DTP Compliance Just Got Tricky

The Seventh Circuit just issued a pivotal decision in U.S. v. Sorenson, reshaping how pharmaceutical and medical device companies should think about direct-to-patient (DTP) advertising and Anti-Kickback Statute (AKS) compliance.

In this case, Sorenson’s company paid marketers to generate patient interest in orthopedic braces reimbursed by Medicare. These marketers gathered patient details and sent unsigned prescriptions to physicians. While most leads went nowhere, the court ruled this did not constitute a referral under AKS, since marketers weren’t influencing medical decisions and doctors retained full judgment.

The takeaway? The court is drawing a line between generating patient interest and influencing prescriber behavior. For pharma marketers, this clarifies that driving patient awareness without steering doctors may reduce AKS risk—at least in the Seventh Circuit.

If your DTP campaigns involve disease awareness, educational tools, or lead gen without prescriber targeting, you're likely on safer ground. But if those leads are used to nudge physicians’ decisions, compliance risks still loom.

Bottom line: Intent and influence are everything. Want help navigating this evolving space? Contact the Kulkarni Law Firm for support with risk-adjusted marketing agreements and compliance reviews.

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