New FDA Rule Will Require Clear, Conspicuous Warnings on Drug Ads for Consumers

Federal regulators have finalized new rules that are designed to better govern how drug companies can promote prescription medications through advertisements that directly target consumers on TV, radio and other forms of media.

The U.S. Food and Drug Administration (FDA) published a final rule on direct-to-consumer prescription drug advertisements in the Federal Register on November 21, which will require advertisers to present warning and risk information in a “clear, conspicuous and neutral manner”, as well as explicitly state the name of the drug and its conditions of use.

The regulations involve five standards, including that information is presented in consumer-friendly language and terminology, and that the key message should include clear text displayed on the screen long enough for it to be read easily by viewers. Additionally, drug makers must clearly lay out potential side effects linked to the drug, when a person should avoid taking the medication, and avoid audio or visual elements that may distract consumers from the drug’s negative side effects.

The audio information about a drug’s side effects must be as understandable as the rest of the commercial. This requirement, specifically, will change the way many drug ads have a rapid and frenzied portion toward the end that lists the long list of potential side effects, a segment of drug ads that is nearly unintelligible.

The new requirements only apply to prescription drugs and not over-the-counter drugs, dietary supplements, and other products.

Consumer Drug Advertising Concerns

Drug advertisements have increased dramatically in recent decades, and now account for billions of dollars in direct-to-consumer marketing. However, many drug ads rely on emotional appeals that highly focus on benefits provided by the medication, instead of equally presenting both benefits and potential risks.

Direct-to-consumer ads are banned in all developed countries, with the exception of the U.S. and New Zealand.

Research indicates drug ads influence consumers and can cause them to seek out information on specific drugs and discuss them with their doctors.

Some critics say federal regulators are not strict enough with existing drug commercials, and those ads violate federal guidelines. The FDA launched several studies in 2018 focusing on drug advertising designed to promote disease awareness instead of specific drugs to test how similar those ads were to direct-to-consumer drug ads.

The agency proposed updating advertising standards in 2010 but did not finalize the regulations until now.

The rule, which falls under the Federal Food Drug and Cosmetic Act added by the FDA in 2007, goes into effect on May 20, 2024, with a compliance date of November 20, 2024.