Statements on Introduced Bills and Joint Resolutions

Floor Speech

BREAK IN TRANSCRIPT

Ms. WARREN. 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.

BREAK IN TRANSCRIPT

Source