WASHINGTON, D.C. – July 12, 2017 – The U.S. House of Representatives today advanced legislation to reauthorize and expand the U.S. Food and Drug Administration’s (FDA) user fee programs. The legislation maintains a strong collaboration between the FDA and industry, with the goal of bringing pharmaceutical drugs and devices to the market, and making them accessible to patients as expeditiously as possible.
The FDA Reauthorization Act (FDARA) includes four separate user fee agreements dealing with new drugs, generic drugs, medical devices, and biosimilars, all of which impact cancer patients who depend on these products during treatment. Additionally, FDARA includes a provision to maximize the drug development of therapies specifically for children with cancer.
A statement from Chris Hansen, president of the American Cancer Society Cancer Action Network (ACS CAN), follows:
“We commend the House of Representatives for passing legislation that makes a significant difference in the lives of cancer patients and their families by providing them with timely access to cutting edge therapies. Today, the House strengthened its commitment to ensuring that Americans have access to innovative, safe and effective treatments by investing in the FDA’s user fee agreements, which are critical to enabling the agency to efficiently review lifesaving cancer drugs and treatments.
“The reauthorization allows the FDA to collect fees from the pharmaceutical industry so the agency has the resources it needs to evaluate and approve drugs and devices in a timely fashion. Without reauthorization, the necessary review of innovative therapies and devices would be significantly impaired. Any delay would impact cancer patients’ access to safe and effective therapies, and block the translation of innovative research into treatments for patients.
“The bill also recognizes the value that patients bring to the review process and directs the FDA to increase the incorporation of patient perspectives into the medical product development and approval processes. ACS CAN has been working with other patient advocacy organizations for years to ensure there is an appropriate way for patients and patient groups to provide input to the FDA drug and device development process, and have a voice in the approval process of treatments that affect their diseases.
“Importantly, the bill also includes provisions that address the ongoing challenges in developing childhood cancer drugs by expanding research of adult cancer therapies in children with cancer.
“Additionally, the bill acknowledges the challenges faced by patients seeking expanded access to unapproved therapies by strengthening recently enacted transparency requirements and seeking to create more inclusive clinical trials.
“We urge the Senate to follow House action and quickly reauthorize the FDA’s user fee agreements to ensure that innovative, safe and effective treatments reach patients in need without any delay.”