FDA Secretly Allowed Contaminated Foreign Drugs Into the U.S., ProPublica Finds

ProPublica released an exposé on the FDA detailing the exemptions that were secretly allowed to foreign substandard drug factories, including a Sun Pharma plant in India. For more than a decade, the FDA has provided exemptions to over 20 foreign factories, allowing them to import more than 150 generic drugs into the United States. This is despite import bans from these factories after violations of contamination, dirty labs, and falsified records.

In 2022, when US inspectors visited the Sun Pharma factory, they found metal shavings on the equipment. Records were found detailing contaminated vials of “blackish” medication that were exported to the United States. Quality testing was not routinely conducted, and unknown “extraneous matter” was mixed into batches of drugs imported into the US.

ProPublica describes a “secretive group inside the FDA” that provided Sun Pharma and other violating factories exemptions to continue sending drugs to the US. This decision was reportedly made to prevent drug shortages for Americans who utilize these drugs to treat cancer and epilepsy, among other conditions.

This small secretive group granted these exemptions kept this information hidden from the public; Congress and many people within the FDA were also unaware that sanctioned foreign factories were sending contaminated medication into the country. Nearly all of the 20+ factories found during ProPublica’s investigation are in India.

Janet Woodcock, who served as the Commissioner of the FDA from 2021-2022 and Principal Deputy Commissioner of Food and Drugs from 2022-2024, said, “We felt we didn’t have to make it a public thing,” according to ProPublica’s report.

The HighWire reported in February about an Indian pharmaceutical company that was raided by Indian authorities following a BBC documentary. The pharma company was found to be distributing a strong opioid that is not legal anywhere in the world. An undercover video showed a director for the company warning about the health harms of this drug but still advocating for teenagers to take two to three pills to “relax and get high.”

ProPublica found that at least 150 medications are connected to these factories that had known contamination, mold, or quality control issues. Some of them were recalled shortly before or after the exemption was granted. Six hundred FDA complaints were linked to just three of the factories that received these exemptions.

Among the adverse event reports, there were 70 hospitalizations and nine deaths. ProPublica reports that these numbers are “conservative” because they only counted reports linked to one specific drug. There are thousands of FDA complaints related to drugs that received secret exemptions, which were hidden from the public.

The FDA granted an exemption for one drug in June 2023 and also received a complaint the same month. The person wrote, “Feeling really hot, breaking out with hives, hard to breathe, had confusion, glucose level was high, heart rate went up, and head, arms, and hands got numb.”

ProPublica notes in its report that drugs cause adverse side effects and sometimes side effects allegedly caused by drugs could be attributed to other factors. In some cases, the competing drugs from non-sanctioned sources also received similar complaints.

ProPublica shared an inspection report from an Intas factory, finding staff “routinely manipulated” data because the drugs had high levels of particulate matter, including glass and fiber.

The FDA, in its 2022 annual report, wrote “In 2022, generic drugs remained a significant public health priority for the FDA. Competition from generic drug makers helped make drugs more widely available and generally less expensive, allowing millions of patients to access the medicines they need more easily.”

The agency also acknowledged that 91% of all US prescriptions are filled with generic drugs. According to a 2024 study, more than 90% of generic drugs in the US rely on imported ingredients. America relies on China and India for the vast majority of active pharmaceutical ingredients (APIs). 85% of all new filings for API come from these two countries.

The FDA’s Office of Generic Drugs website states, “FDA-approved generic drugs have the same high quality, strength, purity and stability as brand-name drugs. The generic manufacturing, packaging, and testing sites used must pass the same quality standards as those of brand-name drugs.“

ProPublica conducted interviews with Woodcock and former FDA Director Robert Califf, who both supported the practice of granting exemptions to meet the end goal of ensuring there is an adequate supply of drugs for the Americans who use them. Woodcock reportedly said she didn’t think the public needed to be informed about the exemptions because the FDA believed the drugs were safe.

An anonymous FDA official reportedly involved in the secretive exemption process told ProPublica, “The odds of these drugs actually not being safe or effective is tiny because of the safeguards. Even though the facility sucks, it’s getting tested more often, and it’s having independent eyes on it.”

The European Union requires all drug imports from China and India to be tested after importation, a practice that the FDA doesn’t do when importing foreign drugs and ingredients. Woodcock said this would have increased confidence but claims the agency didn’t have the budget to allocate funding for this purpose.

Members of Congress have expressed national security concerns related to the reliance on foreign countries, especially India and China, for medical supplies and drugs. In 2020, Senator Bernie Sanders said it is “incomprehensible” that the US relies upon China and other foreign countries for prescription drugs. Senator Josh Hawley said US reliance on foreign countries for prescription drugs is a threat to American health and independence.