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This story was originally published by ProPublica.

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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.

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“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.

In June, 11 years after that first alarming inspection, the agency went back to the factory and chronicled practically identical deficiencies. Equipment was still dirty. Injectable medications still had impurities. One worker wasn’t wearing clean gloves.

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 United States.

“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 U.S. market have received similar exemptions from the FDA since 2013 through a little-known practice used by the agency to prevent drug shortages. ProPublica reported in June that antibiotics, anti-seizure drugs and chemotherapy treatments were shipped from those plants even after inspectors identified critical violations in the way drugs were made. In all, more than 150 drugs or their ingredients received exemptions.

And, just like with Sun, the FDA never shared the........

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