Aegerion Settles with Feds Over Sales Activities
Aegerion Pharmaceuticals has reached preliminary agreements with the Department of Justice and the Securities and Exchange Commission involving a settlement of ongoing investigations by the feds into the company’s sales activities and disclosures related to Juxtapid (lomitapide). Under the agreement, the company will pay both agencies over five years a combined $40 million.
Presumably, Aegerion came into the government’s sights after FDA objected to statements made by CEO Marc Beer on CNBC’s “Fast Money” program that allegedly broadened the indication for the company’s lipid-lowering Juxtapid capsules. An 11/8/2013 Warning Letter from CDER’s Office of Prescription Drug Promotion said Beer’s statements “misleadingly suggest that Juxtapid is safe and effective for use in decreasing the occurrence of cardiovascular events including heart attacks and strokes, and increasing the lifespan of patients with HoFH [homozygous familial hypercholesterolemia], and thus will have an effect on cardiovascular morbidity and mortality as well as overall mortality. However, Juxtapid is approved only for use as an adjunct to a low-fat diet and other lipid lowering treatments, to reduce specific lipids in patients with HoFH; its PI specifically includes a limitation of use stating that the effect of the drug on cardiovascular morbidity and mortality has not been determined.”
Additionally, OPDP said that while Beer‘s statements on CNBC included substantial and repeated efficacy claims for Juxtapid, he failed to communicate any risk information associated with the new intended uses or its approved use. The letter notes that Juxtapid’s approved labeling includes a Boxed Warning regarding potential liver toxicity, and the product is subject to an associated Risk Evaluation and Mitigation Strategy.
“As a company, we are deeply committed to legal and regulatory compliance, and we have made significant investments to ensure that these values resonate throughout our organization,” Aegerion says. “We look forward to putting these matters behind us and to continuing our focused efforts on developing and commercializing innovative therapies for patients with debilitating rare diseases.”
The settlement calls for the company to plead guilty to two misdemeanor FDA misbranding violations. “One count would be based on the company's alleged marketing of Juxtapid with inadequate directions for use (21 U.S.C. §§ 352(f)), and the second count would involve an alleged failure to comply with a requirement of the Juxtapid Risk Evaluation and Mitigation Strategies (REMS) program (21 U.S.C. §§ 352(y)),” according to Aegerion. “The company would separately enter into a five-year deferred prosecution agreement with regard to charges that the company violated the Health Insurance Portability and Accountability Act and engaged in obstruction of justice relating to the REMS program. The preliminary agreement in principle with the DoJ also requires the company to enter into a civil settlement agreement with the DoJ to resolve alleged violations of the False Claims Act.”
Additionally, Aegerion would enter into a non-monetary consent decree with FDA, prohibiting future violations of law. It may also have to enter into a corporate integrity agreement with HHS once the settlement if finalized. The company says no exclusion from participating in federal health care programs is being sought by the feds.