FDA Chides Cipher Pharmaceuticals Over Cholesterol Drug Ad's Superiority Claims

The US Food and Drug Administration (FDA) has sent a warning to Cipher Pharmaceuticals over an email marketing piece sent by the company to promote its cholesterol drug Lipofen, saying the piece over-stated the drug's effectiveness.

The Untitled Letter was sent by FDA's Office of Prescription Drug Promotion (OPDP), which has sent six other Untitled Letters so far this year. Unlike FDA's Warning Letters, Untitled Letters do not threaten immediate enforcement action if a company does not comply with its demands.

In its letter to Cipher, OPDP references an "e-Pharm/alert" marketing email sent by the company. The email is misleading in that it makes "unsubstantiated superiority claims," FDA claimed.

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