Manatt Health January 30, 2023
On January 24, the Food and Drug Administration (FDA) made a long-awaited announcement with major implications for how the agency awards exclusivity for rare disease drugs under the Orphan Drug Act (ODA) (P.L. 97-414). Specifically, FDA issued a Federal Register notice describing how the agency will respond to an 11th Circuit ruling in Catalyst Pharmaceuticals, Inc. v. Becerra.
The ODA provides incentives to support research and development of drugs for rare diseases, including a seven-year term of “exclusivity,” or market protection from competition for the orphan drug, once it is approved and marketed. The law established a two-part process for obtaining orphan drug exclusivity. First, at an early stage in the drug development process and prior to seeking review by...
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