Understanding the New FDA Rules for Prescription Drug Ads: What You Need to Know
The FDA is making significant changes to how prescription drug ads are handled on TV and radio. These changes became effective in May 2024. Starting from November 20, 2024, every ad for a prescription drug must clearly show and explain the drug’s risks, such as side effects and warnings. This information can no longer be rushed through or quickly flashed on the screen at the end of the ad. The goal is to ensure that people watching the ad understand the drug's benefits and risks.
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To help advertisers follow these new rules, the FDA has outlined specific ways to show the risks, including making the information easy to read and hear, presenting it in plain language, and removing distractions.
These new guidelines apply to old and new ads, so it’s essential to start making changes now to ensure all your ads comply with the deadline.
Dual Modality Presentation
The new rules require that the “major statement,” which outlines the key risks of a drug (like side effects), be presented simultaneously in audio and text. This means the risks are spoken aloud and shown on screen simultaneously, helping viewers absorb the information in multiple ways.
Clear and Simple Language
The FDA emphasizes that the risk information must be presented in language that ordinary consumers can easily understand. Medical jargon or overly technical terms are discouraged, as the aim is to ensure clarity for the general public.
Balanced Audio
The volume, clarity, and pacing of the audio that presents the risks must be on par with the rest of the advertisement. This prevents situations where the risks are sped through or spoken too quietly compared to the benefits.
Readable Text on Screen
Regarding the on-screen text, the FDA wants to ensure that viewers can easily read the information. This involves using a significant enough font size, clear contrast between the text and background, and ensuring the text stays on screen long enough for people to read and process it.
No Distracting Visuals or Sounds
During the presentation of the risk information, the ad should not contain distracting visuals or background sounds that could interfere with viewers' understanding of the risks. While some music or visuals may be allowed, they cannot overshadow the importance of the conveyed risk information.
Application to All Ads
These rules apply to new and existing ads running on TV and radio. Additionally, all prescription drug ads, including those that appear in brochures, online, or in print, must be submitted to the FDA electronically before being publicly distributed.
Looking Ahead: Digital Media
While the current rules apply only to TV and radio ads, there is growing pressure to extend these guidelines to digital media, including social media and influencer marketing. Pharmaceutical companies and agencies may want to consider following these standards in all media formats to avoid scrutiny in the future.
The FDA’s goal with these changes is to ensure that consumers receive clear, balanced, and easily understandable information about the risks associated with prescription drugs. With the November 2024 compliance deadline approaching, marketers and drug manufacturers must update their ads to meet these new requirements.
Disclaimer: The information provided in this article is for general informational purposes only and is not intended to be construed as legal advice. Every situation is unique, and you should consult with a qualified attorney for legal advice tailored to your specific circumstances. The author, Simulmedia or Simulmedia employees make no representations or warranties regarding the accuracy or completeness of the information provided and expressly disclaim any liability for actions taken or not taken based on the content of this article.