The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second untitled letter of the year to California drugmaker Vivus because of claims made on the company’s website about its weight-loss drug Qsymia. At issue are statements made by Vivus on its website that suggest Qsymia can help patients lose weight “3 times faster than diet and exercise alone” and other statements that FDA says do not adequately convey the fact that Qsymia is indicated as an adjunct to diet and exercise.
OPDP Claim
On the problematic page, Vivus offered misleading messages and omitted key information about Qsymia, the FDA letter said. OPDP cited claims that the obesity drug “can help you lose weight three times faster than diet and exercise.” Although Vivus drew the claims from the drug’s clinical data, those results do not support a particular rate of weight loss, the letter said. The FDA also hit Vivus for omitting the “material information” that Qsymia is approved only as an add-on to diet and exercise.
“By failing to account for an individual’s baseline weight and waist circumference and omitting this context on the webpage, this presentation misleadingly implies that all patients, no matter their baseline weight or waist circumference, should expect to achieve similar results to the absolute amounts presented on the webpage,” FDA writes.
Vivus has already changed the website—the OPDP letter went out May 22—swapping the “three times faster” claim for a more subdued one. “Extensively studied and prescribed, Qsymia is the once-daily pill that helps you manage your weight-loss plan and set realistic expectations,” the revised page states.
Second letter from OPDP
As noted by Mark Senak’s Eye on FDA, warning letters are issued by many parts of the FDA, but OPDP issues letters squarely aimed at the communication by pharmaceutical companies about the medicines they market. Twenty years ago such letters were issued with great frequency, but in 2019 there have been two.
Senak further explains, “part of the reason for the drop-off has been a change in focus by the agency to be more risk-based in the expenditure of time, resources and effort – something former Commissioner Gottlieb felt strongly about. That has extended to OPDP which used to issue a letter for a technical infraction of communications boundaries that would not have really had an impact from a public health perspective, but are more prone to act now only where the agency sees infractions that are violations where there is a potential for some kind of harm.”