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ProPublica has sued the U.S. Food and Drug Administration in federal court in New York, accusing the agency of withholding information about the safety and availability of generic drugs critical to millions of Americans.
For years, Congress, watchdog groups, doctors and others have questioned the quality of generic drugs made in factories overseas. To better understand how the FDA regulates the industry and protects consumers, ProPublica submitted four records requests last year under the Freedom of Information Act.
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The FDA declined to quickly release the documents, including records that would identify drugs made at some of the most troubled factories in India. Inspection reports that describe unsafe manufacturing conditions are public, but the FDA redacts the names of the medications made in those factories.
“Americans (including pharmacists, doctors, hospital systems, policy makers) cannot see for themselves which drugs may have been made in unsafe facilities,” the lawsuit said.
ProPublica requested the records as part of an ongoing investigation into the safety of America’s generic drug supply. ProPublica has reported that the FDA allowed some manufacturers to continue shipping their drugs to Americans even after the factories that made them were found in violation of quality standards and banned from the U.S. market. More than 150 drugs or their ingredients were given these little-known exemptions over the past dozen years.
In its response to ProPublica’s initial records request, the FDA said the news organization had not demonstrated “a compelling need” to expedite the release of documents. Since the lawsuit was filed in November, the agency has begun to turn over some of the requested records. The case is still active in federal court in New York.
ProPublica has argued the records will help inform American consumers, who increasingly rely on generic drugs made overseas. Quality concerns have dogged the industry for years: In 2023, four people died after using tainted eye drops made in India, and others had to have their eyeballs surgically removed.
“Every single one of us relies on the FDA to ensure that the medicines we take and give our loved ones are safe,” said ProPublica’s outside counsel, Jack Browning, a partner at Davis Wright Tremaine. “With the increasing prevalence of offshore manufacturing, it is imperative for organizations like ProPublica to ensure that safety violations are not being swept under the rug.”
The Department of Health and Human Services, which oversees the FDA, declined to comment on the case, citing the ongoing litigation.
This is the second time ProPublica has sued the FDA in recent years.
In 2023, the news outlet and the Pittsburgh Post-Gazette filed a lawsuit against the agency for withholding records related to the massive recall of breathing machines made by Philips Respironics. The agency ultimately provided the documents.
Dailey and Nguyen are with Northwestern University’s Medill Investigative Lab in Washington, D.C.
