The Food and Drug Administration has approved new rules aimed at ensuring that advertisements for prescription drugs clearly mention the drug’s name and list its side effects in a clear, visible and neutral way, so that consumers can clarify the claims they hear in the ads. in a growing advertising category.
The standards in the final rule help ensure that direct-to-consumer TV/radio advertisements convey a truthful and non-misleading net impression of the advertised drug and help ensure that consumers are better informed when participating in health care decision-making. FDA says in a public notice.
The FDA has approved five new standards in its decision (FDA-2009-N-0582). This includes the rule that information must be presented in consumer-friendly language and terminology that is easily understood by the typical listener or viewer. With regard to radio ads, the FDA says that the audio information in the main sentence of the ad about the side effects of the drug must be at least as comprehensible as the audio information presented in the rest of the ad. the amount, articulation and pacing of information used in the rest of the ad. This means that quick activity disclosure is no longer allowed.
This rule provides more guidance on how to do that, but leaves many of the details of implementation up to the company, the FDA order said. For this voice presentation, the final standard requires that the volume, articulation and pacing make the voice presentation of the main sentence at least as comprehensible as the voice presented in the rest of the advertisement, leaving it essentially up to the company to decide how it is presented. wants to use sound in all ad content.
In advertisements in TV format, the side effects must be presented both on the screen and in the narration, so that the information is long enough for the viewers to read it easily. There will also be new restrictions on the creativity of television commercials, as the FDA says commercials must not contain distracting audio or visual elements when conveying that information.
The FDA is calling the new rules an incremental addition to years of prescription drug advertising regulations already on the books. The new rules also supplement the Federal Trade Commission’s regulations regarding over-the-counter drug advertising. For radio, this has meant that the volume, the speed of the announcers’ delivery and the placement of the revelation have already mattered. According to the FTC, a slow and deliberate manner and a reasonably intelligible volume are required to ensure that a venue meets its clear and visible standards. The FTC also requires that no other sounds, including music, appear in an audio ad during the part disclosing the side effects of the ad, and that the disclosure must immediately follow the claims made in the ads.
The new rules will enter into force next May
Pharmaceutical companies have until May 20, 2024 to update their advertising to comply with the new rules. The changes cover all manufacturers, packers and distributors of prescription drugs.
Matt Kurnick, an attorney at the law firm Foley & Lardner, says the new rule is significant for pharmaceutical companies that engage in direct-to-consumer advertising. In the coming year, prescription drug companies must plan and implement a new strategy to adapt their media practices so that side effects and contraindications are clearly visible in their ads, he writes. in a blog post.
Kurnick also notes that some companies have questioned whether the new rules will categorically ban music when side effects are presented, but the FDA has said it will evaluate each one holistically to make sure the drug’s medical risks are clear to the public.
How big is the problem with the radio? Earlier this year, the FDA released a review of five radio drug ads and found that two violated existing fair balance rules and also violated rules requiring clear and prominent disclosure of side effects.
A good reason to use the radio
Pharmaceutical manufacturers are the largest national advertisers on radio. Like Inside the radio Pfizer, reported last month, was the second-largest radio spender in the first eight months of the year, with $59.5 million in radio investment, according to Vivvix estimates. Miller Kaplan data shows AM/FM ad spending in the category has grown 59% since 2018.
Pharmaceutical companies have good reason to add a dose of radio to their media plans. Score seven brand follow-up studies subscriber Cumulus Media/Westwood One suggests that AM/FM radio can better reach drug users and raise awareness than television.
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