Direct-to-Consumer Changes Under the New Executive Order: What You Need to Know

On May 12th, 2025, President Trump issued an Executive Order—Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients—signaling a significant shift in the U.S. pharmaceutical landscape. With the administration calling on major manufacturers to deliver solutions within 60 days, the spotlight is now on innovative models, such as Direct-to-Consumer (DTC) distribution for prescription medications.

DTC models have the potential to make prescription drugs more accessible and affordable for patients by removing traditional intermediaries and providing greater pricing transparency. For example, manufacturers can leverage digital platforms to enable patients to order medications directly from a brand-supported website or app, with options for home delivery. This streamlined approach can enhance the patient experience, increase medication adherence, and facilitate direct communication between the manufacturer and the patient—enabling tailored education, refill reminders, and disease management support.

However, such a shift also brings significant operational and regulatory complexity. Manufacturers must navigate state and federal compliance requirements, ensure data privacy for patient information, and build the logistical infrastructure needed for direct shipping, payment processing, and customer service. There are also risks of disrupting established relationships with specialty pharmacies, distributors, and healthcare providers.

How Archbow Consulting Can Support DTC Initiatives

Archbow Consulting offers a comprehensive approach to help pharmaceutical manufacturers successfully plan, launch, and optimize DTC strategies:

• Channel Strategy Assessment: Archbow can conduct a complete evaluation of your current distribution and dispensing models to identify opportunities and risks associated with DTC. We help clients weigh the impact on existing channel partners and ensure a smooth transition.
• Regulatory and Compliance Guidance: Our experts will guide your team through the complex regulatory landscape, ensuring your DTC program is compliant with FDA, DEA, and state pharmacy board requirements, as well as data privacy laws (HIPAA, CCPA, etc.).
• Vendor Selection and Partnership Development: Archbow can identify, vet, and negotiate with third-party logistics (3PL) providers, digital pharmacy vendors, telehealth partners, and technology platforms to build a robust DTC infrastructure.
• Patient Support Program Design: We help manufacturers create end-to-end patient support programs, including nurse hotlines, financial assistance, education resources, and adherence solutions—all integrated into the DTC model for a seamless patient experience.
• Digital Platform Implementation: Our team can assist in the design and implementation of user-friendly digital ordering and fulfillment systems, leveraging best practices in e-commerce, patient onboarding, and ongoing engagement.
• Change Management and Stakeholder Communication: Archbow provides strategic communication planning to engage internal teams, educate prescribers, and maintain positive relationships with existing partners throughout the transition to DTC.

In this rapidly changing environment, pharmaceutical manufacturers need a partner with proven experience and practical solutions. Archbow Consulting stands ready to guide your organization through every step of launching a successful direct-to-consumer initiative—ensuring compliance, operational excellence, and an improved patient experience.

To learn more about how Archbow Consulting can support your DTC strategy and execution, Contact us today.