BIO Testifies on Importance of Prompt Enactment of PDUFA V Recommendations

Encourages Reauthorization of BPCA and PREA

WASHINGTON--(BUSINESS WIRE)-- Richard Pops, Chairman and CEO of Alkermes plc, testified today on behalf of the Biotechnology Industry Organization (BIO) before the House Energy and Commerce Subcommittee on Health during a hearing entitled, “Reauthorization of PDUFA: What It Means for Jobs, Innovation and Patients.”

In his testimony, Pops stressed the need for a quick reauthorization of the Prescription Drug User Fee Act (PDUFA) and enactment of the enhancements recommended in the PDUFA V agreement which will improve the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. Most importantly, PDUFA modifications can provide patients and doctors with earlier access to breakthrough therapies.

“BIO looks forward to working with Congress and the Food and Drug Administration (FDA) to fully implement the enhancements contained in PDUFA V in a timely manner,” Pops stated. “We share the goals of providing new medical therapies to patients more quickly and retaining the nation’s global leadership in health care innovation.”

“A fundamental element of biotechnology companies’ ability to innovate and raise private investment is ensuring that FDA has the resources and mechanisms required to effectively and consistently review and approve innovative products in a timely manner based on the best available science,” stated BIO President & CEO Jim Greenwood. “Ultimately, this can help to promote economic growth in the biotechnology sector, as well as biomedical research into key public health priorities.”

In his testimony, Pops also indicated BIO’s strong support for the reauthorization of the Best Pharmaceuticals for Children Act (BCPA) and Pediatric Research Equity Act (PREA) which have been remarkably successful in ensuring the medicines used by children are tested and appropriately labeled for their use. Further, both programs should be made permanent by eliminating the sunset provisions in current law in order to provide certainty in the regulatory environment for pediatric drug development.

“Since their enactment, BPCA and PREA, working together, have been widely acknowledged as effective in promoting pediatric drug research. There is no logical reason to continue to allow such important legislation to sunset, as the ambiguity associated with this situation has the potential for limiting or endangering the pediatric research infrastructure that companies have been working to build and expand,” stated Pops.

The testimony 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.

Upcoming BIO Events

BIO CEO & Investor Conference
February 13-14, 2012
New York, NY

BIO IP Counsels Committee Conference
April 16–18, 2012
Austin, TX

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April 29-May 2, 2012
Orlando, FL

2012 BIO International Convention
June 18-21, 2012
Boston, MA

BIO Business Forum
June 18–21, 2012
Boston, MA


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

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