RARE Act

This bill changes the rules for the 7-year exclusive approval period given to drugs designated for rare diseases or conditions (orphan drugs). Under the bill, that exclusivity would cover only the specific use or indication the drug was approved or licensed for, rather than the whole rare disease or condition. It defines "approved use or indication" as the use approved or licensed by federal regulators for a drug designated for a rare disease. The changes would apply to all designated orphan drugs, no matter when they were designated, approved, or licensed.

Full text and official record on Congress.gov

Sponsors

• Tammy Baldwin Democrat sponsor
• 0 cosponsors