The Food and Drug Administration has adopted new rules to ensure that advertisements for prescription drugs clearly state the name of the drug and list its side effects in a clear, specific, and neutral manner so that consumers will not be affected by the advertisements. To help resolve the claims being heard. In the growing advertising category.
The final rule’s standards help ensure that direct-to-consumer TV/radio advertisements convey a true and non-misleading fair impression about the advertised drug and help ensure that consumers are informed when seeking health care. They get better information if they participate in decision making. the FDA said in a public notice.
The FDA has adopted five new standards in its decision (FDA-2009-N-0582, This includes a rule that information should be presented in consumer-friendly language and terminology that can be easily understood by a general listener or viewer. When it comes to radio ads, the FDA says that audio information in the lead statement, the portion of the ad related to drug side effects, must be at least as understandable as the audio information presented in the rest of the ad. The rest depended on the amount, expression, and pacing of the information used in the advertisement. This means that rapid disclosures will no longer be allowed.
The FDA order says the rule provides more direction on how to do so, but leaves many implementation details up to firms. With respect to this audio presentation, the final standard requires that the volume, articulation, and speed make the audio presentation of the key statement at least as understandable as the audio presented in the rest of the ad, depending largely on the firm. That’s how the ad wants to use audio for all content.
In commercials in the TV format, side effects should be presented both on-screen and in voiceover, with the information on the screen long enough for viewers to read it easily. There will also be new limits on how creative TV ads can be as the FDA says ads can’t include distracting audio or visual elements when information is being broadcast.
The FDA calls the new rules an incremental increase to prescription drug advertising rules already on the books for years. The new rules are in addition to the rules the Federal Trade Commission imposes on over-the-counter drug advertising. For radio, this means that volume, speed of delivery of announcers and place of appearance already matter. The FTC says it requires a slow and deliberate approach and a reasonably understandable amount of time to ensure that the location meets its clear and specific standards. The FTC also requires that no other sounds, including music, appear in an audio ad during the side effect disclosure portion of the ad and that the disclosures immediately follow the ad’s claims.
New rules will come into effect from 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 Kurnik, an attorney at the law firm Foley & Lardner, says the new rule is important for drug companies engaged in direct-to-consumer advertising. Prescription drug companies should design and execute a new strategy in the coming year to adjust their media practices to clearly present side effects and contraindications in their advertisements, he writes. in a blog post,
Kurnik also points out that some companies have questioned whether the new rules explicitly ban music if side effects are presented, but the FDA has said it will evaluate each ad holistically to ensure that it is safe. The medical risks of a drug must be clear to the audience.
How big of a problem are things on the radio? The FDA released a review of five drug commercials aired on radio earlier this year and found that two violated existing fair trade rules and rules that require disclosure of side effects be clear and specific.
Good reason to use radio
Drug manufacturers are among radio’s largest national advertisers. As inside the radio According to last month’s report, Pfizer ranked as the second-largest radio spender during the first eight months of the year with a $59.5 million radio investment, according to Vivix estimates. And Miller Kaplan data shows that category ad spending on AM/FM has increased 59% since 2018.
There’s good reason for pharmaceutical companies to add a dose of radio to their media plans. Results for Seven brand-tracking studies Commissioned by Cumulus Media/Westwood One suggests that AM/FM radio may do a better job than TV in reaching users of pharmaceuticals and raising awareness.
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