FDA Requires Drug Companies to Be More Transparent About Side Effects in Ads

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

In a final ruling published on Tuesday, Nov. 21, the U.S. Food and Drug Administration established five new guidelines regulating how the $1.3 trillion prescription drugs market can advertise its products to consumers on television and radio.

The bottom line is that ads must clearly present side effects and contraindications in plain language so consumers can make informed healthcare decisions.

What Do Drug Companies Have to Do Now?

Advertising from drug manufacturers must now be “clear, conspicuous, and neutral” in lieu of using an emotional appeal that may mislead consumers about the attributes of the product or service, the FDA wrote in the ruling.

The new rules are:

1. Information must be clear and in a language that is readily understandable by consumers
2. Audio must be understandable in terms of volume, articulation, and pacing
3. Television ads must include text and audio, and the text displayed must match the audio, be shown for long enough, and be easy to read
4. Advertising must not include elements, such as statements, text, images or sounds, that distract from the main message of the ad
5. Any text used must be large enough and in an easily-readable font

Notably, ads no longer need to explain how a drug works or what its benefits are. Simply listing major side effects and conditions preventing use is sufficient, according to the ruling.

The ruling is an update of a 2010 decision that required ads to be presented to consumers in easily understandable language and with text that was easy to read. The FDA was given authority by Congress in 2007 to pursue regulation of the pharmaceutical industry.

Why the Update Matters?

Americans see up to 10,000 ads daily, but few provide information as vital as prescription drugs, the FDA wrote, noting that the ads influence healthcare choices, yet often race through risks too fast to comprehend fully—“as if being uttered by an auctioneer.”

When images imply benefits that words contradict, comprehension suffers more. For example, when a prescription drug ad shows a positive scene, but the voiceover is talking about adverse side effects, consumers are at a disadvantage, according to the FDA.

With the $6.88 billion spent in 2021 on direct-to-consumer pharmaceutical ads, clear communication is essential. Though consumers don’t directly access prescription drugs, companies recognize the value of marketing to end-users.

There’s a lot at stake when consumers don’t understand contraindications. Making those clear protects people accessing telehealth services, which increasingly prescribe remotely.

Consumers should always consult doctors and pharmacists first to understand interactions and risks when taking new medications.