If your pharmacy dispenses Farxiga® (dapagliflozin), you may have received a second formal letter from AstraZeneca. These new communications, sent out in mid-September, aren’t routine follow-ups. They represent a clear escalation in how the manufacturer is scrutinizing pharmacies’ dispensing and purchasing data. In this new round of demands, AstraZeneca claims that the number of Farxiga® tablets dispensed exceeds those purchased through authorized channels. Pharmacies are requested to provide detailed summaries of 2024–2025 purchases, dispensing data broken down by payor and month, and proof of communication with PBMs about any “impacted” claims. This is part of a broader trend—manufacturers are increasingly using data to “police” distribution chains. What starts as a “verification” can easily snowball into enforcement. Similar demands can be expected from other manufacturers targeting high-cost and specialty products in the near future.

The tone and scope of the AstraZeneca Farxiga letters suggest serious implications for pharmacy providers. The potential of PBM exposure and compliance risks should not be disregarded and pharmacy operators should engage qualified, experienced counsel to guide them in considering a strategically sound, limited and appropriate response avoiding admissions against interest, speculation or regulatory non-compliance.

At MDRXLAW, we’ve guided pharmacies through manufacturer and PBM investigations for over 15 years. If you’ve received a Farxiga® demand or reconciliation letter, contact our experience healthcare attorneys as MDRXLaw by emailing info@mdrxlaw.com or calling our office at 212.668-0222.