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.

Our colleagues at ML Strategies recently published their Outlook for Fall & Lame Duck, summarizing what to expect from Washington for the remainder of 2016.  The full Outlook is available here, and the portion related to health care is excerpted below.

Congress returns after Labor Day for a four-week sprint that will likely be centered on funding the government by way of a continuing resolution. Since Congress was last in session, the landscape on a number of health care issues remains unchanged. The Senate version of the House-passed Cures package is still in limbo, and mental health reform is no closer to the finish line than it was after the House finally passed its package after months of negotiating. Congress will have an opportunity to advance some issues in September before returning its focus to the 2016 election. After which there will be a, post-election, “lame duck” legislative session – the scope of potential activity for which are uncertain at this point – to put the finishing touches on the 114th Congress. Here’s a look at issues that will likely come up in September: Continue Reading ML Strategies Provides Outlooks for Fall & Lame Duck