The Food and Drug Administration has adopted new rules designed to ensure that prescription drug ads clearly state the name of the drug and list its side effects in a “clear, conspicuous, and neutral manner” to help consumers sort through the litany of claims they hear on commercials in the growing ad category.
“The standards in the final rule help to 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 better informed when they participate in healthcare decision-making,” the FDA says in a public notice.
Five new standards have been adopted by the FDA in its ruling (FDA-2009-N-0582). That includes a rule that the information must be presented in “consumer-friendly” language and terminology that is readily understandable by the typical listener or viewer. When it comes to radio ads, the FDA says the audio information in the major statement – the part of the ad related to the side effects of the drug – must be at least as understandable as the audio information presented in the rest of the ad, with the information delivered volume, articulation, and pacing used in the rest of the commercial. That means rapid-fire disclosures will no longer be allowed.
“This rule provides more direction on how to do so, but leaves many implementation details up to the firm,” the FDA order says. “With regard to this audio presentation, the final standard requires that the volume, articulation, and pacing make the audio presentation of the major statement ‘at least as understandable as the audio presented in the rest of the advertisement’ leaving it substantially up to the firm how it wants to use audio for all the content in the ad.”
In ads in TV format, the side effects must be presented both on-screen and, in the voiceover, with the information on-screen long enough for viewers to easily read it. There will also be new limits on how creative those TV ads can be since the FDA says the commercials cannot include distracting audio or visual elements when that information is being relayed.
The FDA calls the new rules “an incremental addition” to the years’ worth of prescription drug advertising regulations already on the books. The new rules are also in addition to regulations that the Federal Trade Commission puts on over-the-counter drug advertising. For radio, that has meant that volume, speed of the announcer’s delivery, and placement of the disclosure have already mattered. The FTC says a “slow and deliberate manner and in a reasonably understandable volume” are required to ensure that the spot meets its “clear and conspicuous'' standards. The FTC also requires that no other sounds, including music, should appear in an audio ad during the side effect disclosure portion of the commercial and that the disclosures should immediately follow the ad’s claims.
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, says the new rule is “significant” for drug companies engaged in direct-to-consumer advertising. “Prescription drug firms must devise and execute a new strategy in the coming year to adjust their media practices to clearly present side effects and contraindications within their ads,” he writes in a blog post.
Kurnick also points out that some companies have questioned whether the new rules categorically ban music when the side effects are presented, but the FDA has said it would assess each ad holistically to ensure that the medical risks of a drug are clear to the audience.
How big of a problem are things on radio? The FDA earlier this year released a review of five drug ads that aired on radio, and it found that two violated the existing fair balance regulations and also violated the rules that side effect disclosures be clear and conspicuous.
Good Reason To Use Radio
Drug makers are among radio’s biggest national advertisers. As Inside Radio reported last month, Pfizer was ranked as the second-biggest radio spender during the first eight months of the year with a $59.5 million radio investment according to Vivvix estimates. And Miller Kaplan data shows the category's ad spend on AM/FM has increased 59% since 2018.
There is good reason for pharmaceutical companies to add a dose of a radio to their media plans. Results of seven brand-tracking studies commissioned by Cumulus Media/Westwood One suggest that AM/FM radio can do a better job reaching users of pharmaceuticals and driving awareness than TV.
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