Why in the news: Recently the United States Food and Drug Administration (USFDA) granted Gilead Sciences orphan drug status for its antiviral drug, Remdesivir under Orphan Drug Act, 1983. The drug originally developed to treat Ebola but found ineffective, is now being tested for treating COVID-19.
What is Orphan Disease?
United States Food and Drug Administration (USFDA) defines orphan disease as a condition that affects fewer than 200,000 people nationwide. It is also called a rare disease.
What is controversy?
Under the Orphan Drug Act, 1983, companies are provided incentives to develop therapies, or orphan drugs, for rare diseases. Since the number of coronavirus positive cases exceeded 8,000,000, the act shouldn’t apply on drugs being tested for COVID-19. Factually, based on number of COVID-19 patients, it is no more a rare disease.
