Company warned for allegedly marketing a product. The U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has warned New Jersey-based Luitpold Pharmaceuticals over its Injectafer video advertisement.
According to Regulatory Affairs Professionals Society (RAPS), it is the first time this year that the FDA’s pharmaceutical advertisement watchdog has warned a company for allegedly marketing a product for unapproved uses.
ODPD issued an “Untitled Letter” stating that a video advertisement submitted to regulators made claims 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 that these claims could result in the drug being misbranded under federal law. This letter is not as serious as a a formal Warning Letter, which threatens immediate regulatory action if a company does not comply.
Injectafer is used to treat anemia in adults who have not responded successfully to oral iron or who have a non-dialysis dependent chronic kidney disease. The ODPD said the video was problematic because it refers to iron deficiency anemia (IDA) in a general sense without disclosing the limitations of Injectafer’s intended use.
The agency cited this claim made in the ad
The agency cited this claim made in the ad: “In the United States, an estimated 7.5 million people suffer from iron deficiency anemia or IDA and well over one third of those with IDA are women and children,” The company also stated later on that the drug is “the first IV iron approved in the US for patients with iron deficiency anemia caused by any disease.
In fact, it’s also for patients who are intolerant to oral iron or where oral iron is unsatisfactory and it’s also approved in adult patients in non-dialysis chronic kidney disease.”
These claims improperly suggest that Injectafer is intended to treat “all patients, including children, with IDA.” The two approved uses are mentioned as add-ons, the agency said. The FDA also criticized the ad for failing to include potential risks.
“While the audio portion of the interview discusses IDA and the benefits of Injectafer treatment, it fails to discuss any risks associated with Injectafer,” FDA stated. The risks are only conveyed in text format at the bottom of the screen for 30 seconds out of a seven-minute segment.
Furthermore, this information was difficult to ascertain because the text was not presented on a contrasting background. This violates the FDA’s “fair balance” standards for advertisements, the FDA said.