In the alphabet soup that is health and FDA law and policy (if you don\u2019t know what we mean, are you sure you should be reading this blog?), one acronym that doesn\u2019t get a lot of respect is \u201cUFA.\u201d 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.<\/p>\n\n\n\n
UFA stands for \u201cUser Fee Act,\u201d of which there are many flavors in this modern era \u2013 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.<\/p>\n\n\n\n
These laws authorize FDA to collect so-called user fees from members of regulated industries, whether in the form of application review fees, facility registration fees, or other more unique fees like the annual Biosimilar Product Development, or BPD, fee. What\u2019s critical to know about these UFAs is that they authorize FDA to collect user fees for only 5 years at a time \u2013 meaning that they reappear in Congress as \u201cmust pass\u201d legislation every 5 years. If the various UFAs are not reauthorized, FDA can no longer require private entities to pay those large fees to the government and program\/review activities will be adversely affected. The four current user fee authorizations we\u2019ll be discussing all expire at the end of FY 2017 \u2013 September 30, 2017.<\/p>\n\n\n\n
FDA and relevant industry stakeholders negotiate the details of these individual user fee programs \u2013 including how quickly an original new drug application or a medical device application must be reviewed, or the level of feedback the Agency must provide in response to certain industry submissions \u2013 and then those final UFA agreements are submitted to Congress and incorporated into the relevant UFA legislation. However, FDA\u2019s user fee authorization bills have historically been vehicles for enacting other types of drug- and device-related provisions. For example, PDUFA IV, passed in 2007, included new authorities for FDA to require a Risk Evaluation and Mitigation Strategy for certain drug and biological products.<\/p>\n\n\n\n
In an incredible timing coincidence, the 115th<\/sup> Congress and the first year of the Trump Administration will also be the year in which FDA needs to secure reauthorization for its largest user fee programs. Given the \u201cregulatory reform\u201d themes emerging from both of those camps, even as Democrats and patient advocacy groups begin lining up to protect FDA and its public health mission, we expect the UFA process this year to be as contentious as it may be momentous after the dust has settled. The legislative activity will also be interesting to watch, as the Obama Administration\u2019s FDA negotiated all of the user fee agreements with industry in 2016, but the Trump Administration is responsible for sheparding them through Congress. (The pick for FDA commissioner, Dr. Scott Gottlieb, was announced on March 10th and his confirmation timetable remains unknown.)<\/p>\n\n\n\n So as it develops over the next weeks and months, we will provide you with updates on on the UFAs\u2019 progress through the legislative process and our predictions for what related (or unrelated) bills will be tacked on to them.\u00a0 Indeed, the first UFA-related hearing took place on March 2, 2017 in front of the House Energy\u00a0& Commerce\u00a0Committee\u2019s Subcommittee on Health.\u00a0 That\u00a0hearing<\/a>\u00a0focused on the new GDUFA and BsUFA programs that have been created since GDUFA I\/BsUFA I were passed in 2012. It also considered a bill that has been introduced in the House to, in part, create a generic drug priority review voucher (which may also be the first possible amendment to GDUFA II).<\/p>\n\n\n\n So loosen those belts and be prepared for an abundance of alphabet soup!<\/p>\n","protected":false},"excerpt":{"rendered":" In the alphabet soup that is health and FDA law and policy (if you don\u2019t know what we mean, are you sure you should be reading this blog?), one acronym that doesn\u2019t get a lot of respect is \u201cUFA.\u201d This is the first is a series of blog posts that aim to educate and inform … Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_generate-full-width-content":"","footnotes":""},"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts\/4461"}],"collection":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/comments?post=4461"}],"version-history":[{"count":2,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts\/4461\/revisions"}],"predecessor-version":[{"id":4463,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts\/4461\/revisions\/4463"}],"wp:attachment":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/media?parent=4461"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/categories?post=4461"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/tags?post=4461"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}