Outrage of the Month: Protecting Americans From Risky Drugs Made Overseas
Health Letter, November 2025
By Robert Steinbrook, M.D.
Director, Public Citizen's Health Research Group
(An earlier version of this column was published in the September 2025 issue of Worst Pills, Best Pills News)
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 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. Published in June 2025, 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.
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.” 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.
The stated reason for the exemptions was to prevent drug shortages. 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.
Generic and biosimilar prescriptions accounted for 90% of prescriptions filled in the United States in 2024 but only 12% of spending on prescription drugs. Ensuring the quality, safety and availability of these drugs is critical.
In an equally disturbing follow-up article published in October 2025, ProPublica scrutinized the FDA’s long-standing practice of keeping patients, doctors and pharmacists in the dark about which drugs were made in contaminated foreign factories and instances where “manufacturing failures have made medications ineffective or unsafe.” According to the follow-up report, “For decades, the FDA has blacked out the names of generic drugs on inspection reports for foreign factories that were found to have safety and quality violations,” although there was no specific requirement for the agency to redact this information. Moreover, ProPublica found that drug labels often don’t specify the manufacturer of the drug or the addresses of factories.
Why did the FDA keep patients, doctors and pharmacists in the dark? The FDA’s reasons included “a cautious interpretation of a law that requires the government to protect trade secrets” and the fear of “being sued by drugmakers.” Also, the agency doubted the usefulness of the inspection reports for the public. Although Woodcock, the former FDA official, told ProPublica that she favors releasing drug names, she was quoted as saying: “You guys think you are like citizen scientists and you can figure out what this means and it’s just not the case.”
The ProPublica investigation was about FDA actions that occurred before the second Trump Administration took office. The probe, however, raises pressing questions for the new administration.
First, FDA Commissioner Dr. Marty Makary has argued for “gold-standard science, radical transparency, and common sense.” Makary has been on the job for seven months. Will the FDA under Makary’s leadership commit to openness and honesty with the public about inspections of foreign manufacturers and the agency’s actions?
Second, in its FY 2026 legislative proposals, the FDA has asked Congress to amend the Federal Food, Drug, and Cosmetic Act to clearly require that drug labels and related materials include the name, address and “unique facility identifier” of manufacturers and other companies that may have produced the active pharmaceutical ingredients. Will the FDA follow up with Congress and also release more information on its own?
Third, 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? It is exactly the wrong time for the agency to be cutting its foreign inspection force.
Finally, 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 reports offer a wake-up call to the administration on multiple fronts. The next step should be for the FDA to work with Congress to promptly make changes to better safeguard the quality of generic drugs. The FDA must also ensure the public availability of full information about the agency’s activities and the drugs themselves.