Pharma is finally catching up to the on-demand world—offering direct-to-patient (DTP) services that promise convenience, faster delivery, and a more personalized experience. Major players like Pfizer, Lilly, and Novo Nordisk are leading the way, cutting out intermediaries like pharmacists, PBMs, and even traditional physicians.

But convenience comes at a cost.

By removing these safeguards, companies take on massive compliance liabilities. Telehealth prescribing raises serious questions around physician independence and anti-kickback regulations. Fulfillment introduces risks tied to product integrity, recalls, and data privacy. Even cash-based payments can trigger transparency violations and pricing scrutiny.

The risks are real: HIPAA breaches, malpractice claims, and federal investigations can derail even the most well-meaning DTP strategies. That’s why pharmaceutical companies must treat compliance as foundational—not an afterthought.

The path forward? Define clear boundaries between pharma, prescribers, and delivery partners. Invest in internal audits. Build scenario-based risk plans. And most importantly, bring legal and compliance professionals to the table from day one.

At Kulkarni Law Firm, we specialize in helping pharma companies innovate without compromising compliance. If your organization is exploring or expanding its DTP strategy, let’s make sure you’re protected—before risks become reality.

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