The “21st Century Cures Act”
On January 27, 2015, the House Of Representatives’ Energy and Commerce Committee’s Subcommittee on Health produced and publicized a new bipartisan draft bill that is intended to improve the manners in which the pharmaceutical and medical device products are regulated in the United States.
The initiative has held more than twelve roundtables, close to a dozen congressional hearings and has published five white papers focussing on ways in which Congress could improve how new treatments are approved and marketed in the United States.
People with kidney failure requiring dialysis account for close to seven percent of Mediare’s budget. The ESRD allows any American with kidney failure to have coverage regardless of age and income. This is great.
However, in recent decades, dialysis principles, technology and techniques have not really changed and people with ESRD have seen only incremental improvements in their dialysis therapy.
The “21st Century Cures initiative” will possibly provide a chance to encourage and increase new research and could develop potential improvements in effective kidney care.
See below for FDA approving new medications, antibiotics, antibacterial and anti fungal drugs can be approved more quickly if there is a serious or life-threatening disease, condition or indication” that is currently not adequately served by existing therapies.
Here is how the draft bill is constructed and organized:
• Title I—Putting Patients First By Incorporating Their Perspectives Into The Regulatory Process And Addressing Unmet Needs
• Title II—Building The Foundation For 21st Century Medicine, Including Helping Young Scientists
• Title III—Modernizing Clinical Trials
• Title IV—Accelerating The Discovery, Development, And Delivery Cycle And Continuing 21st Century Innovation At NIH, FDA, CDC, And CMS
• Title V—Modernizing Medical Product Regulation
The Cures Act The “21st Century Cures Act” contains a major change to this section: FDA would be permitted to, based on “early stage clinical safety and effectiveness data that provide sufficient evidence for approval of the drug as safe and effective,” approve the drug.
“Antibiotic Drug Development”-Title I, Subtitle D
“The bill calls for the creation of a “limited population pathway” for antibacterial and antifungal drugs. The pathway would allow a sponsor of a new drug to seek approval for the product intended to treat “a serious or life-threatening disease, condition or indication” that is currently not adequately served by existing therapies. The pathway could only be used if the sponsor could identify a specific population in which the medical product would be used.”
With respect to the “21st Century Cures Act”, here is a letter from John R. Sedor, MD, FASN Chair, Public Policy Board-American Society of Nephrology
February 10, 2015
The Honorable Fred Upton
Committee on Energy and Commerce 2125 Rayburn House Office Building Washington, D.C. 20515
The Honorable Diana DeGette Committee on Energy and Commerce 2368 Rayburn House Office Building Washington, D.C. 20515
Re: 21st Century Cures Discussion Draft Legislation Dear Chairman Upton and Congresswoman DeGette:
On behalf of the American Society of Nephrology (ASN) thank you for the opportunity to provide input to the Energy and Commerce Committee regarding the “21st Century Cures Act” discussion document. ASN commends the Committee for its commitment to accelerating the discovery, development, and delivery of promising new treatments to patients and stands ready to collaborate to achieve this important objective.
ASN, the world’s leading organization of kidney health professionals, represents more than 15,000 health professionals and scientists who are dedicated to treating and studying kidney disease and to improving the lives of the millions of patients it affects. ASN particularly supports efforts that bolster the ability of federal agencies and the American research and development enterprise to solve scientific challenges at every level from basic science through care delivery.
Kidney disease affects more than 20 million Americans. There are many unique causes of kidney disease, but when any type of kidney disease progresses to kidney failure, patients require either dialysis or transplantation to stay alive. Currently, 600,000 Americans have complete kidney failure, called end-stage renal disease (ESRD). Kidney disease disproportionately affects racial and ethnic minority populations, is associated with multiple co- morbidities including heart disease and diabetes, and is one of the most costly chronic conditions in the United States.
While America’s scientific leadership has yielded important treatments for some patients, others still wait because the state of biomedical research and innovation in certain diseases is not as advanced; kidney disease is among the conditions for which we must accelerate the pace of innovation.
More info here:
Additional credit to Regulatory Affairs Professions Society.