Looking Back at the Orphan Drugs Act

July 7, 2023

In 1983, the US Congress passed the Orphan Drug Act (ODA) that offers financial incentives for developing drugs for rare diseases that have limited, if any, approved therapeutics. A new study published in the Orphanet Journal of Rare Diseases explores the impact that the ODA has had on the field of rare diseases over the past 40 years.

According to Gianna Melillo, “In addition, comparing the first (1983-1992) to the most recent decade (2013-2022), there were nearly 7 times as many designations and 6 times as many initial approvals in the most recent vs the first decade after the ODA was enacted. Following oncology, the most common therapeutic areas by orphan drug designations were neurology and infectious diseases.”

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(Source: AJMC, July 6th, 2023)

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