BIO Expresses Strong Support for Timely Reauthorization of PDUFA

PDUFA V recommendations promote development of innovative therapies for patients

WASHINGTON--(BUSINESS WIRE)-- The Biotechnology Industry Organization (BIO) provided a statement of support for the Prescription Drug User Fee Act (PDUFA) V recommendations during a public meeting hosted by the U.S. Food and Drug Administration (FDA) today.

In the statement, BIO Managing Director of Science and Regulatory Affairs Andrew Emmett expressed strong support for the PDUFA V recommendations as they will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, strengthen post-market surveillance, and provide patients and doctors with earlier access to breakthrough therapies:

“We as a nation need to focus policy discussions on how to unleash the promise of biotechnology so that American patients can realize the benefits it has to offer - better health, productivity, and well-being. The PDUFA program is a key element of the overall innovation eco-system. A fundamental part of biotechnology companies’ ability to innovate and raise private investment is having an FDA with the resources and mechanisms required to effectively and consistently review and approve innovative products in a timely manner based on the best available science.

“In PDUFA V, industry and FDA have agreed upon a set of enhancements that seek to restore FDA’s review performance and get back-to-basics for patients… Underlying the PDUFA V recommendations are the principles that a science-based, transparent, and well-managed review process that appropriately balances benefits and risks can enhance public trust and increase patient access to new medicines.

“Under the agreement, industry has reinforced its commitment to a well-funded drug and biologics 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 and were never intended to supplant a sound base of appropriations. User fees currently account for nearly two-thirds of the cost of human drug review. We urge Congress to support FDA’s mission and fund the Agency at the Administration’s FY12 requested levels.

“Finally, it is critical for PDUFA to be reauthorized well in advance of PDUFA IV’s expiration in September 2012 in order to avoid a reduction in force at the FDA. Even the threat of a downsizing at the FDA would be devastating to the Agency’s public health mission and its ability to review new drugs and biologics.

“BIO looks forward to working with Congress and FDA to fully implement these enhancements under PDUFA V.”

BIO’s statement is available at

About BIO

BIO represents more than 1,100 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. BIO produces BIOtech Now, an online portal and monthly newsletter chronicling “innovations transforming our world.” Subscribe to BIOtech Now.


Biotechnology Industry Organization
Stephanie Fischer, 202-312-9263
[email protected]

KEYWORDS:   United States  North America  District of Columbia

INDUSTRY KEYWORDS:   Health  Biotechnology  Public Policy/Government  Pharmaceutical  Public Policy  Research  FDA  Science