FDA User Fee Package On Its Way to the President

On Thursday August 3rd,  the Senate passed HR2430, the FDA  Reauthorization Act of 2017.   The bill now moves to President Trump for signature. 

The FDA User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting the public health and accelerating innovation in the industry.  

“The Food and Drug Administration Reauthorization Act of  2017 as  passed by the Senate today, with only one Senator voting “Nay” and by a  House  voice vote in July, is an example of what we can accomplish on key issues when we all work together,”shared AZBio president and CEO Joan Koerber-Walker. “The FDA User Fees collected by the FDA from industry provide major funding to the  agency so that they can work to ensure that innovative products are safe, effective, and get through the approval process much faster than they did in the pre-user fee era.  Today’s vote is a big win for patients.”  

The Congressional Budget Office estimates that  FDA will  collect roughly $9 billion in fees—$8 billion for drugs and $1 billion for devices—from industry between 2018 and 2022, based on the fee level set in the Senate bill.

Industry, FDA, and Congressional leaders worked with the patient community for over three years to develop what became the  Food and Drug Administration Reauthorization Act of  2017 or FDARA.  (HR2430)

The current FDA User Fee packages under FDASIA (2012) expire in September, 2017.


Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement regarding passage of the Food and Drug Administration Reauthorization Act (FDARA) by the U.S. Senate today:

“The user fee program reauthorization package passed by the Senate today is an important victory for patients and for the next generation of medical innovation. This legislation will advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. It also ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development.

“The reauthorization of the biosimilars user fee program, including steps to improve communication between the FDA and Sponsors throughout application review, will create a more robust and competitive marketplace for biosimilar therapies, following an appropriate period of exclusivity for innovator biologic products.”

“The legislation also contains a number of provisions that will accelerate and incentivize the entry of generic medicines to the market, which will help to contain costs through increased competition while improving consumer choice. These provisions are consistent with proposals endorsed by BIO to drive smarter spending within our healthcare system without harming incentives for innovation.

“We commend the leadership of Senate HELP Committee Chairman Lamar Alexander and Ranking Member Patty Murray for their tireless bipartisan efforts in advancing this important legislation, as well as that of their counterparts on the House Energy and Commerce Committee, Chairman Greg Walden and Ranking Member Frank Pallone.

“We look forward to working with the FDA and other stakeholders to ensure that the important patient-centric advances contained in this legislation are most effectively implemented.” 

Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker shared:

“AdvaMed commends the Senate for their vote today on the FDA Reauthorization Act. Passage of this important legislation will enable FDA to continue its critical mission of ensuring safe and effective medical devices and diagnostics remain available to patients everywhere.

“The robust FDA performance goals, process improvements, increased accountability and additional resources provided for under the new user fee agreement represent a victory for the agency, innovation and, most importantly, patients. The bill also includes pro-innovation provisions to improve the FDA inspections process and streamline device accessory classification.

“We urge the president to move swiftly in signing the bill into law, and we look forward to working with FDA to implement the legislation and continue to bring life-saving technologies to patients.”


Posted in AZBio News.