[co-author: Gregory Waterworth]

Last week, the U.S. House of Representatives (the House) passed by voice vote the FDA Reauthorization Act of 2017 (FDARA or the Act). Introduced on May 16, 2017 by House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), Ranking Member Frank Pallone (D-NJ), and Health Subcommittee Ranking Member Rep. Gene Green (D-TX), the Act would reauthorize four key U.S. Food and Drug Administration (FDA or the Agency) user fee programs: (1) the Prescription Drug User Fee Act (PDUFA); (2) the Medical Device User Fee Amendments (MDUFA); (3) the Generic Drug User Fee Amendments (GDUFA); and (4) the Biosimilar User Fee Act (BsUFA). FDARA would reauthorize these user fee programs until 2022.

The Act also sets the stage for evaluating potential reforms to the Agency’s drug and device review processes. Hailed by Chairman Walden as a bipartisan “win for patients” that is designed to “streamline the process for reviewing and approving new treatments and cures for patients,” the Act would reform, among other things, user fees , application timelines, and various drug and device clinical testing requirements. Some of the highlights of the legislation include:

• Altering the timeline for reporting certain medical device malfunctions to a quarterly basis, except the timeline for reporting malfunctions that create patient complications, injuries, or deaths, which are still required to be reported within 30 days of a firm becoming aware of its existence.
• Requiring only quarterly summaries of reported product malfunctions with which the FDA is already familiar, as opposed to the currently-required filing of a detailed report for every malfunction. Any malfunction not previously reported to the Agency would still need to be reported individually, promptly, and in detail.
• Restructuring prescription drug, generic drug, and biosimilar user fees to more accurately reflect FDA’s workload and make such fees more predictable for industry.
• Requiring the Agency to hold a public meeting on clinical trial inclusion criteria and issue a report detailing the barriers to patient participation and potential solutions to overcoming those barriers.
• Requiring FDA to issue guidance to medical device developers on expanding clinical populations and to issue guidance or new regulations to streamline the institutional review board (IRB) process.
• Increasing prohibitions on unauthorized drug importations and counterfeiting.
• Calling on the Agency to issue regulations to establish a category of over-the-counter (OTC) hearing aids. More on hearing aid deregulation can be found here and here.

FDARA would further prompt FDA to contract with third parties to review the Agency’s internal processes and propose reforms to speed up the clinical trial and review processes for prescription drug applications, medical device applications, generic drug applications, and biosimilar applications.

While various industry groups applauded the House’s passage of FDARA, the Trump administration was not as enthusiastic. In a Statement of Administrative Policy, President Trump expressed his general support of the Act’s purpose, but criticized the significant investment of taxpayer resources it would require. The administration is urging “Congress to provide for 100 percent user fee funding within the reauthorized programs,” stating that “[i]n an era of renewed fiscal restraint, industries that benefit directly from the FDA's work should pay for it.” Along with fiscal concerns, the administration questioned how some of the Act’s provisions may impact market competition.

The Senate version of FDARA (S. 943), cosponsored by Committee on Health, Education, Labor and Pensions (HELP) Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.), was passed out of committee on May 11, 2017, but awaits action by the full Senate. Chairman Alexander warned that failure to pass the bill before the August recess would trigger mass layoffs at the Agency.

We will continue to monitor this and other industry developments and provide more information as it becomes available. ​