Senate Reauthorizes FDA User Fee Agreements

August 3, 2017

WASHINGTON, D.C. – August 3, 2017 – The U.S. Senate today advanced the U.S. Food and Drug Administration’s (FDA) Reauthorization Act, which expands four separate user fee agreements on new drugs, generic drugs, medical devices, and biosimilars, and includes a provision to maximize the development of therapies for children with cancer. 

A statement from the American Cancer Society Cancer Action Network (ACS CAN) follows:

“We applaud the Senate for strengthening its commitment to cancer patients’ access to innovative, safe and effective treatments. This legislation maintains a strong collaboration between the FDA and the pharmaceutical industry, with the goal of bringing drugs and devices to the market and making them accessible to patients in a timely way. 

“The legislation also recognizes the value that patients bring to the review process by directing increased incorporation of patient perspectives into the FDA’s medical product development and approval processes. Additionally, the bill includes provisions that address the ongoing challenges in developing childhood cancer therapies by expanding research of adult cancer drugs in children with cancer. 

“Finally, the legislation acknowledges the challenges seriously ill patients can face seeking expanded access to unapproved therapies. It requires the National Institutes of Health (NIH) and the FDA to work together to address barriers patients encounter when participating in clinical trials and release new guidelines on the eligibility criteria for clinical trials. 

“On behalf of those affected by cancer, we thank Congress for their expeditious bipartisan work in reauthorizing the FDA’s user fee agreements, giving patients timely access to cutting edge therapies.”



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