When the drugs you take to get better are bad for your health
Like other manufacturers, drug makers moved to Asia because labor, construction, regulatory and environmental costs were lower there.
Now ProPublica has obtained documents between Indian drugmaker Sun Pharma, one of the leading exporters of medications to the United States, and the FDA showing “how the agency tolerated substandard manufacturing for years.”
An FDA inspection in 2014 had turned up dangerous violations at Sun’s factory in the Indian city of Halol, and Sun promised reform at the factory, its flagship for the U.S. market, ProPublica says.
“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,” ProPublica says.
Not until the final weeks of 2022 would the agency prohibit the factory from shipping its drugs to the United States, says ProPublica. And 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 FDA testing.
“In June, 11 years after that first alarming inspection, the agency went back to the factory and chronicled practically identical deficiencies,” ProPublica says.
More than 20 foreign factories banned from the U.S. market have gotten similar exemptions from the FDA since 2013 through a little-known practice used by the agency to prevent drug shortages, ProPublica says.
“And, just like with Sun, the FDA never shared the details with the doctors prescribing the medications or the patients taking them,” says ProPublica.
ProPublica has put together a list of exempted drugs and ingredients since 2013.
ProPublica says the FDA didn’t respond to questions about the Sun factory, the decision to wait eight years to impose the ban or the exemptions that followed, saying only that it couldn’t discuss potential or ongoing compliance matters.