Earlier this month, biopharmaceutical company AstraZeneca issued notices to pharmacies regarding data discrepancies concerning Farxiga, a sodium-glucose cotransporter 2 inhibitor medication typically used to treat chronic kidney disease, heart failure, and Type 2 diabetes. AstraZeneca’s notices requested pharmacies to provide significant documentation and information relating to their dispensing and purchasing of Farxiga in the calendar year of 2024. Notably, on January 3, 2024, the generic dapagliflozin was introduced to market. Now, with generic versions available, it is clear from AstraZeneca’s request that there is increased scrutiny and concern regarding pharmacies’ dispensing and purchasing practices of Farxiga, questioning whether such pharmacies dispensed Farxiga or its generic equivalent, dapagliflozin. Pharmacies that receive these communications from AstraZeneca should understand their obligations to respond and should seek legal advice from attorneys who have experience and guidance in handling these and similar notices from manufacturers.
What To Expect When You Receive This Request
It is not uncommon for pharmaceutical manufacturers to issue these types of notices to pharmacies, and Frier Levitt has advised many pharmacies on how to address these requests from manufacturers, including AstraZeneca. In fact, often, such requests from manufacturers are accompanied by suggestions that the manufacturer will further escalate the issue if the pharmacy does not comply with the request.
That said, in the recent request from AstraZeneca, pharmacies can expect to be notified of inconsistencies identified from rebate claims information received from PBMs and health plans against the purchase data reported by the wholesalers. To further clarify, AstraZeneca has flagged pharmacies for allegedly not purchasing sufficient amounts of Farxiga to support the quantities billed to PBMs and plans for the calendar year of 2024. As a result, AstraZeneca is requesting that pharmacies provide their dispensing and purchasing data of Farxiga for 2024 to either dispute or confirm the discrepancies identified by AstraZeneca’s independent review.
Understanding Your Obligations and the Implications
There could be several reasons why AstraZeneca is making this request to pharmacies—it may be related to concern of lost rebates, policing of the market, prevention of potential fraud, waste, or abuse as it relates to the medication at issue, etc. While there may be several areas of concern, pharmacies should be aware of their obligation to respond to AstraZeneca and importantly, the potential consequences of providing information to AstraZeneca. Not only could pharmacies experience an adverse action from AstraZeneca, but also from PBMs and even government agencies. Frier Levitt is actively working with several pharmacies in addressing this request from AstraZeneca and encourages your pharmacy to seek effective legal counsel to navigate this request as well. It is clear that this request could impact a pharmacy’s relationship with third-parties, including PBMs and regulatory agencies, such as a State Board of Pharmacy, CMS, etc.
How Frier Levitt Can Help
For many years, Frier Levitt has observed and reported on trends related to manufacturers who have issued similar requests and demands to dispensing pharmacies. If your pharmacy received this request from AstraZeneca, contact Frier Levitt to speak to an attorney today.
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