bloomberg.com

FOIA-POWERED STORY: Facing Cancer Drug Shortage, U.S. Relies on Banned Chinese Plant

STORY CLIP: Last September, U.S. regulators faced a dilemma: whether to allow importation of drug ingredients from a Chinese factory with a history of poor quality controls, or face shortages of treatments for American cancer patients. "During inspections from 1992 to 1995, FDA staff found hidden batches, missing records, as well as possible sanitation issues, such as a failure to fully test the water used to make the drug ingredients, according to documents obtained via the Freedom of Information Act. In 1995, inspectors listed 12 “objectionable conditions” and recommended that the FDA send Hisun a warning letter. The FDA never sent one. The agency said it works with companies to help them correct their deficiencies, and until 2015 Hisun had addressed all of its issues."

WITHOUT FOIA

Without FOIA, readers would not know that in the 1990s the FDA staff found “hidden batches, missing records, as well as possible sanitation issues, such as a failure to fully test the water used to make the drug ingredients,” according to the story. “Inspectors listed 12 “objectionable conditions” and recommended that the FDA send Hisun a warning letter. The FDA never sent one.”