ARTICLE | Politics, Policy & Law

Inflation Reduction Act discourages multiple orphan indications

Provision in the IRA exempts only drugs with a single orphan indication from price-setting

September 15, 2022 7:16 PM UTC

Forty-one words tucked into the Inflation Reduction Act could have a profound effect on the development of orphan drugs, potentially deterring companies from developing indications that could help patients with rare diseases, or delaying access to treatments while manufacturers explore work-arounds.

The provision exempts orphan drugs that are approved for only one rare disease or condition, and no other diseases or conditions, from the price-setting provisions of the IRA. ...