FDA Drug Inspections Overdue: 2,000 Plants Awaiting Quality Checks

FDA Drug Inspections Delayed: A Growing Concern

The failure of the FDA to conduct timely drug inspections has resulted in nearly 2,000 pharmaceutical manufacturing plants being overdue for regulatory checks. This situation, exacerbated by the COVID-19 pandemic, raises substantial concerns about the safety and quality of medications used by millions of American consumers.

Impact of Inspection Delays

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• Of the 4,700 registered drug plants, approximately 42% are overdue for inspections.
• Critical medicines, including antibiotics and cancer therapies, are manufactured in overdue plants.
• Regulatory guidelines stipulate that facilities not inspected in five years are high-risk and should be prioritized for mandatory inspections.
• Most overdue plants are located in the U.S.; however, over 340 are in India and China.

Historical Context and Risks

Last year, contaminated eyedrops from an uninspected Indian factory resulted in severe health consequences for more than 80 Americans. BFDA has historically faced challenges with foreign inspections, impacting the overall safety of the U.S. drug supply.

Policy Implications and Future Outlook

Despite efforts to increase inspections, FDA statistics for last year indicated a 40% decrease from pre-pandemic levels. The ability to restore timely inspections hinges on remedying staffing shortages caused by attrition and enhancing regulatory oversight.