When Prescription Drugs Go OTC, Ads Talk Less of Harms: Study

By Jenifer Goodwin HealthDay Reporter

TUESDAY, Sept. 11 (HealthDay News) -- When prescription drugs become available over-the-counter, advertisements for the medications are far less likely to tell consumers about the potential harms and side effects, new research finds.

The reason for it, experts say, likely has to do with which federal agency regulates the marketing materials for each type of drug. The U.S. Food and Drug Administration (FDA) regulates ads for prescription drugs, while ads for over-the-counter drugs are regulated by the U.S. Federal Trade Commission (FTC).

The FTC has much less stringent standards than the FDA for what manufacturers have to reveal about products in their marketing materials, the researchers noted.

The FDA requires prescription drug advertising to provide consumers with a "fair balance" of risks and benefits -- for drug ads, that often means rattling off a lengthy list of potential side effects.

The FTC, on the other hand, holds drug advertisements to the same standards as other consumer products, requiring a "reasonable" standard of truthfulness.

The looser requirements mean that information about potential side effects and harm aren't included in most over-the-counter drug ads, said study author Dr. Jeremy Greene, an associate professor in the history of medicine department and the department of medicine at Johns Hopkins University.

"One of the FDA's guiding principles for regulating direct-to-consumer ads for prescription drugs is there needs to be a fair presentation of the risks and benefits," Greene explained. "The FTC has fewer requirements or specific regulations for how risks and benefits should be presented. The FTC is interested in making sure there are no fraudulent statements being made, and there is no active deception."

The findings are published in the Sept. 12 issue of the Journal of the American Medical Association.

Greene and his colleagues analyzed print and broadcast advertisements for four commonly used drugs that were heavily marketed to consumers as prescription drugs and then approved for sale over-the-counter.

Read more:
When Prescription Drugs Go OTC, Ads Talk Less of Harms: Study