Changing IRA Orphan Drug Incentives and Proposed Rare Disease Legislation

IPD has released a new report that analyzes the consequences of the sole orphan drug exemption in the Inflation Reduction Act (IRA). Drug manufacturers and organizations such as NORD have stated that the sole orphan exemption will disincentivize drug companies from conducting further research to develop a rare disease drug for an additional indication. In addition, the report outlines other key pieces of legislation pertaining to rare diseases/orphan drug development and their potential impact, such as the ORPHAN Cures Act, the RARE Act, and the Creating Hope Reauthorization Act of 2024.

This report is part of our Federal Legislation & Government Insights subscription, where IPD provides strategic insights written by our team of legal analysts, clinical pharmacists, and senior researchers on federal legislation and government-related lawsuits that may have an impact on drug pricing, patient access, drug reimbursement, and intellectual property covering drug products.