BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA

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Washington, D.C. (March 29, 2012) – Sara Radcliffe, Executive Vice President of Health at the Biotechnology Industry Organization (BIO), testified today on biosimilar user fees (BsUFA) and the Prescription Drug User Fee Act (PDUFA) before the Senate Health, Education, Labor and Pensions Committee in a hearing entitled, “FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients.”

 In her testimony, Radcliffe expressed support for the establishment of a biosimilars user fee program as part of the Food and Drug Administration’s (FDA) implementation of a well-constructed, science-based pathway for the approval of biosimilar products that protects patient safety and preserves incentives for innovative new therapies.

 “A transparent, predictable, and balanced regulatory framework for the review and approval of biosimilars, accompanied by reasonable performance goals and a dedicated, independent funding stream, will ensure that FDA can facilitate the development and evaluation of biosimilars products,” Radcliffe testified.

 “BsUFA will provide FDA with the resources and capacity to facilitate the development and evaluation of biosimilars products, while also continuing to prioritize the review of innovative drugs and biologics under PDUFA so that safe and effective new therapies – many for currently untreatable and serious diseases – can be made readily available to patients,” she stated.

 BIO believes that a principal goal of the new biosimilar user fee program must be to ensure that the workload associated with biosimilar applications does not impede the Agency’s ability to efficiently review innovative new drugs and biologics, and that new treatments continue to have the highest review priority.

 Radcliffe also testified in strong support of the PDUFA V recommendations which will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science and strengthen post-market surveillance.  The recommendations include enhancements that seek to reinforce FDA’s review performance with the goal of minimizing development and review issues that can delay patient access to needed treatments.

 Under the PDUFA V agreement, industry reinforced its commitment to a well-funded drugs and biologics review program that supports sound, science-based regulation consistent with FDA’s public health mission.  However, user fees are intended to support limited FDA activities around the drug review process, not to supplant a sound base of appropriations.  User fees currently account for nearly two-thirds of the cost of human drug review. Radcliffe urged Congress to fund the FDA at the Administration’s FY12 requested levels.

 Radcliffe concluded, “Both user fee programs will enhance FDA’s ability to protect and promote the public health, and we encourage Congress to enact both legislative provisions in a timely manner.”

 The testimony is available at

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.