Introduction: A Policy Imperative Meets Real-World Readiness

On May 12, 2025, the White House issued a landmark executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients." This directive aimed to end the era of U.S. patients paying more—often twice or even three times more—for the same medications manufactured under the same conditions abroad.

Under the executive order, pharmaceutical companies are now under pressure to align U.S. drug prices with those in comparable developed countries. The executive order specifically directs agencies to establish “MFN-aligned” price targets within 30 days, followed by a 180-day negotiation window before further regulatory measures might be enforced.

For pharma executives, the challenge is clear: comply swiftly—or face legal, political, and reputational consequences.

While many companies are scrambling to interpret and meet these demands, Marley Drug and Medicure Inc have been ahead of the curve for years.

ZYPITAMAG (pitavastatin): MFN Pricing Before It Was a Buzzword

Long before the MFN directive became political, Medicure embraced the very principles now being mandated (see our story):

• Low, affordable pricing
  ZYPITAMAG has been offered at a simple, transparent flat rate—just $1.15 per day, no insurance required.
  
  
• Universal access
  Medicure's pricing is available to everyone: insured, uninsured, Medicare, Medicaid—you name it. No tiers, no games.
  
  
• Direct-to-Consumer (DTC) Distribution
  Through Marley Drug, ZYPITAMAG is delivered directly to patients in all 50 states, bypassing PBMs and avoiding the rebate trap.
  
  
• Expansion to other therapies
  Medicure has also extended this model to other chronic medications, offering transparent pricing and fulfillment support through the same DTC channel.

“We didn’t wait for regulation. We built a patient-first system because it was the right thing to do—and it turns out, the MFN directive caught up to us.”
— Reuben S., Medicure

1. Why Doctors, Patients, and Pharma Should Care

• Rising Out-of-Pocket Costs
  Patients in the U.S. routinely face outrageous drug costs—spending over $600 billion annually, with nearly 1 in 4 Americans skipping medications due to cost.
  
  
• MFN: A Double-Edged Sword
  While the EO could lower prices by 30% to 80%, experts caution that mirroring foreign price models may limit access to novel therapies. Countries with price controls often impose strict access barriers, potentially delaying or denying entry to life-saving medicines.
  
  
• Messaging from the Marketplace
  Companies like Eli Lilly and Bristol-Myers Squibb have proactively introduced direct-to-consumer (DTC) channels—bypassing PBMs and insurers to offer discounted drug access. These efforts, though promising, have been branded insufficient by the administration.

2. Why This Matters for Pharma Leaders Right Now

The MFN directive is part of a broader reckoning in U.S. healthcare. The federal government is signaling that PBM opacity, offshore pricing arbitrage, and inaccessible pricing models are no longer acceptable.

But building a compliant DTC infrastructure from scratch is slow, risky, and resource-intensive.

Pharma's Dilemma:

Pharma Challenges vs. Typical Roadblocks

3. Why Building from Scratch Isn’t the Only Option

Most pharma companies are ill-equipped to meet these demands on their own. Crafting compliant infrastructure—covering pricing, fulfillment, adherence, and regulatory compliance—can take years.

However, mature Direct-to-Patient models already exist. DTP pharmacies like Marley Drug can deliver drugs at lower total cost for patients—sometimes even undercutting insurance-based copays.

Moreover, DTP models offer strategic advantages:

• Rich patient-level data for engagement and adherence planning (we are seeing 43% better adherence with ZYPITAMAG at Marley Drug than local pharmacies)
• Clear, transparent pricing—cutting through supply chain opacity
• Simpler patient experience, bypassing PBM complexity

4. Enter Marley Drug: The Operational Advantage Pharma Needs

• Transparent, MFN-Aligned Pricing
  We offer a simple drug + pharmacy fee model—no rebates, no markups, no PBM interference. Our pricing structure mirrors MFN goals by design, not as an afterthought.
  
  
• Nationwide Pharmacy Licensure
  Marley Drug is licensed in all 50 states, eliminating the need for pharma to build or contract new fulfillment infrastructure. We’re ready for launch—today.
  
  
• Regulatory Confidence
  Fully compliant with DSCSA, REMS, HIPAA, and state-specific regulations. Our platform is audit-ready and built to scale.
  
  
• Direct-to-Patient Fulfillment
  From click to doorstep, Marley ensures continuity, clarity, and speed—delivering medication directly to patients without delay or confusion.
  
  
• Real-Time Prescriber & Patient Insights
  Gain access to next-day prescribing data—know which provider wrote the Rx, for whom, and when. A valuable tool for medical affairs, commercial strategy, and patient engagement.
  
  
• Evidence-Based Adherence Programs
  Our Adherence Programs have demonstrated a 43% improvement in refill rates compared to traditional retail pharmacies—helping patients stay on therapy longer and improving outcomes.
  
  
• Integrated Patient Marketing Services
  Use Marley’s trusted, patient-facing brand to promote your pharmaceutical products within a high-integrity, educational framework. We support unbranded and branded initiatives.

In short, partnering with Marley isn’t a workaround—it’s a head start.

Conclusion: MFN Compliance Doesn't Have to Be Reinvented

The MFN directive signifies a watershed moment. Pharma leaders must respond—and fast. But they don't need to build everything from the ground up.

With proven DTP models and real pharmacy infrastructure in place, companies like Marley Drug offer a seamless, patient-first, MFN-compliant path forward.

Let’s build value—for patients and for pharma—together.

Zypitamag proved it’s possible.

Marley Drug makes it scalable.

Now it’s your move.

Ready to Explore Direct-to-Patient for Your Brand?

Reach out to info@marleydrug.com
Learn more: www.marleydrug.com