The 21st Century Cures Act

From Transhuman National Committee
Jump to: navigation, search

Summary:

The 21st Century Cures Act (House Resolution 6 is a bi-partisan proposal introduced by from Congressman Fred Upton (R-MI) and introduced May 19 2015 and assigned to the House Energy and Commerce Committee chaired by Rep. Upton. Representative Diana DeGette as cosponsor and 230 cosponsors, received a favorable vote of 344 - 77 in the House and on July 13, 2015 was sent to the Senate Committee on Health, Labor and Pensions. It has been called a “breakthrough” [[1]] in bi-partisan politics by none other than former House Speaker Newt Gingrich, and is designed to streamline medical interventions for cures.

What Can Be Done Generally:

Provide bi-weekly updates tracking progress[[2]] of bill through Senate and Executive Office

Support recognition of degenerative aging processes as a medical condition, and as the major underlying factor of all aging-related diseases and conditions (incl. cancer, cardiovascular disease, neurodegenerative disease, pulmonary obstructive disease, type 2 diabetes, frailty) hence subject to diagnosis, development and application of “cures” and therefore an indispensable part of the Act, entitled to participate in all its programs.

Use it as a rallying call to enlist top researches of aging (from Buck Institute, Barshop Institute, Albert Einstein University, Rochester University, etc. etc) to support our coalition.

Key Point A

The 21st Century Cures Act would establish in the U.S. Treasury an NIH and Cures Innovation Fund endowed with $1.86 billion in mandatory funds per year for FY2016 through FY2020 to be disbursed across the following initiatives: biomedical research, cures development, an accelerating advancement program, high-risk high-payoff research, and special funding support for early career researchers. The fund offers encouragement to researchers seeking assurance that lack of money will not represent a prominent roadblock to advancement of their lines of inquiry.

What Can Be Done Specifically:

Connect researchers and fellows to appropriate contact persons overseeing CI Fund.

Support dedication of funds to translational aging research within the Cures Innovation Fund.

Key Point B

The 21st Century Cures Act authorizes annual increases in NIH's overall budget from $3.1 billion in 2016 to $3.4 billion by 2018, while directing the agency to target resources, through a “strategic plan," which it is directed to develop to broaden its mission beyond its stronghold in crucial biomedical research and identify contributions to improving U.S. public health through biomedical research.

What Can Be Done Specifically:

Learn how we can be a part of strategic plan, or how one of our fellows could.

Include fundamental and translational research of aging into the “strategic plan” of the NIH.

Key Point C

It accepts alternatives to multiphase clinical trials in certain circumstances, and permits accelerated approval pathways for certain classes of drugs such as novel antibiotics. Under the new criteria the agency may consider not only randomized clinical trial data, but also, observational studies, registries and therapeutic use as evidence of efficacy for drug and device approvals.

What Can Be Done Specifically:

Create brief to distribute to fellows and labs, to enlighten on new opportunities for bringing their work to market.

Support inclusion of trials specifically directed for diagnosis and treatment of degenerative aging processes, as underlying causes of aging-related diseases.

Support increased transparency and reproducibility of studies as additional proofs of efficacy and thus additional indications for accelerated approval.

Support complementary modes of evidence (e.g. comprehensive in silico modeling) as additional proofs of efficacy and thus additional indications for accelerated approval.

Support international collaboration in the development and distribution of cures against aging-related ill health.

Key Point D

Over 250 organizations sent a letter of support to Congress.[[3]]

What Can Be Done Specifically:

Contact the person who organized the sign-ons to that letter (or coalition/alliance org) and ask to sign on, and to connect to their contacts OR just go about forming strategic, PR-based partnerships with the biggest orgs listed.

In negotiations with the partners in the Act support coalition, urge them to recognize the importance of degenerative aging processes as the main underlying risk factor and often direct cause of all aging-related non-communicable diseases, and as a strong aggravating factor in communicable infectious diseases - and therefore in need of urgent inclusion into the Act.


References:

[http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-executive/news/21st-century-cures-act-five-things-know?page=0,3] The Offices of Congresswoman Diana DeGette - Staffperson Andrea Autobee-Trujillo

The critical need to promote research of aging and aging-related diseases to improve health and longevity of the elderly population. [| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4306469/]

Note: this is not the final or official draft but a draft provided to the TNC.

this draft provided by GHPI(Global Healthspan Policy Institute)

http://www.lifeextensioninstitute.net/