FDA Ad Division Objects To User-Friendly Efficacy Claims With Jargon

About the Author

Richard Meyer is a passionate Internet DTC marketer with over 15 years of progressive experience in consumer marketing who`s worked on top pharmaceutical brands like Cialis, Prozac and Sarafem, as well as two years with Medtronic Diabetes. He is currently consulting for his own company, Online Strategic Solutions, and writes a DTC column for PM 360 magazine and blogs for Eye for Pharma in addition to his own blog, World of DTC Marketing.

Another barrier to social media use by pharma? The FDA expects drug advertisements to use the same level of language to convey both safety and efficacy information, according to a pair of letters from the Division of Drug Marketing, Advertising and Communications. In both a Jan. 26 letter regarding Meda’s Astelin and a Jan. 22 letter for Novalar’s OraVerse , FDA’s ad enforcement division took issue with the use of user-friendly language for the efficacy claims while the risk information was presented using less-clear scientific terminology. Even if it’s easier to understand for consumers and patients.

The Astelin (azelastine HCl nasal spray) letter, citing a waiting room sign for the allergy drug, DDMAC objects that “in contrast to the consumer-friendly claims on the sign, some of the risk information that is disclosed (i.e., ’somnolence’ and ‘rhinitis’) is presented in medical terminology that is not likely to be understood by consumers.”

Similarly, the citation of a patient brochure for OraVerse states that: “While the patient brochure presents efficacy claims for OraVerse in language that is easily understandable to consumers, it presents risk information using complex medical terminology that is not likely to be comprehended by the same audience.”

Both citations rely on the prominence standard: FDA considers ads to be misleading “if they fail to present information about the risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug.”

What does this mean for the drug industry and patients? It means that they are likely to continue to be confused by the language that the FDA wants and it means that the drug industry may not be able to engage and talk to consumers & patients via social media without using the label as the script.

While there is a fine line between omission of information and user friendly language this is another clue that the FDA is not willing to make it easier for consumers and patients to understand medical information even though more of them are searching for medical information than ever before. In fact our recent research clearly showed that consumers were frustrated with the language on drug product sites.

Something else to consider;

▪ 46 million American adults are functionally illiterate.

▪ 40 million Americans read at or below 4th grade reading level.

▪ Nearly half of all American adults –90 million people– have difficulty understanding and using health information.

▪ The average American comprehends between a 4th – 7th grade level.

▪ 26% of Americans can’t understand when their next doc appt is scheduled.

▪ 42% of Americans do not comprehend instructions to “take medication on an empty stomach.”

▪ 49% of Americans cannot determine if they are eligible for free care by reading hospital financial aid forms.

▪ 60% of Americans cannot understand a standard consent form.

Leave it to the FDA to think like scientists and enforcers rather than consumers and patients.