Merck sued the US government. Novartis is bracing for a $300 million hit. The pharmaceutical industry has been navigating a challenging environment. Between Medicare’s newfound pricing muscle, the FDA’s DSCSA implementation curve balls, and Europe’s new clinical assessment approach, staying compliant while keeping operations running smoothly has never been more demanding.

But before you panic, take a breath. We’ve analyzed the latest regulatory shifts and explained exactly what they mean for your day-to-day operations. Consider this your roadmap to prepare for what’s ahead.

Regulatory changes reshaping pharma

Medicare’s drug pricing power: Medicare can now negotiate prices for high-cost medications. This could impact pharmaceutical companies’ revenue, requiring adjustments to pricing strategies and revenue models across the supply chain.

DSCSA relief: The FDA has offered some relief regarding DSCSA implementation. Companies facing technical hurdles connecting their data systems have been granted exemptions, and small pharmacies have an extended deadline. This provides breathing room but emphasizes the need for continued progress towards compliance.

Europe’s clinical assessment overhaul: New EU regulations mandate joint clinical assessments for drug approvals. While this streamlines the process, it presents challenges for rare disease treatments and potentially complicates their path to market.

Implications for manufacturers

These regulatory changes can have significant implications for pharmaceutical manufacturers, affecting everything from pricing and revenue planning to system integration and compliance strategies.

• Revenue planning: Manufacturers need flexible revenue models that adapt to Medicare’s pricing negotiations and DSCSA requirements.
• System integration: Legacy data systems need modernization to achieve DSCSA compliance and seamless data sharing with trading partners.
• Compliance strategy: While exemptions offer temporary relief, manufacturers must continue working towards full DSCSA compliance.

Proactive planning for regulatory resilience

Forward-thinking organizations are building resilience by focusing on three key strategies:

1. Operational adjustments: Implement digital solutions that enhance existing workflows and address compliance gaps. Systech’s UniTrace® platform, for example, facilitates DSCSA compliance through real-time data exchange and streamlined data management.
2. Regulatory intelligence: Centralize regulatory monitoring and efficiently disseminate updates. To stay informed, utilize resources like UniTrace®’s collaboration hub, FDA websites, industry publications, and compliance training.
3. Supply chain optimization: Implement end-to-end traceability solutions for real-time visibility and proactive exception management. Systech’s serialization and aggregation systems empower supply chain managers with complete oversight and control.

Embracing the new era

The evolving regulatory landscape presents both challenges and opportunities. Pharmaceutical companies can successfully navigate these changes by embracing innovation, transparency, and proactive compliance.

Systech offers a comprehensive suite of solutions to support you through this transition, from exception management and DSCSA compliance to anti-counterfeiting, diversion detection and supply chain optimization.

Ready to transform these regulatory challenges into opportunities? Contact us today.