The dispatches from one of India’s most troubled generic drug makers were contrite, filled with far-reaching promises to clean up its factory, stop contamination and send safe medication to Americans counting on the company’s drugs.
“We have started addressing FDA concerns very aggressively and comprehensively,” an executive from Sun Pharma wrote to the U.S. Food and Drug Administration in 2015.
“Sun is ensuring the presence of a strong, independent quality unit,” the company repeatedly pledged.
An
FDA inspection in 2014 had turned up dangerous violations at Sun’s factory in the Indian city of Halol, and the details were grim: Managers weren’t following basic rules to prevent the contamination of injectable drugs. They had failed to determine whether “unknown impurities” found in medication were toxic. The factory itself was in disrepair. The ceiling leaked and investigators observed dripping water, another dangerous contamination risk, collecting in buckets in a sterile manufacturing area.
Sun vowed bold reform at the factory, its flagship for the U.S. market. In a series of letters to the FDA after the inspection, executives described a long list of “enhancements” in facilities, in staffing, in quality standards, in training.
But for eight years, as inspectors returned and discovered again and again that Sun’s efforts were grossly inadequate, the FDA did little to warn the public or stop the drugs from coming to the United States.
The trove of Sun correspondence obtained by ProPublica provides a rare glimpse into private discussions between the global drugmaker and the U.S. regulator singularly responsible for protecting consumers from unsafe medication. The documents show how often the FDA tolerated Sun’s broken promises and substandard manufacturing, allowing an uninterrupted flow of generics to an American public clamoring for cheaper medication.
As Sun’s fixes fell short, the agency in 2015 even declared the factory’s products
“adulterated” which, according to
federal law, means they were produced in a way that could have compromised their strength, quality and purity.
Not until the final weeks of 2022 would
the agency bar the factory from shipping its drugs to the U.S. Even then, regulators immediately excluded more than a dozen medications from the ban. The exemptions allowed Sun to continue sending those drugs — with few restrictions and no regular testing by the FDA.
The failings convinced the FDA to keep the import ban in place, but the agency continued to allow Sun to send exempted drugs to the US.
“Would you trust somebody who repeatedly lies to you?” said Dinesh Thakur, an
industry whistleblower and drug-safety advocate. “I don’t know how you can justify your decision to try to give them a pass every time. … You are basically putting people at risk.”
More than 20 foreign factories banned from the US market have received similar exemptions from the FDA since 2013 through a little-known practice used by the agency to prevent drug shortages.
The agency did not respond to questions about the Sun factory, the decision to wait eight years to impose the ban or the exemptions that followed, saying only it could not discuss potential or ongoing compliance matters. The FDA referred further inquiries to Sun.
The FDA also did not answer directly whether it believed that drugs exempted from Sun’s Halol plant and the other factories were safe. To “help assure consumer safety,” the agency said, companies are required to subject exempted drugs to extra testing with third-party oversight before the medications are sent to the United States.
ProPublica’s review of the FDA’s own records, however, shows the potential weakness of such a system. Some of the companies were caught providing unreliable…
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