by Debbie Cenziper, Megan Rose, Brandon Roberts and Irena Hwang

We are still reporting. If you are a current or former FDA employee or someone in the industry with information about the agency, the safety of generic drugs, or the manufacturers that make them, our team wants to hear from you. Megan Rose can be reached on Signal or WhatsApp at 202-805-4865. Debbie Cenziper can be reached on Signal or WhatsApp at 301-222-3133. You can also email us at FDA@propublica.org.

On a sweltering morning in western India in 2022, three U.S. inspectors showed up unannounced at a massive pharmaceutical plant surrounded by barricades and barbed wire and demanded to be let inside.

For two weeks, they scrutinized humming production lines and laboratories spread across the dense industrial campus, peering over the shoulders of workers at the tablet presses, mixers and filling machines that produce dozens of generic drugs for Americans.

Much of the factory was supposed to be as sterile as an operating room. But the inspectors discovered what appeared to be metal shavings on drugmaking equipment, and records that showed vials of medication that were “blackish” from contamination had been sent to the United States. Quality testing in some cases had been put off for more than six months, according to their report, and raw materials tainted with unknown “extraneous matter” were used anyway, mixed into batches of drugs.

Sun Pharma’s transgressions were so egregious that the Food and Drug Administration imposed one of the government’s harshest penalties: banning the factory from exporting drugs to the United States.

But the agency, worried about medication shortages, immediately undercut its mission to ensure the safety of America’s drug supply.

A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned. Pills and injectable medications that otherwise would have been banned went to unsuspecting patients across the country, including those with cancer and epilepsy.

The FDA didn’t routinely test the medications for quality problems or use its vast repository of drug-related complaints to proactively track whether they were harming the people who relied on them.

And the agency kept the exemptions largely hidden from the public and from Congress. Even others inside the FDA were unaware of the details.

In the hands of consumers, according to the FDA’s longtime head of drug safety, the information would have caused “some kind of frenzy.”

“We felt we didn’t have to make it a public thing,” said Janet Woodcock, who spent nearly four decades at the agency.

The exemptions for Sun weren’t a one-time concession. A ProPublica investigation found that over a dozen years, the same small cadre at the FDA granted similar exemptions to more than 20 other factories that had violated critical standards in drugmaking, nearly all in India. All told, the group allowed into the United States at least 150 medications or their ingredients from factories with mold, foul water, dirty labs or fraudulent testing protocols.

Some of the drugs were recalled — just before or just after they were exempted — because of contaminants or other defects that could cause health problems, government records show. And a ProPublica analysis identified more than 600 complaints in the FDA’s files about exempted drugs at three of those factories alone, each flagging concerns in the months or years after they were excluded from import bans in 2022 and 2023.

The “adverse event” reports about drugs from the Sun plant and two others run by Indian drugmaker Intas Pharmaceuticals described medication with an abnormal taste, odor or residue or patients who had experienced sudden or unexplained health problems.

The reports cite about 70 hospitalizations and nine deaths. And those numbers are conservative. ProPublica limited its count to reports that linked problems to a single drug. However, the total number of complaints to the FDA that mention exempted drugs is in the thousands.

“Abdominal pain … stomach was acting very crazy,” one report said about a woman using a seizure drug from Sun Pharma. The FDA received the complaint in 2023, nine months after it excluded the medication from the import ban.

“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,” noted another report about a patient taking a sedative from Intas. The complaint was sent to the FDA in June 2023, the same month the agency exempted the medication.

The outcomes described in the complaints may have no connection to the drug or could be unexpected side effects. In some cases, the FDA received complaints about the same drugs made by other manufacturers.

Still, the seriousness of the reports involving exempted drugs did not galvanize the agency to investigate, leaving the public and the government with no way of knowing whether people were being harmed and, if so, how many.

Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a “cascade of failure” at one of the Intas plants, finding workers had destroyed testing records, in one case pouring acid on some that had been stuffed in a trash bag. At the second Intas factory, inspectors said in their report that records were “routinely manipulated” to cover up the presence of particulate matter — which could include glass, fiber or other contaminants — in the company’s drugs.

The FDA barred both plants in 2023 from shipping drugs to the U.S. Then the agency simultaneously granted more than 50 exemptions to those banned factories — the broadest use of exclusions in ProPublica’s analysis.

Intas, whose U.S. subsidiary is Accord Healthcare, said in a statement that the company has invested millions of dollars in upgrades and new hires and launched a companywide program focused on quality. Exempted drugs were sent to the United States in a “phased manner,” the company said, with third-party oversight and safety testing. Intas also said that some exempted drugs were never shipped to the United States because the FDA found other suppliers. The company would not provide details.

“Intas is well on its way towards full remediation of all manufacturing sites,” the company said.

Sun did not respond to multiple requests for comment. When the FDA imposed the ban, the company said it would “undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company’s remedial action. Sun Pharma remains committed to being … compliant and in supplying high-quality products to its customers and patients globally.”

Both companies’ factories are still under import bans.

“We’re supposed to have the best medicine in the world,” said Joe DeMayo, a kidney transplant patient in Philadelphia who took an immunosuppression medication made by Intas until December 2023, unaware that a month earlier the FDA had excused the drug from an import ban. “Why are we buying from people who aren’t making it right?”

Watch video ➜

How the United States wound up here — playing a game of chance with risky drugs made thousands of miles away — is the story of an agency that has relentlessly pressed to keep the supply of low-cost generics flowing even as its own inspectors warned that some of those drugs posed a potentially lethal threat to the........

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