House Committee Grills FDA Commissioner on Drug Shortages and Inspections

FDA Commissioner Robert Califf faced intense questioning from the House Committee on Oversight and Accountability regarding the agency’s preparedness for crises and its handling of drug shortages. Committee Chairman James Comer criticized the FDA for not ensuring the safety of food and drugs and noted a significant drop in foreign plant inspections since the pandemic. Califf acknowledged the need to accelerate inspections and informed the committee of a revamped inspection system in India and plans to transform the Office of Regulatory Affairs for improved response to drug shortages. He likened the FDA to a referee, constrained by current regulations and requiring more authority and data to address supply chain issues preemptively. While some lawmakers pushed for the FDA to be more proactive, others, including Representative Jamie Raskin, argued for granting the agency greater authority and resources to fulfill its regulatory duties effectively.

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[Source: Fierce Pharma, April 12th, 2024]