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October 3, 2025

AstraZeneca Escalates FARXIGA® Audit Demands: What Pharmacies Need to Know Now

Pharmacies across the country are reporting a new wave of aggressive audit-related letters from AstraZeneca, specifically related to purchasing and dispensing of FARXIGA® (dapagliflozin). These letters suggest inconsistencies between the volume of the drug purchased and volume dispensed, raising significant legal, compliance, and financial risks for pharmacies of all sizes. 

What Are These Letters About?

Since June 2025, pharmacies have reported receiving a first letter from AstraZeneca, alleging that they did not purchase enough FARXIGA to support the reported dispensing in 2024. The letter requested that the pharmacy review its wholesaler invoices and pharmacy dispensing records to ensure AstraZeneca was billed correctly. 

…Then Comes a Second Letter

Many pharmacies are now reporting receiving a second, more aggressive letter expanding the scope of review to 2025. In addition, the second letter also demanded that the pharmacy provide purchasing, dispensing, and PBM data beyond what AstraZeneca may be legally entitled to or contractually prohibited from sharing. 

A Sign of a Larger Industry Shift

These letters reflect a growing and aggressive trend among manufacturers to recoup perceived overpayments, reduce liability, and enforce unilateral pricing compliance. Importantly, most pharmacies have no direct contractual relationship with the manufacturer, meaning the manufacturer may have no enforceable audit rights or entitlement to records from the pharmacy.

Instead, manufacturers are increasingly obtaining claims and purchasing data from PBMs and wholesalers, then using that third-party information—which may be incomplete or misleading—to allege discrepancies between product purchase and dispensing activity. Pharmacies are then pressured to turn over internal business records, dispensing logs, or even PBM data.

Responding to these demands can carry significant risk. Without legal review, a pharmacy may inadvertently disclose protected health information, breach confidentiality obligations under payor or wholesaler contracts, or provide data that is later used to justify repayment demands or trigger further audits.

This is not a routine compliance issue. It represents a widening post-dispensing enforcement strategy, where manufacturers seek to shift financial risk downstream by leveraging indirect data channels and threatening pharmacies with reporting discrepancies to PBMs, wholesalers, or government authorities. If this approach is normalized, it could have far-reaching implications for how pharmacies are monitored and held accountable going forward.

Why Responding Without Legal Counsel Puts Your Pharmacy at Risk

Engaging with manufacturer inquiries without experienced legal guidance can expose your pharmacy to significant and avoidable risks. Although the manufacturer may lack a direct contractual relationship with your pharmacy, any response (especially one involving sensitive data) may have unintended consequences.

How Barclay Damon Can Help

Barclay Damon’s national Pharmacy Team is actively advising pharmacies in response to AstraZeneca’s FARXIGA-related inquiries. It’s critical that you understand your legal position before disclosing any data or documentation.

Our team helps pharmacies assess the legitimacy of these demands, identify what (if anything) must be shared, and craft strategic responses that comply with PBM and wholesaler agreements. 

If your pharmacy has received a letter from a manufacturer, or expects to, contact us immediately for guidance.

If you have any questions regarding the content of this alert, please contact Brad Gallagher, co-leader of the firm's Health Care Controversies and Pharmacy Teams, at bgallagher@barclaydamon.com; Alix Hirsh, associate, at ahirsh@barclaydamon.com; or another member of the firm’s Health Care Controversies or Pharmacy Teams.
 

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