BIO Applauds Energy and Commerce Committee for Approving 21st Century Cures Act
Washington, DC (May 21, 2015) – Today, the Biotechnology Industry Organization (BIO) praises the Energy and Commerce Committee for approving the 21st Century Cures Act.
The following can be attributed to Jim Greenwood, BIO’s President and CEO:
“We are pleased that the legislation prioritizes placing patients at the center of the drug development process, which we believe will help spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on unmet medical needs.
“Together with numerous patient groups, we strongly support establishing a framework for incorporating patient views into the development and regulatory review processes in a more structured and transparent way with respect to both patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making.
“We also embrace the focus on precision medicine through genomics and regulatory science. Industrial scale biomarker qualification and full genome sequencing will help us better understand the molecular basis of disease and develop precision therapies tailored to each patient.
“Additionally, we support modernizing clinical trials to expedite and accelerate drug development through the use of alternative clinical trial designs, biomarkers and surrogate endpoints, and modern scientific approaches and greater utilization of post-market validation and other confirmatory techniques, including the use of real-world data.
“Furthermore, we support enhancing the FDA’s scientific capacity by improving access to adequate funding, enhancing the ability to recruit and retain world-class scientific and technical experts, and expanding management processes and human resource functions to meet the complexities of 21st Century scientific discovery. We especially note the important inclusion in this legislation of provisions to ensure privately-paid user fees to FDA are protected from the effects of any future sequestration.
“We further applaud the Energy and Commerce Committee for recognizing the critical link between research, development, and reimbursement. We look forward to continuing to work with Chairman Fred Upton (R-MI), Congresswoman Diana DeGette (D-CO), ranking member Frank Pallone (D-NJ), and all members of the Energy and Commerce Committee to help expedite the delivery of the next generation of modern medicines that will save lives and reduce and eliminate suffering.”
For more information on BIO and the biotechnology industry organization, please visit www.bio.org.