In just its second enforcement letter this year, the FDA's Office of Prescription Drug Promotion clamped down on Vivus for a webpage marketing its struggling obesity drug Qsymia.
On the offending page, Vivus offered misleading messages and omitted key information about Qsymia, the untitled 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 dinged Vivus for omitting the “material information” that Qsymia is approved only as an add-on to diet and exercise.
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.
Speaking of realistic expectations, Qsymia has fallen far short of early sales hopes. The obesity treatment, approved to much fanfare in 2012, failed to gain traction early on thanks to stubborn payers, skeptical doctors and a cloud of worries lingering after past diet-drug scares.
By 2015, with sales still lagging and an FDA-mandated—and pricey—cardiovascular safety study hanging over its head, Vivus slashed jobs and cut costs. Its salesforce cutbacks didn't make it any easier to promote the med, exacerbating a controversial decision from the company to go without a Big Pharma marketing partner. Though execs touted plans to play up digital media to account for less detailing, by 2018, Qsymia was pulling in just $40.6 million in annual sales, a 10% decrease from the previous year.
The Vivus letter is only OPDP’s second of the year, following an earlier warning to Phoenix Molecular Imaging Center for jumping the gun by suggesting its investigational drug Sodium Acetate C-11 is safe and effective for a purpose that's still under study.
The OPDP has slowed down on warning and untitled letters to pharma in recent years, averaging fewer than 10 letters annually since 2014.
Both letters address misleading claims and the omission of risk information, which may indicate the OPDP is concentrating on those areas, said Eye on FDA blogger and public relations professional Mark Senak, in a recent post.
“By OPDP standards, the year is still young, and it is possible we could see more letters this year, but look for them in areas of risk information and promotion of an unapproved drug or use,” he said.