[Congressional Record Volume 155, Number 115 (Tuesday, July 28, 2009)]
[Senate]
[Pages S8186-S8187]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           HEALTH CARE REFORM

  Mr. BROWN. Mr. President, last week I spoke on the Senate floor about 
the importance of the health care reform bill that passed the Senate in 
the Health, Education, Labor, and Pensions Committee.
  I spoke about how the legislation would reduce costs for families and 
businesses, how it would protect consumer choice of doctors, hospitals, 
and insurance plans, and how it would assure health care stability and 
security for all Americans.
  I spoke about how the bill's public option would increase competition 
in the insurance market, spurring private insurers to offer better 
premiums and better coverage.
  I explained how the bill's insurance market reforms would prevent 
insurers from dodging and weaving to avoid paying claims--an experience 
most of us have had.
  Today, I am here to talk about a provision in the HELP Committee bill 
that I am not proud of--a provision that none of us should be proud of. 
The committee adopted an amendment that would discourage medical 
innovation and perpetuate inflated prices for the medicines that 
millions of Americans need. This provision locks taxpayers into paying 
extraordinarily high prices for medicines covered by Medicaid and 
Medicare, covered by the VA system, and covered by the military's 
TRICARE system. The provision also means huge payments by corporations 
and small businesses that insure their employees, and the provision 
locks patients into paying astronomical out-of-pocket costs for 
medicines they cannot do without. The medicines I am talking about are 
known as biologics. They are medicines used to treat conditions such as 
multiple sclerosis, arthritis, Alzheimer's, diabetes, and cancer. 
Spending on brandname biologics is growing faster than spending on any 
other type of medicine.
  All too often, the pricetag for this type of drug is simply too high 
for the patient who needs it. For instance, annual treatment for breast 
cancer with the brandname biologic drug Herceptin costs $48,000. Even 
if you are lucky enough to have health insurance and you are paying 20 
percent copay, that is $9,600 a year. More than 192,000 American women 
will be diagnosed with breast cancer in 2009. How are they going to 
afford that kind of drug?
  Annual treatment for rheumatoid arthritis with the brandname biologic 
called Remicade costs $20,000. Again, even if you are lucky enough to 
have insurance--pretty good insurance--you will probably have a copay 
of 20 percent, which is $4,000 a year. That is $80 every single week, 
in addition to all your other health care expenses, and maybe the fact 
that you don't have income because you are going through rheumatoid 
arthritis treatment. At least 1.3 million Americans suffer from 
rheumatoid arthritis.
  Annual treatment for colon cancer with the brandname biologic Avastin 
costs $100,000. Again, if you are lucky enough to have good health 
insurance, and you are paying a 20 percent copay, that is $20,000. That 
is $400 a week just for your copay, on your drug, in order to deal with 
your colon cancer. This is far too expensive for many of the 112,000 
men and women in America who are diagnosed with colon cancer each year.
  The typical household income in Ohio, which is not too much different 
from the State of the Presiding Officer, Colorado, is $46,000 a year.
  We are talking about a drug that costs $20,000, another drug that 
costs $48,000, and another drug that costs $100,000 a year, and you are 
trying to pay with an income of $46,000 a year? Even if you have good 
insurance, your copay alone will break the bank. You get the picture.
  More than two decades ago, in response to consumer outrage over the 
traditional price of drugs, Congress passed the Drug Price Competition 
and Patent Restoration Act of 1984, known as the Hatch-Waxman Act. That 
act created a generic pathway for traditional medicines. Prior to that 
bill, the FDA had no approval process to get generic drugs, competitive 
drugs, similar drugs after they have gone off patent, identical drugs 
that can cure you just like brandname drugs can, but there was no 
allowance to bring those generic drugs to market.
  A quarter century ago, Congress took care of that. We need a similar 
generic pathway for biologics. But legislation granting 12 years of 
``exclusivity''--a better term is 12 years of ``monopoly''--protection, 
on top of the 20 years of patent protection--so these companies already 
have patents, and I understand sometimes several years of their patents 
are used up, and several years of the 20-year patents are used up 
during the approval process--maybe even 10 years. But on top of that, 
we are going to give them 12 years of monopoly protection, 12 years of 
exclusivity--the way we talk here--12 years of monopoly protection, the 
way that most people understand it. That gives a drug company a 
monopoly that no other drug in the market enjoys and no other product 
on the market enjoys.
  What we have done is taken these drugs that cost $12,000 a year, 
$20,000 a year, $40,000 a year, or $100,000 a year, and set them in a 
different category to protect them--a protection that nobody else in 
our entire economic system of protection, monopoly protection, and 
nobody else in our economic system enjoys. These are drugs that save 
people's lives. These are treatments for people they cannot get any 
other way.
  Why do we carve out monopoly protection for these drug companies, 
when we don't do it for any other kinds of drugs--so-called orphan 
drugs--or any other consumer product? Why do we do it? It could not be 
because the biotech companies are really good lobbyists, could it or 
because of the campaign contributions they make to my colleagues--it 
couldn't be that, could it? I don't know the explanation.
  Americans are worried that their employer will drop their health care 
coverage because of the cost of biologics. A 12-year biologic monopoly 
balloons the cost of employee-sponsored health care. Consumers worry 
that they won't be able to afford individual coverage. You will see, in 
some cases, some employers totally ending their health care coverage 
overall--the insurance they have for employees--because of the cost of 
biologics. Imagine you are a company with 100 employees, and you are a 
generous employer and you pay your people pretty well, and you are 
doing OK in this economy--not great but you have insurance for 
everybody; and of these 100 employees you have, say 4 or 5 get really 
sick. Say one takes Herceptin and one takes Remicade and one takes 
another one of these drugs--say, the $100,000 drug, Avastin. Do you 
know what that employer is going to have to do because of the cost? 
They are probably going to have to end health care coverage for all of 
their

[[Page S8187]]

employees because they have three or four employees taking these drugs.
  We must fight back for Kyl and his family from Franklin County in 
central Ohio. Kyl's sister nearly lost her house because of the costs 
of fighting a series of immune-related diseases. Kyl's father works 50 
hours a week in a food service job, with no health care benefits. Yet 
he has diabetes and heart trouble. Kyl writes that his father had to 
stop taking medications because he cannot afford the cost.
  We are asking them to wait 12 years so that biotech companies can 
make even more--give them 12 years of monopoly protection.
  I want these companies to do well. That is why I support more NIH 
funding. A lot of these companies get started by using taxpayer dollars 
for their research. Taxpayer-funded research is a good thing. It means 
inventions. And biologics are wonderful. I want them to be profitable 
and to innovate and to have incentive to do that. But 12 years of extra 
monopoly protection that nobody else in our system has?
  We must fight for Laura and her family, from Lake County, OH. She is 
an 80-year-old mother of two sons who have struggled with serious 
medical conditions. One son is a brain cancer survivor, who cannot 
afford medicine or health insurance. He cannot get it because of his 
preexisting condition. Her other son has battled years of illnesses, 
mainly rheumatoid arthritis. His existing insurance coverage doesn't 
cover Remicade, which is the drug I talked about earlier. Remicade 
costs $20,000 a year, about $2,000 a month. If you have some insurance, 
maybe you can get it for a little less. But this employer wouldn't 
cover the brandname drug. Laura writes that her sons' health care costs 
far exceed their ability to pay.

  Remember that traditional medicines receive only 5 years of monopoly 
protection. I am not the only one on the floor who thinks 12 years of 
unchecked monopoly protection is an irresponsible and inefficient 
pathway to biologics. President Obama has recognized the need to create 
an approval process for generic biologics with 7 years of market 
exclusivity.
  Consumer groups, patient safety advocates, insurance companies, labor 
unions, and medical professionals, and many companies, because they are 
paying the freight, want a safer and more efficient pathway to generic 
biologics. They suggest 5 years, as my legislation originally did.
  Groups from AARP to Families USA, to the National Organization for 
Rare Disorders, to the Service Employees International Union, to Blue 
Cross/Blue Shield have called for 7 years or less of monopoly 
protection.
  The FTC released a report which found that lengthy periods of 
exclusivity will actually harm patients, diminish innovation, and delay 
access to affordable generic biologic drugs.
  That is the only argument these biologics have, as they spread 
campaign contributions around. They lobby the halls of Congress and 
have spent literally millions already, and it is only July of 2009, but 
they spend millions of dollars lobbying. The only argument they have is 
they need 12 years of monopoly protection because, otherwise, they are 
not going to innovate.
  The FTC said if they have 12 years, they will get fat and lazy. They 
won't innovate for 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 11 years, because 
why innovate if they are getting $20,000, or $48,000, or $100,000 a 
year for their drug? The FTC explodes the only argument they have.
  Interestingly, the FTC study is the only study out there examining 
this that is not paid for by the industry. The industry studies say one 
thing; the study paid for by the government and taxpayers, which 
doesn't have a dog in this hunt, says something very different.
  I find myself disagreeing with every issue from Medicare, to trade, 
to the Iraq war, to everything else. Even the Post today said:

       With a name like the Affordable Health Care Choices Act, 
     you would think the Health, Education, Labor, and Pensions 
     Committee this month would have made an effort to provide 
     affordable health choices. But, instead, the bill includes a 
     provision that would create a 12-year market exclusivity 
     period [monopoly protection] for brand name biologic drugs. 
     This would drive costs to consumers above even current levels 
     [like the biotech companies aren't making enough with 
     $100,000 dollars a year drugs] making the title little more 
     than a mockery.

  This is a very important issue. I hope when the health care reform 
bill comes to the floor, Congress will get involved on behalf of the 
Americans they serve, the patients and taxpayers, and on behalf of 
American business.
  Let's hope Ohioans from Paulding to Preble, from Montgomery to 
Morrow, from Gallia to Guernsey--Ohioans suffering from MS, arthritis, 
Alzheimer's, cancer, diabetes, and Parkinson's--can afford these 
medicines. Let's hope Congress will shake off, will ignore the pleas 
from lobbyists and recognize a 12-year monopoly reserved exclusively 
for biologic manufacturers is more than a bonus--it is a boondoggle.
  Let's hope that we in Congress take a stand for fiscal 
responsibility, for common sense, and for the Americans we serve by 
ratcheting down the 12-year monopoly sweetheart deal that the big drug 
companies are peddling.
  I yield the floor and suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. BROWN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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