PhRMA Statement on PDUFA Reauthorization - 2010

PhRMA Statement on PDUFA Reauthorization

Washington, D.C. (April 12, 2010) – Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President for Scientific & Regulatory Affairs Dr. David E. Wheadon testified today at the Food and Drug Administration’s (FDA) public hearing on the reauthorization of the Prescription Drug User Fee Act (PDUFA).

The FDA is a cornerstone in our country’s efforts to improve the health of all Americans. One of the Agency’s most important functions is to protect the public health by assuring the safety, efficacy and security of human drugs and biologic products. Another key function is to promote the public health by ensuring that innovative medicines are brought to patients without unnecessary delay. For nearly 20 years, PDUFA has helped the FDA fulfill this dual mission.

PDUFA has been a success for patients and for the public health. In an era of scarce resources, PDUFA user fees have provided the Agency with critical resources necessary to bring needed medicines to patients. While we have been heartened that FDA leadership has embraced the need to advocate for an empowered Agency that is fully funded through enhanced Congressional appropriations, we support a reauthorization of PDUFA in 2012 to bolster these resources.

“PDUFA V can play a critical role in making more life-saving medicines available to patients in a timely manner, strengthening the scientific base of the FDA and providing a steady, reliable stream of resources for Agency scientists,” Dr. Wheadon said (read comments).

User fees provided through the PDUFA program have enabled the FDA to better keep pace with the rapid increase in the number and complexity of new medicines entering the review pipeline. In addition, PDUFA has facilitated the hiring of hundreds of additional review staff at the FDA, helped reduce review times for new drug applications and biologics license applications, improved the efficiency of the review process for priority new molecular entities, and, perhaps most importantly, provided patients with access to more than 1,100 new medicines over the past 18 years.

At the same time, PDUFA has supported – not hindered – the FDA’s focus on patient safety.

Despite this considerable progress, the FDA has acknowledged recent set-backs in its ability to review new drug applications in a timely manner. It is essential that new drug reviews be accomplished in a way that is efficient, predictable and well-coordinated within FDA. PhRMA is encouraged by recent statements by FDA leaders that the Agency intends to improve its performance to align with review goals established under PDUFA, and we look forward to working toward this shared commitment.

“Public health and safety are best served by a science-based balance between the need for quality, timely reviews and rigorous pre-market and post-market surveillance,” Dr. Wheadon said. “Through its history, PDUFA has allowed the FDA to move closer to the appropriate balance, which is why we vigorously endorse a reauthorization of PDUFA in 2012.”


The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

PhRMA Internet Address: www.phrma.org

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For information on the Partnership for Prescription Assistance, visit: www.pparx.org

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For information on the danger of imported drugs, visit: www.buysafedrugs.info

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