AstraZeneca Doubles Down: Pharmacies Face Escalated Requests For Farxiga® Dispensing Records

Pharmacies that dispensed Farxiga® (dapagliflozin) are now receiving a second round of formal communications from AstraZeneca, indicating the manufacturer's growing concern over alleged discrepancies between product purchases and dispensing records. These follow-up letters, issued in mid-September 2025, are not merely reminders—they reflect a coordinated escalation in AstraZeneca's efforts to enforce what it appears to believe are regulatory, commercial, or distribution-related requirements.

The letters are addressed to specific pharmacies and reference earlier correspondence that requested reconciliation of purchasing and dispensing data. In the latest wave of communication, AstraZeneca is now reiterating its concern that the number of Farxiga® tablets reported as dispensed continues to outpace the number purchased by the pharmacy through authorized sources. The manufacturer suggests that the data submitted thus far is insufficient to resolve this discrepancy and is now demanding additional records to clarify the situation.

Pharmacies are being asked to produce updated summaries detailing the total number of branded Farxiga® tablets purchased and billed during both 2024 and 2025. The manufacturer is also requesting a breakdown of tablets dispensed, organized by payor and month. In addition, pharmacies are being asked to confirm that efforts have been made to resolve any impacted claims with their contracted Pharmacy Benefit Managers (PBMs). While the letter may be framed as a routine data verification request, the specificity and tone indicate something more serious: AstraZeneca appears to be building a case based on what it considers to be gaps or inconsistencies in supply chain integrity.

The implications for pharmacies cannot be overstated. This is not an isolated inquiry. This is part of a broader shift in how pharmaceutical manufacturers are using dispensing and purchase data to police the downstream distribution of their products. Over the past few years, we've seen similar tactics used by manufacturers of diabetic test strips. These efforts are often presented as legitimate data reconciliation campaigns, but they frequently evolve into legal threats, commercial disputes, or regulatory escalations.

For pharmacies, the risk lies in how this data may be used once it is turned over. If AstraZeneca shares the data with pharmacy benefit managers, the consequences could include audits, demands for repayment, or even network termination. A pharmacy that cannot reconcile its purchase history with its dispensing activity may be viewed as having violated sourcing requirements, even if the underlying issue stems from innocent recordkeeping gaps or delays in inventory turnover.

In addition to PBM exposure, pharmacies also face privacy and compliance risks. Much of the information AstraZeneca is requesting—particularly data broken down by payor—could implicate HIPAA or state-level data privacy rules. Depending on how this data is formatted or shared, the pharmacy may inadvertently disclose protected health information or confidential payor relationships. Without proper safeguards, even aggregated data could be misused or misunderstood.

The language in AstraZeneca's second letter appears carefully chosen to create urgency without explicitly threatening legal action. However, the escalation is unmistakable. The manufacturer is now expecting pharmacies to act swiftly and thoroughly. The suggestion that prior submissions were insufficient signals a loss of patience and a belief that further delay or lack of cooperation could justify additional steps. Whether those steps involve PBM collaboration, state board complaints, or litigation is unclear—but the risk is now firmly on the table.

Pharmacies that receive these letters should not respond reflexively. The first step should be an internal review of all Farxiga® purchases from January 2024 to the present. This review should confirm the source of each purchase and determine whether all inventory was obtained through NABP-accredited or otherwise reputable distributors. Any inconsistencies should be investigated and documented. Pharmacies should then compare these records against their dispensing logs and claims data to determine whether the volumes align. If timing gaps exist—such as product purchased in late 2023 and dispensed in early 2024—those should be clearly noted and accounted for. Errors in NDC usage or claim submission formatting could also contribute to perceived discrepancies.

Once this reconciliation is complete, pharmacies should consult legal counsel before producing any data. It is critical that the response be measured, protective of the pharmacy's interests, and limited in scope. The pharmacy should avoid producing raw data that could be misinterpreted, and should never volunteer patient-level information unless legally required to do so. Any response should also preserve the pharmacy's ability to dispute or supplement the data if AstraZeneca later raises additional concerns.

In some cases, it may be appropriate to request that AstraZeneca enter into a mutual non-disclosure agreement before any records are shared. This can help restrict how the manufacturer uses the data and may prevent it from being forwarded to PBMs other third parties. Pharmacies should also consider whether to respond with summaries or reconciliations instead of full data dumps. The goal is to address the manufacturer's concern without exposing the pharmacy to unnecessary risk.

Importantly, pharmacies should not admit fault or offer speculative explanations. Any response should be factual and defensible. If there is a reasonable explanation for the data discrepancy, that explanation should be clearly documented and supported by internal records. But pharmacies should not guess, apologize, or speculate. Those statements may later be construed as admissions, even if made in good faith.

This second letter campaign is unlikely to be AstraZeneca's last. Manufacturers have increasingly adopted this playbook to regain control over the downstream distribution of their products. As the pricing and reimbursement landscape becomes more complex, manufacturers are placing greater pressure on pharmacies to adhere to strict distribution and utilization expectations. Pharmacies dispensing high-cost therapies or specialty products should be prepared for similar inquiries from other manufacturers in the months ahead.

The key takeaway is this: what may appear to be a simple request for cooperation is often the opening act in a larger enforcement effort. Pharmacies that respond thoughtfully, with legal oversight and documented compliance, will be better positioned to protect themselves.

If your pharmacy has received one of these second-round Farxiga® letters from AstraZeneca, take it seriously. Assess your data, evaluate your risk, and respond from a position of strength—not reaction. The letter may not say so directly, but make no mistake: you are being investigated.

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