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In 2022, three Food and Drug Administration inspectors headed to India to investigate a giant solar pharma plant that produces dozens of generic drugs aimed at Americans. Over two weeks, they discovered dangerous breakdowns in ways that had serious drugs, and the FDA ultimately placed the factory in an import ban.
However, the agency quietly gave global manufacturers special passes to continue sending dozens of drugs to Americans, despite being made in the same substandard factory officially banned from the US market.
It wasn’t the first time. Here are some key points from Propublica’s FDA’s 14-month survey on monitoring foreign drug makers:
Your Drug Cabinet Threat: FDA Gambling on American Drugs
The agency commissioned to protect the US drug supply has given similar exemptions to some of India’s most problematic foreign drug manufacturers, allowing factories banned from the US market to continue to be banned to unsuspecting Americans. A secret group within the FDA has ostensibly exempt the import ban to prevent drug shortages. With each pass, the agency dismissed warnings from its own inspectors about dangerous violations of drug quality on factory floors. All of them, the FDA has allowed the United States to at least 150 drugs or ingredients that are from banned factories that have been found to have mold, foul water, dirty labs, or fraudulent testing protocols. Almost everything came from factories in India. The FDA did not regularly test drugs exempt from the import ban to see if they were safe or actively monitored reports of potential harm between patients. And as drugs circulated in the US, institutions kept this practice hidden from the public. The FDA said it would implement protective measures, including requiring third parties in the factory to ensure that exempt drugs are safe. Some of the exempt drugs were recalled immediately or just before they were exempt due to contaminants or other defects that could cause health problems. Propublica analysis also identified more than 600 complaints about drugs exempted at only three factories in FDA files. Each flagged concerns months or years after the drug was excluded from the import ban. The report cites 70 hospitalizations and nine deaths. Janet Woodcock, who headed the FDA’s Center for Drug Evaluation and Research for more than 20 years, said that the agency believes it is safe and that it doesn’t need to inform the public about drugs from banned factories if such information creates “some sort of frenzy” among consumers seeking to change prescriptions. “We had to deal with the hands we were treated,” she said. A decision made by the FDA decades ago caused the use of exemptions. In the 2000s, as the costs of branded drugs soared, the FDA approved hundreds of generic drug applications for foreign manufacturers who had previously had problems. Exempt drugs that came to the US include antibiotics, chemotherapy treatments, antidepressants, sedatives and epilepsy medications.
San Pharma did not respond to multiple requests for comments. When the FDA imposed the ban, the company said it would “take all necessary steps to resolve these issues and ensure that regulators are fully satisfied with the company’s corrective actions. San Pharma has committed to acclimating and supplying high-quality products to customers and patients around the world.”
Patricia Callahan and Vidya Krishnan contributed to the report. Alice Crites contributed to the research.
