FDA’s Division of Drug Marketing Communications, this week, posted a slew of warning and untitled letters to pharma firms for misleading skincare advertisements. Johnson & Johnson, Galderma, and Allergan each received a letter documenting complaints ranging from false advertising to unsubstantial efficacy claims.
J&J received a violation letter in response to a journal ad for its topical anti-inflammatory cream Ertaczo, emblazoned with the words “Crush. Kill. Destroy,” in large, orange letters. FDA states that the company is way off-base in touting total annihilation of athlete’s foot, rather that a decrease and potential for cure.
“Although [trial] results show modest effectiveness, they clearly do not support the claims that Ertaczo ‘wipes out’ or crushes, kills, and destroys tinea infections,” DDMAC wrote in the letter.
FDA also took issue with the suggested claims that Erataczo is approved for all patients. In fact, the drug is not approved for patients less than 12 years old.
Allergen got an even harsher letter, stating that its journal advertisement for the acne gel Aczone is a complete misrepresentation of the results of a clinical study, and that the ad “grossly overstates the efficacy of the drug by presenting only the most favorable result for Aczone.”
The ad stated that patients could see a reduction in acne by as much as 24 percent in two weeks. The study FDA is referring to showed that at two weeks, patients showed only a 2 percent decrease in inflammatory lesions.
Finally, Galderma received a warning letter regarding professional visual aids for its skin discoloration cream Tri-Luma. According to DDMAC, the ads “suggest uses for Tri-Luma that have not been approved by FDA, and thus create new ‘intended uses’ for the drug for which the product lacks adequate directions, broaden indication for Tri-Luma, and omit and minimize important risk information for the drug.”
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Feds Chase Down Faulty Skincare Promos
J&J received a violation letter in response to a journal ad for its topical anti-inflammatory cream Ertaczo, emblazoned with the words “Crush. Kill. Destroy,” in large, orange letters. FDA states that the company is way off-base in touting total annihilation of athlete’s foot, rather that a decrease and potential for cure.
“Although [trial] results show modest effectiveness, they clearly do not support the claims that Ertaczo ‘wipes out’ or crushes, kills, and destroys tinea infections,” DDMAC wrote in the letter.
FDA also took issue with the suggested claims that Erataczo is approved for all patients. In fact, the drug is not approved for patients less than 12 years old.
Allergen got an even harsher letter, stating that its journal advertisement for the acne gel Aczone is a complete misrepresentation of the results of a clinical study, and that the ad “grossly overstates the efficacy of the drug by presenting only the most favorable result for Aczone.”
The ad stated that patients could see a reduction in acne by as much as 24 percent in two weeks. The study FDA is referring to showed that at two weeks, patients showed only a 2 percent decrease in inflammatory lesions.
Finally, Galderma received a warning letter regarding professional visual aids for its skin discoloration cream Tri-Luma. According to DDMAC, the ads “suggest uses for Tri-Luma that have not been approved by FDA, and thus create new ‘intended uses’ for the drug for which the product lacks adequate directions, broaden indication for Tri-Luma, and omit and minimize important risk information for the drug.”