On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting (see here and here for our past coverage), these two committees have held numerous public hearings since the beginning of March to learn more about FDA’s “big 4” user fee programs – for prescription drugs, medical devices, generic drugs, and biosimilars. Continue Reading Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017
As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C) Subcommittee on Health. That hearing focused on the UFAs specific to generic drugs and biosimilar biological products. Since then, Congress has held several more UFA hearings, and multiple FDA-related bipartisan bills that could become important to this process have been introduced. So it’s time for an update on how things are going with the UFA reauthorizations. Continue Reading FDA User Fee Hearings Picking Up Steam on Capitol Hill
In the alphabet soup that is health and FDA law and policy (if you don’t know what we mean, are you sure you should be reading this blog?), one acronym that doesn’t get a lot of respect is “UFA.” This is the first is a series of blog posts that aim to educate and inform our readers about why the UFA acronym matters and how the UFA legislative process may be particularly significant in 2017.
UFA stands for “User Fee Act,” of which there are many flavors in this modern era – from the old-timer Prescription Drug User Fee Act (PDUFA), born in 1992, to the more toddler-ish Biosimilar User Fee Act (BsUFA) that joined us in 2012. Other important UFAs for the U.S. health care system and stakeholders are the Medical Device User Fee Amendments (MDUFA), which were enacted first in 2002, and the Generic Drug User Fee Amendments (GDUFA) that launched at the same time as their biosimilar companion. Continue Reading Let the 2017 “UFA” Games Begin!
Today, our colleagues at ML Strategies released their first look at what the results of Tuesday’s election mean for health care. The client alert addresses both the lame duck session and what to expect in 2017 and beyond. Key issues areas include the future of the Affordable Care Act, MACRA, drug pricing, and FDA User Fee Act reauthorization.
In the coming days, ML Strategies will be sharing further insight into what the election means for health care and what to expect from the new administration and Congress.
Written by Kevin Kappel
The Prescription Drug User Fee Act (PDUFA), which provides the framework for the regulation of pharmaceuticals and raises fees to help ensure timely and safe oversight of pharmaceuticals, is due for reauthorization, and Committees in both Chambers of Congress have already held hearings. In addition, the FDA is actively engaging stakeholders on a draft framework for the reauthorization, and last week the FDA requested comments on its first tentative agreement between FDA and the industry. The FDA plans to send the agreement, which would raise approximately $100 million in fees over five years, to Congress in January for approval, but many worry that partisans in Congress could use the issue as a vehicle for waging political attacks on loosely affiliated issues, especially health care reform.