The United States and New Zealand are the only countries in the world that permit the advertising of prescription drugs directly to consumers. In 2020, 564 new ads for prescription drugs were submitted to the FDA for approval; the reported expenditure for those ads, according to the Federal Register, was $4.58 billion. Expensive brand-name drugs for chronic diseases, in my experience, appear to be the favorite subjects.
The new rule, optimistically called the final rule, “…implements a requirement of the Federal Food, Drug, and Cosmetic Act, added by the Food and Drug Administration Amendments Act of 2007, that in such DTC [Direct-to-Consumer] TV/radio ads, the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner.” This rule was published in 28 pages of The Federal Register, Volume 88, No. 223, on November 21, 2023, beginning on page 80958. It will become effective on May 20, 2024.
How will they do that? The final rule specifies 5 major provisions, slightly edited here:
- The information must be presented in consumer-friendly language.
- The audio information [regarding the side effects and contraindications] must be at least as understandable as the audio information presented in the rest of the ad.
- The audio information must also be presented concurrently in text for a sufficient duration for it to be read easily.
- The text must be formatted for easy readability.
- The ad must not include audio or visual elements that could interfere with comprehension of the side effects and contraindications.
The Agency goes on to say:
“In sum, this rulemaking is an important incremental measure, adding to a longstanding body of legal requirements addressing effective communication of risk information about prescription drugs in consumer-directed promotional communications.”
Amen.
More@MedLetter 
These ads shouldn’t even be allowed on TV. Also, new and unheard of
medical conditions that may be duplicating an actual recognized condition.
One wonders if it is likely that the multi-billion dollar annual purchases of TV & radio ads might influence (bias) media news investigations and reporting on issues important to major drug companies. Such issues could include; drug prices, drug costs, drug side-effects, polypharmacy, critical drug shortages, or disease reporting …. I guess one can only speculate.
tn MD
DTC prescription drug advertising is absolutely reprehensible! It is such an overt greed induced practice that is completely unprofessional. Let physicians decide which drugs their patients require, not the the lay public who can be so easily manipulated by Big Pharma.
John Doe, Pharm.D., BCPS