The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has sent a Warning Letter to the CEO of Aegerion Pharmaceuticals, saying comments the executive made while on a television show constituted promotional speech and therefore resulted in the company's product being misbranded.
The OPDP Warning Letter-itself a rarity, as the office usually sends so-called "Untitled Letters" indicating its displeasure-is unusual in that it pertains to a television appearance. The overwhelming majority of deficient materials observed by OPDP relate to print materials.
According to the Warning Letter, Aegerion CEO Marc Beer appeared on the CNBC show Fast Money on 5 June 2013 to discuss his company's drug Juxtapid (lomitapide). Juxtapid is approved by FDA to lower various forms of cholesterol in patients with homozygous familial hypercholesterolemia (HoFH), a rare inherited disease in which the body is unable to remove low-density lipoprotein (LDL) cholesterol from the body. Importantly, the drug is approved as an adjunct-not for use on its own (monotherapy).
Juxtapid has two important limitations: It is not yet approved for patients with non-familial hypercholesterolemia, and has not yet been evaluated with respect to its cardiovascular morbidity and mortality rates. In addition, the drug has a number of serious safety risks, which resulted in FDA giving the drug a boxed warning and restricted access program as part of a Risk Evaluation and Mitigation Strategy (REMS).
The TV Appearance
But when FDA watched Beer's Fast Money appearance, it said his statements on the appropriate use of the drug did not reflect these risks or limitations, creating the "misleading [suggestion] 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."
Similar remarks were made by Beer in a 31 October 2013 appearance on the show, FDA said.
Regulators contend that Beer's remarks had the effect of implying that Juxtapid could be used on its own, when it is only approved by FDA for use in combination with other therapies. "Use as a monotherapy is an unapproved use," FDA wrote.
FDA also explained that Beer had a duty to promote fair balance in his oral remarks as in the company's written materials. "While the statements cited [in the Warning letter] include substantial and repeated efficacy claims for Juxtapid, the presentation fails to communicate any [emphasis original] of the risk associated with these new intended uses or its approved use," OPDP wrote.
OPDP demanded that Beer immediately stop misbranding Juxtapid in the manner he has been doing, saying the violations thus far were "serious."
So serious, in fact, that FDA said it merits corrective advertising, which will need to be sent to FDA in the form of a "comprehensive plan of action to disseminate truthful, non-misleading and complete corrective messages about the issues discussed in this [Warning Letter] to correct any misimpressions about the approved use of Juxtapid.
In a statement, Aegerion said it planned to take "quick action" to address FDA's concerns and took them "very seriously."
OPDP Warning Letter to Aegerion