FDA Adopts New Rules On Radio and TV Ads.

The Food and Drug Administration has adopted new rules designed to ensure that prescription drug ads clearly state the drug’s name and list its side effects in a clear, conspicuous, and neutral manner to help consumers to sort through the litany of claims they hear in advertisements. in a growing ad category.

The standards in the final rule help ensure that direct-to-consumer TV/radio ads convey a truthful and non-misleading net impression about the advertised drug and help ensure that consumers are more informed when they participate in health care decision-making, the FDA said in a public notice.

The FDA adopted five new standards in its decision (FDA-2009-N-0582). That includes a rule that information must be presented in consumer-friendly language and terminology that can be easily understood by the average listener or viewer. When it comes to radio ads, the FDA says that the audio information in the main statement that is part of the ad related to the drug’s side effects must be at least as intelligible as the audio information presented in the rest of the ad. , with the amount of information delivered, articulation, and pacing used in the rest of the commercial. That means quick disclosures will no longer be allowed.

This rule provides more direction on how to do this, but leaves many implementation details up to the company, the FDA order said. With regard to this audio presentation, the final standard requires that the volume, articulation, and pacing make the audio presentation of the keynote at least as intelligible as the audio presented in the rest of the advertisement leaving it greatly to the company how it is. want to use audio for all ad content.

In TV-format ads, side effects must be shown both on-screen and, in voiceover, with information on the screen long enough for viewers to easily read it. There will also be new limits on the creativity of those TV ads because the FDA said commercials cannot include distracting audio or visual elements when that information is being transmitted.

The FDA calls the new rules an incremental addition to years’ worth of prescription drug advertising regulations already on the books. The new rules are also in addition to regulations the Federal Trade Commission is placing on over-the-counter drug advertising. For radio, that means that volume, delivery speed of broadcasters, and placement of exposure are all important. The FTC says that a slow and deliberate approach and in a reasonably understandable quantity is necessary to ensure that the area meets its clear and conspicuous standards. The FTC also requires that no other sound, including music, must appear in an audio ad during the side effect disclosure portion of the commercial and that the disclosures must immediately follow the claims in the ads.

New Rules Kick-In Next May

Pharmaceutical companies will have until May 20, 2024, to update their advertising to comply with the new rules. Manufacturers, packers, and distributors of prescription drugs are all covered by the changes.

Matt Kurnick, an attorney at the law firm Foley & Lardner, said the new rule is important for drug companies that engage in direct-to-consumer advertising. Prescription drug companies must devise and implement a new strategy in the coming year to adjust their media practices to clearly display side effects and contraindications within their ads, he wrote. in a blog post.

Kurnick also points out that some companies have questioned whether the new rules have a category that prohibits music when side effects are presented, but the FDA says it will review each ad as a whole to make sure the medical risks of a drug is clear to the audience.

How big of a problem is the radio stuff? The FDA earlier this year issued a review of five drug ads that aired on radio, and found that two violated existing fair balance regulations and also violated rules that side disclosures effect is clear and noticeable.

Good Reasons To Use Radio

Drug makers are among radio’s largest national advertisers. Count Inside the Radio reported last month, Pfizer ranked as the second biggest radio spender in the first eight months of the year with a $59.5 million radio investment according to Vivvix estimates. And Miller Kaplan data shows that AM/FM category ad spending has increased 59% since 2018.

There is good reason for pharmaceutical companies to add a dose of radio to their media plans. Results of seven brand tracking studies commissioned by Cumulus Media/Westwood One suggests that AM/FM radio can do a better job of reaching users of pharmaceuticals and driving awareness than TV.

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