FDA Hasn’t Inspected Factory with Recalls: ProPublica
A lengthy ProPublica investigative report says that despite India’s Glenmark Pharmaceuticals issuing several recalls for pills that don’t dissolve properly, FDA still hasn’t inspected the Madhya Pradesh facility that made the pills and hasn’t stopped the company from shipping other drugs made at the plant to the U.S. The report focuses on a 5/2024 recall of potassium chloride extended-release tablets, and notes that the Mumbai-based firm had four recalls in the previous eight months and would have two more in the following months, all for the same issue of pills failing to dissolve properly.
“They should have been camping out there,” former FDA inspector Patrick Stone told the journalism outlet. Stone now advises drug companies.
Since the May recall, ProPublica says, Glenmark told FDA it has received reports of three deaths, three hospitalizations, and four other serious problems in patients who took recalled potassium chloride capsules. It’s unclear if the drug was the cause of the adverse events, it says.
“FDA’s anemic response underscores longstanding weaknesses in the way the agency oversees the safety of generic medications manufactured in foreign factories,” the report says. “The agency failed to act on clear patterns of trouble, was slow to warn the public about the potentially deadly pills, and never mentioned that millions of them had been sold to consumers. From the day of the first recall in 10/2023 through the next 12 months, FDA oversaw 22 recalls for drugs that didn’t dissolve correctly and could cause harm, agency data show.”
Stone said that the agency “is always late to respond. This should have been dealt with immediately.”
FDA didn’t explain to ProPublica why Glenmark’s multiple recalls didn’t lead to a risk-based inspection.
“A spokesperson for FDA declined to answer questions about the Glenmark recalls or inspection history, saying the agency could not publicly discuss potential or ongoing compliance matters,” the news service says. In an email, agency spokesperson Amanda Hils told ProPublica, “When there are quality issues identified that could result in harm, patients should rest assured that FDA does everything within our authority to work with firms to ensure a recall is conducted most effectively.”
Former FDA inspector Peter Baker, who also is now an industry consultant, says FDA does not have enough experienced investigators to figure out what’s wrong at factories where there are signs of trouble. “It’s really difficult to be proactive when you don’t have people,” he said.