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Medium urgency

Pay(or) Attention, Drug and Device Makers: FDA’s New Guidance for Talking to Health Plans - ArentFox Schiff

Detected July 23, 2026 · in Pharmaceutical Manufacturing (FDA/DEA)

FDA issued new guidance on communications between drug/device makers and health plans, affecting how manufacturers discuss off-label uses and product value. The guidance clarifies permissible information sharing under the Food, Drug, and Cosmetic Act.

Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 23, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B) should confirm how it applies to their specific situation before acting. There is a time constraint attached: Ongoing; implement changes within 90 days to align with FDA expectations.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.

What changed

FDA clarified that manufacturers may proactively provide health plans with health care economic information (HCEI) about off-label uses, subject to certain conditions, and may share truthful and non-misleading information about product value.

Who it affects

Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B)

What you must do

Review and update internal policies and training for sales and medical affairs teams to ensure communications with health plans comply with the new guidance.

Deadline

Ongoing; implement changes within 90 days to align with FDA expectations.

Source: https://news.google.com/rss/articles/CBMivAFBVV95cUxPdFZ0VFRlZkhZeTU4WERJT3ZFRHUwYnlTeGJqbGRuVW8yR0ZKWG1vaGJ1VmRTMXg4YXE2ajd3VFRYNXM1ek50RWNZQTRZZ3paSzdIaC1DYzVRQWZNS0RhVDJrejZucVpiMDRJejd0U3IzY3ZDM3pBMFpzaXVMdGNQV0lWemNoTUVXV05xa2ZRMUpYdkRZdWEtZTdqVHZ1aEFsTWFhME5wb2JKZEpkOWNJVWV0UmhjYm5xZFhXcQ?oc=5

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