RARE Act
Official title: To amend the Federal Food, Drug, and Cosmetic Act to set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions.
Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.
Referred to the Subcommittee on Health.
Retaining Access and Restoring Exclusivity Act or the RARE Act
This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition.
Current law grants a seven-year period of market exclusivity for an approved orphan drug, during which the Food and Drug Administration (FDA) may not approve an application from another manufacturer for the same drug for the same disease or condition. The FDA's regulations provide that this exclusivity is specific to the same approved use or indication of the drug, rather than all uses or indications, for the disease or condition. However, in Catalyst Pharmaceuticals, Inc. v. Becerra, a court held that exclusivity did extend to all uses or indications for the disease or condition.
The bill provides statutory authority for the FDA's regulations.
- Introduced in House Formatted Text PDF Formatted XML
Cite this page
U.S. Congress. (2026). H.R. 7383: RARE Act. 118th Congress. Open America. https://openamerica.io/bill/118-HR-7383/
"H.R. 7383: RARE Act." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-HR-7383/.
H.R. 7383, 118th Cong. (2026), https://openamerica.io/bill/118-HR-7383/.
[H.R. 7383: RARE Act](https://openamerica.io/bill/118-HR-7383/)