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H.R. 6, the 21st Century Cures Act: Frequently Asked Questions

Jun 25, 2015

Updated July 2, 2015

Q: Where did the idea for the 21st Century Cures Act come from?

A: There are so many factors that have driven the Energy and Commerce Committee to produce this legislation – from Chairman Upton’s history leading the bipartisan effort to double funding for the NIH in the 1990s to the experiences of two little girls waiting and fighting for a cure to their rare disease to the great work already being done by the federal research and innovation apparatus that could improve with the right legislation and resources from Congress. 

Despite the incredible progress that has been made, we have a long way to go to help patients like those little girls. There are 10,000 known diseases or conditions, but we only have cures and treatments for 500 of them. Everyone agrees that is unacceptable; we must do better.

Q: Will the 21st Century Cures Act really increase funding for the NIH and FDA? Why does it use mandatory funding?

A: Under H.R. 6, the NIH will receive at least an additional $1.75 billion per year for the next five years ($8.75 billion total) and the FDA will receive an additional $550 million. H.R. 6 also reauthorizes the NIH for the first time since 2007. Together, these resources will support important new research and the safe and speedy approval of new treatments and therapies.

The Energy and Commerce Committee identified mandatory savings elsewhere in the budget to pay for at least $9.3 billion of advanced appropriations, a type of mandatory spending controlled through the annual appropriations process. This funding ensures real dollars will flow to vital health research and innovation initiatives, and that this spending is fully offset.  Additionally, the mandatory savings included in H.R. 6 will lead to billions in additional savings in Medicare and Medicaid outside the budget window.

This structure allows for a temporary infusion of resources over the next five years to kick-start innovation in critical areas, making the authorizing committee responsible for producing the corresponding savings while still ensuring the appropriations committee actually directs the new spending to NIH and FDA through its annual appropriations process. Unlike most mandatory spending, or entitlements, this funding is set forth for a specific and limited period of time and sunsets after 5 years, the amount is clearly defined, and the regular appropriations process is used to direct it within the agency.

And while every dollar of spending in the bill is offset with other reforms, experts suggest that money spent in the short-term to develop new treatments and cures will yield dramatic savings to the federal budget in the long-term, allowing the 21st Century Cures investment to produce savings for taxpayers that could grow exponentially over time.

One example is how American innovation conquered polio. When the menace of polio peaked in the early 1950s, more than 20,000 Americans contracted the disease and some 3,000 died from it in one year.[1] However, in the early 1950s, a vaccine for polio was discovered. Polio has been eliminated in the United States through the widespread adoption of a safe and effective vaccine. Some estimate that this vaccine has saved the United States $800 billion since 1955.”[2] While we have a vaccine for polio, we do not have cures for many other diseases, which poses a substantial threat for patients and our health care system. For example, as the President’s Council of Advisors on Science and Technology has noted, Alzheimer’s disease, which already afflicts more than 5 million people in the United States, accounts for nearly $140 billion in Medicare and Medicaid payments. One study noted that over the next forty years, caring for patients with Alzheimer’s could cost the federal government as much as $15 trillion dollars.[3] Finding cures and treatments for diseases like Alzheimer’s can help us innovate our way out of the entitlement crisis.

Q: What does the Strategic Petroleum Reserve have to do with health innovation funding?

A: The Energy and Commerce Committee’s jurisdiction includes not only public health, but energy policy and many other key national priorities as well. As part of the committee’s ongoing effort to modernize the federal government to better serve its citizens, the committee is re-assessing energy policies established at a time when we believed we were running out of energy – such as the creation of a Strategic Petroleum Reserve (SPR) established in the wake of the 1970s Arab oil embargo. There are several reasons to re-evaluate the size of the SPR, the world’s largest stockpile of government-owned oil. For one, the reserve contains nearly 50% more crude oil than the law requires, because domestic oil production has risen while foreign imports and consumption have declined. There are also significant structural and logistical challenges with the SPR’s current configuration, including a maintenance backlog that the Department of Energy (DOE) is struggling to address. Through the course of the committee’s oversight, it has become clear that modestly reducing the volume of the SPR would create some breathing room for DOE to more efficiently and effectively manage the SPR without jeopardizing energy security. At the same time, the revenue generated from the sale of SPR oil would be directed toward NIH funding in the 21st Century Cures Act – because just as energy reserves are a national resource designed to protect and serve our citizens, so too is an investment in health innovation and research. The Energy and Commerce Committee is uniquely positioned to make the modest adjustments the SPR needs, and to redirect those savings to benefit the American people.

Q: How does the 21st Century Cures Act help patients access new treatments and cures?

A: The companies that research and manufacture new drugs and devices play a central role in the quest to deliver new cures and therapies to patients, and the 21st Century Cures Act includes steps to improve their ability to deliver new drugs to patients who need them. For example, Cures puts the views of the patient at the heart of FDA’s decision-making by codifying a structured framework for the consideration of patient experience data. This will enable the FDA to better understand what is important to patients when reviewing drugs. At the same time, the 21st Century Cures Act is about so much more than one industry or one element of the health innovation ecosystem.  The bill addresses the entire discovery-development-delivery cycle, and in so doing, makes transformational changes throughout the process. From the outset, the 21st Century Cures Act has been rooted in the idea that Congress should listen to the widest range of stakeholders and combine as many good ideas as possible into a bill that would generate strong support and ultimately make it into law so it can make a difference in patients’ lives.

Will 21st Century Cures make a difference in patients’ lives? Over 250 patient groups have enthusiastically said “yes” and endorsed H.R. 6.    

Q: How will the 21st Century Cures Act change clinical trials and drug approvals?

A: Despite recent advancements in science and technology, designing and conducting clinical trials of new drugs and devices in the United States has become increasingly complex, time consuming, and expensive. Throughout the 21st Century Cures initiative, we heard loud and clear that in order to get life-saving drugs and devices to patients faster, we must modernize clinical trials.

First, we heard that we must remove administrative barriers that, while often well-intentioned, are not providing any added benefit to patients and are inhibiting progress. H.R. 6 would streamline various regulations and requirements to make sure researchers are able to comply with them, and it would eliminate duplication in the review process by fostering broader utilization of central institutional review boards (IRBs) for trials being conducted at multiple institutions.     

In addition, we heard that we must identify the benefits and risks of potential therapies sooner in the process while maintaining patient safety as our utmost priority. For starters, H.R. 6 puts the voice of the patient at the heart of FDA’s decision-making with a structured framework to consider patient experience data. It would also embrace the promise of personalized medicine by opening the door to greater use of drug development tools, including biomarkers, that are critical to making sure the right patients receive the right treatment at the right time. 

In short, the policies in 21st Century Cures Act will help make drug and device development less time-consuming and less costly, which is good news for patients. This regulatory modernization will also help ensure the U.S. remains on the cutting edge of biopharmaceutical and device development.  

Q: Does Cures lower the safety standard?

A: No, it does not. Dr. Woodcock, who runs the FDA’s drug center, stated publicly in June that Cures does nothing to lower FDA’s gold standard (safety standard).

Q: What does the Senate think about the 21st Century Cures Act?

A: Earlier this year, bipartisan leaders of the Senate HELP Committee announced a similar initiative. Chairman Upton applauded that effort, noting, “The more people talking about how to accelerate the discovery, development, and delivery of new cures and treatments, the better.” Senators Alexander and Murray have also spoken well of the 21st Century Cures initiative, and E&C alumni Senators Cory Gardner and Bill Cassidy bring with them their experience working on the 21st Century Cures initiative to be able to develop similar reforms in the Senate.

 

[2] Michael Milken, in the Foreword of The Upside of Aging: How Long Life Is Changing the World of Health, Work, Innovation, Policy and Purpose, by Paul Irving, 2014.

[3] Alzheimer’s Association, March 2013, available online: http://act.alz.org/site/DocServer/2012_Trajectory_Fact_Sheet.pdf?docID=1922

 

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