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. Senate today:
“The user fee program reauthorization package passed by the Senate today is an important victory for patients and for the next generation of medical innovation. This legislation will advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. It also ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development.
“The reauthorization of the biosimilars user fee program, including steps to improve communication between the FDA and Sponsors throughout application review, will create a more robust and competitive marketplace for biosimilar therapies, following an appropriate period of exclusivity for innovator biologic products.
“The legislation also contains a number of provisions that will accelerate and incentivize the entry of generic medicines to the market, which will help to contain costs through increased competition while improving consumer choice. These provisions are consistent with proposals endorsed by BIO to drive smarter spending within our healthcare system without harming incentives for innovation.
“We commend the leadership of Senate HELP Committee Chairman Lamar Alexander and Ranking Member Patty Murray for their tireless bipartisan efforts in advancing this important legislation, as well as that of their counterparts on the House Energy and Commerce Committee, Chairman Greg Walden and Ranking Member Frank Pallone.
“We look forward to working with the FDA and other stakeholders to ensure that the important patient-centric advances contained in this legislation are most effectively implemented.”
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.
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