FDA Faulted For Lapses In Orphan Drug Program
FDA Faulted For Lapses In Orphan Drug Program Enlarge this image toggle caption Al Drago/CQ Roll Call/Getty Images Al Drago/CQ Roll Call/Getty Images 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 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 FDA's rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. "Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options," Hatch said in a statement Friday.
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