What Does the Government Investigation on the Orphan Drug Program Mean for Drug Manufacturers?

Sen. Tom Cotton, R-Ark., is one of three GOP senators seeking an investigation into six-figure annual costs for drugs intended to treat rare diseases. Photo Credit: Alex Brandon/AP The U.S. Government Accountability Office (GAO) will investigate potential abuse of the Orphan Drug Act (ODA) by drug-makers. In a March 3 letter to the U.S. Government Accountability Office, Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) raised the possibility that regulatory or legislative changes might be needed “to preserve the intent of this vital law” that gives drug-makers lucrative incentives to develop drugs for rare diseases. Orphan drugs are granted research and tax credits

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