Posted by Michael Wonder on 06 Dec 2018
Federal officials call out FDA over lapses in rare-disease drug approval
5 December 2018 - The 1983 Orphan Drug Act motivated pharmaceutical companies to develop drugs for people who lacked treatments for their conditions.
The FDA 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.
