For the first time this year, the US Food and Drug Administration's (FDA) pharmaceutical advertising watchdog, the Office of Prescription Drug Promotion (OPDP), has issued a warning to a company for allegedly trying to promote a product for uses for which it had not received FDA approval.
The warning, known as an "Untitled Letter," is less serious than the agency's more formal Warning Letters in that it does not threaten immediately regulatory enforcement action if a company fails to comply.
OPDP's latest letter—its first to be issued in 2015—is addressed to New Jersey-based Luitpold Pharmaceuticals, the owner of the drug application for Injectafer, an injectable treatment indicated for use in adult patients with anemia who have not been successfully treated with oral iron or who have non-dialysis dependent chronic kidney disease.
A Broadened Indication
The problem, OPDP explained in the letter to Luitpold, is 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." Those claims would cause the drug to be misbranded under federal law, FDA claimed.
FDA's contention is that the video advertisement talks about iron deficiency anemia (IDA) in general terms, and without necessary caveats about the limitations of Injectafer's intended use.
"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 advertisement reviewed by FDA explained.
Later in the advertisement, Luitpold added that Injectafer 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.”
FDA said these two segments were especially problematic from a regulatory perspective because they represented the drug as being intended to treat "all patients, including children, with IDA." Injectafer's two approved indications were presented as being add-on conditions, FDA noted.
Other Problems Alleged
FDA also wrote in its letter that it felt Luitpold had minimized potential risks associated with the product in its advertisement.
"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 explained. The risks are instead presented in text format at the bottom of the screen for just 30 seconds out of the seven-minute segment. The text was also difficult to read because it was not presented on a contrasting background, FDA added.
This, FDA said, violated the agency's longstanding "fair balance" standards for advertisements.
The company was also chided for presenting "misleading claims" regarding the efficacy of Injectafer. FDA took issue with an anecdote in the advertisement that the drug had allowed a patient to "blossom like a rose" thanks to the drug. The claim implies a broader benefit to a patient, "including non-health related aspects of life," that have not been proven, FDA said.
OPDP requested the company immediately stop presenting the advertisement.
The Untitled Letter is not the first for Luitpold. In 2010, FDA's OPDP—then known as the Division of Drug Marketing, Advertising and Communications (DDMAC)—cited the company over a print advertisement for a different drug , Venofer. That product had also been marketed using unsubstantiated claims and without the totality of its risk information, FDA wrote.
FDA Untitled Letter to Luitpold