News outlets are reporting that pharmaceutical giant Johnson & Johnson promoted the Ertaczo (sertaconazole nitrate) anti-fungal cream by using a medical journal advertisement that allegedly relied on unproven claims to describe efficacy and downplayed risks.
According to the U.S. Food and Drug Administration’s (FDA) August 21 letter to Johnson & Johnson, the advertisement, “contains unsubstantiated efficacy claims about the product, and omits important risk information… These claims are misleading because they greatly overstate the efficacy of this product.” According to the Wall Street Journal, the agency said that, according to trials conducted on Ertaczo, the trials “clearly do not support the claims that Ertaczo ‘wipes out’ or crushes, kills, and destroys tinea infections.” Tinea, said the Journal, is a fungus that can cause athlete’s foot.”
According to the Journal, the advertisement posted in the medical publication for Ertaczo uses prominent lettering that states, “Crush. Kill. Destroy.” and says that Ertaczo “Wipes Out” the fungus that causes ringworm, athlete’s foot, and jock itch.
Marc Boston, a spokesman for Johnson & Johnson’s Ortho Dematologics unit, the firm is currently reviewing the letter, reported Reuters, and preparing its answer, added the Wall Street Journal. Johnson & Johnson has been asked to respond to the agency by September 4 and is to indicate if it plans on stopping the ad and how it plans on closing down the ad program. “We have received an untitled letter from the FDA, which we are currently reviewing, and are in the process of preparing our response to the FDA,” said Boston, quoted the Associated Press (AP).
According to the FDA, Johnson & Johnson should have—but did not—submitted the questionable ad for review prior to releasing it for publication to a medical journal, said the Wall Street Journal. Current FDA regulations mandate that such advertisements be submitted to the agency for review prior to being released, explained the AP. In fact, Johnson & Johnson waited six months until after the ad first ran to submit it to the FDA, said the Journal, which noted that the ad is known to have run at least in Dermatology Times.
The FDA stated in its letter that, regarding any medication’s efficacy, “Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience.” If promotional materials, “fail to reveal facts that are material” when looking at the advertising materials, “or with respect to the consequences that may result from the use of the drug as recommended or suggested by the materials,” then those advertising materials are considered misleading.
Regarding Ertaczo’s risks, according to the agency, Johnson & Johnson’s ad does not effectively explain, and actually “omits these important risks,” and “misleadingly suggests that Ertaczo is safer than has been demonstrated” via clinical trials.
The FDA called for Johnson & Johnson to, “immediately cease the dissemination of violative promotional materials for Ertaczo.”
The complete letter can be accessed here.