Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now? – Diagnosing Health Care Podcast
Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
Since our last edition of the Mintz IRA Update, the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) and related maximum fair price (MFP) negotiation process for each of the 10 high-expenditure...more
The Biden administration appears steadfast in its efforts to lower prescription drug costs and continues to explore multiple avenues — even as the Medicare Drug Price Negotiation Program continues to move forward — to tackle...more
December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more
This post, Part III, of a three-part series on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA....more
FDA denied citizen’s petitions from Abbvie, the UAW Retiree Medical Benefits Trust, and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations...more