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Propublica sued the U.S. Food and Drug Administration in federal court in New York, accusing them of withholding information about the safety and availability of generic drugs important 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 record requests last year under the Freedom of Information Act.
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The FDA refused to release the document quickly, including records identifying drugs produced in some of India’s most problematic factories. Although inspection reports have been published explaining that unsafe manufacturing conditions are publicly available, the FDA will edit the names of the medicines made in those factories.
“Americans (including pharmacists, doctors, hospital systems and policy makers) cannot see for themselves which drugs were made in unsafe facilities,” the lawsuit states.
Propublica requested records as part of an ongoing investigation into the safety of the general drug supply in the United States. Propublica reports that the FDA has allowed some manufacturers to continue delivering drugs to Americans even after factories are discovered that are banned from the US market in violation of quality standards. Over the past decades, these little-known exemptions have been given over 150 drugs or their ingredients.
In response to Propublica’s initial record request, the FDA said it had not demonstrated a “persuasive need” for news organizations to facilitate the release of documents. Since the lawsuit was filed in November, the agency has begun to take over some of the requested records. The case is still active in federal court in New York.
Propublica claims the record will help inform American consumers who are increasingly dependent on popular drugs made overseas. Quality concerns have been worrisome to the industry for years. In 2023, four people died from contaminated eye drops made in India, and others had to surgically remove their eyes.
“We all rely on the FDA to ensure that the medications we take and give to our loved ones are safe,” said Jack Browning, an external lawyer at Propublica, a partner at Davis Wright Tremaine. “With the prevalence of offshore manufacturing is increasing, it is essential for organizations such as ProPublica to ensure safety violations are not washed away under the rug.”
The Department of Health and Human Services, which oversees the FDA, declined to comment on the case, citing the ongoing lawsuit.
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 an agency to withhold records related to a massive recall of a respiratory machine created by the Phillips Respironix. The institution ultimately provided the document.
Dailey and Nguyen are at the Medill Research Lab at Northwestern University in Washington, DC
