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Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday.

The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

Originally published on KHN.org