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Hagan's TREAT Act Sent to President as Part of FDA Overhaul Bill

Press Release

Location: Washington, DC

U.S. Senator Kay R. Hagan (NC), a member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today applauded final passage of provisions of her Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act. Key provisions of the bill, which Hagan introduced in February, passed the Senate today as part of the bipartisan Food and Drug Administration Safety and Innovation Act and will now go to the President's desk for his signature.

"Today's passage of the TREAT Act represents tremendous progress in bringing medical advances to the patients who need them most," said Hagan. "In North Carolina and across the country, thousands are living with diseases for which there are no adequate treatments - or no treatments at all. The TREAT Act establishes a clear and effective pathway for turning ideas into cures, and cures into life-saving treatments for patients with rare and life-threatening diseases. I am hopeful that the bill will bring renewed hope to these patients and their families."

The TREAT Act would help families like Meagan and Jarrod Hendren of Lumberton, who met Hagan when she visited the North Carolina Children's Hospital in May. The Hendrens' 13-month-old twins, Logan and Lucas, suffer from Gaucher's disease, a painful and potentially debilitating metabolic disorder for which there is currently no cure.

"Passage of the TREAT Act is welcome news for so many of our patients and families," said Dr. Wesley Burks, chief physician of NC Children's Hospital and chairman of the Department of Pediatrics at the UNC School of Medicine. "The thousands grappling with these rare, often life-threatening diseases, here at UNC and across the country need and deserve the accelerated access to treatments this legislation enacts."

Of the 7,000 known rare diseases, fewer than 250 currently have FDA-approved therapies. The provisions of Hagan's TREAT Act included in the FDA Safety and Innovation Act take great steps toward resolving that problem. Hagan's bill will expedite the review of treatments for serious, rare and life-threatening diseases, without compromising the FDA's high standards for safety and effectiveness. These provisions will also help the FDA to assist drug sponsors navigating the approval process.

Amy Comstock Rick, CEO of the Parkinson's Action Network, said, "On behalf of the 500,000 to 1.5 million Americans with Parkinson's disease, we commend Senator Hagan and her Senate colleagues for including provisions of the TREAT Act in the FDA user fee reauthorization legislation because it will accelerate the review and approval process for new treatments that improve the quality of life for people who suffer from chronic, progressive neurodegenerative diseases like Parkinson's."

"The Alliance for Patient Access wants to commend Senator Kay Hagan for her advocacy on behalf of the TREAT Act and congratulate her on its passage," said Brian Kennedy, Executive Director of the Alliance for Patient Access. "By expanding the range of diseases covered under the Accelerated Approval pathway, this legislation will help ensure more patients who face life-threatening conditions will have faster access to new therapies where before they had none."

Muscular Dystrophy Association Senior Vice President for Advocacy Annie Kennedy said, "The Muscular Dystrophy Association applauds the work of Senator Kay Hagan in championing key provisions critical to the neuromuscular community, such as creating an accelerated approval drug pathway and developing innovative surrogate and clinical endpoints to enable rare disease drugs to more quickly demonstrate their effectiveness to the FDA."

Hagan was also encouraged by the bipartisan cooperation that allowed the FDA Safety and Innovation Act to move forward. The bill passed the Senate by an overwhelmingly bipartisan vote of 92 to 4. "This bill should serve as a reminder that yes, when Congress works together across the aisle we can get things done that make a real difference for the American people."

Background on the TREAT Act

To date, the FDA's accelerated approval pathway has been successfully used for the approval of therapies to treat HIV/AIDS and cancer, but has been inconsistently applied to other diseases, including rare diseases.

In fact, a 2011 report by the National Organization for Rare Disorders compared the approval process for 135 non-cancer orphan therapies (rare disease therapies) approved by FDA from 1983 through June 2010. The report found that 45 went through the conventional approval process; 32 were approved with some sort of administrative flexibility; and 58 were approved on a case-by-case flexibility process. This report illustrates that while FDA does have the authority to approve treatments with some flexibility, there does not appear to be uniformity or consistency in employing it.

The TREAT Act will provide a consistent pathway to encourage the development of innovative treatments, and will send a clear message to the FDA that the accelerated approval pathway is to be used for the approval of treatments for rare diseases. Of 7,000 known rare diseases, fewer than 250 currently have FDA-approved therapies.

Below is a list of 35 patient advocacy groups that have voiced their support for Senator Hagan's TREAT Act:

1. Alliance for Patient Access
2. American Autoimmune Related Diseases Association
3. American Institute for Medical and Biological Engineering
4. American Society of Clinical Psychopharmacology (ASCP)
5. Californians for Cures
6. Celiac Disease Center at Columbia University
7. Colon Cancer Alliance
8. Crohn's and Colitis Foundation of America
9. Digestive Disease National Coalition
10. EveryLife Foundation for Rare Diseases
11. HealthHIV
12. Hope4Bridget Foundation
13. Huntington's Disease Society of America
14. Inspire
15. International Cancer Advocacy Network (ICAN)
16. Lung Cancer Alliance
17. Lupus Foundation of America
18. MLD Foundation
19. Muscular Dystrophy Association
20. National Family Caregivers Association
21. National MPS Society
22. National Venture Capital Association
23. NBIA Disorders Association
24. New Jersey Association for Biomedical Research
25. Parkinson's Action Network
26. Polycystic Kidney Disease Foundation
27. RARE Project
28. Sickle Cell Disease Association of America, Inc.
29. Student Society for Stem Cell Research
30. The Reflex Sympathetic Dystrophy Syndrome Association (RSDSA)
31. Tuberous Sclerosis Alliance
32. US Against Alzheimer's
33. Veterans Health Council
34. Vietnam Veterans of America
35. ZERO - The Project to End Prostate Cancer

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