PRIA Logo™
119-s-3716119th CongressWALLET

RARE Act

Sponsored By: Senator Baldwin, Tammy [D-WI]

Introduced

Summary

Limits orphan-drug exclusivity to the drug's approved use or indication. The bill narrows the scope of the 7-year exclusivity for drugs designated for rare diseases by tying protection to a specific approved use or indication instead of the broader disease, and it applies that rule to all drugs designated under section 526 regardless of when they were designated or approved.

Show full summary
  • Manufacturers of drugs designated under section 526: Their existing 7-year exclusivity now covers the specific approved use or indication for which the drug was approved or licensed, not the entire rare disease or condition.
  • Developers of follow-on products: Companies seeking approval for a different use or indication within the same rare disease face a narrower exclusivity barrier than under a disease-wide rule.
  • Regulatory effect: The bill does not change the length of the exclusivity or how exclusivity is triggered, but it changes the comparison from the "same disease or condition" to the "same approved use or indication."

Personalized for You

How does this bill affect your finances?

Personalize government policy and PRIA will tell you what this bill means for your household, plus every other piece of legislation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.

Free to download

Bill Overview

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

Narrower orphan drug exclusivity for patients

If enacted, this bill would narrow FDA orphan-drug exclusivity. It would keep the 7-year exclusivity period. Exclusivity would apply only to the same approved use or indication, not to the broader rare disease. The bill would narrow the unmet-need test so it focuses only on needs related to that approved use or indication. It would define "approved use or indication" as the use approved under the FD&C Act or licensed under the Public Health Service Act. The changes would apply to any drug with a section 526 orphan designation, regardless of when it was designated, approved, or licensed.

Sponsors & CoSponsors

Sponsor

Baldwin, Tammy [D-WI]

WI • D

Cosponsors

There are no cosponsors for this bill.

Roll Call Votes

No roll call votes available for this bill.

View on Congress.gov
Back to Legislation