PhRMA Statement on FDA User Fees
WASHINGTON, D.C. (March 22, 2017) – Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued the following statement in support of the U.S. Food and Drug Administration’s (FDA) user fee programs the Prescription Drug User Fee Act (PDUFA) VI, Biosimilar User Fee Act (BsUFA) II and the Generic Drug User Fee Act (GDUFA) II:
“User fees are an important mechanism to support the critical work of the U.S. Food and Drug Administration in the human drug review process. Moving the Prescription Drug, Biosimilar and Generic Drug User Fee Acts forward in a timely manner is important to support FDA’s mission of protecting public health and promoting innovation, to enhance the competitive market for treatments and to get medicines to patients in need.
“For over two decades, PDUFA has helped bring innovative medicines to patients by providing greater consistency, certainty and predictability in the science-based U.S. drug review process. The PDUFA VI agreement, along with the BsUFA II and the GDUFA II are needed to ensure the best and brightest minds at FDA are able to keep pace with the rapid advance of medicine.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than half a trillion dollars in the search for new treatments and cures, including an estimated $58.8 billion in 2015 alone.