FDA slams small pharma for misleading ad with a dearth of safety info and dubious stat calculations
07 Jun 2022
The FDA’s Office of Prescription Drug Promotion slapped its 3rd untitled letter of the year onto New Jersey-based Althera Pharmaceuticals earlier this month, with the agency saying the firm’s DTC ad created a misleading impression about the safety profile of its cholesterol drug Roszet (rosuvastatin and ezetimibe) and combined study results in an unorthodox way.
The promo, which came in the form of a
pamphlet
, included “scientifically unsound analysis,” according to the FDA, as it depicts numbers that were “retrospectively calculated by combining the results of two unrelated studies, neither of which evaluated the specific combination of rosuvastatin and ezetimibe.”
OPDP also notes
in the letter
dated June 2 and released yesterday evening that the LDL-C reductions claimed in the promotional communication for each dose of Roszet “were calculated by taking the percent change from baseline LDL-C reduction observed in the rosuvastatin monotherapy study and then applying an additional 25% LDL-C reduction which was observed in the separate ezetimibe added to ongoing statin therapy study. FDA is not aware of a scientific basis for combining study results in this manner.”
Though the company’s promo does cite the correct clinical studies described in the Roszet PI, which support FDA’s finding of safety and efficacy of the drug with respect to its labeled indication involving the reduction of LDL-C in certain patients, it fails to achieve “the specific levels of LDL-C reductions claimed” in the advertisement, FDA says.
The agency also calls out the company for only presenting common adverse reactions associated with Roszet under a prominent header while relegating the more serious risks (i.e., contraindications and warnings and precautions) to the bottom of the page and subsequent page in small font and paragraph format that “creates a misleading impression regarding the risk profile of Roszet.”
As companies like Althera, which is run by former McKinsey partner Sanjeev Agarwal, continue to push the limits of what’s acceptable in the ad/promo space, the FDA has fallen further into the back seat on regulating pharma ads and promos, with less than 10 untitled letters issued in the past three years.
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