Tag Archives: user fees

House Energy & Commerce Committee Unanimously Approves FDA Reauthorization, Public Health Bills

On June 8, 2017, the Energy and Commerce Committee voted unanimously to approve an amended version of HR 2430, the FDA Reauthorization Act (FDARA) of 2017. The bill would extend the FDA prescription drug, medical device, generic drug, and biosimilar biological product user fee programs, which are scheduled to expire at the end of September.  … Continue Reading

President Trump’s Proposed FY 2018 Budget Spares Medicare, But Calls for Deep Medicaid Cuts & FDA User Fee Hikes

President Trump has released his FY 2018 budget proposal, which the Administration dubs “A New Foundation for American Greatness.”  The proposed budget – which received a generally chilly reception on Capitol Hill – offers a mixed bag for the health care industry.  On the one hand, a document summarizing the Department of Health and Human … Continue Reading

Congressional Panels Tackle FDA Reauthorization Act and Other Health Policy Issues

On May 11, 2017, the Senate on Health, Education, Labor, and Pensions (HELP) Committee approved S 934, a bill extend Food and Drug Administration user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products. The legislation also includes various policy changes, including provisions intended to improve the medical device inspection process and … Continue Reading

Roundup of Recent Congressional Health Policy Hearings

A number of Congressional committees have recently held hearings on health policy issues, including the following: House Energy and Commerce Committee hearings on “Cybersecurity in the Heath Care Sector: Strengthening Public-Private Partnerships” and Food and Drug Administration (FDA) medical device user fees. A House Oversight and Government Reform Committee hearing on “Federally Funded Cancer Research: … Continue Reading

Congressional Panels Examining Pharmaceutical Distribution Systems, FDA Drug User Fees

Two Congressional committees are holding hearings this week on FDA user fees: a March 21 Senate Health, Education, Labor, and Pensions Committee hearing and a March 22 Energy and Commerce Subcommittee on Health hearing. In addition, on March 22, 2017, the House Oversight Subcommittee on Health Care is holding a hearing on “Examining the Impact … Continue Reading

Trump Administration Proposes 17.9% Cut to HHS Programs, Doubling of FDA User Fees

The Trump Administration is calling for deep cuts to Department of Health and Human Services (HHS) funding for fiscal year (FY) 2018 along with a $1 billion hike in Food and Drug Administration (FDA) user fees in its “budget blueprint,” dubbed “America First: A Budget Blueprint to Make America Great Again.”  The blueprint — which … Continue Reading

FDA Announces Medical Device User Fee Rates for Fiscal Year 2016

Earlier this week, the federal Food and Drug Administration (FDA) issued a notice in the Federal Register (80 Fed. Reg. 46033) announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2016, which apply from October 1, 2015 through September 30, 2016. The Federal Food, Drug, and Cosmetic Act … Continue Reading

FDA Requests RSVP for Public Meetings on PDUFA Reauthorization

The federal Food and Drug Administration (FDA) has issued a notice requesting that public stakeholders –including patient and consumer advocacy groups, health care professionals, and scientific and academic experts– notify FDA of their intent to participate in monthly consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). When the statutory authority … Continue Reading

FDA Public Hearing on the Implementation of Generic Drug User Fee Amendments (Sept. 17)

On September 17, 2014 the Food and Drug Administration (“FDA”) is holding a public hearing at the College Park Marriot Hotel and Conference Center, in Hyattsville, MD, to discuss the Agency’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and its obligations under GDUFA as set forth in the GDUFA Commitment Letter accompanying … Continue Reading

April Congressional Health Policy Hearings & Markups

Earlier this month, the Senate Finance Committee held a hearing on the nomination of Marilyn Tavenner to be CMS Administrator. The Senate Health, Education, Labor, and Pensions (HELP) Committee approved the Mental Health Awareness and Improvement Act, legislation that reauthorizes and amends programs administered by both HHS and the Department of Education related to awareness, prevention, … Continue Reading

President Signs Government Funding Bill Maintaining FY 2013 Medicare Sequestration Cuts

On March 26, 2013, President Obama signed into law H.R. 933, a continuing resolution  that averts a government shutdown by funding the government through the remainder of fiscal year 2013 (through September 30, 2013). The funding bill is subject to the sequestration order triggered by the Budget Control Act, although funding was increased for a limited … Continue Reading

Senate HELP Committee Approves Organ Transplant, Animal Drug User Fee Bills

On March 20, 2013, the Senate Committee on Health, Education, Labor, and Pensions approved an amended version of S. 330, a bill to amend the Public Health Service Act to establish safeguards and standards of quality for research and transplantation of organs infected with human immunodeficiency virus (HIV). Among other things, the bill would remove … Continue Reading

FDA Announces 2013 Generic Drug Active Pharmaceutical Ingredient and Finished Dosage Form Facility User Fee Rates

The FDA has announced the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facility user fee rates for fiscal year 2013. The API facility fee is owed by each person that owns a facility which produces, or which is pending review to produce, one or more APIs identified, or intended to be … Continue Reading

FDA Issues Generic Drug User/Backlog Fee Notices

On October 25, 2012, the Food and Drug Administration (FDA) published in the Federal Register the fiscal year (FY) 2013 rates for certain filings under the Generic Drug User Fee Program. Specifically, the notice establishes the new annual rates for an abbreviated new drug application (ANDA) ($51,520), prior approval supplement ($25,760), and drug master file … Continue Reading

Draft Guidance Regarding Self-Identification of Generic Drug Facilities and Q&A on Generic Drug User Fee Amendments

This post was written by Erin Janssen. On August 27, 2012, FDA issued draft guidance documents for industry entitled “Self-Identification of Generic Drug Facilities, Sites, and Organizations” and “Generic Drug User Fee Amendments of 2012: Questions and Answers.” The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that generic drug facilities, sites, and organizations around the … Continue Reading

FDA Establishes FY 2013 User Fee Rates for Biosimilars and Prescription Drugs

This post was written by Erin Janssen. The Food and Drug Administration (FDA) has announced the rates for biosimilar and prescription drug user fees for FY 2013. By way of background, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes FDA to assess and collect user fees for certain activities in connection with … Continue Reading

FDA Guidance on FY 2013 Medical Device User Fee Small Business Qualification and Certification

This post was written by Erin Janssen. The FDA has issued guidance on FY 2013 medical device user fees for small businesses. The guidance explains how a business may qualify as a “small business” and pay most FY 2013 medical device user fees at substantially discounted rates. While the guidance is substantively the same as the … Continue Reading

Medical Device User Fee Rates for FY 2013

This post was written by Erin Janssen. On July 31, 2012, the FDA published the fee rates and payment procedures for medical device user fees for FY 2013. The fee rates apply from October 1, 2012 through September 30, 2013. To avoid delay in the review of an application, the fee should be paid before or … Continue Reading