An online promotion by Merz Pharmaceuticals for prescription athlete’s foot cream Naftin have run afoul of the Office of Prescription Drug Promotion.
The violations cited in the recently posted letter, dated July 31, include what seems to be the familiar minimization-of-risk notation from the FDA’s advertising watchdog unit, until the second page, when the regulator notes that while the website fails to hit the transparency mark, two banner ads go one step further and “fail to include any risk information associated with the drug.”
The transgression is further compounded by the websites to which the banners link—OPDP wrote that the web pages fall flat because they “completely omit the warning and precaution for local adverse reactions.” OPDP noted that while these pages do include common adverse reactions, the omitted information on the banners and web pages make the drug appear “safer than has been demonstrated.”
OPDP also noted that the promotional claim, “More than 90% of patients were able to adhere to the full course of treatment,” is misleading, because it leverages clinical trial data which did not have adherence endpoints to “evaluate the claimed outcome of patient adherence.”
OPDP precludes possible patient diaries as support for the adherence claims, because “there is no documentation to support that the diaries utilized in the studies are well-defined and reliable assessments of patient adherence for use in support of efficacy claims.”