Propublica is a nonprofit newsroom that investigates power abuse. Sign up and receive the biggest story as soon as it’s published.
The Food and Drug Administration is cracking down on the common drug manufacturers that were targeted by the Propublica investigation last year, citing safety testing issues that delay recalls for drugs related to US deaths.
In December, Propublica reported that the Glenmark Pharmaceutical Factory in central India was responsible for a large share of tablet recalls that could not melt properly and could harm American patients. In a series of recalls, federal regulators determined that more than 50 million potassium chloride expanded release capsules for sale in the United States could be fatal. However, federal drug inspectors at that time had not stepped into the Madhya Pradesh factory for more than four years, Propublica discovered.
Seven weeks after the story was released, an FDA inspector appeared on the plant and discovered a serious problem. Glenmark then recalled 20 more medications made there and sold to patients in the US.
Now, the FDA has sent a warning letter to Glenmark. It is a disciplinary tool used by regulators to lay out serious violations of changes in federal requirements and demand. If one of the issues outlined by Glenmark could not be fixed, the FDA warns it could ban factory-made drugs from entering the US
Additionally, the FDA noted that the company made similar serious mistakes at three other manufacturing sites, acknowledging that these plants were subject to previous warning letters from the agency since 2019. A December survey by Propublica highlighted this pattern, noting that of the five factories Glenmark has produced drugs for the US market in recent years, three have had issues with federal regulators. Despite its track record, the FDA has been backlogged from the pandemic – waiting five years before sending inspectors back to the Madhya Pradesh factory.
In a July 11 warning letter, the director of the FDA’s Department of Manufacturing Quality wrote: (The agency has created a public last week for the letter.)
“We need to evaluate the company’s global manufacturing operations immediately and comprehensively to ensure that systems, processes and manufactured products comply with FDA requirements,” he added.
A company spokesman said in a written statement: “Glenmark is actively involved in the US FDA and has launched corrective actions to address agency observations. Patient safety, product quality and regulatory compliance are the basis of how we operate.”
She declined to comment further, citing the ongoing lawsuits facing the company.
Propublica is investigating FDA monitoring in foreign factories that manufacture generic drugs for the US market.
Since last year, Propublica has repeatedly asked the FDA why they didn’t send inspectors to the Glenmark plant earlier, considering the majority of the recalls and the problematic track record at other factories. The agency has not answered the questions. After the inspection discovered the issue this year, an FDA spokesperson said agents could only discuss potential or continuing compliance issues with the companies involved.
Among the most serious violations outlined in the FDA letter to Glenmark was the company’s failure to quickly test the pills to properly dissolve during the normal shelf life, which was the subject of last year’s Propobrica investigation.
Companies keep samples of tablets from batches sold to US customers and test them regularly until they reach their expiration date. Medicines that do not dissolve properly can cause dangerous shaking during administration. This defect is the reason why Glenmark potassium chloride tablets are potentially fatal, as high potassium levels can stop the heart, according to a June 2024 recall notification.
Glenmark’s backlog tests were “later than three months behind for most of the sample,” the FDA wrote in a warning. Failure to perform these tests on time has kept the discovery of Glenmark’s defective tablets and delayed the necessary recalls, the agency said.
In multiple instances, the FDA discovered that it took 100 days for the test until Glenmark pulled a potassium chloride sample to know that the capsule had not dissolved correctly.
That recall delay could be considered in a lawsuit last year claiming that Glenmark potassium chloride tablets were responsible for the death of 91-year-old Maine woman, Mary Louise Cormier. The letter warning that her pills were recalled arrived three weeks after her death. In court filings, Glenmark denied liability for her death. The company has stopped manufacturing drugs for patients in the US.
Between July and December last year, Glenmark told the FDA that he was reported to have eight deaths in patients who took recalled potassium chloride, federal records show. The reports that businesses must submit are very few details that allowed the FDA to monitor drug safety and that ProPublica could not independently verify what happened in each case. In general, reports of these adverse events reflect the opinions of those who submitted them and do not prove that the drug caused harm, the FDA said. The agency did not mention these deaths in the warning letter.
The FDA blamed Glenmark for failing to thoroughly investigate why tablets made at the Madhya Pradesh factory were not properly dissolved. The agency listed reasons why Glenmark might not have been able to consider, but FDA censorship compiled so many passages – it is impossible to identify what was wrong by citing the protection of trade secrets and confidential business information.
Middle school cheerleaders have made a video of Tiktok, depicting the school shoot. They were charged with a crime.
Citing the same confidentiality provision, the FDA kept the name of another Glenmark drug, which the agency said failed these same tests. When asked why consumers should not tell which drugs they have a problem, the FDA did not answer.
More broadly, the FDA warning letter criticized Glenmark for not verifying the tests that rely on the drug, proving that he had the identity, strength, quality and purity that he should have relied on.
“There is no fundamental guarantee that laboratory data accurately reflects the quality of drug products without assessing the validity of the method,” the FDA wrote.
