The Food and Drug Administration is cracking down on a generic drugmaker that was the subject of a ProPublica investigation last year, citing problems with safety tests that delayed the recall of a medicine linked to deaths in the U.S.
In December, ProPublica reported that a Glenmark Pharmaceuticals factory in central India was responsible for an outsized share of recalls for pills that didn’t dissolve properly and could harm American patients. Among the string of recalls, federal regulators had determined that more than 50 million potassium chloride extended-release capsules sold in the U.S. could be deadly. Yet, federal drug inspectors at that point hadn’t set foot in the Madhya Pradesh factory for more than four years, ProPublica found.
Seven weeks after that story was published, FDA inspectors showed up at the plant and found serious problems. Glenmark subsequently recalled an additional two dozen medicines made there and sold to U.S. patients.
Now the FDA has sent Glenmark a warning letter, a disciplinary tool the regulator uses to lay out significant violations of federal requirements and demand changes. If Glenmark fails to fix any of the problems outlined, the FDA warned, it may bar drugs made at the factory from entering the U.S.
What’s more, the FDA pointed out that the company had made similar serious mistakes at three other manufacturing sites and acknowledged that those factories had been the subject of previous warning letters from the agency since 2019. The problems at one were so severe that federal regulators blocked drugs made there from being imported to Americans. ProPublica’s December investigation highlighted this pattern, noting that three of the five factories where Glenmark made drugs for the U.S. market in recent years had been in trouble with federal regulators. Despite that track record, the FDA — backlogged from the pandemic — waited five years before sending its inspectors back to the Madhya Pradesh plant.
In his July 11 warning letter, the director of the FDA’s Office of Manufacturing Quality wrote, “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.” (The agency made the letter publiclast week.)
“You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements,” he added.
A spokesperson for the company said in a written statement: “Glenmark is actively engaging with the U.S. FDA and has initiated corrective actions to address the agency’s observations. Patient safety, product quality and regulatory compliance are foundational to how we operate.”
Citing ongoing litigation the company faces, she declined to comment further.
ProPublica has been investigating the FDA’s oversight of foreign factories that make generic drugs for the U.S. market.
Since last year, ProPublica repeatedly has asked the FDA why it didn’t send inspectors to the Glenmark factory sooner, given the outsized share of recalls and the company’s troubled track record at its other plants. The agency hasn’t answered the question. After the inspection found problems this year, an FDA spokesperson said the agency can only discuss potential or ongoing compliance matters with the company involved.
Among the most serious violations outlined in the FDA letter to Glenmark was the company’s failure to promptly test pills to ensure they dissolve properly during their normal shelf life, the subject of ProPublica’s investigation last year.
Companies hold on to samples of pills from batches sold to U.S. customers and test them periodically until they reach their expiration date. Medicines that don’t dissolve properly can cause perilous swings in dosing. This flaw is what made Glenmark’s potassium chloride pills potentially deadly since high potassium levels can stop the heart, according to the June 2024 recall notice.
Glenmark’s backlogged testing “was overdue by 3 months or longer for a large proportion of your samples,” the FDA wrote in the warning letter. The failure to perform these tests on time held up Glenmark’s discovery of defective pills and delayed the needed recalls, the agency said.
In multiple instances, the FDA found that it took 100 days from the time Glenmark pulled samples of potassium chloride for testing until the company learned the capsules had failed to dissolve correctly.
A delay in that recall could factor into a lawsuit that alleges Glenmark’s potassium chloride pills were responsible for the death last year of Mary Louise Cormier, a 91-year-old Maine woman. A letter alerting Cormier that her pills had been recalled arrived three weeks after she died. In court filings, Glenmark has denied responsibility for her death. The company stopped making the drug for U.S. patients.
Between July and December last year, Glenmark told the FDA that it had received reports of eight deaths in patients who took the recalled potassium chloride, federal records show. The reports, which companies must file so the FDA can monitor drug safety, contained so few details that ProPublica was unable to independently verify what happened in each case. In general, these adverse event reports reflect the opinions of those who filed them and don’t prove that the drug caused the harm, the FDA says. The agency didn’t mention these deaths in the warning letter.
The FDA lambasted Glenmark for failing to thoroughly investigate why pills made at its Madhya Pradesh factory weren’t dissolving properly. The agency listed possible reasons that Glenmark failed to consider, but FDA censors redacted so many passages — citing the protection of trade secrets and confidential business information — that it’s impossible to discern what could have gone wrong.
Citing the same confidentiality provision, the FDA kept secret the name of another Glenmark drug that the agency said failed these same tests. When asked why consumers shouldn’t be told which medication had the problem, the FDA didn’t answer.
More broadly, the FDA’s warning letter criticized Glenmark for failing to validate the tests it relies on to prove that its drugs have the identity, strength, quality and purity that they’re supposed to have.
“Without evaluating the validity of methods, you lack the basic assurance that your laboratory data accurately reflects drug product quality,” the FDA wrote.
