Should FDA Make More Drugs Available OTC?

By Ronald L. Scott

The U.S. Food and Drug Administration (FDA) recently held public hearings to open debate on the FDAs approach to regulating over-the-counter (OTC) drug products. The FDA is also soliciting comments concerning criteria to be considered in decisions on OTC availability, classes of drug products that should (or should not) be made available OTC, consumer understanding of the benefits and risks of OTC availability, and the FDAs role in switching drugs from prescription to OTC status. The FDA is reconsidering the issue of OTC availability for a variety of reasons. It recognizes the "continuously changing health care environment including the self-care movement."

The criteria for determining whether a drug should be available only by prescription were originally established in 1951 by the Durham-Humphrey amendments to the federal Food, Drug and Cosmetic Act (Act). The Act requires that drugs that cannot be used safely without professional supervision be dispensed by prescription only. Such drugs may be considered unsafe for OTC sale because they are addictive, toxic, have too many potentially harmful side effects, or are for the treatment of medical conditions that cannot be readily self-diagnosed. All other drugs may be sold OTC. See the FDAs Questions and Answers Over-the Counter Drug Products available at

A number of drugs have changed from prescription to OTC status with the FDAs approval, including:

The FDA considers whether labeling can be written that allows consumers to safely self-medicate before allowing prescription drugs to be sold OTC. Labeling is usually re-written when a drug changes from prescription to OTC status, and sometimes the OTC version of a drug may be marketed at a lower dose than the prescription version.

Consumers generally benefit from OTC status by having access to safe and effective drugs that can be taken without a physicians supervision. Cost of drugs typically drops considerably when they switch to OTC status. For example, the allergy drug Claritin is available OTC in Canada, but requires a prescription in the U.S. A months supply OTC costs about $17, while a prescription costs about $60, not including the physicians fee for prescribing the drug. Blue Cross of California would like Claritin to be changed to OTC status. However, the manufacturer opposes selling Claritin OTC in the U.S. reportedly to protect its profits. Also, even if the drug becomes available OTC, and is cheaper as a result, many insured patients may actually be hurt, since few health plans cover the cost of OTC drugs.

The issue of whether more drugs should be available OTC is complex, involving issues of patient safety, freedom of patients to self-medicate, drug costs, insurance reimbursement, and pharmaceutical company profits. Appropriate public policy is clearer for certain classes of drugs. For example, antibiotics should not be sold OTC, since they may become less effective if used too frequently or improperly. Claritin may be an interesting test case for the FDA, since the usual sequence is for the manufacturer to request the change to OTC status. It has been reported that if the FDA allows Claritin to be sold OTC, manufacturer Schering-Plough Corp. will file suit to block the change.