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ORPHAN Cures Act

H.R. 5539 Rep. John Joyce (R-PA-13) In committee
Bill text PDF
  1. Introduced Sep 18
  2. Committee Sep 18
  3. Passed House Next
  4. Passed Senate Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, Sep 18, 2023Next: House vote
680d ago Dec 17, 2024: Referred to the Subcommittee on Health.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
17companies, 25 filings
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Member trades
21trades in the last 90 days
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Companies lobbying on this bill

17 companies
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Biotech & Pharma 17
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Summary

This bill amends the Social Security Act to expand and clarify the exclusion of orphan drugs from the Drug Price Negotiation Program. It changes how the time since a drug's approval is calculated for determining eligibility for negotiation, and it broadens the definition of orphan drugs to include those designated for one or more rare diseases or conditions.

Sec. 2, Expanding and clarifying the exclusion for orphan drugs: The bill modifies the calculation of elapsed time for a drug or biological product's approval by excluding any period during which it was an orphan drug. It also changes the orphan drug definition from 'only one rare disease or condition' to 'one or more rare diseases or conditions,' ensuring drugs with multiple rare disease designations remain excluded from negotiation.

Summary of the bill text as introduced in House (Sep 18, 2023), generated by SecBot from the official bill text; the Library of Congress summary is not yet published.

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 28, 2026.