FDA Sends Warning to Company for Promoting Drug for Unapproved Uses

FDA Sends Warning to Company for Promoting Drug

FDA Sends Warning to Company for Promoting Drug

The Office of Prescription Drug Promotion (OPDP), the Food and Drug Administration’s pharmaceutical advertising watchdog unit, has issued a warning to a company for allegedly promoting its product Injectafer for uses for which it had not received FDA approval.

The warning, an Untitled Letter, is less serious than the agency’s more formal Warning Letters. The untitled letter does not threaten immediately regulatory enforcement action if a company fails to comply, according to Regulatory Affairs Professional Society (RAPS).

The letter, the first to be issued in 2015, was send Luitpold Pharmaceuticals in New Jersey, concerning Injectafer, an injectable treatment for adults with anemia who have not been successfully treated with oral iron or who have non-dialysis dependent chronic kidney disease.

OPDP explained that a video advertisement submitted by the company to regulators contains claims that could be interpreted to mean that Injectafer “is intended for a new use for which it lacks approval, and for which its labeling does not provide adequate directions.” The FDA said such claims would cause the drug to be misbranded under federal law, RAPS reports. The FDA contends that the ad talks about iron deficiency anemia (IDA) in general terms, and without necessary caveats about the limitations of Injectafer’s intended use. According to the FDA, portions of the ad are problematic from a regulatory perspective because they represent the drug as being intended to treat “all patients, including children, with IDA.” The FDA noted that the ad presented Injectafer’s two approved indications as add-on conditions. The FDA felt Luitpold’s ad had minimized potential risks associated with the product.

The risks are presented in text format at the bottom of the screen for just 30 seconds in the seven-minute ad segment. In addition, the FDA said the text was difficult to read because it was not presented on a contrasting background, according to RAPS. OPDP requested that the company immediately withdraw the advertisement.


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