U.S. Sen. Kay R. Hagan (D—N.C.) introduced Wednesday, Feb. 15, the Transforming the Regulatory Environment to Accelerate Access to Treatments Act to get targeted treatments to patients with serious or life-threatening diseases in a quick and safe manner. The bill will be referred to the Senate Health, Education, Labor and Pensions Committee that oversees healthcare issues. Hagan is a member of the HELP Committee.
“The TREAT Act is a commonsense bill that will get innovative treatments to patients more quickly, while maintaining FDA’s high standards for safety and effectiveness,” said Hagan. “Accelerated approval processes helped HIV and cancer treatments advance by leaps and bounds in the 1990s. For patients suffering today from rare diseases for which there are no current treatments, medical advances can’t come fast enough. This legislation creates a consistent process and a clear and effective pathway at FDA that will encourage the development of innovative treatments for patients otherwise dependent on the uncertainty of medical breakthroughs.
“Furthermore, in this global economy, American innovation means American jobs. I will continue to work with my colleagues on both sides of the aisle to build support for this bill.”
The TREAT Act accelerates the review and approval process for medicines that:
• treat an unmet medical need,
• significantly advance the standard of care or
• are highly targeted therapies for serious or life-threatening diseases or conditions.
“NORD appreciates that Senator Hagan and her staff have listened to the concerns of rare disease patients in drafting this proposed legislation,” said Peter L. Saltonstall, president and CEO of the National Organization for Rare Disorders. “We look forward to working with Senator Hagan in support of this effort to accelerate the process for bringing safe, effective therapies to patients who desperately need them.”
Dr. Ellen Sigal, Chair & Founder of Friends of Cancer Research also commended Hagan's efforts.
“Friends of Cancer Research would like to applaud Senator Hagan for her continued support of the Food and Drug Administration," she said. "The bill she introduced today addresses some very important issues that will help the FDA enhance its scientific capacity, continue to review new treatments in a timely and efficient manner and assure that patients—suffering from serious illness and disease—have access to the safest and most effective therapies.”
The bill enhances FDA’s access to external scientific and medical expertise. It allows the FDA Commissioner to better utilize waivers when potential conflicts of interest are outweighed by the need to have input from leading medical and scientific experts. It also recommends that patient and disease research organizations have more representation on FDA advisory committees. This is critical in areas where research is on the cutting edge.
The TREAT Act advances regulatory science within the FDA. It ensures that drug sponsors are provided explanations when their drugs are turned down so that they might address concerns, improve the treatment and get approved medications to patients more quickly.
The TREAT Act updates the FDA mission statement to reflect FDA’s role in advancing medical innovation while promoting and strengthening the agency’s safety and effectiveness standards. The bill establishes new positions to promote innovation, integration and oversight as well as a Management Review Board to help FDA keep pace with advancing medical innovation and ensure that safety precautions are adhered to.
For more background on the TREAT Act, click here.