FDA Policy on Comparative Prescription Drug Advertising

Abstract

Prescription drug advertising is usually designed to develop a particular approach to convince the prescriber that based on clinical safety and effectiveness, that drug should be used in the treatment of a particular disease. Comparing one drug against another has become an increasingly popular method to advertise and promote drugs. Because of the misuse of comparative claims in recent years and the confusion that has resulted in the marketplace, the FDA has taken a stronger stance by clarifying what is and is not acceptable in comparative drug advertising. The use of partial information, the choice of only certain facts from a clinical trial, the use of in vitro evidence, computer modeling, blood or other tissue levels, or pharmacokinetic characteristics of a drug product have been deemed unsuitable to support comparative claims. Evidence must exist that data must relate to clinical significance in humans. The evidence must also be substantial and withstand statistical scrutiny. All promotional claims must be consistent with the approved labeling for the product. By regulation, an advertisement for a prescription drug will be considered false, lacking in fair balance, or otherwise misleading if it contains a drug comparison that represents or suggests that the drug is safer or more effective than another drug when it has not been demonstrated to be safer or more effective by substantial evidence or clinical experience. The drug industry and the FDA both have responsibilities in the pursuit of the best possible advertising and promotion of prescription drugs. The prescribing physician and the public expect this and it would be irresponsible to believe otherwise.