The FDA is changing the rules on orphan drugs, according to a story on NPR. Makers of orphan drugs – which are developed for rare diseases that affect less than 200,000 people – get special treatment from the FDA, such as tax credits, waivers of fees and a seven-year monopoly on the drug. But orphan drugs can command huge price tags to consumers, and an investigation is under way after critics said some of the orphans — such as the psychopharmaceutical Abilify — were already licensed for common use by the FDA. New Commissioner Scott Gottlieb also announced other measures to be implemented.
FDA Steps in to Stop Gaming of Orphan Drug System
Posted on: September 15, 2017. Post written by: Wayne Hanson - Tags: abilify, bigpharma, FDA, orphan drugs, pharmaceuticals, Scott Gottlieb