The Food and Drug Administration (FDA) has identified issues at an Indian facility producing generic drugs for American consumers, including a medication that has been associated with at least eight fatalities, as indicated by federal records.
Following a ProPublica investigation in December highlighting an unusual number of recalls from the Glenmark Pharmaceuticals plant due to pills not dissolving properly, the FDA inspected the facility. Among these recalls was a significant one involving over 50 million potassium chloride extended-release capsules, identified by the FDA last year as potentially lethal to U.S. patients.
ProPublica discovered that FDA had not inspected the Madhya Pradesh, India, plant since prior to the COVID-19 pandemic. Upon visiting the facility last month, five years after their previous inspection, FDA inspectors identified cleaning and testing deficiencies that might impact drugs delivered to American consumers.
In a detailed report, inspectors noted Glenmark’s failure to address the improper dissolution of some medicines and expressed concerns about the factory’s manufacturing protocols. The report also mentioned issues with cleaning equipment and utensils to prevent drug contamination that could compromise their safety and quality.
The FDA, however, heavily redacted the inspection report, preventing a full understanding of the dissolution issues or identification of potentially contaminated Glenmark drugs in the U.S. market. ProPublica obtained the report through the Freedom of Information Act, with the FDA citing trade secrets and confidential information as reasons for keeping certain details undisclosed.
Newly appointed Health and Human Services Secretary Robert F. Kennedy Jr. had committed to bringing “radical transparency” to his oversight of the FDA. ProPublica inquired if Kennedy considered the redacted report consistent with his transparency pledge, but the HHS media team did not respond.
An FDA spokesperson refrained from elucidating why the agency delayed inspecting the plant or specifying steps required for Glenmark to rectify the issues, explaining that the FDA generally does not discuss ongoing compliance matters except with the involved company.
The review of Glenmark’s facility was a “for-cause inspection,” conducted when the FDA suspects quality issues or is following up on received complaints. Improper dissolution of drugs can lead to dangerous dosing variations. Glenmark reported eight U.S. deaths from the recalled potassium chloride capsules to federal regulators, as shown in FDA records. Adverse event reports, required from companies after receiving them from patients or doctors, are part of the FDA’s safety monitoring protocol, though these reports represent individuals’ opinions and do not definitively link the drug to the harm.
A lawsuit was filed by the family of a 91-year-old Maine woman against Glenmark, accusing the company’s recalled potassium chloride of causing her death. Glenmark has denied the claim.
Glenmark’s spokesperson did not provide detailed comments on the inspection, citing ongoing legal proceedings, but emphasized the company’s commitment to working with the FDA to ensure compliance. Glenmark’s managing director disclosed during an earnings call that 25% to 30% of its U.S. revenue derives from products manufactured at the Madhya Pradesh facility.
The inspection took place from February 3 to February 14. The report highlighted deficiencies in cleaning processes that could lead to cross-contamination between drug batches. Although Glenmark rejected three contaminated batches, the equipment was utilized for other drugs shipped to the U.S. The identities of those affected batches were redacted in the report.
ProPublica questioned whether the FDA was testing these medicines for contamination. The FDA spokesperson referred to a website with past test results, which did not include any recent tests of Glenmark products following the recalls.
One quality control issue noted during the inspection was Glenmark’s use of shared equipment without proper decontamination before producing different drugs. Details of affected drugs were redacted by the FDA. Glenmark’s investigation into consumer complaints about adverse reactions to one of its drugs uncovered potential risks related to shared manufacturing facilities, but specifics were likewise obscured by redactions.
Additionally, Glenmark did not fully resolve issues causing improper dissolution of some medications. Their internal investigations often failed to identify specific causes or lacked sufficient evidence, as per the inspectors. Concerns were also raised about the routine reliance on unverified or inadequately validated testing methods for drug release into the U.S. market; specific drugs were not listed due to redactions.
Historically, Glenmark has faced scrutiny from the FDA, with major deficiencies found at three of its other facilities that supply the U.S. market since 2019. In 2022, significant issues at one location resulted in the FDA preventing its medicines from entering the U.S.
The Madhya Pradesh facility became a focal point in October 2023 due to a series of recalls occurring over the ensuing twelve months. It accounted for over 30% of FDA recalls related to faulty dissolution in pills, according to a ProPublica analysis.
Understanding the manufacturing origins of medications can be challenging for consumers, as linked data across various datasets by ProPublica revealed these patterns. While the majority of drug-manufacturing facilities for American markets are located abroad, the investigative arm of Congress has consistently highlighted a shortage of FDA inspectors to adequately oversee them.
