170 patient organizations have signed on to the linked letter of support urging Congress to consider small technical corrections to the IRA’s orphan drug exclusion provisions that would benefit the rare disease community. Final copies of this letter were sent to House and Senate Leaders.
As a reminder, the two changes our organizations are seeking to the IRA’s orphan provisions are:
- Clarify that the number of orphan designations FDA grants a product has no effect on its eligibility for the IRA’s orphan drug exclusion; and
- Maintain the purpose of the orphan drug exclusion by clarifying an orphan product becomes negotiation-eligible 7 or 11 years after it loses that exclusion.
We know these are complicated issues, so also linked is a one-pager to help explain these technical corrections to your community.
Stay tuned for future opportunities to engage on this very important issue, especially in the new year as we target Congress for action in early 2024!
