Omnibus spending bill expands FDA’s unannounced foreign inspections pilot

Regulatory NewsRegulatory News | 12 January 2023 |  By 

The recently enacted omnibus spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to expand its unannounced foreign facility inspection pilot program in a quest to achieve parity with domestic inspections, which are mostly unannounced.
The FY 2023 spending bill was signed by President Biden on 27 December. The bill authorizes $3.5 billion in budget authority for FDA in FY 2023, a 6.5% increase compared to the previous year’s budget. (RELATED: This Week at FDA: Congress passes omnibus spending bill, securing budget increase for FDA, Regulatory Focus 23 December 2022).
Section 3615 of the omnibus spending bill allocates $10 million for the pilot. The legislation requires FDA to conduct a pilot program to increase the conduct of unannounced surveillance inspections of foreign drug establishments.
The pilot is intended to evaluate the differences in the number and type of violations identified during unannounced and announced inspections of foreign drug establishments and any other significant differences between each type of inspection.
The pilot will also weigh the costs and benefits associated with conducting announced and unannounced inspections of foreign facilities, identify the barriers to conducting unannounced inspections of foreign sites and identify any challenges to achieving party between domestic and foreign human drug inspections.
Lastly, Congress calls for the pilot to identify approaches for mitigating negative effects of conducting announced inspections of foreign sites and instructs FDA to launch the program within 180 days of the bill’s enactment.
After completion of the pilot, FDA is required to issue a report on its website identifying its findings and recommendations with respect to evaluating and addressing any barriers to conducting unannounced foreign inspections. The report should also offer recommendations for achieving parity between domestic and foreign drug inspections and include the number of unannounced inspections during the pilot. This report should be submitted to Congress within 180 days of the pilot’s termination.
Members of Congress have been critical of FDA’s practice of preannouncing foreign drug inspections well in advance of the actual inspection, arguing that this practice raises serious questions about the effectiveness of the inspections when firms know when investigators will be visiting. Previously, the FY 2022 appropriations bill directed FDA to pilot an unannounced inspections program in India and expand it to China for short unannounced and short-term inspections. (RELATED: Unannounced FDA inspections in India, China to begin soon, Regulatory Focus 15 December 2021).
Omnibus bill


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