Regulatory Focus™ > News Articles > Implied Claims of Superiority Lead to Untitled Letter for Pharma Company

Implied Claims of Superiority Lead to Untitled Letter for Pharma Company

Posted 19 September 2014 | By Alexander Gaffney, RAC

Implied Claims of Superiority Lead to Untitled Letter for Pharma Company

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.

FDA said the marketing piece makes a number of claims which, together, "misleadingly implies that Lipofen offers a clinical advantage over other available fenofibrate products. For example, Cipher claimed that "all fenofibrates are not created equal," and that "a generic fenofibrate may not be the best option."

While there might be differences between different products, FDA said, whether these differences generate a clinical advantage has not yet been supported by "substantial evidence."

While the company did provide references for its claims, "None of the cited references describe any clinical trial data comparing Lipofen to other fenofibrate products to support claims of superiority," FDA noted.

The email, FDA continued, served to misbrand Lipofen under the Federal Food, Drug and Cosmetic Act (FD&C Act).

FDA asked that Cipher immediately cease marketing Lipofen using the "unsubstantiated superiority" claims.

 

Untitled Letter

Marketing Email


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe