FDA Management and Budget Cut Impact Analysis

The ousting of FDA Commissioner Marty Makary and proposed 5.5% budget cuts have created a challenging environment for his successor. These cuts threaten to exacerbate drug shortages and undermine the US pharmaceutical industry's competitive edge in innovation.

Key Takeaways

• 1.Marty Makary has been ousted as FDA commissioner after one year, leaving a vacancy during a period of significant regulatory and budget strain.
• 2.The Trump administration proposed a $7bn (5.5%) budget cut for the FDA in fiscal year 2026, which is expected to reduce headcount and executive capacity.
• 3.Late or delayed FDA inspections significantly increase the risk of drug shortages, particularly for high-risk medicines and injectables.

Table of Contents

• Executive summary
• Why the FDA's executive capacity matters
• FDA cuts risk increasing drug shortages
• Distribution and production account for two-thirds of medicine shortages
• US drug shortage remains high
• FDA cuts also put the innovative capacity of the US at risk
• Makary's successor should keep the FDA focused on execution

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