POLICY BRIEFINGS


UFA Discussion Draft Released


Lawmakers have released a discussion draft of legislation to reauthorize user fee agreements (UFAs) for the Food and Drug Administration (FDA). The bill from the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions (HELP) Committee is bipartisan, and would give the FDA authority to continue collecting user fees from pharmaceutical and medical device manufacturers. The prescription drug user fee amendments (PDUFA), medical device user fee amendments (MDUFA), generic drug user fee amendments (GDUFA), and biosimilar user fee amendments (BsUFA), last authorized in 2012, all must be updated and reauthorized by Congress before the current user fee agreements expire on September 30. PDUFA VI would support patient-focused drug development, biomarker development and qualification, the creation and review of rare disease treatments, guidance for combination products, and the modernization of clinical trials. MDUFA IV will also focus on the collection of real world safety and effectiveness evidence, and improving the de novo device review process. GDUFA II aims to improve support for small businesses, and would establish priority review timelines. BsUFA II will continue to build the agency’s biosimilars program, and support guidance for product developers. If reauthorization does not occur before the August recess, the FDA will initiate procedures to notify more than 5,000 agency employees of possible lay offs. Both Republican and Democratic leadership on the authorizing committees have stressed the importance of completing their work prior to that point. User fees account for 70 percent of the brand drug review budget, 36 percent of the medical device review budget, 75 percent of the generic drug review budget, and 29 percent of the biosimilar review budget.


Bipartisan Opioid Legislation Introduced in Senate


Sens. Kirsten Gillibrand (D-N.Y.) and John McCain (R-Ariz.) introduced S.892, the Opioid Addiction Prevention Act a bill aimed at reducing opioid misuse and addiction. The legislation would limit opioid prescriptions for acute pain to seven days. The limit would not apply to treatments for cancer care, palliative care, hospice, or end-of-life care. The bill is modeled after legislation that has been passed in several states, including New York and Arizona. Medical professionals would be required to certify, as a part of their Drug Enforcement Agency (DEA) registration, that they will not prescribe an opioid as an initial treatment for acute pain in an amount that exceeds a seven-day supply, and may not provide a refill.


White House Appoints Drug Czar


Rep. Tom Marino (R-Pa.) will leave his position as a member of the House of Representatives to lead the Office of National Drug Control Policy. Rep. Marino has served in the House since 2011, and has been a member of the Judiciary Committee as well as the Energy and Commerce Committee, which has worked to combat the opioid epidemic.


Recently Introduced Health Legislation


S.892 (introduced by Sen. Kirsten E. Gillibrand): A bill to amend the Controlled Substances Act to establish additional registration requirements for prescribers of opioids, and for other purposes; Judiciary

S.898 (introduced by Sen. Amy Klobuchar): A bill to provide incentives to physicians to practice in rural and medically underserved communities, and for other purposes; Judiciary

S.Res.125 (introduced by Sen. Tom Udall): A resolution supporting the goals and ideals of National Public Health Week; Health, Education, Labor, and Pensions

S.Res.128 (introduced by Sen. Benjamin L. Cardin): A resolution designating April 2017 as “National Congenital Diaphragmatic Hernia Awareness Month”; Judiciary



April 17, 2017: | Page 1 Page 2

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