BIO Praises House of Representatives for 21st Century Cures Legislation Passage
Washington, DC (July 10, 2015) – Today, the Biotechnology Industry Organization (BIO) issued the following statement regarding the 21st Century Cures Initiative legislation.
The following can be attributed to Jim Greenwood, BIO’s President and CEO:
“We praise the House of Representatives for today’s vote to pass 21st Century Cures legislation that recognizes the critical link between research, development and reimbursement to expedite the delivery of breakthrough treatments and cures to patients suffering from life-threatening and debilitating diseases.
“This bill represents forward-looking public policies that sustain scientific discovery and promote biomedical advancement. The future of medicine will harness 21st century scientific tools, advancements in molecular biology, and novel bioinformatics to develop and improve upon therapies that can prevent, diagnose, and treat all stages of disease. This landmark legislation would lay the groundwork for transforming patient care by encouraging innovative approaches to drug discovery, development and delivery.
“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.
“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 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 transform healthcare for patients through the delivery of next generation modern medicines.”
For more information on BIO and the biotechnology industry organization, please visit www.bio.org.