Earlier this week in its annual report Aegerion Pharmaceuticals Aegerion Pharmaceuticals provided an update on its ongoing troubles with the FDA and the Department of Justice. As previously reported here and on The Street and on CNBC, the company landed in sizzling water with the FDA last yr following its CEO created a series of off-label statements on the CNBC Fast Cash demonstrate. (The company’s only solution, Juxtapid (lomitapide) is a cholesterol-lowering drug indicated for the unusual situation of homozygous familial hypercholesterolemia. It sells for $ 250,000 a yr.) Now the company reports that by working “a corrective advertisement on CNBC” and by reviewing additional promotional material it believes it will be in a position to resolve its troubles with the FDA.
But the DOJ investigation might demonstrate to be a larger and more critical issue. The details of the investigation continue to be vague: the US Attorney’s Workplace in Boston requested “documents and other data pertaining to our promotion, marketing, and sale of JUXTAPID.” The company asserts that it programs to”vigorously defend” itself but warns that it “may not be ready to resolve this matter without having incurring important fines, sanctions, or other consequences.” Even if they are in the long run effective the process is most likely to be “costly and time-consuming” and “could adversely influence our track record.”
Undoubtedly a lot of the language in the paragraph comes from the company lawyers and is created to shield the organization from long term lawsuits. But until finally we know far more about the investigation it will be not possible to dismiss its likely influence.
Here is the paragraph in the yearly report:
In late 2013, we obtained a warning letter from the FDA alleging that specified statements about JUXTAPID made by our Chief Executive Officer, Marc Beer, during two broadcast interviews on the CNBC television present, Quick Income, promoted a claim that JUXTAPID has an effect on cardiovascular morbidity and mortality and that JUXTAPID is effective as a monotherapy which would be regarded unapproved employs. We responded promptly to the FDA, and are working with the FDA’s Workplace of Prescription Drug Promotion to resolve the worries raised in the warning letter. We are preparing to run a corrective advertisement on CNBC to clarify any misimpressions arising from the interviews. We feel that the corrective advertisement, and the promotional material review we have currently performed, will deal with the FDA’s considerations cited in the warning letter. We also acquired a subpoena in late 2013 from the U.S. Division of Justice, represented by the U.S. Attorney’s Workplace in Boston, Massachusetts, requesting documents and other info pertaining to our promotion, marketing and advertising, and sale of JUXTAPID in connection with a government investigation of our practices. We are in the procedure of responding to the subpoena, and intend to cooperate fully with the investigation. Although we intend to vigorously defend ourselves, we may not be capable to resolve this matter without having incurring substantial fines, sanctions, or other consequences that could have a materials adverse impact on our organization, financial problem, or final results of operations. Even if we can resolve this matter without incurring considerable penalties, responding to the subpoena has been, and is anticipated to carry on to be, expensive and time-consuming. Moreover, this investigation could adversely affect our status and the willingness of doctors to prescribe lomitapide for their HoFH patients, and may possibly divert management’s consideration and resources, which could have a material adverse result on our enterprise, economic issue, or benefits of operations.
Aegerion Warns About Unfavorable Influence Of DOJ Investigation
