Recommended Improvements to Prescription Drug User Fee Program Will Improve Drug Safety

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WASHINGTON, D.C. (January 11, 2007) -- The recommended improvements to the Prescription Drug User Fee Act (PDUFA) announced today by the Food and Drug Administration (FDA) will allow continued enhancement of FDA’s post-market safety capacity and help ensure careful, timely and transparent review of new drugs and biologics, said the Biotechnology Industry Organization (BIO). The FDA’s recommendations come as a result of extensive discussion and input from industry, as well as patient organizations, consumer groups and other stakeholders. Since its inception in 1992, PDUFA has helped to enable FDA to approve more than 1,100 new medicines and reduced review times for innovative drugs and biologics, providing patients and doctors with earlier access to breakthrough treatments. The current PDUFA agreement is set to expire on September 30, 2007.

“The PDUFA recommendations announced today are a win-win,” said BIO president and CEO Jim Greenwood. “If enacted, they will help enhance and improve drug safety while providing resources to continue to enable efficient and comprehensive review of new drugs. These proposals underscore our industry’s commitment to ensuring the government has the needed resources to complete safety reviews for new drugs and biologics in a timely manner.”

The recommendations announced today include proposed increases of nearly $150 million in new user fees over five years to modernize and enhance FDA’s post-market surveillance system. These resources will allow the FDA to enhance its capacity to monitor the benefits and risks of biotechnology products across their marketed lifetime and to adopt new scientific approaches to surveillance.

“With this funding, FDA will be able to further its public health mission while continuing to enable access to safe and effective medical products,” stated Greenwood.

The proposed enhancements would address many of the concerns raised in the recent Institute of Medicine report on drug safety. The new funds will improve FDA’s ability to access medical databases to conduct targeted surveillance, validate risk management and risk communication strategies, establish best practices for epidemiological studies, and minimize medication errors associated with drug name confusion.

In addition, the PDUFA proposals will establish processes to create more predictability and efficiency in pre-market review by allowing for sufficient time in the review process for meaningful agency-sponsor discussions of the product label and proposed post-marketing commitments; allow for the development of science-based guidance to modernize drug development; and fund critical information technology enhancements.

While applauding the new recommendations, Greenwood emphasized that the FDA still needs increased appropriations to continue its mission of protecting patients as it faces a revolutionary new era of scientific innovation and advancement. BIO is a founding member of the Coalition for a Stronger FDA, whose goal is to ensure a strong, consistent public commitment to resources for the FDA.

“In addition to user fees, it is important that FDA have sufficient appropriations for human drug review,” Greenwood stated. “BIO will continue to work with the Administration and Congress to seek needed increases in appropriations for human drug review activities at FDA.”

“BIO looks forward to working with Congress, patient groups, consumer groups and other stakeholders to ensure that this PDUFA package is reauthorized in a timely manner and to urge renewed public support for the FDA,” Greenwood concluded.

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. www.bio.org

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.