ORPHAN Cures Act

Summary

Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act This bill modifies certain provisions under the Medicare Drug Price Negotiation Program with respect to orphan drugs. The Medicare Drug Price Negotiation Program requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation. The program does not apply to orphan drugs that are approved to treat only one rare disease or condition. The bill modifies these provisions so as to exclude any period in which a drug was an orphan drug from market approval calculations. It also excludes orphan drugs that are approved to treat more than one rare disease or condition from the program.

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Timeline

1. 4 February 2025

   Introduced

   Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

   Source: IntroReferral

2. 4 February 2025

   Introduced

   Introduced in House

   Source: IntroReferral

3. 4 February 2025

   Introduced

   Introduced in House

   Source: IntroReferral

4. 6 February 2025

   Introduced

   Sponsor introductory remarks on measure. (CR H535-536)

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

2 official files

• Introduced in House

  Introduced in House · EN · 4 February 2025

  DownloadOpen at official source

• Introduced in House

  summary · EN · 4 February 2025

  Open at official source

Sponsors

• John Joyce · R · Sponsor
• Donald Davis · D · Sponsor
• Rep. Hern, Kevin [R-OK-1] · R · Sponsor
• Scott Peters · D · Sponsor
• Mariannette Miller-Meeks · R · Sponsor
• William Keating · D · Sponsor
• Rep. Hudson, Richard [R-NC-9] · R · Sponsor
• Shri Thanedar · D · Sponsor
• Rep. Bilirakis, Gus M. [R-FL-12] · R · Sponsor
• Rep. Gottheimer, Josh [D-NJ-5] · D · Sponsor
• Lloyd Smucker · R · Cosponsor
• Janelle Bynum · D · Cosponsor
• Thomas Kean · R · Cosponsor
• Dina Titus · D · Cosponsor
• Andrea Salinas · D · Cosponsor
• Rep. Dunn, Neal P. [R-FL-2] · R · Cosponsor
• Adam Gray · D · Cosponsor
• Rep. Crenshaw, Dan [R-TX-2] · R · Cosponsor
• Robert Bresnahan · R · Cosponsor
• · hswm00 · Standing
• · hsif00 · Standing

Related records

• related to ← ORPHAN Cures Act