SKILLS Act

Mr. President, I come to the floor today to announce the introduction of the Medical Innovation Act, which is a commonsense proposal that could dramatically increase our Nation's investment in lifesaving medical research.

During much of the 20th century, America made significant investments in this area through the National Institutes of Health, and it has been a remarkable success. We have transformed medicine across America and around the world. NIH support helps train each new generation of scientists and develop each new generation of medicine. NIH-supported discoveries often get picked up by small, creative, nimble biotechnology companies, which in turn get picked up by large pharmaceutical companies, which in turn sometimes result in wildly successful blockbuster drugs. Each of these blockbuster drugs brings in more than $1 billion a year for the drug companies, and each one transforms lives.

Nearly everyone in Congress supports increased funding for NIH, but for 10 years the NIH budget hasn't even kept up with the pace of inflation. Why? Because nobody wants to step up and find a way to pay for it.

It is time to break the stalemate. The Medical Innovation Act would increase NIH funding without raising taxes and without stealing support from other critical programs. Instead, support would come from blockbuster drug companies--only those that relied on government- supported research to generate billions in sales and only those that break the law and enter into major settlement agreements with the government. In such cases, the government settlements would go forward as they normally do, but the offending company would also be required to reinvest a relatively small portion of the profits it has generated as a result of taxpayer-supported research and put that money right back into the NIH.

We celebrate the accomplishments of our pharmaceutical industry-- especially the industry's billion-dollar blockbuster drugs. These drugs have literally transformed the treatment of high cholesterol, diabetes, HIV, asthma, rheumatoid arthritis, breast cancer, colon cancer, and leukemia. They help Americans live longer, healthier lives. But we also know that blockbuster drugs don't just appear overnight as if by magic. Rarely do they result from a single giant company's individual genius.

I agree with Republican Senators Alexander and Burr, who say in a report released just this morning:

[I]n many cases, the research leading to the discovery and

development of these products has been advanced, funded, or

enabled in some way by NIH.

Drug companies make great contributions, but so do taxpayers.

The big drug companies are making billions as a result of these investments, but over the last 10 years a few of our wealthiest drug companies have been caught making money a second way--by skirting the law. These companies are not getting swept up in minor paperwork mistakes. They are not victims of overly eager regulators. They have been caught defrauding Medicare and Medicaid, withholding critical safety information about their drugs, marketing their drugs for uses that aren't approved, and giving doctors kickbacks for writing prescriptions for their drugs.

Between 2007 and 2012 the world's largest pharmaceutical companies paid over $13 billion in fines and settlements. Despite those numbers, it is clear that for the biggest drug companies this is simply a cost of doing business. In fact, several of the biggest drug companies have been caught breaking the law, have paid a fine, and then have broken the law again. And why not? Even the biggest pharmaceutical settlement ever--a $3 billion penalty for withholding life-threatening safety data and engaging in illegal marketing practices--accounted for less than 10 percent of what the company made selling those drugs. In fact, the day the settlement was announced, that company's stock price actually went up.

It doesn't have to be this way. The Medical Innovation Act would serve

double duty--requiring more accountability from the biggest drug companies while giving medical research the support it deserves.

This isn't a tax; it is simply a condition of settling to avoid a trial in a major case of wrongdoing. If a company never breaks the law, it will never pay. If an accused company goes to trial instead of settling out of court, it will never pay. It is more like a swear jar. Whenever a huge drug company that is generating enormous profits as a result of Federal research investments breaks the law, it has to put some money in the jar to help fund the next generation of medical research.

Since we announced this proposal, we have seen an outpouring of support from hospitals, doctors, patient groups, and research universities. All of them want to break the stalemate on NIH funding and get back to the business of saving lives.

We have also heard some grumbling from the army of lobbyists that works for some of the biggest drug companies--companies that would prefer not to pay a bigger penalty when they break the law. If they have better ideas for ending this congressional stalemate and getting more money into NIH, I am eager to hear them.

These lobbyists have also claimed that there is ``no logical basis'' for asking these companies to pay up when they break the law. Well, I disagree. If a company that is making literally billions of dollars as a result of taxpayers' NIH investments turns around and engages in allegedly illegal conduct and wants to settle to make the case go away, that seems like a pretty logical basis for asking them to invest a little in the next generation of medical breakthroughs.

Lobbyists have also written that the Medical Innovation Act might create ``unnecessary litigation.'' Well, it is illegal to defraud Medicare. It is illegal to pay kickbacks to doctors. It is illegal to hide safety data from the FDA or manufacture drugs in dirty, contaminated facilities. Our biggest and most successful drug companies make billions of dollars by inventing treatments and improving the public's health, and when they do, we applaud them for it. But if they want to avoid unnecessary litigation, then they should follow the law. If they don't want to put a dollar in the swear jar, then stop swearing.

I don't kid myself. I know how difficult it is to get things done in Washington, and I understand that a handful of powerful actors with money and power likes things just the way they are and will fight any effort to change. But even if a few of the biggest drug companies don't like it, I am hopeful that we can build support for this idea because the Medical Innovation Act is a major move toward substantially increasing Federal support for medical research in a way that doesn't raise taxes and doesn't cut other critical programs.

If this policy had been in place over the past 5 years, NIH would have had nearly $6 billion more every year to fund thousands of new grants to scientists and universities and research centers around the country. That is almost a 20-percent increase in NIH funding.

It has been 10 years of stagnant Federal investments followed by sequester cuts, 10 years of rejecting potentially life-changing research proposals at NIH, 10 years of telling young researchers that their innovative ideas have almost no chance of getting off the ground. We are running out of time.

Today we are choking off support for projects that could lead to the next major breakthrough against cancer, heart disease, Ebola, Alzheimer's, diabetes, or other deadly conditions. We are starving projects that would transform the lives of our children on the autism spectrum. We are suffocating breakthrough ideas that would give new hope to those with ALS.

That is not who we are. We are not a nation that abandons the sick. And we are not a nation that says, ``I've got mine, the rest of you are on your own.'' We are a nation of people who work together. We are a nation of people who invest in each other. We have done it for generations--and for generations we have led the world in medical innovation.

It is time to renew that commitment--our commitment to our children, our commitment to our parents, our commitment to ourselves, by making it a little easier for the biggest drug companies to help develop the next generation of cures and making it a little harder for them to profit from breaking the law and defrauding taxpayers. It is time to pass the Medical Innovation Act.

Mr. President, last year we saw an all-time record number of motor vehicle recalls, including those by General Motors, Toyota, Honda, and others.

The commerce committee held five vehicle safety hearings, examining GM ignition switches, Takata airbags, and the related question of whether the National Highway Traffic Safety Administration, or NHTSA, is up to the task of providing effective oversight of the auto industry.

What is absolutely clear, from our hearings and other media coverage, is that we need to ensure potential vehicle safety defects are identified as early as possible so we can protect consumers and hopefully prevent deaths and injuries. That is why earlier today Senator Nelson and I introduced the Motor Vehicle Safety Whistleblower Act.

I am pleased to note that Senators Heller, McCaskill, Klobuchar, Ayotte, Moran, and Blumenthal have cosponsored this important legislation. Senators Moran and Blumenthal being added as original cosponsors of this legislation is important because of their respective responsibilities as the chairman and ranking member of our subcommittee on consumer protection, which has played a large role over the years on various automobile safety efforts.

This afternoon I am pleased that Senator Nelson has joined me on the floor as a lead sponsor to discuss this important piece of legislation and our ongoing work on vehicle issues. As the chairman and ranking member of the Senate Committee on Commerce, Science, and Transportation, one thing that has remained constant on our committee is the spirit of bipartisanship.

With regard to S. 304, the Motor Vehicle Whistleblower Act, this legislation will incentivize auto employees who uncover serious allegations of vehicle defects or violations of motor vehicle safety laws that could lead to death or serious bodily injury to voluntarily provide that information to the Department of Transportation.

If such information leads to the Department of Transportation or the Department of Justice enforcement action that totals more than $1 million in penalties, the whistleblower would be eligible to share in a portion of the total penalties collected. This bill will protect the whistleblowers' identities and allow DOT to share information with the Department of Justice and other Federal agencies where appropriate.

Other agencies have similar programs, including programs that incentivize individuals to report information to the Securities and Exchange Commission and to the Internal Revenue Service. NHTSA plays a key role in ensuring the safety of vehicles that consumers drive on our roadways. Record fines have been levied against Toyota, General Motors, Honda, and other manufacturers.

In 2014, NHTSA issued more than $126 million in civil penalties, a record amount, exceeding the total amount collected by the agency in all of its 43-year history.

Ensuring the safety of American motorists is a priority, but the public's trust has been shaken due to the record number of recalls this past year. Almost 64 million vehicles were recalled in 2014, which is about 3 times the number of vehicles recalled in 2013--and the concerns many have about problems in the industry and at NHTSA.

After my repeated calls on the President to fill what had been a lengthy vacancy regarding the Administrator position at NHTSA, which operated without a Senate-confirmed Administrator for 389 days, I am glad to say the commerce committee did its job to ensure that Dr. Mark Rosekind was confirmed as Administrator before the end of last year. However, there is much more work that needs to be done.

The defects associated with the GM ignition switch recall and the Takata airbag recalls were apparent failures with serious safety consequences that resulted in death and serious injury. As we learned from the GM incident, delays in reporting safety-related defects to the government can cost lives.

In recent years, Congress has enacted, and NHTSA sought to implement, a robust early-reporting regime. I believe we can do more to ensure that NHTSA is informed of potential defects as early as possible. Some of the major automakers and other manufacturers have also instituted or sought to improve internal safety reporting systems that encourage employees to report safety problems.

I applaud these efforts, but reports of employees whose concerns may have been ignored, silenced, or possibly even covered up persist. If there are potential whistleblowers with important information to help NHTSA identify more defects that are not being addressed, we want them to come forward so these problems can be identified much earlier in the process.

I think we would all agree it is better to address a problem before injuries or deaths occur, if at all possible, rather than relying primarily on fines imposed after the fact. This is a commonsense, bipartisan bill that will help to prevent injuries and deaths for American drivers.

NHTSA and other stakeholders have provided input on this legislation. I look forward to working with these groups and my colleagues, and particularly with Senator Nelson, as we move forward with the committee to process and pass this legislation.

I yield the floor to Senator Nelson for his remarks.

Mr. President, today I am introducing the Accelerating Biomedical Research Act.

The bill allows more funding for the National Institutes of Health by allowing NIH funding to grow even while we continue to live under austere funding caps.

NIH funding has been a bipartisan effort working with Democrats-- Senators Kennedy and Harkin, as well as Republicans--Senators Hatfield and Specter. We successfully fought to double NIH's budget from $13.6 billion in 1998 to over $30 billion today. We supported it to speed the transition of discoveries from science to treatment and maintain America's global competitiveness.

But the NIH budget hasn't kept up with inflation. Its budget has been growing, but slowly. That means the NIH budget buys 20 percent less than what it did when the doubling was completed in 2003. Which means we are missing out. Missing out on potential treatments, potential breakthroughs, potential cures. We have no shortage of ideas. Scientists have ideas but they cannot test them without funding. What is the solution?

We need to redouble our commitment to medical research. This bill creates a 6-year plan to put NIH back on stable ground. It is steady growth, it is predictable, and it is fiscally sound.

The bill allows for new spending for NIH that does not count against the strict budget caps. So we can put more money into cures without taking it away from other compelling human needs funded within the Labor-HHS Appropriations bill.

Why NIH? Why should we have new spending for NIH when other spending is stagnant or being cut? Personally, I would lift the sequester caps. I think they are doing real harm, but I recognize we do not all agree on that. I think we do all agree that NIH research is worth increasing because it both helps the economy and saves lives.

First, let me talk about how NIH helps the economy. The NIH is a world-class institution. I call it the National Institutes of Hope, serving as the foundation for U.S. medical innovation which employs 1 million U.S. citizens, including 19,000 at NIH and 14,000 NIH employees who live in Maryland. NIH generates $84 billion in wages and salaries, exports $90 billion in goods and services. Every dollar we invest in NIH generates $2-$3 in economic activity. Every patent NIH generates provides the foundation for 8 private sector patents. In 2013, products built on licensed NIH and FDA inventions reported a total of $7 billion in sales. Investing in NIH is good for our economy

But I do not call NIH the National Institutes of Hope because of its economic impact. NIH gives hope because of its human impact. Just look at what we have done with Federal investments in NIH, cutting the cancer death rate by 11 percent in women and 19 percent in men. HIV/ AIDS is no longer a death sentence. Polio and small pox are essentially eradicated in this country.

These medical breakthroughs did not just happen. They occurred because our government supported the NIH. And because the NIH supported dedicated scientists seeking knowledge and medical breakthroughs.

And now, that support is being eroded.

I have heard the American people say, they want Congress to be frugal. But I haven't heard anyone say: ``Let's

delay finding a way to prevent Alzheimer's'' or ``Let's encourage our young scientists to work abroad'' or ``Let's put a hold on finding a cure for cancer'' or ``Let's discourage our universities from researching treatments for rare pediatric tumors''.

I am for being frugal but we must not jeopardize or hamper America as the gold standard, as the worldwide leader in medical research and innovation.

I am for being frugal but not at the expense of the next generation of scientists and the health of American families.

Discovery is the genius of our country. When President Jefferson commissioned Lewis and Clark to find water route to the Pacific, the mission was called discovery. Discovery is part of our Nation's DNA. It is what makes this Nation great.

To have innovation we must have discovery. This requires: Investing in our human capital, educating our people, and funding their research. That is why I support funding for NIH. And that is why I am introducing the Accelerating Biomedical Research Act today.

I hope my colleagues will agree and support this bill.

Mr. President, today I join with my colleagues Senators Cochran and Whitehouse in introducing the Strengthening Kids' Interest in Learning and Libraries, SKILLS, Act.

Fifty years ago, when President Johnson urged Congress to enact what would become the Elementary and Secondary Education Act, he specifically called for an investment in school libraries, decrying that school libraries were ``limping along.'' Results from a recent National Center for Education Statistics survey show that there are still gaps in access to school libraries. Approximately 8,800 schools did not report having a library media center, and only about \2/3\ of the traditional public schools that did have libraries reported having a full-time, certified librarian. One in five traditional public schools reported having no paid, State certified library staff at all.

Effective school library programs are essential supports for educational success. Multiple education and library studies have produced clear evidence that school libraries staffed by qualified librarians have a positive impact on student academic achievement. Knowing how to find and use information are essential skills for college, careers, and life in general. A good school library, staffed by a trained school librarian, is where students develop and hone these skills.

Our bipartisan legislation would reauthorize and strengthen the Improving Literacy through School Libraries program of the Elementary and Secondary Education Act, the only federal initiative explicitly dedicated to supporting and enhancing our nation's school libraries. The key improvements to the program include ensuring that elementary, middle, and high school students are served; expanding professional development to include digital literacy instruction and reading and writing instruction across all grade levels; focusing on coordination and shared planning time between teachers and librarians; and ensuring that books and materials are appropriate for and gain the interest of students with special learning needs, including English learners.

The SKILLS Act would also strengthen Title I by requiring State and school district plans to address the development of effective school library programs to help students gain digital literacy skills, master the knowledge and skills in the challenging academic content standards adopted by the State, and graduate from high school ready for college and careers. Additionally, the legislation would broaden the focus of training, professional development, and recruitment activities under Title II to include school librarians.

Absent a clear Federal investment, the libraries in many of our high poverty schools will languish with outdated materials and technology or cease to exist at all, and in turn, students will be cut off from a vital information hub that connects them to the tools they need to develop critical thinking and research skills necessary for success. This is a true equity issue, which is why I will continue to fight to sustain our Federal investment in this area and why renewing and strengthening the school library program is of critical importance.

I urge our colleagues to join us in cosponsoring the bipartisan Strengthening Kids' Interest in Learning and Libraries Act, and to work together to ensure that it becomes a part of the upcoming reauthorization of the Elementary and Secondary Education Act.

Mr. President, today I join with my colleagues Senators Cochran and Whitehouse in introducing the Strengthening Kids' Interest in Learning and Libraries, SKILLS, Act.

Fifty years ago, when President Johnson urged Congress to enact what would become the Elementary and Secondary Education Act, he specifically called for an investment in school libraries, decrying that school libraries were ``limping along.'' Results from a recent National Center for Education Statistics survey show that there are still gaps in access to school libraries. Approximately 8,800 schools did not report having a library media center, and only about \2/3\ of the traditional public schools that did have libraries reported having a full-time, certified librarian. One in five traditional public schools reported having no paid, State certified library staff at all.

Effective school library programs are essential supports for educational success. Multiple education and library studies have produced clear evidence that school libraries staffed by qualified librarians have a positive impact on student academic achievement. Knowing how to find and use information are essential skills for college, careers, and life in general. A good school library, staffed by a trained school librarian, is where students develop and hone these skills.

Our bipartisan legislation would reauthorize and strengthen the Improving Literacy through School Libraries program of the Elementary and Secondary Education Act, the only federal initiative explicitly dedicated to supporting and enhancing our nation's school libraries. The key improvements to the program include ensuring that elementary, middle, and high school students are served; expanding professional development to include digital literacy instruction and reading and writing instruction across all grade levels; focusing on coordination and shared planning time between teachers and librarians; and ensuring that books and materials are appropriate for and gain the interest of students with special learning needs, including English learners.

The SKILLS Act would also strengthen Title I by requiring State and school district plans to address the development of effective school library programs to help students gain digital literacy skills, master the knowledge and skills in the challenging academic content standards adopted by the State, and graduate from high school ready for college and careers. Additionally, the legislation would broaden the focus of training, professional development, and recruitment activities under Title II to include school librarians.

Absent a clear Federal investment, the libraries in many of our high poverty schools will languish with outdated materials and technology or cease to exist at all, and in turn, students will be cut off from a vital information hub that connects them to the tools they need to develop critical thinking and research skills necessary for success. This is a true equity issue, which is why I will continue to fight to sustain our Federal investment in this area and why renewing and strengthening the school library program is of critical importance.

I urge our colleagues to join us in cosponsoring the bipartisan Strengthening Kids' Interest in Learning and Libraries Act, and to work together to ensure that it becomes a part of the upcoming reauthorization of the Elementary and Secondary Education Act.