Draft Legislation for User Fee Reauthorization Released on April 14, 2017

On April 14, 2017, the leaders of the Senate and House health committees  released a discussion draft of bipartisan legislation reauthorizing the Food and Drug Administration user fee agreements. 

The Food and Drug Administration (FDA) Reauthorization Act of 2017 renews FDA’s authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, and several vital programs at the FDA. The 2012 prescription drug user fee amendments (PDUFA), medical device user fee amendments (MDUFA), generic drug user fee amendments (GDUFA), and biosimilar user fee amendments (BsUFA) all must be updated and reauthorized by Congress before the current user fee agreements expire on September 30.

According to a media release by the Senate HELP Committee Chair, “If the agreements are not reauthorized before the August work period, the agency will be forced to send layoff notices to more than 5,000 FDA employees. A delay in reauthorizing these agreements would delay the reviews of critical drugs and devices.”

“If we do not move quickly to reauthorize these agreements, in late July, the FDA will be forced to begin sending layoff notices to more than 5,000 employees to notify them that they may lose their job in 60 days,” Sen Lamar Alexander (R-Tenn.), Chairman of the Senate Health, Education, Labor and Pensions Committee said. “The sooner we reauthorize the agreements, the better – to give patients, reviewers, and companies certainty.  In addition to harming patients and families that rely on medical innovation, a delay in reauthorizing the user fees would threaten biomedical industry jobs and America’s global leadership in biomedical innovation.”

“I’m encouraged by our bipartisan work to reauthorize these agreements to advance safe, effective, and innovative medical products,” Sen. Patty Murray (D-Wash.), Ranking Member of the Senate Health, Education, Labor and Pensions Committee said. “Patients and families nationwide are relying on us to ensure FDA can continue its vital work without interruption. I hope that we can continue to put partisanship aside and advance this important legislation.”

“We are fully committed to a timely reauthorization of the agreements and are well on our way,” said Rep. Greg Walden (R-Ore.), Chairman of the House Energy and Commerce Committee. “This represents another opportunity to help expedite the review and approval of new cures and treatments for patients, and we must prioritize it. As this process proceeds, I look forward to continued discussions with my colleagues in the House on other member priorities that could strengthen this important legislation.” 

“The swift reauthorization of these user fee agreements is critical to making sure FDA has the resources and personnel it needs to ensure timely review and approval of safe and effective medical treatments,” said Rep. Frank Pallone (D-N.J.), Ranking Member of the House Energy and Commerce Committee. “These carefully negotiated agreements encourage innovation, improve our regulatory review process, and provide certainty to both patients and industry. I look forward to working with my colleagues to move this legislation through Congress and to the President’s desk.”

The FDA Reauthorization Act of 2017:

Updates and reauthorizes the user fee programs, which, in Fiscal Year 2016, accounted 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. 

Reflects the recommendations sent by FDA to Congress in January, which were based on over a year of negotiations and discussions with industry, Congress, patients, and other stakeholders.

Implements the four user fee agreements authorized by FDARA, which support the goals of the 21st Century Cures act and advance key bipartisan priorities:

  • Prescription Drug User Fee Amendments (PDUFA VI): Enhances patient-focused drug development, supports biomarker development and qualification, dedicates staff to assist in the development and review of rare disease drugs, sets clear timelines and improves guidance for drug and device combination products, and evaluates ways to modernize the clinical trial process.
  • Medical Device User Fee Amendments (MDUFA IV): Enhances the patient voice in the device development process, supports the collection of real world evidence on the safety and effectiveness of devices, and improves the review process for  “de novo” devices—low- to moderate-risk devices that are the first of their kind.
  • Generic Drug User Fee Amendments (GDUFA II): Improves the fee structure to support small businesses, provides goal dates for all outstanding generic applications, and establishes priority review timelines.
  • Biosimilar User Fee Amendments (BsUFA II): Continues to build the biosimilars program, and supports guidance for product developers.

Click here for the text of the discussion draft, here for a section-by-section summary of the discussion draft, and here for a one-pager. Health committee leaders ask that stakeholders who wish to comment on the contents of this draft please submit to FDAuserfees2017@help.senate.gov by April 28.


Press Release by Senator Lamar Alexander

Draft Discussion Bill for FDA Reauthorization Act of 2017: Summary

Text of the Draft

RAPS Summary:  http://www.raps.org/Regulatory-Focus/News/2017/04/14/27343/Senate-House-Draft-Reauthorization-Bill-to-Increase-Drug-Medical-Device-User-Fees/#sthash.wxJueRcf.dpuf

Posted in Advocacy and Regulations, AZBio News.