Pharma DTC Ads Must Be Clear, Conspicuous, and Neutral Manner

The U.S. Food and Drug Administration (FDA) today issued a final rule to amend its regulations concerning direct-to-consumer (DTC) advertisements for human prescription drugs presented in television or radio format.

Since September 1985, the FDA has authorized pharmaceutical DTC advertising and required the advertisements to meet the same legal requirements as those directed at physicians.

Like all advertisers, pharmaceutical firms have incentives to present their products in a positive light to potential consumers.

However, the FDA says that those business incentives do not assure clear communication to consumers of the advertised drug's negative attributes.

In 2022, research data indicates that pharma companies spend about 1 billion dollars monthly.

FIERCE Pharma published a list of the top 10 pharma drug ad spenders for 2022.

Specifically, the FDA's final rule issued on November 21, 2023, implements a requirement of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the FDA Amendments Act of 2007 (FDAAA), that in such DTC TV/radio ads, the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner.

The FDA's final rule establishes five standards that, independently and collectively, help ensure that the major statement is presented clearly, conspicuously, and neutrally. This rule does not change the content of the major statement.

As directed by FDAAA, FDA is establishing these standards.