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# Study Connection Between Foreign Drug Manufacturing and Recalls
- URL: https://www.fdaweb.com/study-connection-between-foreign-drug-manufacturing-and-recalls/
- Published: 2026-09-03T12:00:00.000Z
- Updated: 2026-09-14T12:05:14.000Z
- Author: David McFarland
- Tags: enforcement, #legacy-id-D5161728

Senate Special Committee on Aging chairman **Rick Scott** (R-FL) and ranking member **Kirsten Gillibrand** (D-NY) are asking the Government Accountability Office (GAO) to analyze the connection between foreign drug manufacturing and drug recalls. In their letter to the GAO, the senators said, “Over the past three decades, the United States has ceded an alarming share of its pharmaceutical manufacturing capacity to foreign nations. Since 2000, this trend has accelerated significantly, with active pharmaceutical ingredients (APIs), key starting materials (KSMs), and finished dosage forms increasingly sourced from China and from countries where pharmaceutical manufacturing sectors are substantially dependent on APIs or KSMs sourced from China.”

They ask that GAO undertake a three-prong analysis:

- Recall analysis by country of manufacture – assessing recall frequency, classification by severity, and trends by country of manufacture from 2000 to the present;
- FDA enforcement discretion and the drug shortage list – in terms of Warning Letters, Official Action Indicated, or Voluntary Action Indicated inspection classifications for companies that have products on the drug shortage list; and
- Analysis of FDA disclosure of recalls to patients – the FDA process for disseminating information on recalls to patients.