BIO Testifies on Importance of Prompt Enactment of PDUFA V Recommendations

In&nbsp;the testimony, Richard Pops, Alkermes plc Chairman and CEO,&nbsp;&nbsp;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.&nbsp;</p>

Washington, D.C. (February 1, 2012) – 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