[Congressional Record (Bound Edition), Volume 149 (2003), Part 12]
[House]
[Pages 15883-15886]
[From the U.S. Government Publishing Office, www.gpo.gov]




H.R. 2544, THE MEDICAL INDEPENDENCE, PRIVACY AND INNOVATION ACT OF 2003

  The SPEAKER pro tempore (Mr. Garrett). Under the Speaker's announced 
policy of January 7, 2003, the gentleman from California (Mr. 
Rohrabacher) is recognized for the remaining time until midnight as the 
designee of the majority leader.
  Mr. ROHRABACHER. Mr. Speaker, before my colleagues leave, let me just 
note that that quote from Newt Gingrich that was bandied around 
earlier, we have seen that quote used many times, and those of us who 
have been who have seen the full quote know that that quote was taken 
out of context and often Mr. Gingrich pointed that out as an example of 
the abuse of the public trust by presenting something that was totally 
misrepresented.
  Mr. SANDLIN. Mr. Speaker, will the gentleman yield?
  Mr. ROHRABACHER. No, I would not.
  Mr. Speaker, I think I control the body. I have the floor.
  Mr. SANDLIN. I am just asking if the gentleman would yield.


                         Parliamentary Inquiry

  Mr. SANDLIN. Mr. Speaker, parliamentary inquiry.
  The SPEAKER pro tempore. The gentleman has not yielded for a 
parliamentary inquiry.
  Mr. ROHRABACHER. I would ask that the gentleman be removed from the 
floor.
  Mr. SANDLIN. Mr. Speaker, Parliamentary inquiry.
  Mr. ROHRABACHER. Mr. Speaker, I am reclaiming my time. I would ask 
that the Sergeant at Arms remove the gentleman from the floor if he 
insists on taking my time.
  Mr. SANDLIN. I do not want the gentleman's time.
  Mr. ROHRABACHER. I would ask the Sergeant at Arms to remove him from 
the floor if he continues to interrupt.
  The SPEAKER pro tempore. The gentleman from California has not 
yielded. The gentleman from California is recognized.
  Mr. ROHRABACHER. Mr. Speaker, we have seen this misuse of this quote 
so often in this body, and I would just like to make sure that the 
public is aware when they hear it misused again that Mr. Gingrich has 
time and time again demonstrated that that quote was being misused by 
people who were trying to misrepresent what he said.

                              {time}  2330

  Mr. SANDLIN. Mr. Speaker, would the gentleman yield at this point?
  Mr. ROHRABACHER. Mr. Speaker, I would be happy to yield.
  Mr. SANDLIN. Mr. Speaker, I would just like to ask the gentleman, if 
that has been misquoted, I would like the gentleman, number one, to 
read the entire quote, because the gentleman will see that, in fact, he 
did say that it should wither on the vine; and possibly the gentleman 
could comment on Senator Santorum's comment that we should phase out 
traditional Medicare. I thank the gentleman for yielding.
  Mr. ROHRABACHER. Mr. Speaker, I thank the gentleman. Let me just note 
that this quote, as I have stated, has been refuted over and over again 
and demonstrated by Mr. Gingrich in many public forums that it was 
being used in a very irresponsible and dishonest manner.
  I would just note now that I would like to discuss a different 
approach to medical independence and privacy and health insurance and 
the whole issue that we have been discussing tonight and will be 
discussing further in the next few days.
  I have a piece of legislation that I would like people to consider 
and that I would like them to look at; it is H.R. 2544. It is a piece 
of legislation that I believe offers a whole new approach to medical 
care and health care in America.
  Unfortunately, all too often, the discussion of medical reform 
legislation has been focusing on the allocation of more funds. 
Sometimes those funds would help in our society those who are lacking 
resources to purchase their own adequate health care and medical care; 
but at other times when we are talking about spending more funds, what 
we are not talking about is helping those who really need it and cannot 
provide for themselves, but what we are talking about is subsidizing 
everybody, whether or not they need it. Rarely does Congress, when they 
are focusing on just spending more money, whether or not someone needs 
that help, rarely do we focus on how can we do things more wisely and 
more efficiently, and how can we bring down the costs of getting health 
care that would make more people able to take care of themselves. 
Rarely does government focus on how to create an environment which 
would spur the supply of medical services, and rarely do we focus on 
encouraging cost-cutting innovation or to provide incentives for those 
who create and innovate and bring up new, cost-effective methods of 
dealing with illness in our society.
  In essence, what government does, and what this body often does, is 
focus on medical care demand rather than on medical care supply. This 
focus all but guarantees the price of drugs and hospital care and 
medical treatment will continue to soar and outpace the ability of many 
Americans to afford the price of being healthy and; certainly, as it 
brings the price of health care up, it then creates even more 
Americans, a pool of even more Americans who cannot take care of their 
own health care costs. So it is a cycle that leaves even more Americans 
dependent on the government, and then the government creates a 
situation where even more Americans cannot take care of themselves.
  The Federal Government took over responsibility for the health care 
of America's seniors back in 1965. When

[[Page 15884]]

Medicare was first enacted into law back in 1965, very few people 
remember what it was like back then. But before then, our economically 
disadvantaged were taken care of by tax dollars. Yes, they were. But 
most Americans who became seniors were expected to take care of 
themselves. And we need to ask ourselves, what has happened to the 
price of health care since the government assumed responsibility of 
taking care of all Americans over a certain age? What has happened to 
our health care since the emergence of Medicare?
  Today, I dare say the price of health care is so high that it is 
inconceivable that most of our seniors can take care of themselves. 
Before Medicare, people were expected, if they could, to take care of 
themselves. Medicare came in and decided to take care of everybody. 
Now, almost nobody is able to take care of themselves.
  Of course, the massive escalation of health care prices have hit the 
rest of the population as well as our seniors. Now, the same can be 
expected, I might add, of the price of prescription drugs if, indeed, 
we end up having the government take over, providing prescription drugs 
for all seniors, whether or not those seniors can afford to take care 
of themselves. What will happen is the price of drugs will soar, not 
only for seniors who will be paid for by the government, but by 
everyone else as well, again, making it even more difficult for people, 
for American citizens, to take care of their own health needs.
  Last week, I introduced a bill entitled the Medical Independence, 
Privacy, and Innovation Act of 2003. This legislation combines a 
creative mix of market-oriented reforms that will encourage 
independence and, hence, wise personal medical care choices. If 
enacted, this legislation will further expand the protection of our 
medical care privacy. It makes long overdue changes in the Federal Drug 
Administration procedures that will encourage innovation and invention 
of new pharmaceuticals and, thus, will have a major effect on bringing 
down the cost of health care. This legislation, if enacted, will expand 
the variety, quantity, and availability of medical innovation. It is 
innovation, new technology, and our creative genius that will enable 
Americans to overcome the monumental challenge of providing health care 
to the baby boomer generation as this generation slips into its senior 
years. Today, the entire system of health care delivery needs to be 
reshaped if we are to prevent a collapse as the baby boomer generation 
begins to retire and to go on Medicare.
  In my legislation, I propose a program of reforms based on sound 
economic principles that are vital to improving medical care in 
America. It assures that people make choices for themselves rather than 
accept bureaucratic or political mandates. Today, nonseniors, as with 
seniors, in fact, find that health care decisions are being taken out 
of their hands. So even our nonseniors now, much less our seniors, are 
finding that they do not control their own destiny. They do not make 
those health care decisions that are so important to their lives. What 
we have done to the nonseniors in America, while co-opting the decision 
of every senior in America by just suggesting no one will be taking 
care of themselves, even those who could, we have now taken over full 
responsibility and taken the decision out of their hands; but we are 
doing that, in a way, to the people before they become seniors.
  What we have done is structured a system where the employer has 
become the primary source of a health care service through employer-
based health insurance plans. That is a fact of life, and we just had 
to accept it. Well, unfortunately, it means so many resources and so 
much power has been co-opted that consumer sovereignty and 
responsibility has been all but negated. Most people really do not have 
a choice. It is what the boss offers. If the boss offers it, it is take 
it or leave it.
  There is an old economic truth, by the way, and that is, if the cost 
of a private or public good approach is zero, that means if you are 
being offered something and there is no cost to you taking advantage of 
it, there will be overuse and a waste of that good.
  Today's system leaves us with almost no personal choices, but it 
leaves us with a system that does not rely at all on personal 
responsibility. We have no choices, and there is no personal 
responsibility as part of the system. It leaves people, American 
citizens, with a sense of helplessness and hopelessness and resigned to 
whatever is going to happen to them that is totally inconsistent with 
our heritage as a free people.

                              {time}  2340

  We spend more and more money on health care. We spend, in fact, more 
money on health care supposedly than any other country of the world. So 
as you are listening to people debate the issue of Medicare and debate 
the issue of prescription drugs and debate the issues of health care in 
America, remember we already spend more money by far than any other 
country of the world.
  Perhaps part of this is due to the fact that individual 
responsibility has all been extracted from the system because what it 
is is we spend more money but we do not have the best health care 
system in the world and our people are not getting what they pay for or 
what is being paid for in the United States of America. We have, as I 
say, all but extracted from our system the idea of individual 
responsibility and personal authority over one's destiny, not to 
mention, of course, the profiteering and exploitation of the system by 
lawyers.
  Now, it is time to make a new approach and our system and my bill 
does not reflect on the exploitation of our system by lawyers. That is 
another bill. That is a whole different area. But those are obviously 
one group of people who siphon money out of the system that should be 
going to people's health care. It is time to take a new approach and, 
again, over and above the medical malpractice situation.
  It is time to take a new approach and what we need, for example, in 
my legislation, I am proposing that we establish medical checking 
accounts that incorporate both deductions and credits into our system 
so that our people will be free to control their own destinies.
  Many American families would benefit through the ideas that I am 
proposing in my legislation. They would benefit by being able to 
purchase high deductible catastrophic health insurance plans and pay 
for the year to year or day to day doctor, dentist and pharmaceutical 
costs out of a medical checking account.
  I have sat in my office with self-employed constituents who would 
love to be able to design their own package of medical care coverage. 
This approach would protect their family against the huge costs of 
serious medical illness, of accidents or some type of illness or 
disease, but it would allow them to pay out of their pocket for normal 
month to month costs.
  Now, imagine how the intelligently a consumer spending his money 
would help to limit overspending and over-utilization of insurance 
coverage. Imagine in a society where individual families could shop 
around for medical insurance plans that suit their needs and not have 
to squeeze their life-styles into their employer options. My bill 
would, for example, in the end and it would end the unfair 
discrimination against individuals who seek independent alternatives to 
their employer health insurance plans that are mandated in many big 
businesses or many normal businesses as well, I might add. It would 
naturally integrate market discipline through personal choice and 
responsibility into Medicare spending.
  My plan creates a medical checking account plan where the account 
base of $4,000 per family or $2,000 for an individual is built with tax 
deductible dollars and the estimated yearly variable costs are built in 
with a $1,000 tax credit replenished on a yearly basis. Now, we are 
beginning to find out that once we have been relegated, as we are in 
our current system, to cogs in a machine, either big government or big 
business machine, that the rights of privacy are no longer paramount or 
even considered. My legislation would reestablish the principle that a 
person owns his own medical history and must consent before it is 
passed on to others.

[[Page 15885]]

  The emergence of big government and big insurance as the dominant 
force in health care has eroded the ideas of medical privacy, if not 
totally just extinguished it. It is time to swing the pendulum back. My 
bill restores the issue of prior consent and protects the private 
relationship information relationship between patient and doctor. It 
eliminates loopholes in the current law that will result in unsolicited 
merchandising, disclosures of private medical information and the 
diminishing privacy for millions of Americans.
  Americans have visited their local pharmacy and many millions of have 
visited the pharmacy in the past several months and have been asked to 
sign a new HIPAA notice. Do these Americans realize that what they are 
signing is a set of rules that undermines their right to disclose or 
not to disclose their private and personal medical history?
  This country was at one time based on the principle that you owned 
your medical history and that your property is your property and 
without your concept that that information should not be placed in the 
hands of another, whether that person is in big government or private 
corporations. We need to go back to that principle. When big government 
starts taking the power, of course, to protect us from ourselves, and 
that is what they always say, they are trying to protect us from 
ourselves, not just protect the people who cannot help themselves but 
protect everybody. They are protecting us from ourselves, you better 
watch out.
  The government can and is protecting us to death. Not from death. 
They are protecting us to death. Today, for example, FDA approval 
standards require new pharmaceuticals not just be safe, new 
pharmaceuticals coming on the market, the requirement is not that they 
be safe, they have to be nearly 100 percent effective for everyone. It 
is a 96 percent efficacy rate that is demanded by the Federal 
Government. That makes it dramatically longer more difficult and more 
costly for a new drug to get on the mark. By doing this we are 
condemning hundreds of thousands of people to needless suffering with 
these overly high standards, we create hurdles to development of new 
drugs urgently needed and we end up preventing the use of drugs that 
are already available to help people, but it might only help 75 percent 
of the people. But if it only helps 75 percent, that cannot go on the 
market because the rule is it has to be 96 percent effective.
  No, this is not fair and it is not right. And it is no coincidence 
that families of victims of leukemia, cancer, AIDS and other diseases 
plead to no avail for the abilities to use drugs that were legally 
available throughout the world. I have sat if my office with 
constituents who have children with leukemia or siblings with AIDS or 
patients with cancer who beg for us to do something to allow them to 
have those pharmaceutical products that are available to people in 
other countries. Tragically at the same time, as new drugs are 
provided, or excuse me, are approved for both safety and efficacy, 
those drugs who do manage to jump all the hurdles and become effective 
for almost everybody, it ends up where the price is sky high and very 
few people can afford them.
  Then there is the case, of course, where inventors often place on 
their shelves and innovators and researchers and developers and 
scientists, they put on their shelves unused and undeveloped many 
innovative potential technologies and products because they can not 
afford the exorbitant costs of passing all of these FDA efficacy tests 
and are making it absolutely prove that 96 percent of the people will 
be totally cured by this drug.
  Well, that makes no sense if 85 percent of the people are going to be 
cured by a drug, and I have sat in my office with inventors who have 
told me horror stories of these new inventions that they have but they 
will not bring them out because they cannot jump over these FDA 
hurdles.
  Well, why does the FDA regulation concerning, for example, drug 
cocktailing today block the availability of new innovation? Why are we 
so afraid of new innovation? That new invasion can be set on the 
standard of it does no harm. I am proposing that we have the standard 
of it does no harm rather than a 96 percent or 100 percent efficacy 
rate. That is, it seems to me that that is what we should leave in the 
hands of the American people, the right to choose drugs that will do 
them no harm and they should have a right to take them if they feel, 
especially with the doctor's prescription that they can take that drug 
and treat themselves even if only 85 percent are cured rather than 96 
percent.
  Today, websites, consumer interest groups, investigative reporting 
will make the people of our country, with the help of their doctors who 
can help them with prescriptions and give them advice, they help the 
American people fully able to make these choices that were not possibly 
available to them or maybe the American people could not do it in the 
past.
  Another oddity in the current system that drives up the price of 
drugs, not just this 96 percent efficacy standard that is insisted 
upon, one thing that drives up the price for drugs for Americans is the 
way we deal with the ownership rights of inventors, of those very same 
inventors and innovators that develop new drugs and find new ways of 
treating people more efficiently and for less costs in the long run.

                              {time}  2350

  What we do, if an individual or a corporation invests tens of 
millions or hundreds of millions of dollars in developing a new health 
alternative, all too often it takes years for them to get through this 
FAA approval process and the other governmental restrictions, and by 
the time a new drug or health care technology can be sold to the 
American people, almost all of the ownership time that the innovator 
and the patent owner has has been used up. So you only have about 20 
years or 17 years with a patent, and if it takes them 15 years to get 
through the process, the company has to immediately charge a huge 
amount of money for that drug in order to cover its cost of 
development, to get it back, and then, of course, the drug has been 
held up for all of these other years. So it has not been available to 
the public; and then, of course, when it gets on the market we end up 
putting the company in a situation where it has to charge even more 
money to recoup its investment.
  My bill speeds up the process. It basically establishes that the 
patent clock does not start ticking against that company until the drug 
can be put on the market, until it is actually sold. Thus, new drugs, 
rather than waiting for 20 years or waiting for 15 years, can be put on 
the market sooner because people want to get this thing on the market 
because they have lowered those FDA restrictions and the company will 
make money over that time period.
  My bill also makes sure that once that patent term runs out, unlike 
today, there are many legal maneuvers these companies can play in order 
to keep the generic drug manufacturers from coming in and producing 
their drug. We eliminate those maneuvers.
  So what we have done is put a drug available on the market and in the 
hands of the American consumer earlier and cheaper, and then we make 
sure that the drug companies can make a profit, and we end up making 
sure that the generic manufacturers can jump in earlier without being 
deterred by legal maneuvers.
  In the end, my bill gives the people more access, more time with the 
drug. It can cure more people. Hundreds of thousands of people, if not 
millions of people, will be available to be treated with a new, 
innovative approach, drug, or a new health technology if my legislation 
sets these new standards and we move forward with a system based on 
those standards, rather than protecting the people of the United States 
to death, which is precisely what we have been doing. When we hear the 
FDA say we are approving the drug today and it is going to save the 
lives of 10,000 people a year who are dying from this disease, and then 
you find out it is taking 10 years for the drug to get on the market, 
that FDA official has just admitted that they have been in the process

[[Page 15886]]

of participating in the unnecessary death of 100,000 people. That is 
ridiculous.
  As we expand the ability of our drug innovators to create and make 
available new drugs that will, under my legislation, be protected, they 
will be able to make a profit at what they are doing; and the public 
will actually have more choice in their hands, and what we need to 
know, by the way, on the other hand, if the taxpayers end up financing, 
and there are some drug companies, we have to admit, they get money 
from the government to try to develop new drugs, they are subsidized by 
the taxpayers in developing new drugs. My bill will say if a company 
does that, if a private company does that, they will be subject to 
price controls, meaning if Uncle Sam pays the price of research and 
development, Uncle Sam will tell you what is a reasonable price to have 
on that drug; and the consumers will be protected right off the bat, 
even though there will be a reasonable profit margin made as well, but 
my bill insists that the government then put a reasonable price on that 
drug if the taxpayers did pay for that research.
  If a company pays for its own research and development, which we want 
to encourage more companies to do, they will not be limited by this 
type of price control.
  By encouraging private investment, and whether it is in the 
development and research of drugs or in other types of health care 
technology, we will thus be increasing the supply of health care of 
those things in our society which treat people's illnesses. By 
increasing that supply, it should help bring down the cost and thus the 
price of health care to our people. More new drugs and more new 
technology that can help bring health to our people being introduced on 
the market, that means a healthier life and a more affordable healthy 
life for our people.
  The medical reform bill I have introduced is a creative package of 
reforms. I urge all of the Members and fellow colleagues to study these 
proposals and to support this legislation. As health care costs are 
obviously going up and even ordinary Americans are struggling to pay 
the bill and many Americans, of course, cannot pay it all, it is 
imperative that we begin to seriously think about new approaches to 
health care.
  If the only thing that comes to us while we are looking at the 
Medicare system and the problem of health care in America is just the 
only thing we come up with is spending more and more money, we are 
going to increase the demand for drugs in our society. For example, if 
all we are doing is taking now a financial situation where the people 
who can pay for their own health care and their own prescriptions do so 
and we end up having the government take over all of that, we are going 
to end up not only dramatically increasing the price of drugs for the 
government but those people outside the government, younger people, the 
price of their drugs will dramatically go up.
  No, we cannot just simply handle this Medicare system, of course, by 
dramatically increasing the price of drugs, which will happen, will 
make sure the Medicare goes bankrupt much earlier than is scheduled. 
Right now, in the outyears, we can try to do something to keep Medicare 
solvent. If we are just going to take responsibility for everyone, even 
the people who can take care of themselves in terms of a drug benefit, 
it is going to bankrupt the system; and we will all be worse off, and 
the price of drugs will soar for ordinary families who are not seniors.
  We ignore half the problem if we only try to spend money. We need to 
free up the supply end of the medical care system, the supply of people 
who will be producing more health care for America. Yet we also have to 
be, of course, concerned about the escalating costs; but we cannot be 
stampeded into easy answers, quick fixes, because those just spending 
more money without creating any innovation in the system or any reforms 
in the system, it will make all of our problems worse. Backing up the 
Federal dump truck and just pouring in a mammoth load of tax money is 
not a quick fix. It will not work; and with new expenditures, it is 
going to bankrupt the system and cause the price of drugs to go sky 
high for all the American people, not just the seniors.
  No, the tooth fairy is not going to leave the money that is going to 
be spent on health care and improving our health care system under our 
pillow. Each and every one of us will pay. So it is irresponsible not 
to try to make the system more competitive, less bureaucratic, more 
innovative as we are talk about expanding Medicare and trying to take 
care of those people who need prescription drugs but cannot afford it.
  Our focus should be on those who cannot afford it rather than 
coopting this whole field and trying to take care of everybody. A 
government that tries to do everything for everybody is not going to be 
able to do anything for anybody in the long run as this economic 
insanity takes hold and has its effect on our society. We are going to 
make our problems for insurance worse if we do not try to make our 
system more effective and cost effective.
  One last note about health care in America. In recent years, 
Americans have witnessed an explosion of alternative health care 
health-related nutrition, acupuncture, chiropractic, vitamins, 
exercise, mental health programs that are based on self-help and 
individual responsibility. These are exciting, new alternatives; and 
most of them are not even covered by insurance, much less being paid 
for by the tax dollars. The American people need to have these 
available to them, these and other vehicles for a good healthy life; 
and we must use mass communications and the Internet to make sure our 
people know what their alternatives are, but instead, now what are we 
focusing on here in the Federal Government, instead we are just trying 
to focus on spending more money.
  New opportunities are needed. We do not need to just regulate these 
new approaches and these new things that people can do for health care. 
We do not need to regulate it, control it or ration it. We need, like 
my legislation will do, is to open up new opportunities. My legislation 
is based on the principles of freedom and the incentives of the market. 
This at least will have to be part of the solution, if not the entire 
solution, we seek to the challenges we face today.

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