Modeling Drug Development Part 2: Post-Approval Development

Modeling Drug Development Part 2: Post-Approval Development

July 2025 brought a flicker of hope for people with serious health needs: Congress exempted drugs with multiple orphan indications from the Inflation Reduction Act (IRA)’s Medicare Drug Price “Negotiation” Program. This means that medicines developed for multiple orphan diseases (each of which affects fewer than 200,000 people) will not be subject to price regulation in Medicare. While some expressed concerns about the cost of the exemption, oth…