Posted by Michael Wonder on 25 Jun 2020
How orphan drug policy could impede access to COVID-19 treatments
25 June 2020 - The Orphan Drug Act of 1983 was passed to promote the development of rare disease treatments.
To qualify for incentives under the act, sponsors must first receive “orphan drug designation” from the Food and Drug Administration (FDA). In almost all cases, the FDA grants an orphan drug designation because the disease treated by the drug affects 200,000 or fewer Americans.
Most orphan-designated drugs are never FDA approved to treat a rare disease; those that have at least one such approval are called “orphan drugs.”
