Do you think this ad is "fair and balanced"; ie, presents risk information that is "comparable in depth and detail with the claims for effectiveness or safety" as required by the Federal Food, Drug, and Cosmetic Act?
FDA issues "notice of violation (NOV)" letters to drug companies when it feels that promotional pieces overly minimizes risk information.
Should FDA send a NOV letter to Allergan, which markets Juvederm?
"Promotional materials are misleading," said FDA in a recent letter to Meda Pharmaceuticals regarding an Astelin promo piece (see "FDA Warns Meda Pharmaceuticals that Astelin Isn't Approved as a Cure for House Cleaning!"), "if they fail to present information about risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug."
With regard to the Astelin promo piece, FDA noted "the only risk information contained on the sign (a disclosure of common adverse events) is presented at the bottom of the sign after the indication for the drug in extremely small font size and in a single-spaced format that makes this information very difficult to read."
Clearly, the Juvederm ad also presents risk information in hard to read "mouse typeface." But let's take a more scientific, quantitative approach. I compared the area devoted to risk information versus benefit information in both the Astelin and Juvederm ads. My thesis is that there is a similar quantitative de-emphasis of risk information in the latter as in the former and that Allergan should also receive a letter from the FDA.
I don't know if the FDA will send a letter to Allergan or not. FDA has sent letters regarding violations that seem as trivial as this one may be. I'll be keeping an eye out.
I agree, John. I do not see the risk information clearly communicated. The ad makes this sound like the beauty fairy will just wave a wand over my face and viola, I am young again. As a woman who has those parens on my face (sigh) I would be motivated to consider this treatment if Allergan presented a more serious ad rather than play to my assumed vanity and attempt to use this as a lever to change my behavior.
ReplyDeleteHi John,
ReplyDeleteI'm not defending Allergan, and I like your post and how you've quantified the manner in which this ad does not meet the required standards, but what is the real problem here?
Yeah, so they accentuate the positive over the possible negatives, probably stepping over the line in the process. Big deal! Fact remains, this product received regulatory approval; therefore it is likely to be safe overall or it wouldn't be on sale, right?
I would never make a major purchasing or lifestyle decision without doing my research - why should pharmaceuticals be treated any different? "Caveat emptor" as they used to say...
I admit I have a bone to pick with Allergan, which has run Botox reminder ads for years without having to list any of it's side effects. They could do this because Botox had no competition and then it became so well known, it was necessary to mention it's indication in ads - nor its side effects. Juvederm, however, does have competition. Therefore Allergan can't get away with reminder ads and must include side effect info. Allergan, however, appears to be trying to make Juvederm ads look just like Botox ads.
ReplyDeleteIn previous comment, I meant to say "it was NOT necessary to mention it's indication in ads" re Botox ads.
ReplyDeleteI think you missed the point of the FDA letter re Astelin:
ReplyDelete"The sign is misleading because it implies that Astelin is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience. Specifically, it prominently presents the headline, “Allergic to house cleaning?” and suggests Astelin will treat this condition. House cleaning is typically associated with exposure to perennial allergens such as dust mites, molds, and pet dander. Astelin is not approved to treat perennial allergens associated with perennial allergic rhinitis, therefore please stop implying it will cure house cleaning allergy."
The issue is NOT whether the 2 companies devoted equal space to risks and benefits.
Your question should be whether Juvederm has the indication to treat parentheses lines.