FDA Blasts Another Drugmaker for Misleading Electronic Promotions

The FDA slammed Cipher Pharmaceuticals for an email that contains overblown superiority claims promoting a cholesterol drug, the latest signal this year that the agency is scrutinizing drugmakers’ electronic promotions.

The e-mail said Cipher’s generic Lipofen (fenofibrate capsules, USP) is better than other generic and branded versions because of an improved formulation, according to an FDA untitled letter. The drugmaker, which develops improved formulations of existing products, contends that other versions are formulated with small particles that may affect absorption of the drug’s active ingredient.

The problem is there isn’t any substantial evidence to back up that claim, the FDA said. Cipher should cite data from clinical trials comparing its Lipofen to similar versions but fails to do so, said the agency, which asked Cipher to stop sending out the email.

The FDA has stepped up its scrutiny of drugmakers’ promotions on social media and other electronic platforms. Of the seven untitled letters issued this year by the Office of Prescription Drug Promotion (OPDP), four have focused on misleading electronic promotions through emails, web pages or social media.

For instance, the FDA slapped Institut Biochimique SA and Akirmax Pharmaceuticals for omitting risk information on its Facebook page for the hyperthyroid drug Tirosint (levothyroxine sodium). And the agency asked Gilead Sciences to remove a sponsored link on Google that misrepresented its hepatitis B drug Viread (tenofovir disoproxil fumarate).

The notices are a steep jump from last year, when OPDP issued 24 untitled and warning letters to drugmakers, but none focused on social media or sponsored link violations. Only one company, Mobius Pharmaceuticals, was rapped for distributing misleading emails promoting its ophthalmic drug Mitosol (mitomycin for solution).The majority of untitled and warning letters in 2013 focused on sales aids, advertisements and other printed materials.

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