The U.S. Food and Drug Administration (FDA) has allowed pharmacies in China and India to import drugs into the U.S. market, despite concerns about quality and safety raised by industry experts and adverse event data. These findings were highlighted in a report.
Critics argue that the FDA's policy permits drugs from Chinese and Indian pharmacies to enter the U.S. market without undergoing the same rigorous oversight required of domestic producers. According to ProPublica, several overseas factories received exemptions from import bans even after inspectors identified unsanitary conditions and falsified records, raising concerns about the quality of imported drugs. U.S.-based companies, such as Empower Pharmacy, operate under more direct FDA supervision and emphasize their adherence to higher safety and quality standards, creating a disparity between foreign and domestic regulatory scrutiny.
According to ProPublica, the European Union mandates that all medications produced in India and China undergo independent quality checks on EU soil before being distributed within its borders. In response to concerns over foreign drug quality, the U.S. Department of Defense has independently tested more than three dozen generic drugs made abroad and discovered potency and other quality issues. This contrast in oversight highlights a gap in the FDA’s approach compared to international standards.
An analysis of the FDA’s adverse event database revealed thousands of incident reports associated with drugs from factories granted exemptions, with cases involving cardiac arrest, blurred vision, choking, vertigo, and kidney injuries. Some reports detailed specific concerns about drug composition and manufacturing practices. Despite these signals, the FDA did not implement systematic monitoring of harm patterns linked to the exempted drugs.
Murray Lumpkin, former deputy commissioner for international programs at the FDA, questioned the agency’s oversight of imported drugs by asking: "If you don’t know about the quality of the product, why are you letting it in?" as reported by ProPublica. Lumpkin made this statement after leaving the agency in 2014 when import policies were becoming more permissive but before most exemptions were granted. His remarks reflect ongoing concerns from regulatory experts regarding the safety of exempted foreign-made drugs.
Founded in its modern form in 1906 and headquartered in Silver Spring, Maryland, the FDA is an agency within the U.S. Department of Health and Human Services. It traces its regulatory lineage to the 1862 Bureau of Chemistry and evolved steadily through the 20th century—joining various departments before firmly establishing its independent regulatory mandate. Today, the agency is divided into specialized centers (e.g., Center for Drug Evaluation and Research [CDER], Center for Devices and Radiological Health [CDRH]), with a broad mission to "protect public health" through oversight of food, drugs, devices, and more.
