The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently sent an untitled letter to Amgen regarding its promotion of its own biological product, Neulasta (pegfilgrastim), over a banner ad intended for healthcare professionals. Neulasta is a leukocyte growth factor approved to decrease the incidence of febrile neutropenia (FN) infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of FN.
In the July 7, 2021, letter, OPDP states that the banner ad “makes false or misleading claims and representations about the benefits of Neulasta” and therefore, the product is misbranded and its distribution is illegal. OPDP specifically points out Amgen’s claims in the banner ad about the incidence of febrile neutropenia in patients taking Neulasta using Amgen’s Onpro on-body injector compared to patients taking Amgen’s pegfilgrastim product delivered via pre-filled syringes. According to the banner add, “In a Real-World Study with nearly 11,000 patients Pegfilgrastim PFS [pre-filled syringes] resulted in a significantly higher risk of FN vs Onpro.”
OPDP noted that “[t]hese violations are concerning from a public health perspective because this promotional communication’s misleading claims could cause healthcare providers to conclude that Neulasta delivered via the Onpro on-body injector (OBI) is more effective than Neulasta delivered via prefilled syringe (PFS) or that it is more effective than FDA-licensed biosimilar pegfilgrastim products, which are only delivered via PFS.”
OPDP also pointed out that the study was not designed to ensure that patients with FN were appropriately identified for inclusion in the analysis and that the study relied on an “unvalidated algorithm” to identify study participants. Data that Amgen provided to OPDP “included no information about the performance characteristics (e.g., sensitivity, positive predictive value) of the algorithm or the diagnostic codes that were used.”
According to OPDP, the study was not designed to properly balance or control participants based on the delivery method and that the “study did not control for factors other than the delivery device that may influence the incidence of FN in the compared groups. Eligible patients for the study had highly diverse clinical characteristics, and the study report did not include any information on the baseline comorbidity or risk factors for FN of the two exposure groups or on design or analytic strategies to minimize the risk of selection bias.”
Additionally, while Amgen did make note of the limitations in the study in the seventh and eighth frames of the ad, OPDP did not find that disclosure “does not mitigate the misleading claims and presentations in the banner.”
OPDP also mentioned the way Amgen framed the two delivery methods as “Neulasta Onpro”/”Onpro” and “Pegfilgrastim PFS.” OPDP felt that by using the proper name on the PFS product and the proprietary name with the on-body injector product “could result in healthcare providers failing to understand that Amgen’s Neulasta was used in both arms of the study” and that healthcare providers may conclude that a biosimilar pegfilgrastim product delivered via PFS is not as effective as Amgen’s on-body injector product.
The Untitled Letter sent to Amgen is the second one issued by OPDP this year.