Bill > HR1629

This bill, the Fairness in Orphan Drug Exclusivity Act, amends the Federal Food, Drug, and Cosmetic Act to place limitations on the exclusive approval or licensure of orphan drugs. Specifically, the bill requires that for a drug designated for a rare disease or condition, the Secretary of Health and Human Services cannot grant exclusive approval or licensure unless the sponsor demonstrates that there was no reasonable expectation at the time of approval that the cost of developing and making the drug available in the U.S. would be recovered from sales within 12 years of its first marketing. The bill applies these requirements retroactively to drugs already granted exclusive approval or licensure. The bill also specifies that the Secretary and the sponsor must consider sales from all related drugs developed or marketed by the same sponsor or manufacturer when making this determination.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/117th-congress/house-bill/1629/all-info