Shannon Wiley Co-Authors Article On Building Compliance-Driven Infrastructure For Direct-To-Patient Programs

Bass, Berry & Sims attorney Shannon Wiley co-authored an article in Pharmaceutical Commerce examining the growing adoption of direct-to-patient (DTP) pharmaceutical programs and the complex compliance challenges that accompany their expansion. As manufacturers increasingly pursue DTP models to improve patient access and affordability, Shannon and her co-author Chander Viswanathan – chief technology, product and operations officer at PHIL Inc. – emphasized that program growth is outpacing regulatory guidance, requiring companies to navigate an evolving patchwork of federal, state, pharmacy, and payer requirements.

In the article, the authors discusses key legal and regulatory considerations shaping the DTP landscape, including Anti-Kickback Statute risks, state telehealth and corporate practice of medicine requirements, payer and PBM obligations, data-sharing concerns, and heightened scrutiny of patient-facing interactions. The authors note that the lack of comprehensive regulatory guidance creates significant challenges for manufacturers seeking to balance patient experience, commercial objectives, and compliance obligations.

Shannon and Chander advocate for a “compliance-by-design” approach, arguing that manufacturers should build flexible infrastructure capable of adapting to evolving legal and regulatory requirements in real time rather than relying on reactive compliance measures. According to the authors, dynamic compliance frameworks can help organizations maintain program effectiveness while supporting patient access, affordability, and adherence as the DTP marketplace continues to evolve.

Read the full article, “The Critical Layer for Pharma’s Growing Direct-to-Patient Play,” published in Pharmaceutical Commerce on August 11.

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