Pharmaceutical manufacturers whose products are participating in government drug pricing programs must navigate an ever-evolving legislative landscape to strike a balance between risk and value. In 2025, manufacturers are entering a new era in which compliance is less about following mandated protocols and more about mitigating government program liability. Unlike simply altering their assumptions to deal with these changes, pharma companies are now faced with overhauling their models to adjust to many net-new challenges.

This white paper covers:

• The latest developments in three key compliance challenges that will continue to impact pharma companies this year – the Inflation Reduction Act (IRA), the 340B Drug Pricing Program, and state drug price transparency laws.
• How some U.S. manufacturers are pushing back on regulatory demands.
• Expert insight for staying compliant and protecting revenue in this dynamic landscape.