Touting an off-label use is a big no-no when it comes to pharma marketing, and that's exactly what's landed Metuchen Pharmaceuticals in trouble with the FDA's promo police.
The agency's Office of Prescription Drug Promotion (OPDP) slapped Metuchen with a warning letter for misleading risk and efficacy claims online and in print for erectile dysfunction drug Stendra. The print ad also included information about an unapproved Stendra use with the headline, “Treat ED and Reduce Risk of Heart Failure with a PDE-5 inhibitor.”
The ODPD letter notes that while there is some evidence that PDE5 inhibitors may be effective for men with some types of heart disease, Stendra's own product information includes a warning for cardiovascular risks and is not recommended for certain groups. The print ad ran in the American College of Cardiology’s magazine CardioSmart.
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The problematic online banners, which appeared on adult websites, downplayed Stendra's risks, with at least two submitted to OPDP that did not contain any risk information at all. Those Stendra-branded ad headlines read: “Get Hard & Stay Hard,” followed by only two other lines of copy—“Indulge in life’s sweetest pleasures whenever you want” and a directive at the bottom of the ad to “Ask your doctor for more information.”
OPDP’s reprimand noted that the digital ads were not only misleading but also suggest "that Stendra can safely be dosed to provide efficacy at any time point,” which is not true. The directions for use on the product recommend a maximum of once per day, with efficacy lasting from 15 minutes to two hours.
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Metuchen grabbed exclusive marketing rights to Stendra from Vivus in the U.S., Canada, South America and India after poor sales spurred one-time partner Sanofi to dump its rights to the drug.
The Metuchen letter OPDP's first warning letter of the year, although OPDP did dole out four untitled letters before the Stendra letter hit. With only five letters total to date in 2019, the OPDP trend of issuing fewer letters each year seems to be continuing. The FDA promotion watchdog has averaged fewer than 10 warning or untitled letters sent annually over the past five years.