US House of Representatives Path to 21st Century Cures

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Does anyone know if anyone has tried to tap into this iniative on behalf of the ME/CFS community?

http://energycommerce.house.gov/cures

This is the link to their white paper

http://energycommerce.house.gov/sit...lysis/21stCenturyCures/20140501WhitePaper.pdf

From the wesite:

The committee is seeking input on this bold new initative from a wide variety of interested stakeholders.

Engage on social media by liking us on Facebook, Following us on Twitter, and using the hashtag #Path2Cures.

Email the committee using the email address cures@mail.house.gov

- See more at: http://energycommerce.house.gov/cures#sthash.SOlyCSr4.dpuf

 

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I'm not sure if this is the right place for this thread or not. Please move it if it is not.

On 7/11/14, the 21st Century Cures House of Representatives Committee heard testimony from 4 groups regarding the patient perspective in regards to advancing health in the US. The link to the testimony can be found here: http://energycommerce.house.gov/hearing/21st-century-cures-incorporating-patient-perspective

Janet Woodcock, M.D. Director Center for Drug Evaluation and Research, Food and Drug Administration - testified on behalf of the FDA and mentioned the initiative with ME/CFS as follows (my bolding):

".....FDA Efforts on Patient Engagement

In accordance with our commitments in the Prescription Drug User Fee Act of 2012 (PDUFA
V), FDA has initiated the Patient-Focused Drug Development (PFDD) program. The objective
of this five-year effort is to more systematically obtain the patient’s perspective on a disease and
its impact on patients’ daily lives, the types of treatment benefit that matter most to patients, and
the adequacy of available therapies for the disease. As part of this commitment, FDA is holding
at least 20 public meetings over the course of PDUFA V; each of which will focus on a specific
disease area. We have already held patient meetings on several major diseases.

After conducting a public process to nominate disease areas for Fiscal Years 2013-2015, FDA
held the first PFDD meeting on April 25, 2013. This meeting focused on chronic fatigue
syndrome (CFS) and myalgic encephalomyelitis (ME), sometimes called CFS-ME, a debilitating
disease for which there are currently no FDA-approved treatments.

Here, we heard directly from patients, patient advocates, and caretakers about the symptoms that
matter most to them, the impact the disease has on patients’ daily lives, and the patient
experience with currently available treatments. FDA staff, including members of FDA’s
Division of Pulmonary, Allergy, and Rheumatology Products, listened carefully to the personal
accounts of this devastating condition.

After the meeting, we released a report titled The Voice of the Patient: Chronic Fatigue
Syndrome and Myalgic Encephalomyeliti, a detailed summary of the meeting. In this report we
documented, in the patients’ own words, what disease impacts and treatment approaches
mattered most to them. This summary included patient testimony at the meeting, perspectives
shared in 230 docket comments, as well as unique views provided those joining the meeting via
webcast. Moreover, on March 11, 2014, FDA also released draft guidance (found at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM388568.pdf) for industry entitled “Chronic Fatigue Syndrome/Myalgic Encephalomyelitis:

Developing Drug Products for Treatment.” The purpose of the guidance is to assist sponsors in
developing drug products for the treatment of CFS-ME.

The PFDD reports, such as the one developed after the CFS-ME meeting, will serve an important
function in communicating to both FDA review staff and the regulated industry what
improvements patients would most like to see in their daily lives...."

Well, at least we got mentioned!

 

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Committee Members Take 21st Century Cures From Coast to Coast.
you can read about this latest update here.

And for anyone in New Jersey's seventh district, Congressman Leonard Lance is asking for input from his constituants.

"Congressman Leonard Lance today, July 25, announced his office is welcoming constituent testimony and comment on a major initiative launched by the House Energy and Commerce Committee. The 21st Century Cures Initiative seeks to accelerate the pace of cures by exploring advancements in technology, the role of federal programming, regulation and research and how best to contribute to medical breakthroughs.

“Remarkable advancements in technology and innovation are transforming health care in the 21st century and presenting an excellent opportunity to advance new cures and treatments. Many young people will see cures in their lifetime for some of today’s greatest public health challenges. To help get there, the 21st Century Cures Initiative is – for the first time – taking a comprehensive look at the full arc of accelerating cures. To do this right we need first-hand experience and testimony from people who fight this battle every day,” said Lance, a member of the Energy and Commerce Committee. “We need the ideas and contributions from patients, health care professionals, innovators and those advocating for a loved one.”

Lance is asking constituents from New Jersey’s Seventh Congressional District to email in their ideas, suggestions or questions on the initiative to NJ07cures@mail.house.gov. These ideas will then be researched and incorporated into a report Lance will present to the Committee.

“New Jersey has always been on the forefront of scientific advancement and medical innovation. If we want to save lives, tackle these major challenges together and keep New Jersey and the United States as an innovation capital then we need all the good ideas we can get,” concluded Lance. "

Read the article online here.

 

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Today's update.

The 21st committee cures committee approved 7 health related bills today, one of which deals with tick borne illnesses, which I know is an issue for many on this forum.

From the press release:

"Health Subcommittee Chairman Joe Pitts (R-PA) discusses H.R. 4701, the Tick-Borne Disease Research Accountability and Transparency Act, introduced by Rep. Chris Gibson (R-NY).

The bill addresses the growing threat of Lyme Disease and establishes a working group to review federal activities at the Department of Health and Human Services related to Lyme and tick-borne diseases.

H.R. 4701 was approved as amended, by a voice vote."

The bill can be found here.

 

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Anyone live in Hillsbourough county near Lutz Florida?

Representative Gus Bilirakis will be hosting a roundtable open to the public to get input for the 21st century cures house committee:

"The process includes input from the public at roundtable discussions beginning at 1:30 p.m. Aug. 19 and Aug. 22 at the Bethany Center in Lutz."
You don’t have to live in Bilirakis’ district to participate.
“It will be an open discussion,” he said. “We want to find out people’s concerns and discover what barriers they are facing. I know there are a lot of frustrated people out there.”"

More here.
Article from the Tampa Tribune here

 

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Wow, a politician having a public event OPEN to anyone and everyone! How rare My rep has not had an event I could attend since she got into office, nearly her 2 year term! How disgusting So much for be accountable to the people of your state!

GG

 

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Interesting discussion on medical research in the US

with 21st Century Cures leaders Fred Upton and Diana DeGette

 

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Latest 21st century cures initiative news--prehaps providing some hope for millions with untreatable diseases?

OPINION: Reps. Upton and DeGette in CNN: Can We Find Cures for 7,000 Diseases?
January 13, 2015

Upton and DeGette: #Path2Cures is “Clearer than Ever”

Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) last year embarked on the 21st Century Cures initiative with the goal of getting more cures and treatments to patients more quickly. Over the course of the year, the committee and its members issued four white papers and hosted a number of hearings and roundtables in Washington, D.C., and around the country. Now as the 114th Congress begins, Upton and DeGette write for CNN, “The path to faster cures is clearer than ever. … Our review revealed several areas of reform that will close the gap between the science of medicine and the regulations that impact the volume and fate of new therapies. Our legislation will modernize all of these categories, removing outdated hurdles that can prevent innovation from flourishing or fleeing the United States.”

21st Century Cures will release a discussion draft in January and plans to move quickly to get the job done for patients.

Learn more about 21st Century Cures online here, join the conversation on Twitter @ECcures, like us on Facebook, and share your thoughts using #Path2Cures.



January 13, 2015

Can We Find Cures for 7,000 Diseases?

By Fred Upton and Diana DeGette

Despite the conventional wisdom that Washington is a frozen island of partisanship, a hopeful thaw is underway. For the past year, we have been spearheading a bipartisan effort to update the process of discovering, developing and delivering medical therapies to help people live longer and better lives.

After months of listening to experts and stakeholders, the path to faster cures is clearer than ever. We call it the 21st Century Cures initiative, and Congress is about to take a major leap down this road of hope.

There are over 7,000 diseases yet we only have cures and treatments for 500 of them. This unacceptable fact led to one simple question: What policies can we enact to help get more cures and treatments to patients?

Our review revealed several areas of reform that will close the gap between the science of medicine and the regulations that impact the volume and fate of new therapies. Our legislation will modernize all of these categories, removing outdated hurdles that can prevent innovation from flourishing or from fleeing the United States. …

America has a strong history of finding solutions to diseases through medical innovation. Today, partnerships with patients and advocates, health care workers and researchers, and government and the private sector can speed the cycle of finding faster cures.

Given the rate of recent scientific progress, it's time to modernize policy to move the process of discovery, development and delivery even faster. The 21st Century Cures initiative is a bipartisan effort to melt Washington's polarization and do just that.

Read the article online HERE.

- See more at: http://energycommerce.house.gov/icy...find-cures-7000-diseases#sthash.7katAL4v.dpuf

 

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An updated for those that are interested. This bipartisan committee has issued a "discussion draft" that calls for an increase of $10 billion in NIH funding over five years beginning in 2016 along with a number of other mandates that could help PWME. This would be an opportune time to ride the coat tails of the IOM report and get on agenda for increased funding.

FOR IMMEDIATE RELEASEApril 29, 2015

CONTACT: Press Office(202) 226-4972

Bipartisan Leaders Release #Cures2015 Discussion Draft as Legislative Process Continues
Draft Bill to Provide Hope for Patients and Boost Research Is the Product of Months of Bipartisan Negotiations
WASHINGTON, DC – After nearly a year of listening to patients, innovators, researchers, providers, consumers, and regulators, bipartisan Energy and Commerce Committee leaders have released a discussion draft marking continued progress in the 21st Century Cures initiative. On Thursday, exactly one year to the day since full Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) launched the initiative, the Subcommittee on Health will hold a legislative hearing to review the draft. The committee has held eight hearings, issued a number of white papers, and committee members have hosted more than two-dozen roundtables across the country to generate ideas for this initiative. The discussion draft is the product of months of bipartisan negotiations and bipartisan staff continues working toward finalized legislation.
Chairman Upton, Oversight and Investigations Subcommittee Ranking Member DeGette, full committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX) together released the draft. The draft legislative text is available online here.
The five bipartisan leaders said, “We’ve done things differently with 21st Century Cures, taking our time to listen and solicit feedback from every corner of the health care innovation infrastructure. It is because of this transparent, collaborative process that we are now ready and excited to take the next step in boosting research and delivering hope to patients and families all across the country. The ideas outlined in this draft represent a year of listening and working together to develop a product that we believe will truly help patients and bring our health care innovation infrastructure into the 21st century.”
The bipartisan leaders continued, “While we have made significant progress over the last year, there is still work left to do, and our staffs, as they have done for months, will continue working round the clock to ensure that the finalized legislation can gain broad support. We look forward to Thursday’s testimony from the NIH and FDA and appreciate the input and involvement of all those who have been a part of this truly collaborative effort.”
The discussion draft includes provisions to:

• 
  
  
  • Incorporate the patient perspective in the discovery, development, and delivery process.
  • Increase funding for the National Institutes of Health, both through reauthorization and $10 billion over five years in mandatory funding, starting in FY 2016.
  • Foster development of treatments for patients facing serious or life-threatening diseases.
  • Repurpose drugs for serious or life-threatening diseases and conditions.
  • Modernize clinical trials.
  • Break down barriers to increased collaboration and data sharing among patients, researchers, providers, and innovators.
  • Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time.
  • Provide for continued work in the telehealth space.
  • Advance a truly interoperable health care system.
  • Provide clarity for developers of software products used in health management and medical care.

A complete section-by-section summary of the discussion draft is available online here.
A one-page summary is available online here.
Dr. Kathy Hudson, Deputy Director for Science, Outreach, and Policy at the National Institutes of Health, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the Food and Drug Administration, and Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health at the FDA will testify at Thursday’s hearing.
Learn more about 21st Century Cures online here.