WASHINGTON, D.C. (May 4, 2022) – The Pharmaceutical Research and Manufacturers of America (PhRMA) spokesperson Andrew Powaleny released the following statement after the House Committee on Energy and Commerce released their legislative text around reauthorization of the Prescription Drug User Fee Act and Biosimilar User Fee Act:
“Every five years, Congress plays a pivotal role in reauthorizing user fee agreements that are critical to the development of innovative medicines and biosimilar products. The release of the legislative text for this year’s reauthorization process marks an important step to ensure these programs continue – without interruption.
“As the legislation moves forward, it is important that the integrity of the reauthorization of these critical programs not be undermined by the inclusion of extraneous policies that would slow the reauthorization process and jeopardize the U.S. Food and Drug Administration’s (FDA) timely review and approval of critical new medicines.
“We urge lawmakers to move swiftly in reauthorizing these programs that were negotiated with the FDA. It is vital FDA’s workforce can continue to support patient safety, maintain high standards of independent regulatory review and promote timely access to safe and effective medicines for patients.”