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FDA Margin Call On Off-Label Promotion

FDA’s Office of Prescription Drug Promotion (OPDP) just issued a warning letter to the CEO of Aegerion Pharmaceuticals Inc. (Aegerion) for making unapproved drug claims during two television interviews on CNBC.  FDA says Aegerion CEO, Marc Beer, on two separate occasions earlier this year, made off-label, unapproved claims, and failed to provide risk information.  You can watch the interviews here and here.

Though the warning letter arises in the context of off-label promotion of a prescription drug, the rationale has broader applicability to any statements that any company’s representatives might make about their company’s FDA-regulated products – be them foods, devices, etc.

Aegerion holds an FDA-approved drug application for Juxtapid™ (lomitapide) limited to the following:

JUXTAPID is indicated as an adjunct to a low-fat diet and other lipid lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high ­density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

The drug has significant limitations upon its use and its labeling includes warnings regarding numerous serious risks.

On June 5, 2013, and October 31, 2013, Mr. Beer appeared on the CNBC program Fast Money.  According to FDA, Mr. Beer made statements during those interviews that “misleadingly suggest[ed] that Juxtapid™ [wa]s 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, and thus will have an effect on cardiovascular morbidity and mortality as well as overall mortality.”  Juxtapid™, however, was not (and is not) approved for those uses.  Further, prescription drug promotions must provide a fair balance of risk and benefit information, and Mr. Beer did not communicate any risks associated with Juxtapid™ during his interviews.

The warning letter alleges that Mr. Beer’s statements, which communicated unapproved uses for Juxtapid™, and failed to provide any risk information, misbranded Juxtapid™ in violation of the Food, Drug and Cosmetic Act.  Notably, FDA did not address Mr. Beer’s failure to provide the required FDA-approved full prescribing information (PI) for Juxtapid™ or a brief summary of that PI during the CNBC broadcast – requirements in the context of prescription drug promotion.

FDA’s demands for corrective action for Aegerion’s violations were pretty severe.  Aegerion must:

  • Identify for FDA all promotional materials that contain the objectionable statements;
  • Explain its plan for discontinuing use of such materials or, in the alternative, the plan “to cease distribution of Juxtapid”; and
  • Submit a comprehensive corrective communication plan of action to counter any misimpressions about the approved use of Juxtapid™.

The fundamentals of FDA’s rationale are not new as the Agency historically has used company representatives’ oral statements as evidence of a product’s intended use.  The circumstances of the Aegerion warning letter, however, appear unique and particularly harsh insofar as a CEO’s statements on a popular newscast misbranded an FDA-regulated product, resulting in a warning letter, and a demand that the company either cease distributing its product or issue corrective communications.  Ultimately, although the violations are drug-specific, the rationale could broadly apply to any statements a company’s representatives might make that misbrand their FDA-regulated product.

It also is worth noting that Mr. Beer’s statements were made in the context of an appearance on the investment-focused show, Fast Money.  This was not a sit down with Doctor Oz or Oprah where the public tunes in specifically to hear about the latest advances in disease management and cutting-edge treatments.  This was about the financial strength of Aegerion during a show focusing on investments, stocks, and market analysis.

So beware . . . FDA watches more than Discovery Health.

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