FDA Comissioner Responds to Investigation of Agency’s Oversight of Tainted Syringe Factory

The Food and Drug Administration’s newly sworn commissioner promised a more aggressive approach to product safety in response to a ProPublica and Chicago Tribune report about the agency’s oversight of a North Carolina plant that produced syringes contaminated with bacteria.

“This incident underscores my belief that it is critically important for the FDA to take an aggressive approach to inspections and maintain vigilance in ensuring that manufacturers fully comply with their regulatory, legal and moral obligations to ensure that the products they produce for the American people are safe and effective,” Dr. Margaret Hamburg said in a statement issued Saturday. “I intend to make this a top priority as commissioner of the FDA.”

Hamburg, an expert in bioterrorism and community health, was confirmed in late May. She starts the job as the agency faces high-stakes challenges in food and medical-device safety. Numerous reports have concluded that FDA resources haven’t kept pace with demands placed on the agency.

In the case of AM2PAT, which produced the contaminated syringes, the FDA ignored guidance in its own operations manual to investigate the plant just weeks before tainted devices reached the hands of medically fragile patients.

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