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When medications manufactured overseas are sold in the United States, the assumption is that they are as safe and effective as drugs made in this country, regardless of where they are made and whether the drug is brand name or generic. That is why a recent ProPublica investigation of the Food and Drug Administration (FDA)’s oversight of foreign factories, where many generic drugs sold in the United States are manufactured, is particularly disturbing.[1] The investigation’s central finding was...
When medications manufactured overseas are sold in the United States, the assumption is that they are as safe and effective as drugs made in this country, regardless of where they are made and whether the drug is brand name or generic. That is why a recent ProPublica investigation of the Food and Drug Administration (FDA)’s oversight of foreign factories, where many generic drugs sold in the United States are manufactured, is particularly disturbing.[1] The investigation’s central finding was that the FDA, without any public warning, permitted more than 150 drugs or their ingredients into the country over the past 12 years even though they were manufactured at factories banned from shipping products to the United States.[2]
According to the report, the factories that made these drugs were “found to have mold, foul water, dirty labs or fraudulent testing protocols. Nearly all [of the drugs] came from factories in India.”[3] The exempted drugs included antibiotics, chemotherapy agents, antidepressants, sedatives and epilepsy medications. Some of the exempted drugs were recalled after contaminants or other defects that could cause health problems were found.
The FDA did not routinely test the drugs after they became available in the United States or actively determine whether people had been harmed, the report said. ProPublica’s “conservative” review of adverse-event reports identified mentions of about 70 hospitalizations and nine deaths.[4]
The stated reason for the exemptions was to prevent drug shortages. Dr. Janet Woodcock, the government official who for more than two decades led the FDA’s Center for Drug Evaluation and Research, said the agency believed the exempted drugs were safe and that the public release of information would have caused “some kind of frenzy” among people seeking to switch their prescriptions. “We felt we didn’t have to make it a public thing,” Woodcock was quoted as saying.[5]
Generic and biosimilar prescriptions account for 90% of prescriptions filled in the United States but only about 13% of prescription-drug spending.[6] Assuring the quality, safety and availability of these drugs is critical.
The ProPublica investigation was about FDA actions before the second Trump Administration took office. The probe, however, raises pressing questions for the new administration.
First, FDA Commissioner Dr. Martin Makary has embraced “gold-standard science, radical transparency, and common sense.”[7] Will the FDA under Makary’s leadership commit to openness and honesty about inspections of foreign manufacturers and the agency’s actions?
Second, will the FDA be willing and able to maintain its overseas investigative capacity by pushing back against mandated layoffs that undermine its ability to ensure the safety of medications made at foreign factories?[8] It is exactly the wrong time for the agency to be cutting its foreign inspection force.
Third, will the FDA effectively work to prevent drug shortages by identifying other manufacturers and working to improve manufacturing practices throughout the generic-drugs industry?
The ProPublica investigation offers a wakeup call to the administration on multiple fronts.
References
[1] Cenziper D, Rose M, Roberts B, Hwang I. Threat in your medicine cabinet: The FDA’s gamble on America’s drugs. ProPublica. June 17, 2025. https://www.propublica.org/article/fda-drug-loophole-sun-pharma. Accessed July 15, 2025.
[2] Cenziper D, Rose M, Roberts B, Hwang I. Seven things to know about ProPublica’s investigation of the FDA’s secret gamble on generic drugs. June 23, 2025. https://www.propublica.org/article/fda-drug-safety-foreign-manufacturers-takeaways. Accessed July 15, 2025.
[3] Ibid.
[4] Cenziper D, Rose M, Roberts B, Hwang I. Threat in your medicine cabinet: The FDA’s gamble on America’s drugs. ProPublica. June 17, 2025. https://www.propublica.org/article/fda-drug-loophole-sun-pharma. Accessed July 15, 2025.
[5] Ibid.
[6] Association for Accessible Medicines. Report: The U.S. Generic & Biosimilar Medicines Savings Report. September 2024. https://accessiblemeds.org/wp-content/uploads/2025/01/AAM-2024-Generic-Biosimilar-Medicines-Savings-Report.pdf. Accessed July 15, 2025.
[7] A statement from FDA Commissioner Dr. Marty Makary, M.D., M.P.H: 100 days of embracing gold-standard science, transparency and common sense. July 10, 2025. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-100-days-embracing-gold-standard-science-transparency. Accessed July 15, 2025.
[8] Malis V, Dailey K, Leite S. FDA layoffs could compromise safety of medications made at foreign factories, inspectors say. July 7, 2025. https://www.propublica.org/article/fda-cuts-drug-factory-inspections. Accessed July 15, 2025.
