ASF & FAST Advocate for Corrections to Orphan Drug Exemption

ASF and FAST are proud to be among over 160 patient advocacy organizations urging Congress to consider two technical corrections to address the unintended consequences of the orphan drug exemption of the Inflation Reduction Act that will help preserve hope and protect critical rare disease therapy development incentives. ASF and FAST are members of the EveryLife Foundation for Rare Diseases community congress.

The two changes our organizations are seeking to the IRA’s orphan provisions are:

1. 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
2. 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.