Joint BIO/PhRMA Statement on PDUFA Reauthorization

Washington, D.C. (July 15, 2015) – Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President of Science and Regulatory Advocacy Sascha Haverfield, Ph.D., and Biotechnology Industry Organization (BIO) Senior Vice President of Science Policy Kay Holcombe released the following joint statement on the reauthorization of the Prescription Drug User Fee Act (PDUFA):

"For more than 20 years, PDUFA has helped the Food and Drug Administration (FDA) fulfill its central mission of protecting and promoting public health by allowing the Agency to keep pace with the rapid increase in the number and complexity of innovative drugs and biologics requiring regulatory review.

"PDUFA V refocused the program on its original intent – patient access to life-saving medicines. It made meaningful improvements to the human drug review program such as increased communication between FDA and biopharmaceutical companies during drug development and regulatory review to promote regulatory transparency and predictability. It also initiated the Patient-Focused Drug Development program to better incorporate patient input throughout the drug development and regulatory review processes.

"Despite the significant progress that has occurred through PDUFA V, many challenges remain. In PDUFA VI, the biopharmaceutical industry will advance and support policies that scientifically integrate the patient perspective in innovative drug development and regulatory decision-making, enhance the FDA's scientific expertise and tools, and promote long-term stability of the PDUFA program while ensuring the Agency can recruit and retain a highly-skilled workforce.

"By focusing on these principles, PDUFA VI can play a critical role in continuing to advance an effective, science-based U.S. regulatory review program that helps ensure that biopharmaceutical companies can continue to bring innovative medicines to patients."

About BIO

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling "innovations transforming our world" and the BIO Newsletter is the organization's bi-weekly email newsletter. Subscribe to the BIO Newsletter.

About PhRMA

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 $600 billion in the search for new treatments and cures, including an estimated $51.2 billion in 2014 alone.

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