-by-case basis, using a new-drug application (NDA) …