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E&C considers rare-drug bills that could alter IRA

Feb 29, 2024
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The House Energy and Commerce Committee appeared divided Thursday morning on some legislation among a slate of bills aimed at providing access to treatments for rare diseases.

Why it matters: Three of the bills would exempt certain drugs from Medicare drug price negotiations, either permanently or for longer than dictated by the Inflation Reduction Act, or alter the manufacturer rebate system.

  • Democrats argued that the legislation would weaken the drug negotiation process, while Republicans said they were needed to incentivize more orphan drugs or drugs for rare diseases.

Among the bills that could be teed up for markups:

  • ORPHAN Cures Act: This bipartisan bill, sponsored by Reps. John Joyce and Wiley Nickel, would exclude orphan drugs from Medicare drug price negotiation if they are designated as treating one or more rare diseases.
  • The current IRA provisions exclude just orphan drugs that treat only a single rare disease.
  • MINI Act: Also sponsored by Nickel and Joyce, along with Rep. Don Davis, this bill would exempt advanced drug products, defined as a drug using a genetically targeted technology, from price negotiations for 11 years rather than seven.
  • That would put them on par with biologic drugs under the IRA.
  • PLASMA Act: This bill, also sponsored by Nickel, Davis and Reps. Richard Hudson and Greg Murphy, would phase in Medicare Part D manufacturer rebates for plasma-derived medicines over five years, with manufacturers not needing to pay the full rebate amount until 2031.

Between the lines: Nickel and Davis, the Democrats who are sponsoring these bills, are both North Carolina representatives who represent biotech-heavy areas.

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