FDA partner Donna Lee Yesner will speak at the American Conference Institute’s Conference on The Average Manufacturer Price (AMP) Final Rule. The one-day intensive seminar is designed to drill down into the practical application and nuances of the final rule.
Turning Back the Clock with Authorized Generics
Monday, May 23 | 1:45 pm
In the AMP final rule, the Centers for Medicare and Medicaid Services (CMS) largely finalized its proposed regulations for the treatment of authorized generics in the calculation of AMP and best price of the branded drug. Although the regulatory text appears relatively straightforward, the final rule includes a significant amount of commentary from CMS, which creates a muddled picture, similar to the prior AMP final rule, for the treatment of authorized generics in the AMP of the branded drug.