Senator Kay R. Hagan (D-N.C.) has introduced the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) 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 (HELP) Committee, which oversees healthcare issues, and of which Hagan is a member.
If passed, the TREAT Act would accelerate 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.
"The TREAT Act is a common-sense 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.”
The bill would enhance the 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, which is critical in areas in which research is on the cutting edge.
The TREAT Act also would ensure the FDA provides drug sponsors with explanations when their drugs are turned down so that they might address concerns, improve the treatment and get approved medications to patients more quickly. Furthermore, the bill updates the FDA Mission Statement to reflect the 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 the FDA keep pace with advancing medical innovation and ensure that safety precautions are adhered to.
"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 NORD. "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."