Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement regarding passage of the Food and Drug Administration Reauthorization Act (FDARA) by the U.S. House of Representatives:
“The PDUFA reauthorization package passed by the House of Representatives today is an important victory for patients and for the next generation of medical innovation. This legislation ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, while advancing important patient-centered policies that will help streamline the clinical trial process—the most time-consuming, complex and expensive step in the drug development process. It also takes important steps to advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. The reauthorization of the biosimilars user fee program, including steps to improve communication throughout application review, will move the needle on getting more affordable biosimilar products to patients in a timely way, once the IP protection expires for new biologics.
“We applaud the work of the House for making sure that this important legislation remained a priority. We particularly want to recognize Chairman Walden and Ranking Member Pallone for their tireless, bi-partisan leadership in crafting and advancing the Act. We urge the Senate to swiftly consider and pass the Act to ensure the continuity of the FDA’s many critical functions, and so that patients may begin to benefit from the important advances in drug development that the Act will usher in.”
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.