OPDP: Risk, Efficacy Claims for Cholesterol Drug in Doctor Promotion Are False/Misleading

June 27, 2022 – False or misleading claims and representations in a professional promotion about the efficacy and risks of a prescription drug for high cholesterol are cited in a June 2 Untitled Letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to Althera Pharmaceuticals LLC.

OPDP reviewed a “Doctor Info” promotional communication piece through the Form FDA 2253 process for Roszet® — a drug that helps to lower low-density lipoprotein cholesterol (LDL-C) as an adjunct to diet in patients with primary non-familial hyperlipidemia or alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia. According to OPDP, Roszet is a drug with multiple serious and potentially life-threatening risks, which makes false or misleading claims about its efficacy and risks “especially concerning.”

“High cholesterol is a significant public health concern that affects millions of adults in the United States,” OPDP asserts in the letter. “Consumers and patients who seek assistance with managing their high cholesterol should receive truthful and non-misleading information about the serious risks and expected benefits associated with the use of a cholesterol-lowering prescription drug product, such as Roszet.”

Specifically, OPDP said Althera’s claims about Roszet’s efficacy are misleading because they attribute specific levels of LDL-C reductions to various dosages, based not on clinical studies of Roszet, but on an analysis that combines the results of two separate and unrelated studies from the clinical studies section of Roszet’s PI. “FDA is not aware of a scientific basis for combining study results in this manner,” OPDP states, adding that these studies also differed in patient population and type, the dose of statins, as well as the duration of use.

The promotional piece also makes misleading claims – such as “Patients Can Get Below 70 mg/dL with One Pill” — about the efficacy of Roszet “in achieving specific levels of LDL-C reduction over specific periods of time,” the Untitled Letter states. “There are multiple limitations to the cited studies that preclude drawing conclusions regarding the quantitative treatment effect of Roszet on LDL-C.”

Although the full indication of Roszet, which states that it is indicated as an adjunct to diet, is included at the bottom of the first page of the promotional piece, “unlike the benefit claims in the promotional communication, which utilize significant white space and a colorful font, the full indication is included … in paragraph format in a much smaller font size and with minimal white space,” OPDP notes. “Therefore, this does not mitigate the misleading impression.”

Further, the Roszet promotional piece is misleading because it fails to present information relating to the contraindications and warnings and precautions for Roszet “with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Roszet,” according to OPDP, which comments that some of the most common adverse reactions are presented in the body of the promotion in table format under the header “Safety and Tolerability,” while the serious risks of the drug were relegated to the bottom of the page, which “creates a misleading impression about the risk profile of Roszet” and “minimizes the risks” associated with its use.

This is the third Untitled Letter issued by OPDP in 2022.