Adam Steinmetz

1 week ago | jdsupra.com | David Dorsey |Zachary S. Pfister |Adam Steinmetz

The Medicare drug price negotiation provision in the 2022 Inflation Reduction Act treats small molecule drugs and biological products differently. For small molecules, drug price negotiations can start seven years after Food and Drug Administration (FDA) approval, with the negotiated price taking effect in year nine after FDA approval. For biological products, negotiations start at 11 years, and the negotiated price can take effect in year 13, after FDA approval.