Washington D.C. - The Biotechnology Industry Organization (BIO) today releases the following statement on the 21st Century Cures Initiative discussion draft shared by Chairman Fred Upton (R-MI), Rep. Diana DeGette (D-CO), Rep. Frank Pallone, Jr. (D-NJ), Rep. Joe Pitts (R-PA), and Rep. Gene Green (D-TX). his statement can be attributed to Jim Greenwood, BIO President and CEO:
“Today, we applaud the Committee on Energy and Commerce for releasing its 21stCentury Cures Initiative discussion draft intended to accelerate the discovery, development and delivery of next generation modern medicines.
“We are pleased that the discussion draft 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. We strongly support establishing a framework for incorporating patient views into the development and regulatory review processes in a more structured and transparent way, both with respect to patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making.
“Further, 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. We applaud the Committee’s recognition, in this draft, of the need for the Food and Drug Administration’s (FDA) involvement in validating and facilitating the use of cutting-edge drug development tools, while also taking account of the agency’s limited resources.
“We also strongly support provisions intended to further incentivize biomedical innovation and help expedite the development of new treatments and cures, particularly in areas of unmet medical need where existing incentives may be inadequate to drive sufficient investment. We want to continue to work with the draft’s authors to ensure that additional incentives are included in either the next draft, or the final bill.
“In addition, 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 look forward to working with Chairman Upton, Rep. DeGette and members of the Energy and Commerce Committee to ensure that the 21st Century Cures Initiative expedites 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.
“We are pleased that the discussion draft 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. We strongly support establishing a framework for incorporating patient views into the development and regulatory review processes in a more structured and transparent way, both with respect to patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making.
“Further, 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. We applaud the Committee’s recognition, in this draft, of the need for the Food and Drug Administration’s (FDA) involvement in validating and facilitating the use of cutting-edge drug development tools, while also taking account of the agency’s limited resources.
“We also strongly support provisions intended to further incentivize biomedical innovation and help expedite the development of new treatments and cures, particularly in areas of unmet medical need where existing incentives may be inadequate to drive sufficient investment. We want to continue to work with the draft’s authors to ensure that additional incentives are included in either the next draft, or the final bill.
“In addition, 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 look forward to working with Chairman Upton, Rep. DeGette and members of the Energy and Commerce Committee to ensure that the 21st Century Cures Initiative expedites 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.
