Our Core Advocacy Priorities

 

Our policy agenda is focused on creating clear, efficient pathways that incentivize VAM innovation and ensure fair market access.

 

 

1. Regulatory Clarity and Efficiency

 

We advocate for modernizing the drug approval process to properly reflect the unique nature of VAM development.

• Objective: Establish streamlined, predictable, and distinct regulatory pathways that recognize the efficiency of the 505(b)(2) pathway and its ability to build upon existing safety data.

• Key Action: Working with the FDA to develop explicit guidance that clarifies data requirements and reduces application review times for reformulated, repurposed, combination, and other projects.

• Targeted Outcome: Faster patient access to enhanced therapies, encouraging greater investment in the VAM sector.

 

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2. Market Access and Value Recognition

 

We challenge payer and provider policies that treat VAMs as simple generics, which undermines the investment needed for quality improvements.

• Objective: Ensure VAMs and biosimilars receive reimbursement and formulary placement that reflects their clinical and economic value—such as improved adherence, reduced side effects, and lower overall healthcare costs.

• Key Action: Engaging with the Centers for Medicare & Medicaid Services (CMS) and private payers to establish specific coding and payment policies for VAMs that acknowledge their superior patient utility.

• Targeted Outcome: Policy mechanisms that distinguish VAMs from generics, rewarding innovations that directly improve adherence and patient outcomes.