What The Hell America!

The Food and Drug Administration has found problems at an Indian factory that makes generic drugs for American patients, including one medication that was manufactured there and has been linked to at least eight deaths, federal records show.

The agency inspected the factory after a ProPublica investigation in December found that the plant, operated by Glenmark Pharmaceuticals, was responsible for an outsized share of recalls for pills that didn’t dissolve properly and could harm people. Among the string of recalls, the FDA had determined last year that more than 50 million potassium chloride extended-release capsules had the potential to kill U.S. patients.

Still, ProPublica found, the FDA had not sent inspectors to the factory in Madhya Pradesh, India, since before the COVID-19 pandemic.

When FDA inspectors went to the Glenmark plant last month — five years after the agency’s prior inspection — they discovered problems with cleaning and testing that they said could affect medicines that were shipped to American consumers.

In a report detailing their findings, the inspectors wrote that Glenmark failed to resolve why some medicines weren’t dissolving properly, and they raised concerns about the factory’s manufacturing processes.

“Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product,” the inspectors wrote.

The FDA redacted large swaths of the inspection report, making it impossible to tell whether inspectors uncovered the reason for the pills not dissolving correctly or which Glenmark drugs sitting in American medicine cabinets were potentially at risk of contamination.

ProPublica obtained the report through the Freedom of Information Act. To justify censoring the document, an FDA attorney cited trade secrets “and/or commercial or financial information that was obtained from a person outside the government and that is privileged or confidential.”

Health and Human Services Secretary Robert F. Kennedy Jr., who was sworn in the day before this inspection wrapped up, has vowed to bring “radical transparency” to his agency, which oversees the FDA. ProPublica asked the HHS media team whether Kennedy thinks the heavily redacted inspection record is in line with his transparency promise and whether he believes the names of drugs that inspectors raised safety concerns about are trade secrets. The media team did not respond.

An FDA spokesperson would not say why the agency waited so long to inspect this factory or what, if anything, federal regulators will require Glenmark do to fix the problems. “The FDA generally cannot discuss potential or ongoing compliance matters except with the company involved,” she wrote.

The FDA’s review of the Glenmark plant, she noted, “was a for-cause inspection, which can be triggered when the agency has reason to believe that a facility has quality problems, to follow up on complaints or other reasons.”

Drugs that fail to dissolve properly can cause perilous swings in dosing. Since Glenmark’s potassium chloride recall in May, the company has told federal regulators it received reports of eight deaths in the U.S. of people who took the recalled capsules, FDA records show. Companies are required to file reports of adverse events they receive from patients or their doctors so the agency can monitor drug safety. The FDA shares few details, though; as a result, ProPublica was unable to independently verify what happened in each of these cases. In general, the FDA says these reports reflect the opinions of the people who reported the harm and don’t prove that it was caused by the drug.

The family of a 91-year-old Maine woman sued Glenmark in federal court in Newark, New Jersey, last year, alleging the company’s recalled potassium chloride was responsible for her death in June. In court filings, the company has denied responsibility.

A spokesperson for Glenmark, which is based in Mumbai, declined to answer detailed questions about the inspection, citing the ongoing litigation. “Glenmark remains committed to working diligently with the FDA to ensure compliance with manufacturing operations and quality systems,” the spokesperson wrote.

Glenmark’s managing director told investors and analysts on an earnings call last month that 25% to 30% of its U.S. revenue comes from drugs made at its Madhya Pradesh factory.

Inspectors visited the factory between Feb. 3 and Feb. 14. Like all such reports, this one notes that the inspectors’ observations “do not represent a final Agency determination” about the company’s compliance with the FDA’s drug manufacturing rules.

Glenmark lacked proper cleaning procedures that prevent residues of one medicine from winding up in batches of the next pills produced with the same machinery, the inspectors found. While Glenmark rejected three batches when tests found cross-contamination, the inspectors said that the same equipment was used to make other drugs that were shipped to the U.S. Their report went on to list the “impacted batches,” but it is unclear what those drugs are because the next three pages are censored.

ProPublica asked the FDA if the agency was testing any of these medicines for contamination. The spokesperson wouldn’t say and instead referred a reporter to an FDA website that shows past test results but does not include any for Glenmark products since the recalls.

Major production equipment is not decontaminated before the company uses it to make some drug products, a Glenmark vice president in charge of quality told the inspectors. It’s unclear what those drugs are because the FDA censored that part of the report.

The inspectors noted that Glenmark received two consumer complaints about adverse reactions to one of its drugs. When Glenmark investigated the complaints, the company failed to assess the potential problems that can occur when pharmaceutical products are manufactured using shared facilities and equipment, the report said. But the name of the drug and the type of potential contamination that inspectors worried about were not clear due to the FDA’s redactions.

Glenmark also didn’t get to the bottom of why some medicines made at the factory weren’t dissolving properly, the FDA inspectors found. The company’s investigations of some batches of faulty medicine didn’t identify specific root causes, and those that did pinpoint a reason weren’t adequately supported with evidence or didn’t explain all the data, the inspectors wrote.

The inspectors also raised concerns that some drugs made at the factory and the key ingredients that go into them “are routinely released by testing with analytical test methods that have not been adequately validated or verified.” The inspectors listed the ones that are currently on the U.S. market, but the FDA redacted the names of the drugs.

When Glenmark analysts’ tests found problems with a medicine, the company at times declared those results invalid and “retested with new samples to obtain passing results,” the FDA report said. “The batches were ultimately released to the US market.”

Glenmark has been the subject of FDA scrutiny for years. Since 2019, the agency’s inspectors have found major deficiencies at three of the company’s four other factories that have made drugs for American patients. The problems at one plant were so bad that in 2022 the agency barred medicines made there from entering the U.S.

The concerning string of recalls stemming from products made at the Madhya Pradesh factory in central India began in October 2023. Over the next 12 months, that single plant accounted for more than 30% of all FDA recalls for pills that didn’t dissolve correctly and could harm patients, a ProPublica analysis found.

The federal government often doesn’t make it easy for consumers to know where their medicines are manufactured. To identify this pattern, ProPublica had to match drug-labeling records from the U.S. National Library of Medicine with details in two FDA databases.

The majority of the factories making drugs for American patients are in foreign countries, but the investigative arm of Congress has repeatedly found that the FDA has too few inspectors to adequately oversee them.