ProPublica Sued the FDA for Withholding Records About the Safety of Generic Drugs

ProPublica: “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. Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs – 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…”

Posted in: Freedom of Information, Government Documents, Health Care, Legal Research, Medicine