Bennet, Hatch and Burr Introduce Bipartisan Bill to Bring Breakthrough Treatments to Patients More Q Bill Would Expedite FDA Approval and Increase Clinical Trial Flexibility of Drugs and Treatments That Show Dramatic Early Responses
PoliticalNews.me - Mar 28,2012 - Bennet, Hatch and Burr Introduce Bipartisan Bill to Bring Breakthrough Treatments to Patients More Quickly
Bill Would Expedite FDA Approval and Increase Clinical Trial Flexibility of Drugs and Treatments That Show Dramatic Early Responses
U.S. Senators Michael Bennet (D-CO), Orrin Hatch (R-UT) and Richard Burr (R-NC) introduced a bipartisan bill to help bring breakthrough drugs and treatments to patients who need them more quickly.
The Advancing Breakthrough Therapies for Patients Act would expedite U.S. Food and Drug Administration (FDA) approval and provide more flexibility when a drug or treatment shows dramatic responses early in development, while still ensuring drug safety and efficacy. For patients, this proposal would allow FDA the ability to move towards more innovative clinical trials, such as minimizing the number of patients enrolled in trials and shortening the duration of trials, when scientifically appropriate.
“We’re seeing major breakthroughs in drugs and other treatments for debilitating and terminal diseases, but we’re not always getting them to patients though the most efficient and safe pathways,” Bennet said. “I have heard from countless Coloradans that the FDA needs to modernize its regulatory science to keep up with 21st century science and technology. Our bill provides the flexibility in approval mechanisms so home-run treatments that show great promise early on reach patients more quickly. It also strikes a careful balance between providing regulatory certainty for developers of these breakthrough treatments and maintaining the level of drug safety and efficacy patients expect and deserve.”
“This common sense legislation ensures that patients across the country can receive breakthrough treatments faster and more efficiently than ever before,” Hatch said. “Time and again we’ve seen regulators in Washington fail to keep up with the industries they are tasked to oversee. This bipartisan bill ensures that when it comes to treating patients suffering with cancer or other devastating illnesses, science and patient care will not be slowed down by government red tape.”
“As our understanding of diseases and conditions has advanced, targeted cutting-edge medical therapies are increasingly being developed,” Senator Burr said. “We owe it to patients to provide a clear pathway for expediting the development and review of breakthrough therapies so promising innovation can reach patients as soon as possible. Clarifying the regulatory pathway for breakthrough therapies for innovators and the FDA will help fulfill the potential of these therapies for America’s patients, while spurring future generations of life-saving treatments.”
The Advancing Breakthrough Therapies for Patients Act is supported by several organizations, including Friends of Cancer Research, a cancer research think tank and advocacy organization, and the National Venture Capital Association (NVCA), the preeminent trade association for venture capitalists.
“Friends of Cancer Research applauds Senators Bennet, Hatch and Burr for this bipartisan legislation focused on strengthening FDA's ability to get new treatments to patients suffering from diseases like cancer,” said Dr. Jeff Allen, Executive Director of Friends of Cancer Research. “With the passage of this bill, and the establishment of a Breakthrough Therapy Designation, FDA will be able to more actively keep pace with scientific
