OIG Issues Special Advisory Bulletin on Direct-to-Consumer Drug Programs - orrick.com
OIG issued a Special Advisory Bulletin warning that certain direct-to-consumer (DTC) drug programs may violate the Anti-Kickback Statute (AKS) and could lead to increased enforcement. The bulletin clarifies that offering free or discounted drugs to patients, even through copay assistance or patient assistance programs, may be considered illegal remuneration if they induce the purchase of federally reimbursable drugs.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 28, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B) that operate or participate in DTC drug programs, including copay assistance, patient assistance, or free drug programs. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Immediately; OIG expects compliance with existing law, and enforcement actions may be imminent.. 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
OIG clarified that DTC programs offering free or discounted drugs to patients may violate the AKS if they are intended to induce the purchase of drugs reimbursed by federal healthcare programs. The bulletin provides examples of problematic arrangements and emphasizes that even indirect benefits to patients can trigger liability.
Who it affects
Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B) that operate or participate in DTC drug programs, including copay assistance, patient assistance, or free drug programs.
What you must do
Review all DTC drug programs, including copay assistance, patient assistance, and free drug offers, to ensure they do not violate the AKS. Consider restructuring or discontinuing programs that could be viewed as inducing federal program beneficiaries.
Deadline
Immediately; OIG expects compliance with existing law, and enforcement actions may be imminent.
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