Matthew Sample

Direct-to-patient (DTP) models are positioned as a way to simplify and improve the patient experience—but their success depends just as much on how well they integrate into the day-to-day realities of healthcare professionals (HCPs) and pharmacies. As manufacturers expand their use of DTP strategies, friction often emerges not at the patient level, but within the workflows of the stakeholders responsible for prescribing, dispensing, and supporting access.

On Oct. 9, 2024—49 days before the end of the one-year stabilization period under the Drug Supply Chain Security Act (DSCSA)—the FDA issued an exemption1 for eligible trading partners that will continue to delay enforcement regarding compliance with the law’s final enhanced drug distribution security requirements. The exemption duration varies by partner type: Manufacturers and Repackagers: Until May 27, 2025 Wholesale Distributors: Until Aug.