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house Bill H.R. 6

Funding More Research, Development, and Delivery of New Medical Treatments

Argument in favor

This legislation is a robust and collaborative overhaul of the way that new treatments are developed, tested, approved and delivered — it will help bring our health care system into the 21st Century.

AndrewGVN's Opinion
···
11/02/2015
More funding to research in the medical field is a must. We need to have our health care system modernized to the highest extent. This also will provide young scientists and people interested in the medical field to help with research in return to pay off their student debt, WHICH IS FANTASTIC.
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Shira's Opinion
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06/28/2016
We have treatments and potential cures (even if they're off label.) As a teenaged rare disease patient I'm already living on borrowed time and that isn't acceptable. I need cures now.
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NurfSerd's Opinion
···
03/10/2016
As a 28 year old male with degenerative stenosis of the spine and 5 discs ruptured while playing on the Falcon Football Team at The US Air Force Academy and Preparatory Academy, Title L and Title M of this bill will, hopefully, positively effect my ability to receive the most advanced and effective disc replacement technology available in the world. We are far behind other esteemed developed ally nations that have been using this new, less invasive and more advanced tech, device for years. This, coming from the opinion of the Neurosurgeon to perform my initial spinal procedure, a laminectomy, considered safe but very rare for someone of my age (typical patients are around 55 and over) and as a result the typical anesthetics used for it were of little use when I, as a 230 pound 25 year old and prescribed OxyContin narcotics for 12 months to manage daily pain at the time, woke and began seizing at which point an accidental incision of my spinal membrane caused spinal fluid to flow from my spinal cavity and brain. Fortunately, and after 3 weeks off work, of which 1 week was not guaranteed at the time due to their sick-leave and vacation policy (yes, I had to use all my vacation for the year and receive 1 extra week directly from the CEO. And yes, this inspired him to change their policy to a more Euro-mentality of sick days and holidays). Without an alternative to the current disc replacement procedures available via The FDA within the US, I will have to live the rest of my life undergoing surgeries, such as described, to put off this archaic disc replacement procedure of which is sadly our only option as US Citizens. Let our allegiance to the human race and proper ethics overpower our political posturing.
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Argument opposed

While its objectives are noble, this bill is so unwieldy, it will be difficult for industries to adapt to the reforms. It also poses threats to patient safety by cutting the time that the FDA has to approve new medical treatments.

Larry's Opinion
···
11/29/2016
Big Pharma has hijacked this 21st Century Cures Act – and every good, common-sense, bipartisan proposal will die unless Democrats make it easier for giant drug companies to commit fraud, give out kickbacks, and put patients’ lives at risk. I know the difference between compromise and extortion – and I cannot vote for this bill as it currently stands. E. Warren
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Mary's Opinion
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11/29/2016
While I agree that there is improvement needed in time to market for new discoveries, that improvement must not come from letting drug companies be less transparent. All of the science needs to be out in the light for peer review.
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Paul's Opinion
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12/01/2015
No the government needs to stay out of it and leave it to private enterprise
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What is House Bill H.R. 6?

With a wide reach, this bill aims to enhance medical innovations and reforms the ways that the Food and Drug Administration (FDA) approves new drugs and medical devices. The bill is divided into three major titles; discovery, development, and delivery. Here are the highlights:


Discovery

The National Institutes of Health (NIH) would be reauthorized, and funded with over $31.8 billion for fiscal year 2016, $33.3 billion in fiscal year 2017, and $34.8 billion for fiscal year 2018. This bill establishes an Innovation Fund within the NIH for medical research. This fund would receive an additional $2 billion in appropriations beyond what is given to the NIH as a whole for each fiscal year between 2016 and 2020.

The NIH would also develop a five-year strategic plan for biomedical research. Individual research centers within the NIH would use that plan for their research activities. Rare and pediatric diseases would remain a strategic priority for NIH research.

To incentivize young scientists and researchers to join the NIH, the federal government would pay $50,000 per year of student loans taken out by health professionals who are conducting qualified research.

A clinical trial registry database on eligibility for clinical trials would be established by the NIH. It would be accessible to the public in hopes of facilitating collaborative research.

This bill would also establish a Council for 21st Century Cures, which would be organized as a nonprofit unaffiliated with the U.S. government. It would focus on accelerating the development of cures, treatments, and preventive measures for patients.


Development

The Food and Drug Administration (FDA) would develop and utilize patient experience data when assessing the risks and benefits of drug development. It would also create drug development tools to help applicants get approval, licensing, or deeper investigation of medical products when creating new treatments.

Drug developers could apply for an accelerated approval development plan after they've applied for the drug’s investigation. That said, the Secretary could require the plan to be modified or terminated if the drug is shown to be unsafe or not effective enough.

The FDA would be mandated to create an Expanded Access Policy for investigational drugs to give patients who could benefit from the drug earlier access to it. Access wouldn’t be guaranteed, but information about the policy would be publicly available. A finalized version of this policy would be settled within 12 months of this legislation’s enactment.

Patients facing life-threatening or serious infections could receive certain antibiotic drugs, as the FDA would be allowed to approve antibiotics and antifungal drugs for use in small populations of patients where there is an unmet medical need. These drugs would be labeled with the phrase ‘Limited Population’ featured prominently on the packaging.

The FDA would also be responsible for monitoring resistance to antibiotic and antifungal drugs. In order to encourage the development of new drugs of these categories, the FDA would offer additional payments through Medicare for types of these drugs that make it to the market for the first four years that the drugs are in use. There would be a cap on these payments so that they may not comprise more than 0.06807 percent of the total payments for that year.

An Advisory Committee on Immunization Practices would establish a process for reviewing and approving new vaccines. That process would be reviewed and approved by the Centers for Disease Control and Prevention (CDC). The CDC would meet with vaccine developers to help them with licensing, and context, like the demographic data of populations affected by relevant diseases.

So-called ‘breakthrough devices’ that can provide treatments which have no approved alternatives could be given priority during the review and approval process. New medical devices would also have their quality assessments conducted by third parties. Within one year, the Secretary of the FDA would make recommendations about continuing this program, and evaluate its performance.

The FDA would allow adaptive trial designs for new drugs that utilize Bayesian statistical methods in research. Evidence from clinical experience could also be applied to new drug research to satisfy post-approval study requirements.


Delivery

The interoperability of health information technology would be based on the secure transfer of a patient’s data, and complete access to that health data without information being blocked.

Within one year, the Centers for Medicare and Medicaid would provide a report on what types of illnesses could be diagnosed through telehealth among Medicare beneficiaries.

To promote transparency for treatment prices, estimated payment amounts for outpatient procedures would be listed on a publicly searchable database so that beneficiaries can be aware of their liability.

Programs to protect patients while preventing and reducing drug abuse would be established, including a program to protect at-risk beneficiaries.

Impact

People in the U.S. who need health care, health care providers and the facilities they work for, pharmaceutical companies, the FDA, the CDC, CMS, the Secretary of Health and Human Services.

Cost of House Bill H.R. 6

$106.40 Billion
A CBO cost estimate found that this bill would cost $106.4 billion over the 2016-2020 period.

More Information

Of Note: There are more than 2 million U.S. jobs in the medical device industry, while the biopharmaceutical industry as a whole supports over 4 million U.S. jobs.

Rare diseases account for somewhere between 6,000 and 8,000 of the 10,000 known diseases, and there are only treatments for only 500 of those rare diseases.

Estimates from 2014 found that it now costs about $2.6 billion to bring a new drug to market after going through the process of developing, testing, and obtaining approval for the new drug.


In-Depth: The Chairman of the House Energy and Commerce Committee, Rep. Fred Upton (R-MI), called this bill: 

“A big bipartisan step forward on our path to cures. We have all said too many early goodbyes to people we love and treasure. Every single person has a common goal: we want more time with those we love. In this, the greatest country in the world, Americans deserve a system second to none. We can and must do better. The time for 21st Century Cures is now.”

Unsurprisingly, some of this bill's biggest critics are top officials at the FDA, who are concerned that these reforms pose risks to patient safety by streamlining the approval process for new treatments. One example they foresee is: 

"By potentially permitting shorter clinical trials and letting drug companies use alternative measures of health as evidence of a drug’s effectiveness and safety."

This legislation was passed unanimously by the House Energy and Commerce Committee on a 51 to 0 vote, after the Committee spent more than one year receiving input from patients, caregivers, innovators, researchers, and regulators.


Media:

Summary by Eric Revell
(Photo Credit: Flickr user Wolfman-K)

AKA

21st Century Cures Act

Official Title

To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.

bill Progress


  • Not enacted
    The President has not signed this bill
  • The senate has not voted
      senate Committees
      Committee on Health, Education, Labor, and Pensions
  • The house Passed July 10th, 2015
    Roll Call Vote 344 Yea / 77 Nay
      house Committees
      Committee on Energy and Commerce
      Committee on Ways and Means
    IntroducedMay 19th, 2015

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    More funding to research in the medical field is a must. We need to have our health care system modernized to the highest extent. This also will provide young scientists and people interested in the medical field to help with research in return to pay off their student debt, WHICH IS FANTASTIC.
    Like (8)
    Follow
    Share
    Big Pharma has hijacked this 21st Century Cures Act – and every good, common-sense, bipartisan proposal will die unless Democrats make it easier for giant drug companies to commit fraud, give out kickbacks, and put patients’ lives at risk. I know the difference between compromise and extortion – and I cannot vote for this bill as it currently stands. E. Warren
    Like (5)
    Follow
    Share
    As a 28 year old male with degenerative stenosis of the spine and 5 discs ruptured while playing on the Falcon Football Team at The US Air Force Academy and Preparatory Academy, Title L and Title M of this bill will, hopefully, positively effect my ability to receive the most advanced and effective disc replacement technology available in the world. We are far behind other esteemed developed ally nations that have been using this new, less invasive and more advanced tech, device for years. This, coming from the opinion of the Neurosurgeon to perform my initial spinal procedure, a laminectomy, considered safe but very rare for someone of my age (typical patients are around 55 and over) and as a result the typical anesthetics used for it were of little use when I, as a 230 pound 25 year old and prescribed OxyContin narcotics for 12 months to manage daily pain at the time, woke and began seizing at which point an accidental incision of my spinal membrane caused spinal fluid to flow from my spinal cavity and brain. Fortunately, and after 3 weeks off work, of which 1 week was not guaranteed at the time due to their sick-leave and vacation policy (yes, I had to use all my vacation for the year and receive 1 extra week directly from the CEO. And yes, this inspired him to change their policy to a more Euro-mentality of sick days and holidays). Without an alternative to the current disc replacement procedures available via The FDA within the US, I will have to live the rest of my life undergoing surgeries, such as described, to put off this archaic disc replacement procedure of which is sadly our only option as US Citizens. Let our allegiance to the human race and proper ethics overpower our political posturing.
    Like (3)
    Follow
    Share
    We have treatments and potential cures (even if they're off label.) As a teenaged rare disease patient I'm already living on borrowed time and that isn't acceptable. I need cures now.
    Like (3)
    Follow
    Share
    If they want big profits they will learn to adapt.
    Like (2)
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    While I agree that there is improvement needed in time to market for new discoveries, that improvement must not come from letting drug companies be less transparent. All of the science needs to be out in the light for peer review.
    Like (2)
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    I originally voted yes on this, but after watching Senator Warren speak, I must change my vote. This bill has good provisions, but is basically a bill that big Pharma is pushing to get passed. This bill will allow them to sell drugs without FDA approval, allow them to keep secret their give-always to doctors and hospitals to push their drugs. Big Pharma gave a lot of money to GOP senators as bribes to pass this bill. The GOP put good provisions about foster care, and other things to try to push democrats into voting for it. The bill also doesn't fund the NIH and the FDA at levels that enable them to do the work that needs to be done.
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    Not the. Governments jurisdiction.
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    More funding for research and development.
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    Anything that side steps safety in the name of profits- no
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    We elderly need help
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    No the government needs to stay out of it and leave it to private enterprise
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    We are at the threshold of the post-antibiotic age of medicine. New methods of dealing with antibiotic resistant illnesses must be developed to safeguard the lives of all people.
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    This is not the place of government. Hospitals are abusive, profit-driven, machines. Read TIME magazine article "Bitter Pill".
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    I'm all for research to improve medical procedures. But the answer is capitalism. Not legislation.
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    Let's get Medicaid out of the dark ages.
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    Why should we taxpayers fund more medical research and development when government will not cover the costs associated with receiving new healthcare procedures and drugs through Medicare and Medicaid? We taxpayers should pay for development but cannot benefit from it? No way. Until Medicare (an institution forced upon us when we have 65 birthdays) and Medicaid (a healthcare debacle whose low payments for fees are designed to bankrupt all healthcare providers) decide we taxpayers (who are NOT and have never been members of Congress and who are NOT and never have been federal employees) deserve the same level of care that those who inflict this upon us keep for themselves. Otherwise, this is just an addition to the legal pyramid scheme the federal government forces upon us.
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    This should be privatly funded.
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    Government is to big. I think the government has changed how long testing is done and patients are used as testing putting us in danger. Off topic, I am very concerned about our medicine being made by Chia, India and other countries. The government has put us in terrible danger; they can't handle all agencies now (Post Office)! What would happen if Chine, for instance, we're at war with us. What about our medicine then?
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    "I don't think we should have the most advanced medicine there is because God"
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