30 November 2018 - The FDA has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials said 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 people.

The investigation began at the request of three high-profile Republican senators last year after a Kaiser Health News investigation. The reporting found that the program was being manipulated by drugmakers to maximise profits and to protect niche markets for medicines being taken by millions.

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