Freedom First Society

Issue: H.R. 34, Title: [with this amendment] 21st Century Cures Act (initially, the Tsunami Warning, Education, and Research Act of 2015). Question: On Concurring in the Senate Amendment with an Amendment.

Result: Passed in House, 392 to 26, 16 not voting. Passed in Senate 12-7-16 (Senate vote 157). Became Public Law 114-255 (signed by the President, 12-13-2016). GOP scored.

Freedom First Society:  This heavily lobbied 312-page “catch-all” bill expands several areas of unconstitutional federal involvement. Its heralded focus is funding innovation in biomedical research and development of new treatments. But the package includes several other proposals, such as Division B, which incorporates H.R. 2646, the Helping Families in Mental Health Crisis Act of 2016, passed by the House on July 6, 2016 (Roll Call 355).

Since several of the six Democrats who opposed this bill were unhappy that the Cures Act did not spend more (right vote, wrong reason), we do not score the Democrats on this one. 

We have assigned (good vote) to the Noes and (bad vote) to the Ayes. (P = voted present; ? = not voting; blank = not listed on roll call.)

Bill Summary:  This 312-page bipartisan “catch-all” package combines many agendas and bills. Here are several:

  • Provides $4.8 billion over 10 years to the National Institutes of Health.
  • Provides States with $1 billion in federal grants over the next 2 years to help combat the opioid epidemic.
  • The Safe Medications for Moms and Babies Act.
  • The EUREKA Act, which incentivizes and rewards research on rare diseases.
  • The Helping Families in Mental Health Crisis Act.

Analysis: The “Cures Act” advances the collectivist revolution that hypes government as the solution to all problems.  This is particularly dangerous when applied to the federal health care system.

The unconstitutional federal assumption of responsibility for universal health care dates back to the Johnson years. That socialist breakthrough occurred after decades of socialist campaigning.

The socialist drivers of this power grab deceitfully argued a pretext of caring concern, but their real agenda has been control — to transform government from servant to master by making the public dependent on government for health care. (See Media-Controlled Delusion, Chapter 1. Socialized Medicine and Code Blue by Edward R. Annis, M.D., a past president of the American Medical Association.)

As the “debate” on this measure makes clear, many in Congress have embraced the concept that that the federal government has unlimited deep pockets and consider it a sin to restrict spending that targets problems. They conveniently ignore where the money comes from and the impact of that cost on the public and the economy. They also have no respect for constitutional limitations on areas of federal involvement.

Congressional Record Excerpts (11-30-16) [emphasis added]:

Rep. Fred Upton (R-MI, Chair, Energy & Commerce Committee):

“Every day, countless folks living vibrant lives are delivered unexpected diagnoses. It is a cycle that repeats itself over and over in every community. Life changes in an instant, and hope seems out of reach, whether it be Alzheimer’s, lupus, MS, cancer, you name it.

“No matter where you are from, one thing that binds us all together is that we all want more time with our loved ones. That is why we are here today, because the clock is ticking for patients and their families.

“So, Mr. Speaker, this brings us to the 21st Century Cures Act. This bipartisan bill will ensure that our health system can keep pace with the incredible advances in science and technology. In Cures, we have got a medical innovation game-changer that will deliver hope to patients across the country.

“We have been here before. In July of 2015, after a series of roundtables, hearings, white papers, and public feedback, the House overwhelmingly voted in support of 21st Century Cures….

“So 3 years ago, we had an idea that, yes, we could do better. We needed to do something to transform our health research system to effectively fight disease in this century. Finding cures and boosting research and innovation was absent from any policy to-do list. People didn’t seem to care that the gap between biomedical innovation and our regulatory process was widening, or that of the 10,000 known diseases — 7,000 of which are rare — there are treatments for only about 500. We needed to change the conversation and restore urgency. And working together, we have….

“This legislation breaks down regulatory barriers and expedites the approvals for drugs and devices, coupled with billions more for research….

“But this package is not just about Cures. No. It also achieves several additional top-line priorities for our Energy and Commerce Committee, including valuable resources to fight the opioid epidemic and delivering landmark mental health reforms spearheaded by Dr. Tim Murphy to help families in crisis and treat mental illnesses rather than incarceration. This is, without a doubt, the most important and impactful bill that we will enact in this Congress.

We are on the cusp of something special, a once-in-a-generation opportunity to transform how we treat disease. With this vote, we are taking a giant leap on the path to Cures.”

Rep. Diana DeGette(D-CO):

“Mr. Speaker, I rise today in strong support of the 21st Century Cures Act, knowing that I am far from alone in supporting this bill. More than 700 groups representing patients, healthcare providers, researchers, and others have voiced support for the bill, as has the White House, which provided its enthusiastic endorsement last night.

“This is a watershed moment in this country for biomedical research. With this bill, we bring hope to millions of patients who suffer from cancer, Alzheimer’s, diabetes, and a host of other ailments….

Among the key provisions, this consensus version of the bill will provide $4.8 billion to the National Institutes of Health, including money for Vice President Biden’s Cancer Moonshot initiative, including money for Precision Medicine and the BRAIN Initiative. It will provide almost $1 billion in grants to the States to address the urgent opioid crisis in this country.”

Rep. Frank Pallone (D-NJ, Ranking Minority Member, Energy & Commerce Committee):

“This is not a perfect bill, but, after much consideration, I believe the benefits outweigh my concerns, and I fully support its passage.

“This final bill includes many provisions that my Democratic colleagues and I, as well as the administration, fought hard to have included.

“The bill provides new funding for the National Institutes of Health, the President’s Precision Medicine Initiative, and the Vice President’s Cancer Moonshot initiative. It also provides new resources for the Food and Drug Administration and grants for States currently battling the opioid abuse crisis….

“I am also pleased, Mr. Speaker, that the bill includes a new FDA grant program to study the process of continuous drug manufacturing. This innovative process will allow for more effective drug production without sacrificing quality. The bill also includes important hiring provisions to help the FDA recruit and retain the best and the brightest and policies to move us closer to ensuring we have interoperable electronic health records, which are critical to reducing costs and improving care.

“As I said, this is not a perfect bill, and I have some concerns with the final product. I am disappointed that the bill does not contain guaranteed funding. Instead, we must ensure each year that the Appropriations Committee and the Republican majority lives up to the promises they make today, and we will hold them to these promises. The lack of immediate funding for the FDA is a particular concern given the fact that this bill asks the FDA to take on significantly more responsibilities that we know are extremely resource intensive….

“I am pleased, Mr. Speaker, that this package includes the Helping Families in Mental Health Crisis Act. This is a helpful step towards the more substantial reforms our broken mental health system needs.

“I am specifically proud that the bill expands an important set of Medicaid benefits to kids receiving inpatient psychiatric treatment. However, let’s be clear, the benefits of the mental health bill will be far outweighed by the catastrophic harm caused by individuals with mental illness if the Republicans move forward with their radical plans to repeal the Affordable Care Act or block grants for Medicaid or cut benefits for low-income individuals.

“Again, on balance, this is a good bill. I fully support it.”

Rep. Tim Murphy (R-PA):

“Mr. Speaker, this is a moment of great joy out of a situation of tremendous tragedy.

“After the last 4 years, since the time of the terrible tragedy at Sandy Hook Elementary School followed by repeated other ones, our Nation has awoken from a slumber of ignoring the problems of mental illness in America, one that when we closed down our institutions decades ago, we turned our eye to those who lay homeless on the street, who filled our prisons, who filled our cemeteries or lay on a gurney in an emergency room or were sent back home to a family who felt helpless and hopeless.

“We have changed now to a situation where we are coming together on a bill that will save lives. This is a new era of health care and the next generation of hope for Americans that really transcends boundaries.

Rep. Kathy Castor (D-FL):

“This legislation supports an additional $4.8 billion for the National Institutes of Health, specifically for President Obama’s Precision Medicine Initiative and the BRAIN Initiative so we can tackle the challenge of Alzheimer’s. It supports Vice President Biden’s Cancer Moonshot initiative….

“While additional support for NIH is vital and this is a move in the right direction, I would have much preferred that we put this in the mandatory category as we voted on in H.R. 6 earlier in the year. I know many of you agree with that, that medical research in America today shouldn’t be subject to the whims of congressional budget battles or political fights. I will continue to advocate for mandatory funding for NIH so that we can remain on the cutting edge of medical innovation and boost higher wage jobs back home….

“I am very pleased that legislation I introduced with my colleague Representative Herrera Beutler was included in this package. The Safe Medications for Moms and Babies Act ensures that expectant mothers and doctors have accurate information about medications used during pregnancy and when nursing to facilitate the best health outcomes.”

Rep. Steve Cohen (D-TN):

I don’t think there is enough money that we can put into the [National Institutes of Health], because it is important and it affects all Americans independent of political party, race, sexual orientation — you name it.”

Rep. Marcy Kaptur (D-OH):

“This legislation includes a much-needed renewed emphasis on evidence-based strategies for treating serious mental illness, improved coordination between primary care and behavioral health services, reauthorization of important programs focused on suicide prevention and other prevention services, and mental health and substance use disorder parity provisions….

“Although not perfect or complete, this legislation offers advances in health that greatly outweigh any concerns we might have. I am proud to add my strong support for 21st Century Cures Act.”

Rep. Rosa DeLauro (D-CT):

“Mr. Speaker, I rise in opposition to this bill. The 21st Century Cures bill aims to promote biomedical innovation and mental health, noble goals that I share. Unfortunately, this bill sets a dangerous precedent and has the potential to do more harm than good for millions of Americans….

“Rather than protect those who rely on the healthcare system, it reduces the already weak regulation on medical devices, allows drugs to be approved with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics….

“When the cost of our prescription drugs is skyrocketing, this bill does nothing to combat excessive prices.

“Finally, this bill strips away funding from the public health and prevention fund. While the bill authorizes $4.8 billion to the NIH over the next 10 years — on average, a mere $480 million a year — this is barely a quarter per year of what the House passed last year. Let us not forget that we would need to provide $7 billion a year to keep up where we were in 2003.”

Rep. Jim McDermott (D-WA):

This bill is a typical lameduck bill. It has one provision in it that people really want, and that is a giveaway to the pharmaceutical industry….

“My colleague, Ms. DeLauro from Connecticut, was absolutely right: the weakening of the FDA in protecting the American public is the central part of this bill.

Now, it is wrapped in $4 billion worth of inadequate money for NIH. It would take $7 billion to keep us where we are today….

“The other thing that is wrong with this bill and that this House has failed to do is to deal with the cost of pharmaceuticals in this country. There is not one single thing in this bill.

“There is a specialty drug called Sovaldi. It is a treatment for hepatitis C. There are actually several million people in this country who need that drug. One pill costs $1,000. Full treatment costs $84,000. Who can afford it? Who is going to pay for that? Are you going to be willing to put the money into part D of Medicare to pay for it?

“The question here is: What are we doing in giving away to the pharmaceutical companies an open door to push any drug out they want or that they can get through the screen, make the screen big so that it is easy to get them out, and then we pick up the pieces for the American people? That is the reason I oppose this bill. I think there are good things in it.”

Rep. Lloyd Doggett (D-TX):

“Madam Speaker, while certainly saluting the many Members who have worked so diligently on this measure, I cannot vote for it.

“In a wide and endless desert of support for research funding, even getting a few drops of rain is understandably welcomed by the thirsty. Under Republican rule, we have seen a dreadful drought in research funding. This is a bill that attempts to address that shortfall. I voted for the bill when it was on the floor of the House at a previous time. At that point, it promised the hope, after this long drought of almost $10 billion in assured, certain funding, for research so that we might find cures for some of these diseases before we get them ourselves–the concern of so many people.

“Now, under this new measure, we have only about a fourth of the funding previously approved in the House, and it is no longer certain money; it is maybe money for the future. So there may be bipartisan agreement, but there is not a bipartisan advancement.

“At the same time that research dollars are dramatically cut — the very research dollars that were the reason for having this bill in the first

place — Big Pharma got some of its wish list approved. And how very appropriate that this measure and so many other moving parts have been packed into what it calls the Tsunami Warning bill….

“So what we get in this bill are a few things that Big Pharma wants that have been on its wish list for a long time, and consumers, they get nothing to look forward to other than more of those big waves of huge price increases.”

Rep. Erik Paulsen (R-MN):

“There are more than 10,000 known diseases in the world, and many of them are rare diseases. Yet, there are only 500 of them that have an FDA-approved treatment….

“Madam Speaker, this is an innovation game-changer. It is a once-in-a-generation, transformational opportunity to change the way we treat disease. It expedites the discovery, the development, and the delivery of new treatments and cures; and it ensures that America will be a leader in the global fight for medical innovation.” 

Rep. Sheila Jackson Lee (D-TX):

“Increased funding set forth in H.R. 34 will only strengthen NIH’s focus on diversifying the biomedical workforce by requiring NIH to focus on ensuring participation from scientists from underrepresented communities.

“In addition to addressing the needs of underrepresented communities, H.R. 34 also calls for specific action to increase representation of racial minorities….

“Under H.R. 34, the National Institute on Minority Health and Health Disparities will necessarily include strategies for increasing representation of minority communities in its strategic plan.



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