“The Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act will help unleash the promise of biotechnology to speed life-saving cures, novel medicines and scientific breakthroughs to patients living with debilitating diseases such as cancer, HIV/AIDS, Parkinson’s and diabetes.
“The TREAT Act will help break the institutional barriers to a faster idea-to-market pathway and speed new cures to patients most desperately in need. Through this bill, Senator Hagan has offered renewed hope to patients desperately in need of cures and breakthrough new medicines as well as a boost to our nation’s economy. The legislation will help the U.S. Food and Drug Administration (FDA) retain its leadership position as the global ‘gold standard’ for regulatory science and consumer protection.
“This bill will modernize the FDA and allow the agency to keep up with the fast pace of American scientific breakthroughs. Further, it will ensure a transparent and more predictable pathway for the development of safe and effective next generation medicines and cures while maintaining U.S. leadership in biomedical innovation. A more streamlined and forward-thinking regulatory review process will ensure that innovative biotech firms can focus their resources where they belong – in research and development that leads to breakthrough medicines and cures, and job creation – rather than navigating an overly complicated regulatory process that discourages the innovation that leads to cures.
“This new legislation includes a provision to modernize the Accelerated Approval pathway to expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases, while preserving robust standards for safety and effectiveness. The pathway would apply only to treatments for diseases or conditions that are serious or life-threatening.
“The TREAT Act also includes key elements to improve the operational excellence of the FDA and help the agency integrate the most modern tools and methodologies to ensure a science-based, patient-focused review process.
“It is simply unacceptable that in the United States, as patients suffer and die, the time to take a new drug from discovery to patient is 10 to 15 years. More, regulatory uncertainty is having a major negative impact on the private funding of biomedical innovation, deteriorating the ability of our member companies to deliver cures and new medicines. Sixty-one percent of venture capitalists now cite FDA regulatory challenges as having the highest impact on their investment decisions, and 40% expect to decrease investment in the development of new therapies.
“The need to reform the investment and regulatory environment for biotechnology innovation has never been more urgent. Only by transforming the policy environment can we develop new cures and medicines, grow a robust 21st century innovation economy, maintain our nation’s global leadership in biotechnology, continue to create high-paying jobs in the U.S and prevent the tsunami of additional health care costs that will be associated with the aging baby-boomer population.
“We look forward to supporting efforts to pass the TREAT Act and ultimately tap into the enormous scientific potential that resides in the thousands of small, medium and large American biotech companies to develop products that save, extend and improve the quality of life for patients worldwide.”
Biotech companies hold the greatest promise for finding cures to life-threatening diseases. There are currently 800 new treatments being developed for cancer by biotech companies, 300 for heart disease, 200 for diabetes, and 100 for Alzheimer’s.
When biotech finds cures it saves lives and dollars. Reducing cancer death rates by just 10 percent would have a $4 trillion economic impact. Delaying the onset of Alzheimer’s by just five years could save up to $50 billion per year. (Source: Murphy, K.M. and R.H Topel, 2003. “Measuring the Gains from Medical Research.” University of Chicago Press; Alzheimer’s Association.)