Lexology May 31, 2023
This is an article in our 2023 series, “Life Sciences Transactional Insights”, which aims to provide key practical takeaways for our transactional colleagues by anticipating the needs of their regulatory, intellectual property, and business stakeholders.
The Inflation Reduction Act of 2022 (IRA) includes a number of provisions relevant for drug pricing and reimbursement, including the Drug Price Negotiation Program (Price Negotiation Program), which seeks to lower the prices of certain Medicare high spend drugs by subjecting them to a “maximum fair price” (MFP). The net effect of this new Price Negotiation Program is that with certain exceptions, a commercially successful product may face price controls prior to entry of any generics or biosimilars for such product.
Our team has previously...