New FDA rules for TV drug ads: Simpler language and no distractions
Source: AP
Updated 10:09 AM EST, November 14, 2024
WASHINGTON (AP) — Those ever-present TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different look: New rules require drugmakers to be clearer and more direct when explaining their medications’ risks and side effects.
The U.S. Food and Drug Administration spent more than 15 years crafting the guidelines, which are designed to do away with industry practices that downplay or distract viewers from risk information.
Many companies have already adopted the rules, which become binding Nov. 20. But while regulators were drafting them, a new trend emerged: thousands of pharma influencers pushing drugs online with little oversight. A new bill in Congress would compel the FDA to more aggressively police such promotions on social media platforms.
“Some people become very attached to social media influencers and ascribe to them credibility that, in some cases, they don’t deserve,” said Tony Cox, professor emeritus of marketing at Indiana University. Still, TV remains the industry’s primary advertising format, with over $4 billion spent in the past year, led by blockbuster drugs like weight-loss treatment Wegovy, according to ispot.tv, which tracks ads.
Read more: https://apnews.com/article/drug-ads-fda-risks-side-effects-influencers-80bbe076f4ed743ebde3923dd28be004
Link to Federal Register FINAL RULE - Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format
Link to GUIDELINES (PDF) - https://www.fda.gov/media/175074/download
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Because over 60 years ago, Congress told FDA to do it (rather than have the FTC do it like they do other TV advertising) - S. 1552 (87th): An Act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to assure the safety, effectiveness, and reliability of drugs, authorize standardization of drug names, and clarify and ...... strengthen existing inspection authority; and for other purposes
At the time, most of that was done as "labeling via inserts" or through medical publications, but not really to TV, so it wasn't necessarily a big deal until obviously TV became a huge "thing". You also had many consumers desire this because they felt their doctors were operating in some kind of "black box" without any impetus to explain the whats and whys of the drugs they were prescribing. I know I grew up with a PDR (Physician's Desk Reference) in my household!
Congress has tried to amend those amendments to the FD&C Act for years but none have been able to get through and come to fruition.
