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Thinning blood from China has been 17 years since the injury or killing hundreds of Americans, and since then contaminants and other defects have appeared in the cross sections of American generic drugs.
To understand how high-risk drugs end up in our medicine cabinets, Propublica has investigated over a year of overseeing the oversight of the US Food and Drug Administration’s foreign factories accused of violating key quality standards. The reporter focused primarily on factories in India, the leading supplier of generic drugs around the world.
The investigation reveals how the FDA has allowed the United States to have more than 150 drugs or their ingredients over the past decades, despite being made in factories here, without warning the public. Because it is distributed in the US, agents were actively tracking whether they either didn’t test the drug on a regular basis or whether consumers were harmed.
Officials from the FDA and several former agencies told Propublica they believe that drugs exempted from the import ban are safe. They said the agency requested a popular drug manufacturer to perform additional quality checks before the drug was sent to the US.
To carry out that analysis, Propublica used Redica Systems to find hundreds of “import alerts” lists published by the FDA over more than 15 years, using a quality and regulatory intelligence agency with a vast collection of agency documents, as well as a Wayback machine in the Internet Archives. The list has identified that it is prohibited from transporting the drug to the United States as the FDA discovered a manufacturing violation.
While examining these lists, reporters found references to drugs or raw ingredients that the FDA excluded from the ban. Exemptions are mentioned with little explanation and are often scattered throughout the lengthy alerts.
The FDA does not hold a comprehensive list of drugs that have been exempt from the ban for many years, so Propublica had to build it. Reporters have adopted two different methods to do this. First, Propublica wrote code using keyword search and pattern matching to extract drug names and manufacturing locations from FDA alerts. Second, Propublica used artificial intelligence to extract the same information. The results of each analysis were cross-checked and reporters confirmed their results.
When completing the analysis, Propublica counted all drugs exempted from each prohibited factory. Sometimes the same drug was exempt from multiple factories and added to the total of each factories. In a small number of cases, the FDA exempted different formulations of the same drug, such as tablets, capsules, or injectable. Propublica counted these different forms as distinct drugs.
Propublica’s drug list, exempt from the import ban, may be missing. Without a full accounting from the FDA, there is no way to know for sure.
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The reporting team interviewed more than 200 people, including former FDA inspectors who repeatedly reported drugmaking breakdowns overseas and breakdowns from top managers directly involved in drug safety. Propublica also obtained the majority of government and corporate documents in the US and India and filed a lawsuit against the FDA in November. The FDA has since started offering some of the requested records. The case operates in federal court in New York.
Propublica paid Redica for access to FDA inspection records and ultimately reviewed reports that lasted over 20 years.
To measure what the FDA knew about the drug before and after it was exempt from the import ban, ProPublica elicited reports from the institution’s adverse event reporting system. The report is submitted to the FDA by consumers, health professionals, pharmaceutical companies, and others, and is used by agencies to detect safety concerns and potential harm patterns. Each contains information about drug-related conditions or reactions, and in some cases complaints about the quality of the product.
Propublica has identified more than 8,000 reports of drugs allowed from factory-wide import bans, both before and after the ban was introduced. Propublica’s analysis included reports from 2010 to early 2025.
The FDA warns that the information in the report has not been verified and that there may be no “causal relationship” between the drug and the adverse event. Multiple drugs may be listed in a single adverse event report. Propublica limited the analysis to cases that listed only one major suspect drug.
Some reports do not list specific concerns, but please refer to academic research instead. Propublica has ruled out these reports.
To investigate the role of FDA in the growth of foreign drug makers, Propublica used the orange book, a register of drugs considered safe and effective by the FDA. This list includes both the brand name and generic drug approval, the date the drug was approved, and the name of the company that submitted the application. Propublica’s analysis shows that companies with problematic regulatory history have received numerous approvals to introduce generic drugs in the United States. Some companies have been exempted from import bans.
For years, journalists have been revealing the problems with generic drugs. Katherine Evan’s bestseller 2019 book, “Bottle of Lies,” reveals how Indian pharmaceutical companies failed to follow basic quality and safety standards, often deliberately sending poor drugs abroad. In 2023, a Bloomberg survey revealed, among other things, how cough syrup made in India spreads around the world. And the independent Watchdog People’s Pharmacy raised repeated concerns about the quality of some generic drugs.
Propublica collaborated with journalism students at Medill Investigation Lab at Northwestern University in Washington, with DC Haajrah Gilani, Emma McNamee, Julian Andreone, Isabela Lisco, Aidan Johnstone, Megija Medne, Yiqing Wang, Phillip Powell, Gideon PardoBastra, Lake She, Alice Brown, Zhiyu Solstice Luo, Jessie Nguyen, Sinyi Au, Kate McQuarrie and Katherine Dailey contributed to this report.
