[Editor's note: an earlier version of this story indicated the website was run by Quintiles. Quintiles is only the marketing representative of Swedish Orphan Biovitrum AB in the US, and was not responsible for the website.]
The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to Swedish Orphan Biovitrum AB for allegedly making misleading claims regarding the safety and efficacy of Kepivance (palifermin) on a website for the product.
Swedish Orphan Biovitrum AB-a Swedish company billing itself as a provider of biologic medicines focusing on rare diseases-received the letter through Quintiles, a contract research organization representing the company in the US. One of the company's products, Kepivance, is FDA-approved to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support.
In its 7 June 2012 warning letter, FDA said Swedish Orphan Biovitrum AB's website-www.kepivance.com-"omits important risk information about the drug." FDA explained while Swedish Orphan Biovitrum AB included the most common serious adverse reactions, the website failed to contain the entire range of risks known to be associated with the product. Other omissions include potentially dangerous drug-drug interactions, prominent warnings and precautions and the known instances of adverse reactions.
"By omitting this important risk information, the webpage misleadingly suggests that Kepivance is safer than has been demonstrated by substantial evidence or substantial clinical experience," wrote FDA.
While Swedish Orphan Biovitrum AB had linked to a webpage including the prescribing information and its safety profile, FDA said the links "were not sufficient to mitigate the misleading impression created by the omission of this important risk information from the webpage."
FDA's thinking on this issue could be a harbinger for other enforcement actions in the future. Some pharmaceutical companies have used the social media site Twitter to advertise a product approval for the treatment of a disease, and included safety information in the link within the Tweet.
FDA's warning letter also included a number of other "misleading claims and presentations," including one the agency described as a "picture of a woman holding a slice of watermelon." Other claims on the webpage indicated Kepivance made it easier for patients to eat, drink and swallow.
"The overall implication of these claims and presentations is that treatment with Kepivance in patients with severe oral mucositis will improve a patient's ability to eat, drink, swallow, and talk," wrote FDA. The agency further explained these claims were based on data within its biologics licensing application (BLA) to FDA, which do not support the claim.
Further, FDA took issue with Swedish Orphan Biovitrum AB claiming Kepivance improved "associated sequelae" in patient, which the agency said mistakenly implied the product significantly improved "all sequelae of oral mucositis."
Regulators also took issue with website's implication that "treatment with Kepivance will result in decreases in duration of opioid use and reduction in the need for total parenteral nutrition" based on the same data used to support the product's BLA.
Finally, FDA cited Swedish Orphan Biovitrum AB for failing to submit to OPDP a copy of the webpage used to market Kepivance.
As of 25 June 2012, www.kepivance.com appeared to have been scrubbed of information and taken offline, per FDA's request.
FDA's Letter to Swedish Orphan Biovitrum AB
An FDA-provided Snapshot of the Website