Posted 22 November 2013
By Alexander Gaffney, RF News Editor
Biopharmaceutical manufacturer Amgen is the latest company to receive an Untitled Letter from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP), the latest in a flurry of letters sent by the office in recent weeks regarding allegedly deficient marketing practices.
The 19 November 2013 letter to Amgen, made public on 22 November, references a direct mailer used by the company to market its anemia drug Aranesp (darbepoetin alfa). Regulators wrote in the Untitled Letter, addressed to Executive Director of Regulatory Affairs Alan Dunbar, that the company made false and misleading statements by virtue of its omission of material facts and inclusion of unsubstantiated claims.
As with letters sent earlier this month, OPDP claimed the company's marketing materials had served to broaden the population for which Aranesp has obtained FDA approval. The drug is now approved for the treatment of anemia due to chronic kidney disease (CKD) and in patients with non-myeloid malignancies where anemia is caused by the chemotherapy drug. The drug is also specifically contraindicated in a number of patient populations, such as those receiving certain types of cancer treatment.
However, FDA claimed that the direct mail piece failed to note these contraindicated populations in a number of claims, painting the misleading impression that the drug would be useful for certain patients regardless of their current status.
This, FDA explained, acted to expand the label to a "much broader range of patients than has been demonstrated by substantial evidence or substantial clinical experience" without first having obtained FDA approval, and was therefore an unapproved claim.
Regulators also said the drug advertising had failed to include a number of important risks. At least three major warnings regarding increased mortality, a lack or loss of hemoglobin, and pure red cell aplasia were absent from the direct mailer despite presenting all other material facts.
The letter also points to instances in which Amgen allegedly made unsubstantiated claims and omitted material facts. To the former, the company's piece claimed that Aranesp allows patients to achieve a "gradual and steady" rise in hemoglobin. OPDP said it was unaware of any substantial evidence supporting this claim. "The rate of Hb rise was not an endpoint in any of the clinical studies," FDA wrote.
To the latter, FDA said the mailer omitted a material fact by failing to mention "ANY other information regarding the approved dosing of Aranesp" relative to a claim that the drug can be synchronized with many chemotherapy regimens.
"Without any of this important dosing information, the direct mailer fails to provide the information necessary for healthcare practitioners to determine how to appropriately dose Aranesp so as to synchronize it with their patients' chemotherapy regimens, as the piece suggests."
The company was given until 4 December 2013 to respond to the letter.
The letter to Amgen is at least the seventh letter sent by OPDP in the last month, with other recipient companies including Kadmon, WorldMeds, Daiichi Sankyo, Aegerion, Sunovion and Duchesnay.
Direct Mail for Aranesp