[Congressional Record Volume 149, Number 111 (Thursday, July 24, 2003)]
[House]
[Pages H7595-H7611]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PHARMACEUTICAL MARKET ACCESS ACT OF 2003
Mr. TAUZIN. Mr. Speaker, pursuant to House Resolution 335, I call up
the bill (H.R. 2427) to authorize the Secretary of Health and Human
Services to promulgate regulations for the reimportation of
prescription drugs, and for other purposes, and ask for its immediate
consideration.
The Clerk read the title of the bill.
The text of H.R. 2427 is as follows:
H.R. 2427
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Pharmaceutical Market Access
Act of 2003''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Americans unjustly pay up to 1000 percent more to fill
their prescriptions than consumers in other countries.
(2) The United States is the world's largest market for
pharmaceuticals yet consumers still pay the world's highest
prices.
(3) An unaffordable drug is neither safe nor effective.
Allowing and structuring the importation of prescription
drugs ensures access to affordable drugs, thus providing a
level of safety to American consumers they do not currently
enjoy.
(4) According to the Congressional Budget Office, American
seniors alone will spend $1.8 trillion dollars on
pharmaceuticals over the next ten years.
(5) Allowing open pharmaceutical markets could save
American consumers at least $635 billion of their own money
each year.
SEC. 3. PURPOSES.
The purposes of this Act are as follows:
(1) To give all Americans immediate relief from the
outrageously high cost of pharmaceuticals.
(2) To reverse the perverse economics of the American
pharmaceutical markets.
(3) To allow the importation of drugs only if the drugs and
the facilities where they are manufactured are approved by
the Food and Drug Administration, and to exclude
pharmaceutical narcotics.
(4) To require that imported prescription drugs be packaged
and shipped using counterfeit-resistant technologies approved
by
[[Page H7596]]
the Bureau of Engraving and Printing (technologies similar to
those used to secure United States currency).
SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS.
Section 804 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 384) is amended--
(1) in subsection (a)--
(A) by striking ``The Secretary'' and inserting ``Not later
than 180 days after the date of the enactment of the
Pharmaceutical Market Access Act of 2003, the Secretary'';
and
(B) by striking ``pharmacists and wholesalers'' and
inserting ``pharmacists, wholesalers, and qualifying
individuals'';
(2) in subsection (b)--
(A) by amending paragraph (1) to read as follows:
``(1) require that each covered product imported pursuant
to such subsection complies with sections 501, 502, and 505,
and other applicable requirements of this Act; and'';
(B) in paragraph (2), by striking ``, including subsection
(d); and'' and inserting a period; and
(C) by striking paragraph (3);
(3) in subsection (c), by inserting ``by pharmacists and
wholesalers (but not qualifying individuals)'' after
``importation of covered products'';
(4) in subsection (d)--
(A) by striking paragraphs (3) and (10);
(B) in paragraph (5), by striking ``, including the
professional license number of the importer, if any'';
(C) in paragraph (6)--
(i) in subparagraph (C), by inserting ``(if required under
subsection (e))'' before the period;
(ii) in subparagraph (D), by inserting ``(if required under
subsection (e))'' before the period; and
(iii) in subparagraph (E), by striking ``labeling'';
(D) in paragraph (7)--
(i) in subparagraph (A), by inserting ``(if required under
subsection (e))'' before the period; and
(ii) by amending subparagraph (B) to read as follows:
``(B) Certification from the importer or manufacturer of
such product that the product meets all requirements of this
Act.''; and
(E) by redesignating paragraphs (4) through (9) as
paragraphs (3) through (8), respectively;
(5) by amending subsection (e) to read as follows:
``(e) Testing.--
``(1) In general.--Subject to paragraph (2), regulations
under subsection (a) shall require that testing referred to
in paragraphs (5) through (7) of subsection (d) be conducted
by the importer of the covered product, unless the covered
product is a prescription drug subject to the requirements of
section 505B for counterfeit-resistant technologies.
``(2) Exception.--The testing requirements of paragraphs
(5) through (7) of subsection (d) shall not apply to an
importer unless the importer is a wholesaler.'';
(6) in subsection (f), by striking ``or designated by the
Secretary, subject to such limitations as the Secretary
determines to be appropriate to protect the public health'';
(7) in subsection (g)--
(A) by striking ``counterfeit or''; and
(B) by striking ``and the Secretary determines that the
public is adequately protected from counterfeit and violative
covered products being imported pursuant to subsection (a)'';
(8) in subsection (i)(1)--
(A) by amending subparagraph (A) to read as follows:
``(A) In general.--The Secretary shall conduct, or contract
with an entity to conduct, a study on the imports permitted
pursuant to subsection (a), including consideration of the
information received under subsection (d). In conducting such
study, the Secretary or entity shall evaluate the compliance
of importers with regulations under subsection (a), and the
incidence of shipments pursuant to such subsection, if any,
that have been determined to be misbranded or adulterated,
and determine how such compliance contrasts with the
incidence of shipments of prescription drugs transported
within the United States that have been determined to be
misbranded or adulterated.''; and
(B) in subparagraph (B), by striking ``Not later than 2
years after the effective date of final regulations under
subsection (a),'' and inserting ``Not later than 18 months
after the date of the enactment of the Pharmaceutical Market
Access Act of 2003,'';
(9) in subsection (k)(2)--
(A) by redesignating subparagraphs (D) and (E) as
subparagraphs (E) and (F), respectively; and
(B) by inserting after subparagraph (C) the following:
``(D) The term `qualifying individual' means an individual
who is not a pharmacist or a wholesaler. ''; and
(10) by striking subsections (l) and (m).
SEC. 5. USE OF COUNTERFEIT-RESISTANT TECHNOLOGIES TO PREVENT
COUNTERFEITING.
(a) Misbranding.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352; deeming drugs and devices to
be misbranded) is amended by adding at the end the following:
``(w) If it is a drug subject to section 503(b), unless the
packaging of such drug complies with the requirements of
section 505B for counterfeit-resistant technologies.''.
(b) Requirements.--Title V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 505A the following:
``SEC. 505B. COUNTERFEIT-RESISTANT TECHNOLOGIES.
``(a) Incorporation of Counterfeit-Resistant Technologies
Into Prescription Drug Packaging.--The Secretary shall
require that the packaging of any drug subject to section
503(b) incorporate--
``(1) overt optically variable counterfeit-resistant
technologies that are described in subsection (b) and comply
with the standards of subsection (c); or
``(2) technologies that have an equivalent function of
security, as determined by the Secretary.
``(b) Eligible Technologies.--Technologies described in
this subsection--
``(1) shall be visible to the naked eye, providing for
visual identification of product authenticity without the
need for readers, microscopes, lighting devices, or scanners;
``(2) shall be similar to that used by the Bureau of
Engraving and Printing to secure United States currency;
``(3) shall be manufactured and distributed in a highly
secure, tightly controlled environment; and
``(4) should incorporate additional layers of non-visible
covert security features up to and including forensic
capability.
``(c) Standards for Packaging.--
``(1) Multiple elements.--For the purpose of making it more
difficult to counterfeit the packaging of drugs subject to
section 503(b), manufacturers of the drugs shall incorporate
the technologies described in subsection (b) into multiple
elements of the physical packaging of the drugs, including
blister packs, shrink wrap, package labels, package seals,
bottles, and boxes.
``(2) Labeling of shipping container.--Shipments of drugs
described in subsection (a) shall include a label on the
shipping container that incorporates the technologies
described in subsection (b), so that officials inspecting the
packages will be able to determine the authenticity of the
shipment. Chain of custody procedures shall apply to such
labels and shall include procedures applicable to contractual
agreements for the use and distribution of the labels,
methods to audit the use of the labels, and database access
for the relevant governmental agencies for audit or
verification of the use and distribution of the labels.''.
Announcement by the Speaker Pro Tempore
The SPEAKER pro tempore. The Chair would remind Members who are
speaking to remove the yellow tags from their lapel.
Pursuant to House Resolution 335, the gentleman from Louisiana (Mr.
Tauzin) and the gentleman from Michigan (Mr. Dingell) each will control
30 minutes.
The Chair recognizes the gentleman from Louisiana (Mr. Tauzin).
Mr. TAUZIN. Mr. Speaker, I ask unanimous consent that the gentleman
from Minnesota (Mr. Gutknecht) be permitted to control 15 minutes of
the debate time allocated to me.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Louisiana?
There was no objection.
Mr. DINGELL. Mr. Speaker, I ask unanimous consent that the gentleman
from Ohio (Mr. Brown) be permitted to control 15 minutes of the time
allocated to me.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Michigan?
There was no objection.
General Leave
Mr. TAUZIN. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days within which to revise and extend their remarks
on H.R. 2427.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Louisiana?
There was no objection.
Mr. TAUZIN. Mr. Speaker, I yield myself 2\1/2\ minutes.
Mr. Speaker, I join my colleague, the ranking member of our
committee, the gentleman from Michigan (Mr. Dingell), in opposing this
bill because it is dangerous.
This week the gentleman from Michigan (Mr. Dingell) and I and all of
the members of the Committee on Energy and Commerce had to face a
horrible realization: This week we faced the parents of Steve Bechler,
the 23-year-old pitcher for the Baltimore Orioles, who died of a heart
attack at that young age taking ephedra tablets, tablets which we in
1994 voted to exempt from FDA safety regulations. I have got that on my
conscience now. In 1994, you and I decided, those of you who were here
with me, that safety did not matter when it came to ephedra.
Mr. Speaker, as the Justice Department criminal investigations are
under way and as our own Committee's investigation is under way, we
learned this week that over 17,000 serious events
[[Page H7597]]
have occurred as a result of the use of unregulated ephedra; young
athletes, young people, dying, suffering strokes, heart attacks, like
Steve Bechler, because we voted in 1994 to say that safety did not
count when it came to ephedra.
And with this bill tonight, its authors I know well-intentioned,
angry at the price of drugs in America, angry at Canada because they
impose price controls that take advantage of our citizens, angry at
those trade laws that let it happen, they are asking us tonight to do
exactly what we did in 1994, to vote for a bill that says safety does
not matter when it comes to drugs, that safety does not really count;
that we are going to repeal tonight, if they get their way, the
language that is in the law that says that FDA must certify the safety
of any drugs that are imported into this country; to take away the
language that says FDA must do those things appropriate to ensure that
the drug supply in this country is never compromised; that bogus,
counterfeit, diluted, old, rotten drugs are not permitted into this
country.
I voted wrong in 1994. I am not going to vote wrong tonight. I will
never vote to compromise safety again in the use of drugs or products
for our young people and our old people and our citizens.
Tonight we will learn about those rotten drugs that are coming into
this country from Canada, yes, and from a lot of other countries,
transhipped through Canada. We will have the smoking gun for tonight to
show what is about to happen if we open the door to that awful problem.
I urge Members, vote against this bill.
Mr. DINGELL. Mr. Speaker, I yield myself 3\1/2\ minutes.
(Mr. DINGELL asked and was given permission to revise and extend his
remarks.)
Mr. DINGELL. Mr. Speaker, this is a bad bill. On its face it would
appear to be a good bill. It is not. It will allow this country to be
flooded with unsafe, counterfeit drugs; drugs that will not do what
they should; drugs that are unsafe; drugs that will kill the American
people. I tell Members, it is a bad bill, and I ask them to remember
the experiences that were reported by my colleague from Louisiana.
This bill would reduce the capacity of the Food and Drug
Administration to protect our people from unsafe prescription
pharmaceuticals, which will begin to flood the country if and when it
is passed.
H.R. 2427 is a prescription for trouble. They open our borders. They
provide millions of Americans with access to perhaps drugs which are
cheaper, but drugs which are unsafe and which evade the responsibility
and the ability of Food and Drug to protect the American people.
Mr. Speaker, do not take my word for that. Listen to what the health
care professionals and regulators say.
The American Medical Association says, ``We believe H.R. 2427 would
be so dangerous to patient safety that we must oppose it. This
legislation would eliminate most of the important restrictions on
reimportation of pharmaceuticals in current law and replace them with a
system of unverifiable and unsafe provisions.''
The National Medical Association has said, ``This legislation would
result in counterfeit, adulterated, and dangerous drugs entering the
United States. We do not believe that H.R. 2427 should be enacted at
the risk of jeopardizing patient safety.''
The American Osteopathic Association says, ``H.R. 2427, while
increasing the possible number of drugs reimported into the United
States, does nothing to ensure the safety and efficacy of these drugs.
There is no bargain to be found for our patients who purchase drugs
that are ineffective or contaminated.''
The Food and Drug Administration says, ``H.R. 2427 would authorize
the importation of prescription drugs from foreign sources without
adequate assurances that such products are safe and effective. H.R.
2427 creates a wide channel for large volumes of unapproved drugs and
other products to enter the United States that are potentially
injurious to public health and pose a threat to the security of our
Nation's drug supply. The bill would do so by taking unprecedented
steps that limit FDA's authority to assure the safety of prescription
drug products to be used by American consumers.''
Mr. Speaker, this will enable foreign manufacturers to import into
Canada for reimportation into the United States tons of counterfeit
foreign drugs, drugs which are ineffective, over-age, unsafe,
unregulated and improperly manufactured in ways which will offer
threats to the United States, to our citizens and to the people who are
looking to you to see to it that their food, drugs and cosmetics are
safe.
Mr. Speaker, let us look at it. Foreigners are going to use this
device to enter Canada to sell unsafe drugs to the American people. Do
not deceive yourself to think that any one of those importers will be
bound by any requirements of American law or that they will, in fact,
sell those drugs at less price. They will simply sell them at U.S.
market prices, and you are going to have on your hands the possibility
that you have voted to injure, sicken, hurt or kill the American people
by allowing the importation of unsafe drugs.
Recent Counterfeits
Counterfeit Lipitor
Lipitor, a cholesterol-lowering medicine, is used by 11
million Americans each year to help prevent serious heart
disease. Last month, according to FDA, a large quantity of
fake Lipitor entered the U.S. market. The product was
imported to the U.S. and repackaged here, for sale to
distributors and pharmacies. To date, FDA and Lipitor
manufacturer Pfizer have recalled 200,000 bottles of this
dangerous phony product.
Fake and Mislabeled Zerit
Counterfeit Zerit, a medication to treat HIV infection, was
first discovered in 1997. According to the real manufacturer,
Bristol-Myers Squibb, this not only was not its authentic
product, but the labels incorrectly told consumers they were
taking 30 mg, when in fact the capsules inside the bottles
allegedly contained 40 mg of the active ingredient. Patients
were exposed both to a product of unknown origin and the
dangerous possibility of an overdose.
Phony Clarithromycin
This antibiotic, called Biaxin, is used to treat infections
such as pneumonia, bronchitis, and ear infections--including
infections in children. Recently, according to the drug's
manufacturer, Abbott, counterfeit Biaxin, containing
absolutely no active ingredient, has been found in Russia
(where counterfeits make up 15 percent of the prescription
drug market). Because the legal system in Russia makes
pursuit and punishment of these counterfeiters difficult,
these dangerous products remain available in Russia as well
as for export to other lucrative markets like the U.S.
Counterfeit Neurontin, Accupril, and Celebrex
Counterfeits of these Pfizer products--Neurontin, for
seizures in children 3 and older and adults and for treating
shingles pain in adults; Accurpril, for high blood pressure;
and Celebrex, for treating debilitating arthritis pain--have
recently been found in California, at a company called NuCare
Pharmaceuticals. Laboratory analysis confirmed no active
ingredient in any of the tablets, which actually were
vitamins. Neither the origin of the bottles nor the
disposition of the original medications is known.
Fake Allegra
Fexofenadine, an important active ingredient in products to
treat allergies, is sold under the name Allegra in the U.S.
Recently, security personnel of the product manufacturer,
Aventis, ordered Allegra from an internet site purported to
be based in the UK. The product shipped was one called
Telfast, a fexofenadine product sold in other countries, but
not approved by the U.S. FDA. Furthermore, a stick-on label
indicated an expiration date of 1/03; the product actually
had expired in 1/02. Finally, although the web site appeared
to be promising products from a ``safe'' country in the UK,
this product came not from the UK but from Vanuatu, an island
off the coast of New Zealand well known for businesses
trafficking in illegitimate prescription drugs destined for
the U.S.
Fake Losec
Losec (omeprazole), a treatment for ulcers and other
gastric conditions, is sold in the U.S. as Prilosec. A
generic version of Prilosec is also on the market in the U.S.
Counterfeit Prilosec, according to its manufacturer
AstraZeneca, was manufactured in an underground facility and
distributed through an affiliated wholesaler. The
counterfeiter boasted that the copies were sufficiently
clever to avoid detection by the government and, in fact,
only AstraZeneca had the technical information necessary to
determine this product was a fake.
Counterfeit Monopril
Fakes of this high-blood-pressure medication were
discovered earlier this year by the LA County Sheriff's
Office. The counterfeit operation was uncovered after a local
printing company contacted the sheriff to report a suspicious
order for thousands of drug product labels. The product,
vitamins substituted for the real pills, bottle caps, and
seals were all counterfeit. Arrested individuals were owners
of prescription drug diversion businesses in Canada, Europe,
and Asia. Many other drugs found in the LA raid were
[[Page H7598]]
expired or fake, then repackaged, relabeled, and sold to
American doctors and pharmacies.
Counterfeits from India
According to FDA, an American patient ordered product from
an internet site promising ``Canadian drugs manufactured in
the U.S.'' The drug he appears to have needed was a seizure
medication called gabapentin. What he received was a knock-
off from India, labeled ``Gabantin.'' What IS ``gabantin?''
Only the counterfeiter in India, and the so-called
``Canadian'' on-line pharmacy knows. The patient was the
unwitting dupe.
Counterfeit Procrit
Epoetin alpha, marketed as Procrit, treats anemia in
patients with chronic kidney disease, HIV, and cancer. The
first discovery of counterfeit Procrit was made in 2002;
subsequent discoveries followed. The counterfeit, of unknown
origin, has been found at two large wholesalers and a number
of retail outlets. The counterfeit, some with 20 times less
active ingredient than the real drug and some with no active
ingredient but bacteria-contaminated water, appeared
identical with the authentic product. Sophisticated anti-
counterfeiting technology used on this product failed to
challenge the ingenuity of the counterfeiters, who quickly
learned to mimic it.
Fake Crixivan, Pepcidine, Zoroxin, and Zocor
According to Merck, the manufacturer of these products,
substantial quantities of counterfeits were found in a police
raid on a home in Bogota, Columbia. In addition to these
products, the home possessed many other counterfeits. English
language labeling suggested the final destination for many;
unwary U.S. patients.
Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentlewoman
from Connecticut (Ms. DeLauro), who knows that the drug industry
imports $15 billion worth of drugs into this country, but then claims
that importation is unsafe in order to protect their profits.
Ms. DeLAURO. Mr. Speaker, in my 13 years in Congress, no issue has
made such a deep impression on my constituents than the rising price of
prescription drugs. This is an issue for seniors, but high health care
prices are eroding the living standards of middle-class families across
this country. We all have a stake in driving drug prices down.
Last week, the Congress of the United States abrogated its
responsibility to address the problem of soaring drug prices. It did
worse than nothing, barring the government from negotiating lower
prices for seniors.
We can strike a blow for lower prices with a simple step, giving
ordinary Americans the choice they are taking on their own out of
desperation. It should be legal to reimport drugs from some countries.
This alone would save Americans $600 billion in the next decade,
savings passed directly on to the consumer. We know that this is a safe
option. In 2001, U.S. drug companies reimported $14.7 billion worth of
brand name medications from their overseas plants.
{time} 0115
This legislation guarantees safety. It not only requires that drugs
reimported from other countries are FDA-approved, but that the
facilities they are manufactured in are rigorously inspected and
approved by the FDA as well. Add to that the requirement that all
prescription drugs use counterfeit-resistant packaging, which means
every drug purchased here in the United States, reimported or
otherwise, will be safer than the drugs that are available today.
The FDA's opposition is one more instance of a regulatory agency
becoming captive of the industries they are supposed to regulate. There
is no safety issue here. This bill would only allow the importation of
FDA-approved drugs manufactured in FDA-approved facilities from 26
designated countries, clearly, a superior system to what we have today
in the area of food and drug safety both.
The issue is not safety, I say to my colleagues. The issue is price.
It is time that this Congress stop acting as a wholly owned subsidiary
of the pharmaceutical companies and step up to its responsibility to
help the consumers of this Nation.
I urge my colleagues to support this bill.
Mr. GUTKNECHT. Mr. Speaker, I just want to clarify real quickly that
nothing in this bill deals with controlled substances like RU486 or
morphine, and nothing in this bill would have anything to do with
Ephedra.
Mr. Speaker, I am happy to yield 1\1/2\ minutes to the gentlewoman
from Missouri (Mrs. Emerson).
Mrs. EMERSON. Mr. Speaker, I want to thank the Speaker of the House
for his graciousness in letting us bring this bill to the floor for
debate tonight.
And speaking of the leadership in the House, I thought it would be
important to all my colleagues for a little clarification. We hear talk
about the FDA blasting the Gutknecht bill, saying that it is unsafe. I
want my colleagues to know, and it is very important that they know,
that in 2000 when we passed the reimportation language that is current
statute, that language was written, that statute was written by our
leadership, by a person who is now working at the White House, by me,
and by the FDA.
My colleagues might remember it passed in the Agriculture
appropriations act. The FDA chose the 26 countries where it felt it was
safe to import from those countries, because our current drug
manufacturers, U.S. manufacturers, are today manufacturing drugs in
those facilities that are approved and inspected by the FDA.
It is very important that my colleagues know this. This is the
underlying bill of Gutknecht. Plus, we have added extremely high-tech
packaging, tamper-resistant, counterfeit-proof packaging. And this is
in addition to the safety requirements, the chain of custody that the
FDA has written in the underlying bill today.
Mr. TAUZIN. Mr. Speaker, I would point out that the packaging is held
by a single company and the bill they have mandates a monopoly. We
ought never do this in this country.
Mr. Speaker, I yield 1\1/2\ minutes to the gentleman from Florida
(Mr. Bilirakis), the chairman of the Subcommittee on Health of the
Committee on Energy and Commerce.
Mr. BILIRAKIS. Mr. Speaker, this dangerous bill is a legislative
Trojan Horse that uses a promising veneer to hide dangerous realities.
I do not have the time to go into all of the reasons why I personally
am opposing this legislation, but I want to remind my colleagues that a
number of patient advocate organizations dedicated to the health and
well-being of our constituents, including the ALS Association, the
National Alliance for the Mentally Ill, and the Friends of Cancer
Research, and this long list here, and so many others that will not fit
on this chart, are joining me in my opposition tonight. They, they
consider the issue safety. They consider the issue safety.
Also, the bill, in addition to the devastating impact on patient
safety, would adversely affect the ability of our research-driven
pharmaceutical and biotechnology industries to develop breakthrough
cures for a myriad of devastating diseases.
Many of the solutions to high pharmaceutical prices have already been
considered on this floor. They include a meaningful Medicare
prescription drug benefit and Hatch-Waxman reforms to ensure quicker
access to less costly generic drugs. We also need to find a way to
reduce the number of Americans without health insurance. In fact, I
recently introduced a bill that would attempt to do just that.
Mr. Speaker, this is a bad bill. It will do more harm than good. I
urge my colleagues to do the responsible, the responsible and not the
political thing, and that is to defeat H.R. 2427 tonight.
Mr. DINGELL. Mr. Speaker, I yield 1 minute to the distinguished
gentleman from New York (Mr. Towns), my good friend.
Mr. TOWNS. Mr. Speaker, this is a bad bill. If we vote for this
legislation tonight, we are kissing safety regulations good-bye and
saying to patients, fend for yourselves in determining what drugs are
safe. The FDA will have no oversight responsibility here.
I will admit that I am not qualified to determine what drugs are
safe. It takes expertise to distinguish between counterfeit medicines
and the genuine article. We rely on our government's health and safety
officials like the Food and Drug Administration to keep unsafe drugs
out of American medicine cabinets.
It is a mystery to me why anyone would vote for a bill that would
prevent our health officials from doing their job. That just blows my
mind. And it is a giant step in the wrong direction.
I ask all of my colleagues here tonight to vote against this bill
because
[[Page H7599]]
safety is a nonpartisan issue. The life you save might be your own.
Mr. BROWN of Ohio. Mr. Speaker, I yield 2\1/2\ minutes to the
gentlewoman from California (Ms. Lee), who knows the drug industry
profits for 20 years running are the highest of any industry in
America.
Ms. LEE. Mr. Speaker, let me just thank the gentleman for yielding me
this time, and I thank all of my colleagues on this side of the aisle
and also our colleagues on the other side of the aisle, especially the
gentlewoman from Missouri (Mrs. Emerson) and the gentleman from
Minnesota (Mr. Gutknecht) for leading this very important fight for
more affordable prescription drugs.
Mr. Speaker, I want to start off tonight by sharing with my
colleagues the news from a study which was featured today in the Wall
Street Journal. Now, this article begins, ``Black Medicare
beneficiaries are more than twice as likely as white beneficiaries to
go without a prescription drug because they could not afford it.'' This
is a study conducted by the Robert Wood Johnson Foundation. Let me
repeat: African Americans are two times more likely to go without
needed medicine.
Now, this study goes on to detail the deep disparities in access to
drugs, reporting that fully 16 percent of black recipients of Medicare
said they could not afford to fill at least one prescription in 2001
compared with 7 percent of whites.
Mr. Speaker, make no mistake, African Americans are suffering
disproportionately and mightily under the current laws crafted to
protect the drug companies and their inflated prices. And make no
mistake, that the suffering will only get worse if we do not pass this
bill. And the suffering will last for as long as there is this huge,
and I cannot believe this huge, resistance to efforts to reduce the
skyrocketing and irrational cost of these lifesaving medicines.
The reality for African Americans and millions of Americans on
Medicare is outrageous and shameful, but we have the option tonight to
do something about it. We should and we must seize this opportunity to
provide lifesaving medicine to millions of Americans who are going
without, simply because they cannot afford the bloated costs of drugs.
And we should do so by voting to allow, as this bill does, safe, FDA-
approved prescription drugs to be reimported into the United States.
Now, much has been said about safety and logistics of reimportation,
and I think it is very important to point out that the FDA-approved
drugs are already frequently and legally imported into this country,
but only by the manufacturers. It is also important to note that more
than 1 million Americans already purchase their medicines from outside
the United States, and there has not been one reported death or illness
from Americans taking such products.
Mr. Speaker, the simple fact is that seniors' drug costs increased 44
percent between 2000 and 2003, with the top 50 drugs prescribed to
seniors increasing in cost by 3.5 times the rate of inflation in the
last year.
The simple fact is, Americans pay 30 to 300 percent more for
medicines than do people in other industrialized countries. We should
pass this bill tonight.
Mr. GUTKNECHT. Mr. Speaker, I am happy to yield 1 minute to the
gentleman from Connecticut (Mr. Shays), the author of the Shays act.
Mr. SHAYS. Mr. Speaker, I thank the gentleman for yielding me this
time.
The debate tonight to allow the reimportation of FDA-approved drugs
is obviously long overdue. The arguments that Americans will be put at
risk and the pharmaceutical industry will be harmed is specious and
reminds me of the debate on the use of generic drugs that we had years
ago in States throughout America.
Like the reimportation of drugs, the use of generic drugs was illegal
and stayed that way for years and years because the pharmaceutical
industry opposed it. Like the reimportation of drugs, we were told,
generic drugs would harm the pharmaceutical industry and endanger
individual Americans. Fortunately, we did not listen to those false
arguments then, and we should not listen to them now, as they relate to
the importation of FDA drugs. If Canadians, Germans, and others have
the ability to buy FDA-approved drugs at a fraction of the cost, then
Americans in this day and age should have the same opportunity.
Please vote for H.R. 2427, the Pharmaceutical Market Access Act.
I thank the proponent, the gentleman from Minnesota (Mr. Gutknecht)
and others, for their efforts and the House leadership for bringing
this bill before the chamber.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 1 minute to the
gentleman from Pennsylvania (Mr. Greenwood), the distinguished chairman
of our Subcommittee on Oversight and Investigation.
Mr. GREENWOOD. Mr. Speaker, I thank the gentleman for yielding me
this time.
We all want safe and affordable drugs, especially for our senior
citizens. And in recent years, as the price of drugs skyrocketed and
seniors were without a benefit through Medicare, they became desperate,
and many considered it a calculated risk to buy drugs from other
countries that were not certified safe by the FDA; and this
reimportation legislation grew from that desperation. But today we are
on the verge of providing seniors affordable and safe drugs through
Medicare. It will happen this fall.
The reimportation bill is now an unnecessary relic. We do not have to
trade off safety for affordability. We can offer our seniors both
through Medicare, and we ought to.
The risk is real. The gentleman from Florida (Mr. Deutsch) and I have
been to airports and watched these packages come through, opened up by
the Customs people, and what we saw would turn your stomach. Drugs
coming from countries all over the world where there is no regulation,
drugs that have incalculable content, unknowable safety. We do not need
to put our seniors at that risk.
Mr. DINGELL. Mr. Speaker, I yield 2 minutes to the distinguished
gentlewoman from California (Ms. Eshoo).
Ms. ESHOO. Mr. Speaker, I thank the distinguished ranking member for
yielding me this time.
I rise in opposition to H.R. 2427. Mr. Speaker, I think it is very
important for everyone in the House to really understand exactly what
this bill will do.
Some think that drug reimportation will dramatically reduce drug
costs in the United States. This has never been proven. Secretaries of
Health and Human Services for two Presidents have stated that they
could not certify that reimportation would actually save Americans
money.
Now, minus this guarantee that the bill would ever achieve its
primary purpose, I think we are taking huge risks for little or no
gain.
Secondly, the bill is dangerously flawed and poses considerable risks
to the people that we represent. Current law states that the Secretary
of HHS must certify that reimportation will not add risks to the public
health. This bill removes that requirement, effectively eliminating our
last line of defense against unsafe and illegal pharmaceuticals.
The bill expands reimportation to 25 countries, many of which do not
have the regulatory regimes that even remotely, remotely match the FDA.
{time} 0130
This is very different from ``Canada only.'' We have the safest drug
supply in the world today, and Americans rely on this safety every day.
Do we really want to dilute this?
The sponsors of 2427 have said the bill contains numerous provisions
that will ensure that drugs reimported into our country are safe. I
disagree. The bill purports to only allow reimportation of drugs made
in FDA-approved factories, but the bill also eliminates the
requirements that reimporters demonstrate who has had custody of a drug
since its creation. Now, how can we verify that a drug is made in an
FDA-approved facility if we do not even know who had custody of it
last?
The bill requires reimporters to test the drugs they are bringing
back into the United States to ensure they are legitimate. The results
of those tests are to be verified by the FDA. Is there an appropriation
to this bill to fund the added mandate to the FDA? There is not.
The bill requires counterfeit-proof packaging for many of the drugs
that will be reimported to the United States. And yet there is not any
guarantee that the counterfeit technology
[[Page H7600]]
itself will not be counterfeit or tampered with. This is happening in
the United States today as we debate this bill. This is an example of a
hologram that has been tampered with. You and I would not know the
difference. The FDA would. My mother would not.
We have to remember that nearly 20 years ago the gentleman from
Michigan (Mr. Dingell) introduced and passed the prescription drug
marketing law. He did so on the heals of a multiyear investigation by
oversight and investigations of the Committee on Commerce. We should
not give up this safety. What my fear is is that we have so taken for
granted the efficacy of pharmaceuticals that we are willing to let it
go tonight. Vote against this bill.
Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentleman
from Arkansas (Mr. Berry), who knows that a Federal Government that
says it can store nuclear waste for 10,000 years can surely ensure the
safety of imported prescription drugs.
Mr. BERRY. Mr. Speaker, I am the only registered pharmacist in this
Congress. And I know what I am talking about.
Now, do not confuse safety with the fact that FDA many times just
simply does not do its job. Let me tell you what the real danger is.
The danger is not getting or not being able to afford the medicine you
have to have to stay alive, stay healthy, and have a decent life-style.
That is danger.
Now, this safety deal is bogus. I am not even going to tell you how
bogus it is. On the front page of Roll Call this morning it says, ``The
Food and Drug Administration has formed an unofficial alliance with the
pharmaceutical industry to urge House Members to vote today against a
bill that could flood the Nation with cheap prescription drugs from
Canada and overseas.''
Now, would that not be a tragedy, that our people could afford the
medicine that they need? This is a classic, cynical example of crony
capitalism. An alliance between the Food and Drug Administration has
existed for many years, and the pharmaceutical industry makes them
nothing better than common thieves. And if you vote against this bill
tonight, just think about what you are going to tell your constituents
when you go back and say, I voted to keep your medicine five times more
expensive than any place else in the world. I voted to let the
pharmaceutical industry continue to rob the old people in this country.
You go back and tell them that.
What I have seen here this evening makes me think of that old
Southern philosopher, Brother Dave Gardner, who said when you get
people down, kick them. It gives them an incentive to rise above
themselves.
We were charged by our Founding Fathers with this responsibility, and
we will be judged by God Almighty as to how we do it.
Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I would point out that both the American Pharmacists
Association and the Arkansas Pharmacists Association have sent letters
in strong opposition to this bill.
Mr. Speaker, I yield 1 minute to the gentleman from Indiana (Mr.
Buyer).
Mr. BUYER. Mr. Speaker, I am quite bothered that someone would
actually come to the floor and denigrate the great minds of the world
that come to the only free market, America. And these individuals
improve the quality of our life, not only just us, but around the
world. This debate needs to be elevated, elevated, because other
countries out there who call themselves friends of America are taking
advantage of those manufacturers. This is a serious trade issue, and we
think we can only address it by addressing price? I do not know where
you all went to school. You cannot address it just on price.
This is safety. We have a closed system. When you take that pill, you
have trust and confidence that it will do exactly what the label will
say.
Somebody brought up the issue of chain of custody. When those drugs
end up, and we create a very wide berth and a very wide channel for
drugs, we lose that chain of custody. We do not know what it is going
to do. You can go to Canada, but it will not have the labeling. This is
very serious.
Mr. DINGELL. Mr. Speaker, I yield 2\1/2\ minutes to the distinguished
gentleman from New York (Mr. Meeks).
Mr. MEEKS of New York. Mr. Speaker, as we enter this late night, I am
reminded of a show: Things that make you say hmmm. When I think of just
the title of this bill and what is referred reimportation of drugs, I
say hmmm.
Reimportation tries to give the implication that the drugs were
manufactured here, gone over, and they are coming back here so,
therefore, they are safe. If the issue of safety were not there, what
would we be talking about? We are really talking about the
reimportation of drugs from many a different country. The FDA, if you
just look up at the Web site of the FDA, over the last 5 years they
have only inspected labs, labs over the last 5 years. Yet, we say
safety is not an issue.
My esteemed colleague from Illinois talked earlier. He said he spoke
with the former Secretary of the FDA, Donna Shalala; and she said if
the FDA had additional money, maybe they could do this. Well, as
indicated, there is no additional appropriations here because the
implication is if the FDA does not have the money, they cannot ensure
safety of the medicine.
What money will go to the FDA? There is no appropriations to this
bill.
Just recently there was a situation that occurred in Florida where 19
individuals were indicted for distributing millions of dollars of
counterfeit cancer, AIDS and other drugs. It occurs all over this
country. If H.R. 2427 were to pass tonight, this is exactly what the
Congress would be encouraging. Yes, we would be encouraging counterfeit
drugs, improperly stored drugs, expired drugs, diluted products to
enter our borders and to be distributed by qualified individuals, who,
when I read the bill, qualified individuals, who they are? They have
added, qualified individuals can bring this in, but there is no clear
definition of who those qualified individuals are.
Supporting this bill suggests that health and safety warnings, I
present, are simply myths. I beg to differ.
I have two pills in my hands. Distinguish between an authentic pill
and a counterfeit pill. I ask anybody to just tell me how you, not
experts, can determine which is the real one and which one is the
counterfeit.
Mr. DINGELL. Mr. Speaker, how much time remains?
The SPEAKER pro tempore (Mr. LaHood). The gentleman from Louisiana
(Mr. Tauzin) has 9 minutes. The gentleman from Minnesota (Mr.
Gutknecht) has 12\1/2\ minutes. The gentleman from Michigan (Mr.
Dingell) has 5 minutes. The gentleman from Ohio (Mr. Brown) has 8\1/2\
minutes.
Mr. BROWN of Ohio. Mr. Speaker, I yield 1 minute to the gentleman
from Vermont (Mr. Sanders), who recognizes that 270 Members voted for
free trade for Singapore yesterday while many oppose free trade for
prescription drugs for American today.
Mr. SANDERS. Mr. Speaker, I became involved in this issue several
years ago when I took women who were struggling with breast cancer
across the border from Vermont and they were able to purchase the
breast cancer drug Tamoxifen for one-tenth of the price that they paid
in the United States. Mr. Speaker, tonight we must end the national
disgrace of Americans being forced to pay by far the highest prices in
the world for prescription drugs.
Tonight, in terms of safety, we must understand that one million
Americans have gone to Canada to buy their medicine without one death,
without one problem. To the gentleman from Louisiana (Mr. Tauzin), yes,
the death of one baseball player is a tragedy; but it is a far greater
tragedy that millions of elderly people in this country are suffering,
and in some cases dying, because they cannot afford prescription drugs.
And the issue tonight is do we stand up to the money interests and
protect the American people or are they going to buy the House of the
people? Let us stand tall.
Mr. GUTKNECHT. Mr. Speaker, I yield myself 15 seconds to respond.
First of all, I hope Members would at least read the bill. We have
heard a lot about safety tonight. This bill specifically includes
section sections 501, 502, 505, which are the safety codes. As the
gentlewoman from Missouri (Mrs. Emerson) said earlier, essentially the
FDA wrote all the law that is here. Secondly, the FDA has inspected,
this is the report, 949 facilities, all the way to China in the last 5
years.
[[Page H7601]]
Mr. Speaker, I yield 2 minutes to the gentleman from Texas (Mr.
Hensarling).
Mr. HENSARLING. Mr. Speaker, I rise tonight to appeal to my fellow
conservatives to open markets and help seniors by supporting this act.
Some critics say this act will merely import price controls. But
every day in America we import a myriad of products from food to
machinery that have some form of government price controls embedded
within them, be they subsidy, tax preference or direct price controls.
Yet we do not block their import even though their prices are not
derived in a truly free market.
The relevant question for us ought to be: are we working for more
competition or less competition and whether or not we respect the
economic liberties of our citizens.
Now, other critics say this bill will cause less research and
development. I am uncertain if this is true, but I do know that closing
our borders to trade and denying Americans their economic liberties is
not the answer. Typically, we let private individuals within a
competitive marketplace make these R&D decisions. If we choose to
second guess them and believe that they have underinvested, then
Congress can easily remedy the situation by a variety of means, like
tax credits and subsidies. This body does it every day, wind energy,
aerospace technology, semiconductors, the list goes on.
Finally, critics contend that seniors will be hurt by a rash of
counterfeit imported drugs. Are thousands dying in Europe and Canada
from fake drugs? Can counterfeit drugs not be produced domestically as
well as overseas?
Every year we import tons of food and occasionally this food may be
tainted, yet we do not prohibit agricultural imports. Should
pharmaceuticals be different?
Perhaps the safety argument may have some merit, but I also know it
is usually the first argument of the protectionist. Mr. Speaker, it is
time for my fellow conservatives to choose. We can choose free trade
over protectionism. We can choose to side with seniors' interests over
pharmaceutical companies' interests. We can choose less government and
more freedom. The choice is ours. And if there should be any doubts
whatsoever, we should err on the side of freedom.
Mr. TAUZIN. Mr. Speaker, I yield 1 minute to the distinguished
gentleman from New Jersey (Mr. Ferguson), who knows the difference
between a cancer drug and a strawberry.
Mr. FERGUSON. Mr. Speaker, after the attacks on our Nation on
September 11 when thousands of Americans died, many from my
congressional district, what was our collective response in this House?
What did we do? Did we decide to eliminate the safety and security laws
of our Nation to make ourselves more vulnerable to those who would seek
to do us harm? Of course not. We did the opposite. We strengthened our
laws.
{time} 0145
We strengthened our laws. We took steps to protect our citizens and
we made America a safer place.
Then why, I ask, at a time when we are at an increased danger of
counterfeit and altered drugs, when we are having a tough time keeping
up with attempts by criminals who want to smuggle dangerous,
counterfeit drugs into this country, why would we then pass a law which
would gut the current law of this Nation? Why would we pass a law that
would eliminate 16 different health and safety regulations which are
specifically designed to protect our citizens against these dangers?
Unfortunately, that is exactly what this bill would do.
Mr. DINGELL. Mr. Speaker, I am low on time and I would reserve.
Mr. BROWN of Ohio. Mr. Speaker, could the Chair let us know how much
time each of us has.
The SPEAKER pro tempore (Mr. LaHood). The gentleman from Louisiana
(Mr. Tauzin) has 8 minutes remaining. The gentleman from Minnesota (Mr.
Gutknecht) has 10\1/4\ minutes remaining. The gentleman from Michigan
(Mr. Dingell) has 5 minutes remaining. The gentleman from Ohio (Mr.
Brown) has 7\1/2\ minutes remaining.
Mr. BROWN of Ohio. Mr. Speaker, I yield 30 seconds to the gentleman
from Hawaii (Mr. Abercrombie) who knows the drug industry has 1.5
lobbyists for every Member of this body.
Mr. ABERCROMBIE. Mr. Speaker, this is about money, money, piles of
money, oodles of money, tons of money. This is what this is about.
You do not have to worry about safety because if you cannot afford
the drug in the first place, you are not even going to get it to take
it, and if you are a Democrat, a minority Democrat, and you do not vote
for this bill, there is not any Democrat in the country that is not
going to say you sold out and you rolled over belly up again and you
are not standing up for the people of this country.
We deserve to be in the minority if we cannot pass this bill. We are
defying everything that makes us Democrats, and if you are a
Republican, then they are going to say you are in the pockets of the
big pharmaceuticals again and you are just acting like a Republican.
If you are a Republican or Democrat, vote this bill through and save
the integrity of this House.
Mr. GUTKNECHT. Mr. Speaker, I yield 1 minute to the gentleman from
Michigan (Mr. Hoekstra), who has the unenviable task of following that.
Mr. HOEKSTRA. Mr. Speaker, amen, Brother. I notice that none of the
folks that are opposed to the bill are willing to answer the single
most important question tonight which is, why do drugs cost 40 percent
more in the United States than they do in Canada and in Europe? That
question is not being answered.
It is about safety, but they are missing the big elephant in the
room. They do not want to talk about pricing. We have to realize that
when working Americans pay 40 percent more for prescription drugs than
the rest of the world, our workers are subsidizing the health care
costs of the rest of the world.
If we reject this bill, once again this Congress will undercut
America's workers, will force American workers to continue to subsidize
foreign workers' prescription drugs; and then we will go out and ask
them to compete in global markets. No wonder America is facing a crisis
in manufacturing. This is blatantly unfair. How long do we believe
American workers can survive under this burden?
Tonight, we have a wonderful opportunity to support working
Americans, let them have access to fairly priced products and improve
their global competitiveness.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 1 minute to the
distinguished gentleman from Illinois (Mr. Crane).
Mr. CRANE. Mr. Speaker, I thank the chairman for yielding me the
time, and Mr. Speaker, I rise today in opposition to H.R. 2427.
It is clear to me that the best way to help seniors is both to ensure
that they have access to safe, affordable prescription drugs and to
foster an environment where innovation can flourish, where new and
better drug treatments will be developed for future generations.
The U.S. continues to be the world leader in the development of new
drugs and treatments that improve the quality of every American. I want
to lower drug costs for the seniors in my district, but not at the risk
of stifling the very innovation that creates the drugs in the first
place.
Some have called this a free trade issue. Yet it runs contrary to the
fundamental tenets of free trade. Free trade creates efficiencies by
opening borders, lowering tariffs, and giving consumers access to
products and services from other countries. Reimportation stands this
fundamental tenet on its head by giving Americans access to American
pharmaceuticals that have been sold to the Canadian Government, a
single payer that can, in effect, name its price at a lower cost than
the laws of supply and demand allow.
Congress can take a number of different steps to lower the cost of
drugs for all consumers. We have already taken the most important one
by passing a $400 billion drug benefit for Medicare beneficiaries.
Mr. GUTKNECHT. Mr. Speaker, I am happy to yield 1 minute to the
gentleman from Nebraska (Mr. Osborne).
Mr. OSBORNE. Mr. Speaker, I thank the gentleman for yielding me the
time.
I think ultimately each of us has to be responsible to our
constituents, and what I hear from Nebraska seniors contacting me is
much more concern about high prescription drug prices
[[Page H7602]]
than safety issues. Many of those Nebraskans are already getting their
prescription drugs from Canada, and if drug prices continue to escalate
as they have been and as they will continue to do, the $400 billion
prescription drug benefit passed by the House will be insufficient. I
think we all know that intuitively, and I think OMB knows that
empirically.
So I see that the only solution, that I can think of at least, is
holding drug prices down through competition in the free market, which
I think most of us believe in. We import meat, fruit, wine, cheeses for
direct consumption without undue alarm about safety. Americans take
millions of dollars of imported prescription drugs each year, and yet
no deaths or significant problems have occurred.
I have a lot of confidence in this country. I believe we can have
cheaper drugs and also have the intelligence and technology to have
safe drugs.
Mr. DINGELL. Mr. Speaker, I yield 1 minute to the distinguished
gentlewoman from the Virgin Islands (Mrs. Christensen), my good friend.
Mrs. CHRISTENSEN. Mr. Speaker, I rise in opposition to H.R. 2427, not
because I do not believe, like my fellow Democrats, that we must do
something about the high cost of medicines, I am committed to that end,
but this is not the way to do it.
I will always be against bypassing established authorities and
applying quick fixes to complex challenges. The first because it is
always a mistake, proven sooner or later, and sometimes with grave
consequences, and the latter because such remedies usually end up no
fixes at all. This bill fails on both tests.
I know through my years of medical practice the difficulty of lower-
income people and seniors and even middle-income people having to pay
for life-improving and -saving medication, but there are also cases
where medicines have been brought back in from other countries and
caused harm.
This is not an easy issue because health and lives are at the center
of it, and the high prices present a major barrier to the important
goal of eliminating disparities and improving the well-being of many,
especially our racial and ethnic minorities.
We must continue to seek ways to lower drug prices safely, and we
must eliminate this and every other barrier that exists in this country
to good health, but H.R. 2427 is not the way.
I urge my colleagues to vote no.
Mr. BROWN of Ohio. Mr. Speaker, I yield 1 minute to the gentleman
from New Jersey (Mr. Pallone) who knows opponents of this bill offer no
alternative strategy for bringing down drug prices.
Mr. PALLONE. Mr. Speaker, I urge my colleagues, do not believe the
FDA or the drug companies on this bill. They do not have any
credibility.
If you think about it, the bill says that these products can be
imported for FDA-approved drugs from FDA-approved facilities. We are
already importing drug products from these types of facilities in these
various countries that are mentioned in the bill. If the FDA had a
problem with it, why are they not shutting down the facilities? They
are not credible when they tell you there is a problem because they
have the authority to shut them down if they are not safe or they think
the product is causing a problem here in this country.
The drug companies, forget that. They have no credibility at all.
They have told you to oppose reimportation. They told you to oppose any
kind of Medicare benefit that has a negotiated price reduction. They
told you to oppose Hatch-Waxman and any kind of generic drugs being
used in some type of competition. They have no credibility. They are
only concerned about price. They only want to make sure that their
profits are secure.
That is all there is here, and I do not believe that we are going to
get Hatch-Waxman reform. I do not believe that we are going to get even
a Medicare benefit. This is the only alternative for the seniors to
lower prices.
This is it. Vote for it. Do not vote against it. Do not leave those
seniors hung out to dry.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 1 minute to the
distinguished gentleman from Indiana (Mr. Pence).
(Mr. PENCE asked and was given permission to revise and extend his
remarks.)
Mr. PENCE. Mr. Speaker, I rise in opposition to the reimportation
bill, but I do so with the deepest respect and affection for the author
of this bill whose character and tenacity I admire greatly.
America, without a doubt, has the greatest health care system in the
history of the world. Some have spoken of riding buses to Canada to
purchase prescription drugs. Well, they have, and I am sure they could
wave at the many tens of thousands of Canadians that come on buses
across our border to receive the elective treatment that takes 9 to 18
months in some cases in their system.
It has been asked today by my colleague from Michigan, why do drugs
cost 40 percent more in Canada. Well, the answer is very simple.
Because Canada, like Germany, like France, are socialist countries. I
am sure pharmaceutical drugs would have been cheaper in the Soviet
Union.
The truth is, reimportation of drugs is simply reimportation of price
controls and socialism. Let us not import Canadian price controls and
socialism. Let us export the free market health care principles that
make our system the envy of the world.
Mr. GUTKNECHT. Mr. Speaker, I am happy to yield 1 minute to the
gentleman from Arizona (Mr. Shadegg).
Mr. SHADEGG. Mr. Speaker, I rise in strong support of the
Pharmaceutical Access Act against protectionism and in favor of a free
market.
I want our pharmaceutical companies to be profitable. I particularly
want them to have the funds they need to do the research and
development they must do. I just do not want them to take that money
from Americans and only Americans and to impose the burden of that R&D
on our seniors only. It simply is not fair to impose the entire cost of
the phenomenally expensive research and development on just America's
seniors and to allow the rest of the world to profit from that.
Over and over again, we hear the issue is safety, safety, safety, and
yet there are thousands of counterfeit drugs in the market today
precisely because we do not have a free market, precisely because we do
not allow reimportation. The minute you allow reimportation, a system
similar to the Good Housekeeping Seal of Approval or the Underwriters
Laboratory will arise and that system will advertise, If you buy our
drug, we have inspected the plants where they came from; we have
certified the shipping of that drug; and we certify it safe. Americans
will buy those drugs and those drugs only.
Trust the market. End protectionism. Americans cannot afford to pay
protectionist prices for our drugs any longer. Fix this market. Allow a
free market to work.
Mr. BROWN of Ohio. Mr. Speaker, I yield 30 seconds to the gentlewoman
from Ohio (Ms. Kaptur) who knows that the breast cancer drug Tamoxifen
is more expensive in our country than in Canada.
Ms. KAPTUR. Mr. Speaker, I thank the gentleman for his leadership on
this important issue and rise in support of H.R. 2427.
I wish to say, last year, average drug prices in our country were 67
percent higher than in Canada and double that of Europe. The real issue
is that pharmaceutical companies have been gouging the American public
for far too long, and the leadership in this Congress has allowed them
to do that.
This bill requires the FDA to do what it must to assure safety, but
more than that, it finally blows the whistle on an industry that has
been taking America's seniors to the cleaners. It is time their gig is
up. Support H.R. 2427.
{time} 0200
Mr. TAUZIN. Will the Speaker announce how much time remains.
The SPEAKER pro tempore (Mr. LaHood). The gentleman from Louisiana
(Mr. Tauzin) has 6 minutes remaining, the gentleman from Minnesota (Mr.
Gutknecht) has 7\1/4\ minutes remaining, the gentleman from Michigan
(Mr. Dingell) has 4 minutes remaining, and the gentleman from Ohio (Mr.
Brown) has 5\1/2\ minutes remaining.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 1 minute to the
gentleman from Texas (Mr. Burgess).
(Mr. BURGESS asked and was given permission to revise and extend his
remarks.)
[[Page H7603]]
Mr. BURGESS. Mr. Speaker, drug prices can be higher in some cases for
consumers than in other industrialized countries because the
governments of Canada, Mexico, and Europe hold down the costs through
market intervention. In other industries we do not permit the
imposition of foreign price controls on American businesses, and we
should not in this case either. These price controls would stifle the
development of new drugs, drugs like Avastin, a powerful and promising
new anti-cancer drug that inhibits blood vessel growth in tumors, an
entirely new approach to treating cancer. This drug took 20 years and
millions of dollars to develop.
In my own medical practice, I have witnessed what might be politely
called therapeutic misadventures resulting from drugs illegally
imported from Mexico. Vote ``no'' on H.R. 2427 and let us work together
on feasible solutions that will bring down the cost of prescription
drugs in a constructive manner, not proposals like this that will put
our constituents at risk.
Mr. GUTKNECHT. Mr. Speaker, I am happy to yield 1 minute to the
gentlewoman from Louisville, Kentucky (Mrs. Northup).
Mrs. NORTHUP. Mr. Speaker, I thank the gentleman for yielding me this
time.
Mr. Speaker, despite the histrionics we have seen tonight, there is
not one Member of Congress that would vote for a bill that would
endanger the people in this country, not the seniors, not our children,
and no one in between.
The false arguments, the scare tactics, the unrelated examples should
not surprise anybody because we hear them every day, and these tactics
have worked in the past. But Americans know the truth. Over 1 million
have imported drugs every single year into this country safely. They
buy drugs that are manufactured and regulated on how they are
distributed the same way we regulate them in the United States. In
fact, they are the same plants, and they are the same distribution
systems.
Our unions and our businesses are telling us that drugs are costing
them a fortune, and without relief our taxpayers are going to foot the
bill for our seniors who are going to have to pay extraordinary prices
for their drugs. Tonight is historic. We are going to, without the
money, without the staff, and without the army of lobbyists take back
the House and pass this bill to reduce the cost of drugs for our
seniors.
Mr. DINGELL. Mr. Speaker, I reserve the balance of my time.
Mr. TAUZIN. Mr. Speaker, I yield 1 minute to the gentleman from Texas
(Mr. Sessions).
Mr. SESSIONS. Mr. Speaker, I thank the gentleman from Louisiana for
yielding me this time. Tonight is a very important debate for this
country. It is important for us to understand that the drugs that get
reimported in this country may not be known and understood exactly for
what they are by the consumers of this country.
As a person who travels overseas, when I want to buy a shirt that
might be on the street in Bangkok or in Shanghai, I know that that is
probably a counterfeit. I buy that and purchase that shirt knowing
that. But as a consumer in this country, going on the Internet,
thinking I am buying something from Canada, it can be from somewhere
else. It happens every day.
Let us not let this happen to consumers. Let us let them know what
they are buying, where they are getting it from; and let us make sure
we reduce the cost of prescription drugs in this country. We have a
plan to do that. That plan is called a prescription drug plan that the
Republican Party has had on this floor. Let us reduce the cost of
prescription drugs but let us keep our seniors safe.
Mr. GUTKNECHT. Mr. Speaker, I am happy to yield 1 minute to the
gentleman from Georgia (Mr. Kingston).
Mr. KINGSTON. Mr. Speaker, I thank the gentleman for yielding me this
time. I want to say as a supporter of the Gutknecht bill that this bill
is about safety because it is unsafe not to take your medicine.
If you need Glucophage, if you need Lipitor, if you need Tamoxifen,
you have to get it as inexpensively as you can or you are going to be
skipping your groceries to do it.
What you can do is join millions of Americans and go to our biggest
trade partner, Canada, and get it at 40 percent less than what we are
paying now. And incidentally, in the next 10 years senior citizens
alone will spend $1.8 trillion on prescription drugs.
What should we do about the people who are buying these drugs from
Canada? Should we arrest them now? Or since it is so unsafe, why do we
not just wait for them at the hospital and then arrest them?
The reality is that this right now is the domain of the border State
constituents and the savvy Internet buyer. I want to support this bill
so that the working people can have access at their local pharmacists
to these low-cost prescription drugs. That is what this is about.
Support the Gutknecht bill.
Mr. BROWN of Ohio. Mr. Speaker, I yield 30 seconds to the gentleman
from Texas (Mr. Green), who knows that a drug you cannot afford is
simply not a safe drug.
(Mr. GREEN of Texas asked and was given permission to revise and
extend his remarks.)
Mr. GREEN of Texas. Mr. Speaker, I rise in support of the
Pharmaceutical Market Access Act, and I would not be here this morning
supporting this reimportation bill if we had passed a real
pharmaceutical prescription drug plan under Medicare that did not have
a hole you could drive an M-1A tank through.
I have constituents who now go to Mexico and order pharmaceuticals
through Canada on the Internet. I have bought pharmaceuticals in Mexico
myself to use. They are safe. We need to make sure they are available
for our constituents legally.
If we are not going to pass a real pharmaceutical prescription drug
plan under Medicare, we need to at least pass this bill.
Mr. Speaker, I rise today in support of the Pharmaceuticals Market
Access Act, and urge my colleagues to join me in voting for this
important legislation.
For far too long, Americans have been paying a premium for
prescription drugs. Our constituents are paying top dollar for their
drugs, while citizens from other industrialized countries like Canada,
France, Italy, Germany, and Great Britain are getting deeply discounted
prescription drugs.
American consumers are charged, on average, 38 percent more than
consumers in Canada, 31 percent more than citizens of Great Britain, 45
percent more than French consumers, and 48 percent more than Italian
citizens. This is simply unacceptable.
Now I know that opponents of this bill will try to muddy the waters
by raising the specter that reimportation is unsafe and unfair, but
this is simply not true.
Manufacturers have been safely importing drugs into this country for
years. In 2001 alone, they spent $14.7 billion bringing prescription
drugs into the United States.
Additionally, H.R. 2427 specifically prohibits counterfeit drugs,
drugs that have been tampered with, and expired drugs from entering the
United States.
Under this bill, only FDA approved drugs would be allowed into the
country. The only difference from U.S. manufactured drugs will be the
more affordable price.
And don't be alarmed by cries that this will decrease research and
development into new medicines. Pharmaceutical companies' after-tax
profits--and after expenditures for R&D--averaged 17 percent from 1994
to 1998. This leaves plenty of money for R&D.
The bottom line is that opponents of this bill want to protect
pharmaceutical industry profits.
I urge my colleagues to stand up a against these special interests,
and for your constituents.
Mr. GUTKNECHT. Mr. Speaker, I am happy to yield 1 minute to the
gentleman from Arizona (Mr. Flake).
Mr. FLAKE. Mr. Speaker, I thank the gentleman for yielding me this
time.
It has been a great debate tonight. I am not supporting this bill
because I believe that it will lower drug prices substantially in the
long term. I do not believe that it will. But what it will do is, as
has been pointed out earlier tonight, it will force some of the other
countries who have been freeloading off of us for far too long to pay
some of the costs of R&D to develop these medicines for the future.
That is important.
I want to also read this. From ``The Wealth of Nations,'' Adam Smith
addressed this issue. He said: ``To narrow competition can only serve
to enable the dealers, by raising their profits above what they
naturally would be, to levy, for their own benefit, an absurd tax on
the rest of their fellow citizens.''
[[Page H7604]]
The absurd tax has been paid by Americans for far too long. It ought
to be shared by the rest of the world to pay for the cost of research
and development.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 1 minute to the
gentleman from California (Mr. Gary G. Miller).
Mr. GARY G. MILLER of California. Mr. Speaker, I rise in opposition
to this bill. The argument is we are dealing with reimportation, not
drugs manufactured in Canada.
Ask yourself the question, why are there no major manufacturing
facilities in Canada? The reason is they invest billions of dollars in
these drugs to save our lives. Of every thousand they work on, seven
hit the market place and one makes a profit. Now, ask yourself the
question, Canada represents 1 percent of the marketplace. That is all
they represent. Do you believe that U.S. manufacturers are going to
ship enough drugs to Canada to sell them back at less prices in the
United States to fill the volume that is needed in the largest market
in the world?
When people get sick in Canada and they are seriously ill, they come
to the United States. Why? Because we have the best health care and the
best treatment forms in the world.
It is already legal to reimport if you can prove safety, but they
cannot prove safety; and you know it. And they will have that same
difficulty in the future. So do not believe there is some manufacturer
in Canada who is just arbitrarily going to ship drugs here. Our
companies do not meet the demand.
Mr. BROWN of Ohio. Mr. Speaker, I yield 30 seconds to the gentleman
from Rhode Island (Mr. Langevin) who knows that a Federal Government
who says it can build a national missile defense can surely ensure the
safety of imported drugs.
Mr. LANGEVIN. Mr. Speaker, I rise in strong support of H.R. 2427, the
Pharmaceutical Market Access Act. We know that Americans pay 30 to 300
percent more for their medications than those in other industrialized
nations. The United States has failed time and time again to assert our
force in the pharmaceutical marketplace, and we should continue to
pursue all available avenues to lower drug costs for our citizens.
Today, we have the opportunity to take action by passing H.R. 2427.
This bill makes possible the reimportation of FDA-approved drugs from
FDA-approved facilities. It includes new standards for safety messages
in the packaging of drugs. It is the right thing to do for our seniors
and we must act now.
Mr. Speaker, I rise in support of H.R. 2427, the Pharmaceutical
Market Access Act. I am grateful that the House of Representatives has
the opportunity to substitute existing reimportation language in the
House-passed Medicare bill with a meaningful provision, one that could
result in billions of dollars in savings to American seniors and bring
balance back to the global marketplace for prescription drugs.
American taxpayers heavily subsidize the research that leads to life-
saving medications, used worldwide. Despite that, citizens of this
country pay 30 to 300 percent more than those in other industrialized
countries. The reason for this disparity is that the government of
every other industrialized nation works on behalf of it's citizens to
control the cost of medication--through the use of bulk purchasing
power, and other methods the United States has failed to adopt. The
recently-passed Medicare bill failed to incorporate any meaningful cost
control measures for the 54 million Medicare beneficiaries--in fact the
legislation strictly forbade the U.S. government from negotiating for
these seniors and discouraged reimportation. There are other steps the
United States should be taking to lower costs, and we should continue
to pursue the use of bulk purchasing power and speeding the approval
process for generic drug entry to the market--but tonight, we have the
opportunity to vote on market access.
Americans are suffering because of their government's failure to
assert their force in the pharmaceutical market. Last month, I joined
the Rhode Island Academy of Family Physicians in releasing a survey
showing that a third of seniors in Rhode Island are relying on
physician samples for their necessary medications and 20 percent are
failing to take them as prescribed because of cost--skipping
prescriptions to make them last longer and failing to refill them.
There is absolutely no reason for this. Today, we have the opportunity
to take action by passing H.R. 2427, which would level the playing
field by allowing American pharmacists, wholesalers and individuals to
legally and safely import the same drugs they are paying inflated
prices for at home from other countries. The tangible result of this
policy will be significant savings--savings that will be passed from
pharmacists and wholesalers to American consumers.
It is ironic that the drug companies are telling us that importation
cannot be done safely. For years now, drug manufacturers have safely
and legally reimported drugs--$14.7 billion worth in 2001--and in
certain circumstances, individuals have been able to purchase their own
medications abroad. In the years of this legal reimportation--there
have been zero reported deaths from Americans taking imported
pharmaceuticals. However, thousands of Americans become ill or die from
food-borne illnesses each year, yet no one suggests the banning of the
importation of food. Instead, we work hard to regulate the importation
of food, and we incorporate current technology to ensure the safety of
the process. H.R. 2427 includes new standards for safety measures in
the packaging of drugs and limits importation to FDA-approved drugs
from FDA-approved facilities. This can be done, and it can be done
safely.
Earlier today we heard a number of Members on the floor talking about
the benefits of free trade, as we debated the United States-Chile Free
Trade Agreement. I am certain that these Members recognize drug
companies can set drug prices at extraordinarily high prices in the
United States, because current law protects them from competition. I
hope that, in the spirit of consistency, these Members will support
H.R. 2427, and allow the market forces to work in favor of American
consumers when it comes to the purchase of life-saving medications.
We must not let the opportunity to lower the cost of prescription
drugs for Americans pass us by. I urge all of my colleagues to vote in
favor of H.R. 2427.
Mr. TAUZIN. Mr. Speaker, may I inquire once again as to the time
allocations.
The SPEAKER pro tempore. The gentleman from Louisiana (Mr. Tauzin)
has 3 minutes remaining, the gentleman from Minnesota (Mr. Gutknecht)
has 4\1/4\ minutes remaining, the gentleman from Michigan (Mr. Dingell)
has 4 minutes remaining, and the gentleman from Ohio (Mr. Brown) has 4
minutes remaining.
The order of closing will be the gentleman from Ohio (Mr. Brown) will
go first, the gentleman from Minnesota (Mr. Gutknecht) will go second,
the gentleman from Michigan (Mr. Dingell) will go third, and the
gentleman from Louisiana (Mr. Tauzin) goes last.
Mr. BROWN of Ohio. Mr. Speaker, I yield 30 seconds to the gentleman
from Ohio (Mr. Strickland) who knows this debate is not about safety,
but about drug industry profits.
Mr. STRICKLAND. Mr. Speaker, this is an interesting debate because it
is not primarily between Democrats and Republicans; it is between the
people and the pharmaceutical companies.
The gentleman from Louisiana (Mr. Tauzin), the distinguished chair of
my committee, says he is concerned about safety, that if we pass this
bill people may die. I contend that people are dying every day in this
country. People are dying because they are not getting the medicines
they need because they cannot afford the medicines they need.
Does the gentleman believe if we pass this bill others may die? I
believe if we do not pass this bill there will be many Americans who
will die as a result of our inaction.
Mr. TAUZIN. Mr. Speaker, I reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker, I yield 30 seconds to the gentleman
from Ohio (Mr. Kucinich).
Mr. KUCINICH. Mr. Speaker, night after night my Democratic colleagues
come to this floor to characterize the Republican Party as being the
party controlled by monied special interests. Well, this evening, my
fellow Democrats, is a moment of truth for the Democratic Party and
what we stand for and who we stand for and who we stand with: the
people or the big drug corporations.
Seniors in my district are splitting their pills to make their
prescriptions last. And if a big PhRMA splits our party over the issue
of lowering drug prices, it is a prescription for disaster for the
Democratic Party. It is time we stood up and showed America who we
really are, with the people or with the corporations.
Mr. GUTKNECHT. Mr. Speaker, I yield 1 minute to the gentleman from
Arizona (Mr. Hayworth).
{time} 0215
Mr. HAYWORTH. Mr. Speaker, I thank my friend from Minnesota for
[[Page H7605]]
yielding me this time, and I thank my friends across this Chamber for
the warm reception.
Mr. Speaker, when a prescription is written by a physician, there is
not an inquiry as to partisan affiliation or political persuasion. A
decision is made that a medicine is needed. The question tonight in
this House is how best can that delivery be achieved. Economic
conditions are the overwhelming criteria upon which this must be
decided.
My friend from Arizona spoke earlier, and he was quite right. An
unfair tax has been levied on Americans. We have borne the costs that
should be shared with others. Oh, yes, and we already subsidize many of
those costs and we also have a research and development tax credit that
exists currently in the Tax Code.
Vote ``yes'' on the Gutknecht legislation. Let us seek a rational
solution.
Mr. DINGELL. Mr. Speaker, I yield 1 minute to the distinguished
gentleman from North Carolina (Mr. Price).
Mr. PRICE of North Carolina. Mr. Speaker, H.R. 2427 is both a
diversion and a danger. It is a diversion from the prescription drug
coverage we should be providing.
What have we done instead? We have instead passed a Republican
Medicare bill which actually denies the Secretary of HHS the ability to
negotiate volume discounts. So much for my colleague's elephant in the
room.
And it is a danger. This bill is a danger. It would allow
distributors to import drugs that have been sold, stored and
transported outside the FDA's closed regulatory system. Massive and
haphazard reimportation is the wrong prescription for a very real
problem, the lack of drug coverage under Medicare available to all
beneficiaries.
I urge colleagues not to be diverted, to vote against the inferior
and dangerous solution which H.R. 2427 represents.
Mr. TAUZIN. Mr. Speaker, I am honored to yield 1 minute to the
distinguished gentleman from California (Mr. Dreier), chairman of the
Committee on Rules.
(Mr. DREIER asked and was given permission to revise and extend his
remarks.)
Mr. DREIER. Mr. Speaker, yesterday afternoon, earlier this
legislative day, we made history by passing two very important measures
which are designed to eliminate tariff barriers in our relationship
with both Singapore and Chile. And now we have people who have injected
the issue of free trade in this debate.
Mr. Speaker, the fact of the matter is, as we look at this challenge,
what it is that we are dealing with is government subsidization,
government cost controls and mandatory licensing, which is antithetical
to the entire concept of the free flow of goods and services and ideas.
Vote against this measure.
Mr. BROWN of Ohio. Mr. Speaker, I yield 30 seconds to the gentleman
from New York (Mr. Nadler) who knows that if you want to talk safety,
we should talk about Americans having to split their pills to afford to
pay for their expensive medicines.
(Mr. NADLER asked and was given permission to revise and extend his
remarks.)
Mr. NADLER. Mr. Speaker, for 30 years the pharmaceutical companies
have opposed proposals for the government to help senior citizens buy
their products. Why? Because they are afraid that the government, as a
bulk purchaser, would exercise market power to do what a bulk purchaser
in a free market society should do, use bulk market power to get lower
prices. And they tell us that lower prices will mean they could not do
research and development when they spend 33 percent of their revenues
on marketing and 14 percent on research and developing.
That is why the Republican bill we debated a few weeks ago prohibits
the government from negotiating prices. This bill is a substitute for
that, not a good substitute, but the best we are likely to get. It will
help the seniors buy their drugs and we ought to pass it.
Mr. BROWN of Ohio. Mr. Speaker, I yield 30 seconds to the gentlewoman
from Texas (Ms. Jackson-Lee) who knows the drug industry's pricing
policies put the health of American patients at risk every day.
Ms. JACKSON-LEE of Texas. I thank the distinguished gentleman for
yielding me this time.
Mr. Speaker, tonight's vote is a vote of the heart and a vote of
one's conscience. This weekend, many of us spent time with our senior
citizens, and I am glad that we are talking now not about Democratic
and Republican politics but about saving lives.
I grappled with this whole question of pharmaceuticals and senior
citizens, but when I got this letter from Ms. Davis and said, ``My
pressure pill is too high, the rest of my medicine is too high, I
cannot afford no medicine; my doctor gives me samples, I cannot afford
the regular medicine,'' I had to stand with these senior citizens who
need our help.
We have got to vote for this bill so we can save lives in America.
Mr. Speaker, I must say that this is one of the toughest votes I have
made in my tenure in Congress. We have an epidemic upon us in America
today. It is not an epidemic caused by a virus or a bacterium. Instead,
it is the epidemic of Americans who have no access to affordable
healthcare.
One of the fastest growing segments of our nation's healthcare budget
is the cost of prescription drugs. I had a town hall meeting last week,
so that I could hear the seniors in my district talk about their
prescription drug costs, and what they want me to do about it. The
conversation turned to the question of why Americans pay 2 to 10 times
more than Canadians, for the exact same prescription drugs. It was then
that I realized the truth: that those seniors, 70, 80, one over 90
years old--many living on about $12,000 per year that they receive from
Social Security--are buying drugs for rich Canadians. Every Canadian or
German or Brit, no matter of their income gets a giant discount on
their drugs, because the elderly in our Districts here in the U.S. are
paying on average about 60 percent too much for their drugs. They are
having to choose between eating and taking their medications on a
regular basis, and they are subsidizing the costs of people around the
world with much more.
That is outrageous.
I and my fellow Democrats have been fighting to ensure that more
Americans have access to affordable medications, and I believe that the
drug industry wants more people to be able to buy their medications.
Surely we should be perfect collaborators. Furthermore, the drug
industry has made tremendous advances in their labs, that have
lengthened and improved the lives of millions of people around the
world. That is why I have been trying to work with our nation's drug
companies to find common ground, to seek compromise that helps people
get the drugs they need, and enables our companies to get the profits
and recognition they deserve. On several occasions they have stepped up
to the plate--with patient assistance programs giving free drugs to the
working poor, and discount cards, like Together Rx, that give discounts
to low-income seniors. They have also donated drugs to those suffering
in Africa and other developing nations. I commend the drug industry for
their good works.
I was hoping to build on those modest steps, and continue to make
progress toward increasing access to state-of-the-art prescription
drugs, by partnering with the good people in the industry--and I do
believe there are good people in PhRMA. But the Republican leadership
put an end to that, and turned this into a political war. I and my
fellow Democrats fought to give the Secretary of HHS the ability to
negotiated with the drug industry on behalf of our 40 million seniors
on Medicare, to lower their drug costs. Such negotiations would have
brought about prices lower than we pay now, but probably not quite as
dramatic a decrease in PhRMA profits as H.R. 2427 will bring about. The
Republican leadership denied us that common sense provision, so a door
was closed.
As H.R. 2427 was coming to the floor, there were some of us who felt
that there could be compromise legislation, that would increase safety,
and would perhaps lessen the impact on our drug industry, and their
workers, and their investors. But we knew, as usual, that there would
be no chance for such smart improvements, and as we see today the Rules
Committee has sent this bill to the Floor with yet another Closed Rule.
Again a door was closed.
In 2006, a Medicare Prescription Drug benefit will probably kick in.
If it looks like anything that came out of the House or Senate last
week, that benefit will leave many of our seniors far worse off than
they are today. According to Republican estimates, a senior paying
$5000 per year will only get 20% of their costs covered by their
insurance plan. But by 2006, drug costs will have risen more than 20%,
and also the discount card programs that the industry has put forth,
will end as seniors get a drug benefit.
So, I don't see many options here. I do not like the idea that under
this legislation, we will
[[Page H7606]]
be shipping American drugs overseas, paying foreign middlemen to handle
them, then ship them back to us, all in an effort to get a better price
out of companies in our own backyards. There should have been a better
way; but I do not see it today.
Today the problem of access is out of hand; it is about life and
death. Every one of us has an elderly friend or relative, who has
suffered a catastrophic blow to their health and watched the emotional,
physical, and financial struggle that that can cause. We have people in
the richest nation in the world choosing amongst eating, or paying
rent, or buying their medications. Losing any one of the three can be
deadly. I cannot help perpetuate this nightmare. I will support this
bill.
The one issue that might have caused me to rethink my vote is that of
safety. If I really believed the hype--that this bill would lead to a
deluge of dirty drugs from Canada, or Switzerland, or Japan, or
wherever--I would have voted against it. But I do not. We have the
technology and the creativity to make this venture safe. And the bill
before us does not strip the FDA of its powers to search for potential
sources of counterfeits, or damaged, or outdated products, and stop
their influx into this country. Those abilities are specifically
protected in the bill.
This is a bill whose time has come, and I believe that it will save
lives. My one regret is that it may cause some temporary hardship to
some excellent companies. But I am confident that they will survive.
They are creative and industrious, and I hope that they will work
harder to increase their profits overseas.
I also want to work with the industry to create provisions that will
improve the Medicare Prescription Drug Bill in a way that will increase
access to fairly priced drugs to ensure fair profits for producers, and
protect the health of consumers. It is possible, but the leadership
will need to put lives before politics.
Again, it is an idea whose time has come.
Mr. BROWN of Ohio. Mr. Speaker, I yield the balance of my time to the
gentleman from Illinois (Mr. Emanuel) who knows the same Federal
Government that put a man on the Moon certainly can ensure the safety
of prescription drugs.
The SPEAKER pro tempore (Mr. LaHood). The gentleman from Illinois is
recognized for 2 minutes.
Mr. EMANUEL. Mr. Speaker, people from around the world come to
America for their medical care. Yet Americans travel around the world
for affordable medications. Between 2000 and 2003, seniors'
expenditures on prescription drugs increased 44 percent.
The legislation we are debating today is about inserting competition
and the free market into the pricing of medication to ensure that
Americans no longer have to pay a 25 to 40 percent premium over the
prices paid in other countries.
For too long, our constituents have subsidized the starving French,
Germans, Italians and Canadians. Americans have also subsidized the
research and development for pharmaceutical companies through the NIH
funding and through the R&D tax credit. We are about to embark on the
largest expansion of entitlement in over 40 years and spend $400
billion of the taxpayers' money. We owe it to the American taxpayer to
ensure that they are getting the best price for their money, not the
most expensive price.
I want to address and speak to the myth of safety concerns. Last
year, Americans imported $14.8 billion worth of medications from around
the world. Lipitor is a cholesterol drug that is on every
pharmaceutical counter. It is made in Ireland, but we import it. If it
is unsafe, get it off the counter and get those ads off the television,
because we import Lipitor from Ireland.
Folks, when somebody tells you it ain't about money, it is about
money, and that is what this debate is about. I know how this system
works like everybody else here. There is a pharmaceutical lobbyist and
a half for every Member of Congress. They have spent over $100 million
in contributions, entertainment, lobbying expenses, all focused on us.
But meanwhile our seniors are being overcharged approximately $100
billion.
The question before us tonight is, are we going to put more priority
on the $100 million focused on us or the $100 billion that our
constituents are overcharged?
I know why we all came here. We ran for a set of ideas, a set of
values and a set of principles. They may be different, but we share a
common set of values. Whether you believe in competition in the free
market, protecting our taxpayers or ensuring affordable prices, tonight
the vote is about the special interests versus the American people. I
ask you to support our constituents.
Mr. GUTKNECHT. Mr. Speaker, I yield myself the balance of my time.
The SPEAKER pro tempore. The gentleman from Minnesota is recognized
for 3\1/4\ minutes.
Mr. GUTKNECHT. Mr. Speaker, first of all, let me say thank you to the
gentlewoman from Missouri (Mrs. Emerson), because we would not be
having this historic debate tonight without her courage, and I want to
thank her.
Mr. Speaker, I have been down on this floor many, many times with my
charts, talking about this issue. I have had charts and plenty of
statistics, but the saddest statistic of all that I have come across is
this from the Kaiser Foundation. Twenty-nine percent of seniors say
that they have had prescriptions that went unfilled because they could
not afford them. Shame on us.
I was at a community pharmacists meeting a few months ago. There were
300 community pharmacists there. I asked them this question: Has this
ever happened to you where someone comes into your store with a
prescription, they hand you the prescription, you tell them how much it
is going to be and their head drops, their voice drops, and they say,
Well, maybe I'll be back tomorrow. And they never come back. Shame on
us.
We have heard about safety. We have heard about intellectual property
rights. No one wants unsafe drugs or to steal patents. We have heard
about price controls and aren't we simply importing them. But the plain
truth is today, Americans are subsidizing them.
This bill is not perfect, but it is not complicated, either. We
simply take away the FDA's power to defy the will of this the people's
House and in its place we put counterfeit-proof, tamper-proof
packaging.
I will not question any Member's motives, but others will. If you are
going to vote against this bill tonight, you had better go back to your
office and write a letter to your constituents explaining exactly why,
because you will be asked. Maybe it will be at a town hall or a
candidates forum, or maybe in your opponent's ads next year, but you
will be asked. Someone is going to hold up a package of pills and they
are going to ask this: Why is it that Americans have to spend $360 for
this drug, this lifesaving drug, when Germans can buy it for $60? And
then they are going to ask the even tougher question: Congressman, what
did you do about it?
Tonight we can send a very simple but clear message. The status quo
is unacceptable, and we will not stand idly by and allow Americans to
be forced to pay the world's highest prices for prescription drugs.
Members, all I ask is vote your conscience. Millions of proud
Americans are counting on us.
Mr. DINGELL. Mr. Speaker, I yield the balance of my time to the
distinguished gentlewoman from Colorado (Ms. DeGette).
The SPEAKER pro tempore. The gentlewoman from Colorado is recognized
for 3 minutes.
Ms. DeGETTE. Mr. Speaker, this legislation will harm patients. It
will harm the children, and it will harm the elderly. It lacks the
necessary guarantees of safety and we should not subject the American
people to it.
Permitting reimportation would significantly increase the risk that
counterfeit, misbranded and adulterated drugs would show up in U.S.
pharmacies and American homes. Every one of us here tonight is
concerned about the high cost of prescription drugs, but we should not
and must not substitute the hope of lower prescription drug prices for
the fundamental safety of the drugs that we are providing to our
citizens. We have a duty to protect the people of this Nation.
Every expert agrees, this bill will not help Americans. The Food and
Drug Administration, along with the U.S. Customs Service, currently
cannot enforce the existing laws. Counterfeit drugs are pouring across
our borders. I used to think I supported this legislation, and then the
Subcommittee on Oversight and Investigations had hearings. This chart
is just one example of counterfeit Viagra that was received in the
Miami office. There are tons of counterfeit drugs coming into this
country right now.
Proponents of the bill say that the quality of the drugs will be
protected.
[[Page H7607]]
I have not heard one Member on either side of the aisle say how that
will happen, when you have drugs that are coming in from all parts of
the world. This is counterfeit Voltaren. It is a pill that is used to
relieve pain, tenderness, inflammation and stiffness caused by
arthritis.
{time} 0230
Every one of these pills is marked with the manufacturer. It looks
real. There is no active ingredient in these pills. I challenge anybody
who just thinks that we will be safe to come get on a plane to Miami
and see the counterfeit drugs that are coming into this country.
The gentleman from Arkansas (Mr. Berry) said the country will be
flooded with cheap prescription drugs. That may happen under this bill,
but we cannot guarantee that any of those cheaper prescription drugs
will have any active ingredients in them. The gentleman from
Pennsylvania (Mr. Hoekstra) asked why the Canadian drugs are 40 percent
cheaper. I have a different answer than the gentleman from Indiana (Mr.
Pence) had. I think they are cheaper because Canadian law allows the
government to negotiate with pharmacies for lower prices. And that is
what we should do too in this country. We should not go in a roundabout
way letting these counterfeit drugs come in, putting our citizens at
risk simply because we want lower prices.
Here is the bottom line. We were elected to preserve the health and
safety of the people we represent, over 600,000 each. Let us not
sacrifice that fundamental right for a convoluted bill that is not even
guaranteed to do what it is supposed to do. Vote ``no'' on this ill-
conceived legislation.
Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume.
Current law allows importation. Current law contains 10 provisions to
protect the safety of drug supplies in this country, 10 provisions
protecting the safety of those drugs that are imported into this
country. This bill that the Members are asked to vote on tonight
strikes all 10 of those safety provisions, all 10.
I am going to show the Members tonight what we get if we pass this
bill. What we are looking at now is a Web site of a Canadian
prescription center where one can order prescriptions from Canada right
now which would be legalized under this bill, illegal under current law
because the FDA cannot verify the safety of drugs obtained on this Web
site.
The FDA obtained some drugs on this Web site to just see what they
could get. I want to show the Members what they got. What they got was
this drug. This is a drug called Gabapentin. It is used as an
antiseizure measure. It is to prevent seizures for people who have all
kinds of seizures with all kinds of diseases. Do the Members know where
it was made? It was made in India, not in Canada; and it came to an
American over that Canadian Web site. And do the Members know what is
in it? Nothing. It is water inside this package. And the folks who buy
it in America at these cheap prices we are told they are going to get
it for nothing except fake drugs.
Here is another set of drugs to look at. This is one is called
Serostim. It is used by HIV/AIDS patients to prevent wasting. This is
the authentic one; this is the fake one. The fake one contains nothing
but pond water. Imagine giving that to an HIV/AIDS patient. Is the
price, half price, quarter price worth it to take a drug like that?
I want to ask the Members something before we end this debate, and I
have the greatest respect for those who bring this issue to the floor
because I hate the fact that Canada and other countries take advantage
of our patients in America, and we have to end those trade imbalances.
We have to fight them. We do. We do. But I want to ask one question. If
the Members vote to say that safety does not count and Americans
increasingly buy these drugs full of nothing but pond water and diluted
and old and rotten drugs, are they going to have to face the mother and
father the way we faced them this week who said, Why is my son dead,
because you did not put FDA regulations into place?
Vote down this bill. It is dangerous for every American. It needs to
be defeated.
Mr. HOLT. Mr. Speaker, I am sad to say that for the second time
during this Congress, the House has considered legislation offering a
false promise to help for seniors struggling to pay for prescription
medications.
Last month, the House passed a bill that purported to offer Medicare
prescription drug coverage. I have long supported providing seniors
with a reliable, comprehensive, and affordable drug benefit under
Medicare. I could not in good conscience vote for the bill passed by
the House, however, because it would provide only a meager benefit
while quite possibly leading to the death of the traditional Medicare
program that has served seniors in my district so well.
Congress has an obligation to help Americans who cannot afford the
prescription drugs they need. Seniors need and deserve a voluntary,
universal, prescription drug benefit under Medicare that can help lower
prices using the collective buying power of the Medicare population.
But making it easier to bring counterfeit, substandard medicines into
the United States is not the way to help seniors get the drugs they
need. H.R. 2427 poses a very serious danger--exposing American
consumers to unsafe counterfeit drugs.
The evidence of this is well documented. The Food and Drug
Administration, which has for nearly a century been responsible for
certifying the safety and efficacy of medications sold in the United
States, opposes reimportation. According to FDA Commissioner Mark
McClellan, ``At a time when FDA faces more challenges than ever in
keeping America's supply of prescription drugs safe and secure, H.R.
2427 would create new drug safety problems. H.R. 2427 creates a wide
channel for large volumes of unapproved drugs and other products to
enter the United States that are potentially injurious to public health
and pose a threat to the security of our Nation's drug supply. The bill
would do so by taking unprecedented steps that limit FDA's authority to
assure the safety of prescription drug products to be used by U.S.
consumers.
These sentiments are shared by eight former FDA Commissioners as well
as current and former HHS Secretaries Tommy Thompson and Donna Shalala,
who both refused to certify the safety of reimportation. The Nation's
largest association of physicians, the AMA, also opposes this dangerous
policy.
The dangers of reimportation were brought to life recently, when 19
people in Florida were arrested in charges of selling ``adultered''
drugs, including fake Lipitor pills imported illegally from England. We
were lucky in this case. Sometimes the dangers of counterfeit imported
pills don't become apparent until it's too late.
Mr. Speaker, I cannot vote to jeopardize the safety of our supply of
medications. The United States is the envy of the world because its
medicines are the safest. Opening our borders to the peril of
counterfeit drugs is simply a foolish way to increase accessibility. We
need a Medicare prescription drug benefit--not a flood of dangerous
counterfeits. Do we really want to open our borders to let in drugs
from other countries when the worldwide rate of counterfeit drugs is 8
percent.
I urge my colleagues to protect the safety of U.S. consumers and vote
no on H.R. 2427.
Mr. UDALL. of Colorado. Mr. Speaker, I cannot support the
reimportation bill because it will create a flood of unsafe,
counterfeit or ineffective drug products that will end up in the
medicine cabinets of millions of Americans, and I do not think it will
result in the cost savings that supporters are hoping for.
First and foremost, this issue is about patient safety. I agree with
the Food and Drug Administration, the American Medical Association and
many physician and patient organizations who say that allowing
wholesalers and pharmacists to reimport drugs from foreign countries
will pose serious public health concerns for our country. There are no
safety provisions in this bill that will assure Americans that the
drugs they are taking are safe and effective. And the bill does not
provide any resources to the FDA, Customs, or other Federal agencies to
test, inspect and certify that drugs coming into our country from
around the world are safe.
In addition to the safety issues involved, I do not think this bill
will lower the cost of drugs in the U.S. Recently, the non-partisan
Congressional Budget Office released a report saying that reimportation
legislation ``would not produce substantial savings to the Federal
government.'' Furthermore, some regulations in the bill will result in
higher prices for pharmaceuticals. If our aim is to make drugs more
affordable for seniors, Congress should pass a fair and affordable
Medicare drug benefit bill.
Pharmaceuticals play a critical role in our health care delivery
system. As such, I want to support initiatives that spark research and
innovation in the pharmaceutical industry and that increase
accessibility to prescriptions drugs. These should not be mutually
exclusive goals. Ultimately, I cannot support legislation that will
endanger the health of millions of Americans who rely on medications to
treat a condition or an illness.
[[Page H7608]]
Mr. DAVIS of Illinois. Mr. Speaker, I rise today in strong support of
H.R. 2427, the Pharmaceutical Market Access Act of 2003. Those who are
debating this bill can be divided into just two separate groups: those
who support making pharmaceuticals more affordable to Americans, and
those who are swayed by the pharmaceutical industry's attempts to
maintain astronomical profit margins. I proudly stand with the first
group.
You cannot deny the skyrocketing prescription drug costs in this
country. The price of the top 50 drugs used by American seniors rose at
three and a half times the rate of inflation in 2002. At community
clinics, physicians prescribing common antibiotics find that their
patients cannot afford them. Americans with diabetes, high blood
pressure, and other manageable diseases go without life-preserving
medications. Meanwhile, those in other countries pay as little as one
tenth what Americans pay for the exact same pharmaceuticals. In Canada,
the country's national health care system allows them to negotiate
prices with drug companies, substantially reducing costs for Canadians.
In their quest for profit, those drug companies raise prices in the
U.S. to compensate for lost profits in Canada.
Contrary to our opponents' claims, H.R. 2427 has built-in provisions
to ensure the safety of reimported drugs. The new technologies
developed to ensure the safety of reimported drugs will also safeguard
domestic pharmaceuticals against counterfeiting. Our opponents claim
that the FDA fails to adequately monitor the safety of drugs already
being imported into the U.S. The answer is not to deny Americans the
right to reimported pharmaceuticals, but to hold the FDA accountable
for its failures and demand improvement.
Our opponents claim that H.R. 2427 would hurt low-income Americans,
in attempts to win more support for their position. In fact, this bill
would only provide poor Americans with more access to the medicines
they need through cost reductions.
Mr. Speaker, as health care costs rise out of control, we must take
every step possible to improve health care for the 41 million uninsured
and countless underinsured Americans. I urge you to join me in support
of H.R. 2427. Do now allow our opponents, influenced by the
pharmaceutical industry, to deny safe, affordable prescription drugs to
Americans.
Mr. KIND. Mr. Speaker, I rise today in support of the Pharmaceutical
Market Access Act (H.R. 2427). Every day, seniors in western Wisconsin
face the escalating cost of prescription drugs. A recent Families USA
study found that the prices of the 50 drugs most commonly used by
seniors increased by an average of three and a half times the rate of
inflation over the past year. And between 2000 and 2003, seniors'
expenditures on prescription drugs increased by 44 percent.
One solution for many Wisconsin residents is to drive to Canada where
they can purchase prescription medication at a substantial savings
compared to a drug store in the United States. On average, American
consumes in 2002 were charged 38 percent more than consumers in Canada.
A 38 percent savings is sizable amount of money to an individual on a
fix income. H.R. 2427 would help all seniors realize this savings.
The legislation we are debating today is about inserting competition
into drug pricing, to ensure that Americans no longer have to pay a 25-
to 40-percent premium over the prices paid in other countries. As we
embark on the largest entitlement expansion in recent history, $400
billion, we must ensure that we get the best price for prescription
medicines. We owe it to our taxpayers to ensure that they are getting
the best bang for their buck.
The legislation before us would lower prescription drug costs for all
American consumers by allowing the importation of drugs with
appropriate safeguards. This legislation mandates that the Food and
Drug Administration approve drugs and manufacturing facilities before
reimportation. In addition, imported drugs must be packaged and shipped
using approved counterfeit-resistant technologies. The truth is, more
people in Wisconsin have become sick from imported strawberries than
from imported prescription drugs. Today, the FDA only imports roughly 1
percent of imported food. Surely we can do a better job of ensuring the
safety of imported drugs.
As I travel around my district in western Wisconsin I consistently
hear about the high cost of prescription medicines, not only from my
seniors but also from businesses and average citizens. The
Pharmaceutical Market Access Act is a significant step in the right
direction to bring prescription drug costs down and ensure that all
Americans have better access to affordable medicines. I urge my
colleagues to support H.R. 2327.
Mr. SIMMONS. Mr. Speaker, I rise in opposition to H.R. 2427,
Prescription Drug Reimportation legislation. My fear is that this bill
will result in a flood of fake foreign pharmaceuticals into our
country.
Immediately following 9/11/01, Congress came together in a bipartisan
fashion and moved quickly and swiftly to protect our borders, protect
our airports, protect our drinking water, our food supply.
Yet the reimportation bill before Congress today would allow the
import of unregulated prescription drugs through our borders.
That's why so many groups oppose H.R. 2427. This bill, although well-
intentioned, jeopardizes the safety of consumers who use prescription
drugs.
Among the opponents to the bill is the Food and Drug Administration.
In a letter to Congress, the FDA stated that H.R. 2427 ``would erode
the ability of the FDA to fulfill its challenging mission of ensuring
the safety and efficacy of the U.S. drug supply.'' The FDA goes on to
state it, ``simply cannot support legislation that exposes Americans to
greater potential risk of harm from unsafe or ineffective drugs.''
The American Medical Association, who also opposes the bill, stated
in a recent letter, ``We believe that H.R. 2427 would be so dangerous
to patient safety that we must oppose it.''
From my home state, the Connecticut Medical Society says, ``While we
support broader availability of prescription drugs at the lowest price
possible, quality must be assured. For the safety of our patients in
Connecticut, we respectfully urge you to reject H.R. 2427.''
Our Nation's pharmacists also oppose the measure. The National
Community Pharmacists Association says it ``is strongly opposed to any
legislation that legalizes and/or encourages the importation of
prescription drugs by individuals.''
Mr. Chairman, I believe in listening to the experts. And it's clear
that the experts all oppose this unsafe policy.
Instead of supporting a risky reimportation bill, Congress must work
harder to bring a cost-effective prescription drug bill to our
citizens. American citizens deserve access to safe, effective American
drugs.
I urge my colleagues to join me in voting against H.R. 2427.
Ms. KILPATRICK. Mr. Speaker, I rise in support of H.R. 2427, the
Pharmaceutical Market Access Act of 2003, sponsored by Representatives
Gutkneckt and Emerson. I appreciate their hard work and efforts to
bring this bill up for debate in this chamber. They have faced
considerable obstacles in trying to get this bill considered by this
chamber. They are to be commended for their success in having H.R. 2427
debated tonight.
Opponents of this bill suggest that patients whom we intend to help
with the passage of this bill will actually be harmed. They charge that
they will be vulnerable to purchasing unsafe prescription drugs and
that we are encouraging patients to purchase lower-cost drugs from
countries that have less stringent regulatory regimes. Opponents are
also concerned that the bill repeals language that requires the
Secretary of Health and Human Services to certify that reimportation of
prescription drugs is safe before any reimportation occurs. There are
more objections to the legislation, but I have mentioned the major
arguments advocated by the bill's opponents.
Not too long ago a pharmacist from Michigan visited with my
Washington staff. He told my staff how seniors would leave his pharmacy
in tears because they did not have the resources to purchase their
medicine. This is an important issue to seniors. It is an important
issue to all Americans because the high cost of prescription drugs is
driving many families to dilute prescribed dosages in order to stretch
out their prescription orders to make them last longer. If pharmacists
were able to purchase drugs, lower costs would be passed on to our
seniors and families who are struggling with the high cost of health
care.
This is the only opportunity that this Congress will have to vote on
legislation dealing with the cost of prescription drugs. I am using
this opportunity to support lower drug prices for many Americans. This
bill puts people before profits. It puts affordable health care for
Americans ahead of profit margins for the pharmaceutical industry. It
is time to send the industry and the Administration a message:
Americans want affordable drug prices. Support this bill and put people
ahead of the profit margins of the pharmaceutical industry.
Mr. EVANS. Mr. Speaker, everyone knows American seniors are facing
staggering prescription drug costs. Currently, safe and cheaper drugs
lie across our northern border in Canada. Seniors do not have to go far
to see how much less the rest of the world pays for the same FDA-
approved drugs sold many times higher in our country.
The issue of the safety is a non-issue. Seniors in Illinois know that
the pharmaceutical industry is fighting one of the biggest and most
expensive fights to keep the United States in this protectionist state,
not because drugs from FDA-approved facilities in other industrialized
countries are unsafe, but because this measure forces drug companies
here to lower their hugely inflated prices.
With the implementation of affordable, anti-counterfeit technology,
we will know that drugs that come into this country are indeed safe,
[[Page H7609]]
reliable, and tamper-free. There is a counterfeit technology currently
being used by the drug industry in the EU. This is a similar technology
used on billions of pieces of currency around the world which is a
testament to its effectiveness and true affordability. There is no
evidence to believe that the importation of prescription drugs will
increase Americans' risk of receiving tainted drugs.
It is ironic, Mr. Speaker, that the discussion of drug re-importation
comes hours after debate on two free trade bills. While we have debated
and passed today two bills that do not meet these standards, many of my
colleagues are not willing to engage in the trade of FDA-approved drugs
from industrialized nations that do indeed meet these standards. Many
of these countries already have free trade agreements with the U.S. and
the most important factor is that this reimportation will benefit
Americans greatly through reduced pharmaceutical prices; not taking
away a single American job.
H.R. 2427 will make sure that Americans have access to fair prices by
forcing the drug industry to play by the same rule as every other
business. My colleagues continually come to this floor to speak on
behalf of ``free markets'' and this is one opportunity to demonstrate
whether they support an industry hiding behind protective trade
barriers or one providing a needed good at a competitive price. I urge
my colleagues to do the right thing for America's seniors and support
this legislation.
Ms. SCHAKOWSKY. Mr. Speaker, I rise tonight in support of H.R. 2427,
the Pharmaceutical Access Act.
Over 13 million senior citizens on Medicare and 42 million uninsured
Americans have no access to prescription drug coverage. Millions of
others have skimpy coverage that runs out quickly, leaving them to face
months of bills that they must scramble to find the money to pay. The
excessive price of prescription drugs creates financial crises for
those who struggle to pay exorbitant bills and health crises for those
who are forced to go without needed medications, to share drugs with
family members, or to take half doses in an attempt to make their
prescription last a little longer.
I wish that we were on the floor tonight debating legislation to
force U.S. drug manufacturers to charge reasonable prices for their
products, products that are developed and tested with significant
amounts of U.S. taxpayer dollars. It is shameful that we--alone among
the industrialized world--have left the pharmaceutical industry free to
price gouge our constituents. We should be here tonight debating
measures to ensure that health care consumers can go to their local
pharmacy and get the drugs that they need at a price that they can
afford. We should be passing legislation to make sure that American
consumers here at home are not charged many times more than their
neighbors in Canada for the same drugs.
Unfortunately, the drug companies have used their financial clout to
prevent those debates. Last year, drug companies spent over $91 million
to lobby Congress. They hired 675 lobbyists--enough to provide each
member of Congress with their own personal lobbyist with more to spare.
They have spent millions of dollars on front groups to get their
message out. Tragically for the American consumer, those investments
have paid off. Last month, this body even passed a Medicare
prescription drug bill that prohibits Medicare from using its power to
negotiate for discounts or from interfering in any way to lower
unconscionably high drug prices. Ironically, a number of my colleagues
who support H.R. 2427 because it will give American consumers access to
affordable drug prices established through negotiations by other
governments, voted to prevent Medicare from using the same techniques.
Tonight, the drug industry is now working to shut down the only
remaining avenue open to senior citizens and other health care
consumers. Having stopped access to affordable drugs here in the United
States, the drug companies are now trying to block access to affordable
drugs from Canada and other countries.
Reimportation can and must be done safely. We all want to make sure
that consumers get safe medications. H.R. 2427 provides access only to
FDA-approved drugs manufactured in FDA-approved facilities. There are
requirements that drugs must be packaged to prevent tampering. There is
not a single documented death from imported drugs, and we have the
means to maintain that record.
We all know that the reason the drug industry is pulling out all the
stops to prevent passage of the Pharmaceutical Access Act is not their
concern about safety, it is their concern about their profits. We could
put every safety protection in a reimportation bill and the U.S. drug
industry will still oppose it. They will oppose any bill that prevents
U.S. consumers from being held hostage to their price-gouging
practices.
If this body is unwilling to take on the drug industry here at home,
the least that we can do is to ensure that U.S. consumers will have
access to safe and affordable drugs through reimportation. We should
pass H.R. 2427 but, in doing so, we should not be too quick to claim
victory. We should not be proud of telling our constituents that they
must rely on the actions of foreign governments to provide them with
affordable medications. The real solution--the solution of which we
could all be proud--would be if we were willing to join those
governments in confronting the power and greed of the pharmaceutical
industry.
Mr. LEVIN. Mr. Speaker, tonight I vote for H.R. 2427 with some
reservations. I have put those reservations aside because this is not
the final step in the process.
I would have much preferred if the Republican leadership had not
blocked a vote on the Emerson ``Save Our Seniors Act'' and all other
amendments. Unfortunately, the Republican leadership decided to block a
vote on Emerson and all amendments in the hopes of shutting this effort
down and saving the pharmaceutical industry's policy of charging
Americans the highest drug prices in the world.
Our senior citizens are more likely to need prescription drugs and
less likely to have insurance to cover them than any other group. As a
result, many of them pay high prices or go without needed medication.
That is wrong.
In recent years, many seniors in my district have tried to solve this
problem by traveling to Canada, where drugmakers charge lower prices
for the same medications. Some of them have been able to purchase
medications, especially for chronic illnesses, at a thirty to 50
percent discount. I strongly support allowing them to continue doing
this without interference from the Food and Drug Administration or the
U.S. Customs department. I believe that Canada's system of regulating
prescription medications sold at its pharmacies is safe and reliable
for my constituents.
But bus trips to Canada should not be the answer to the serious
problem facing our seniors. The real answer is a Medicare prescription
drug benefit so that they can get the drugs they need here at home. I
have cosponsored H.R. 1199, which would add a comprehensive
prescription drug benefit to the Medicare seniors know and trust. If
H.R. 1199 becomes law, the federal government will be able to negotiate
lower prices for medications and help seniors afford to buy them.
Last month, the House instead passed a bill which uses an inadequate,
unreliable drug insurance program for seniors as a decoy to distract
people from the bill's real purpose--privatizing Medicare and turning
it into a voucher program. I voted against that bad bill. That bill is
now in a House-Senate conference, which is charged with combining it
with a very different Senate bill. If H.R. 2427 passes the House
tonight, it will become part of the discussion for that conference
committee and increase the pressure for that committee to address the
issue of affordable drugs, rather than focusing on privatizing
Medicare.
I believe we must address the issue of real drug coverage for seniors
and the issue of unreasonably high drug prices. The Republican
leadership hoped to avoid that issue by only allowing a vote on the
broadest possible approach. Tonight, I stand with my colleagues in
refusing to play games, and I will vote for H.R. 2427 to keep this
issue alive and force action.
Mr. STARK. Mr. Speaker, I rise in support of H.R. 2427, the
Pharmaceutical Market Access Act.
This bipartisan legislation overcomes the stranglehold that the drug
lobby has on Congress and provides a means of providing safe,
affordable medication to all our citizens. It allows for the
importation from Canada and Western European countries of Federal Drug
Administration (FDA)-approved prescription drugs that sell at prices
significantly below those charged for the same medications in the
United States.
Last year, average drug prices in the United States were
approximately 67 percent higher than those in Canada and about twice
those in Italy and France. Yes, for the same drugs! As a result of
these high prices, many Americans are denied the medical treatment they
require. They just cannot afford to pay for the drugs they need for
their health. This bill takes a commonsense approach to address this
problem; it provides Americans ready access to these same lower cost
drugs from other countries.
The opponents of this bill--most notably the administration,
Republican House leaders and the powerful drug lobby--contend that the
passage of this legislation would compromise the safety of prescription
drugs in this country. Let's examine the validity of this contention:
There is no validity to opponents' claims that this legislation would
open our markets to counterfeit drugs. The legislation not only
requires that these imported drugs meet current Federal drug
regulations, but it strengthens these standards by requiring all
prescription drugs sold in the country to use high security,
counterfeit-resistant packaging. (A technology already being used
throughout the European Union). Furthermore, the legislation only
allows the importation of FDA-approved drugs manufactured in FDA-
approved facilities.
Opponents falsely claim that state this legislation would allow
individuals to access drugs
[[Page H7610]]
without prescriptions. The regulations currently in effect controlling
the accessibility of prescription drugs are not changed at all by this
legislation.
Despite protests from those who oppose this bill, the fact is that
drug manufacturers safely import an estimated $14.7 billion worth of
FDA-approved drugs into this country today. It is also estimated that
more than a million Americans already purchase their medications from
outside the American market--for example, by taking trips into Canada
or by making an Internet purchase--without any evidence of adverse
effects.
Thus, it appears that the safety argument is just a red herring. A
bogus argument to defeat this legislation and continue the practice of
providing Americans with ready access solely to drugs offered at
inflated prices that feed the insatiable profit-hungry appetite of the
pharmaceutical industry and corporate investors. It is time to put an
end to this practice.
The goal of this bill is simple. It will allow American consumers the
right to purchase needed medication at a lower price. I urge my
colleagues to support the passage of the Pharmaceutical Market Access
Act.
Mr. BLUMENAUER. Mr. Speaker, I am glad that the House has finally
decided to confront what can only be described as a national
embarrassment. Today we must take steps to prevent our low-income
seniors from paying the highest prescription drug prices in the world.
Reimportation is a valid approach. While it may slice drug profits,
it costs taxpayers nothing.
If we do not act to protect seniors from skyrocketing drug prices, I
worry that it is because we are choosing to protect drug companies from
competition on the world market. This competition with willing sellers
of FDA approved drugs from abroad will ensure that our seniors get the
lower prices that citizens in other countries enjoy.
Opponents of this common sense solution warn of grave risks, which
the evidence suggests are wildly exaggerated. There are certainly fewer
risks than continuing the mass underground reimportation that takes
place today.
Tonight's vote is an important step in this struggle to stop the
exploitation of seniors. It is, however, just a beginning. I look
forward to building on this momentum for the hard task ahead.
Mr. SMITH of Texas. Mr. Speaker, I rise in opposition to H.R. 2427.
Like many of my colleagues, I am greatly alarmed by the negative
ramifications of this legislation. This bill threatens continued
patient access to safe and regulated prescription drug products, fails
to address affordability issues for senior citizens, and violates U.S.
drug patent and trade agreements.
This bill directly undermines the current regulatory system to
prevent unapproved or otherwise unsafe prescription drugs from entering
the U.S. consumer market. It prevents regulating authorities from
enforcing drug labeling standards, inspecting the quality and
components of imported drugs, verifying that strict safety standards
are met, and maintaining market-related drug prices.
In addition, H.R. 2427 fails to provide lower prescription drug costs
to patients and senior citizens. According to the congressional Budget
Office, the importation program does not result in savings to the
federal government or consumers as previously predicted. In fact, CBO
reports that if ``manufacturers were unable to limit the supply of
drugs entering the U.S. market from Canada, the likely result would be
that brand-name prices in Canada would rise much more than the price in
the U.S. would decline.''
Finally, this legislation allows the wholesale and individual
importation of drugs into the U.S. from Canada even where a U.S. patent
exists. This will nullify a patent owner's exclusive right to prevent
importation and thereby undermine U.S. patent rights. Further, these
provisions breach various U.S. international treaty obligations. By
allowing drugs with a U.S. patent to be imported, the provisions
violate several free trade agreements to which the U.S. is a party
because most require that the owner of a patent be able to prevent
third parties from importing the product without their consent.
This legislation would dangerously decrease the overall quality of
drug products that consumers purchase, sabotage the regulatory system,
and conflict directly with U.S. patent and trade agreements. All
without lowering prescription drug prices.
I urge my colleagues to vote ``no'' on H.R. 2427.
Mr. FRANKS of Arizona. Mr. Speaker, a wise man once said, ``markets
are more powerful than governments.'' Ronald Reagan believed in the
power of a free market system. He believed that the market is a model
for growth throughout the world. That is why I rise today in support of
H.R. 2427, the Pharmaceutical Market Access Act. As a co-sponsor of
this legislation, I believe this bill breaks open a market that
currently does not exist. We live in a terrible anomaly where Americans
continue to pay drug prices that are 30 to 300 percent more than in
European and other industrialized nations. Over the next 10 years,
seniors will spend $1.8 trillion on prescription drugs. That is a
shocking statistic--one that will cause prescriptions to go unfilled
because prices are too high in the United States. But, if seniors had
access to world market drugs, they would save 35 percent, or $630
billion. We, as American consumers, have the power to knock down this
unfair barrier to growth and freer access to pharmaceuticals.
The Opponents of this legislation will tell you that this legislation
will bring dangerous drugs into this country. They will tell you that
it allows for faulty packaging and poor shipping conditions. They will
tell you that this legislation forces American consumers to risk their
own health. None of these claims are true. The Pharmaceutical Market
Access Act contains language written by people at the FDA that requires
that each pharmaceutical shipment be tested, unless the package already
uses counterfeit-resistant technology. This kind of technology is the
same technology that the U.S. Department of the Treasury uses to secure
U.S. currency. And, more importantly, market access would be limited to
25 industrialized nations, such as Canada, Australia, Japan, Norway,
Switzerland and New Zealand. The FDA will implement a system to allow
Americans access to FDA-approved drugs from FDA-approved facilities.
Today, we prohibit Americans access to other markets, but other
products in the consumer chain--like, fruit or meat--are allowed. This
is or opportunity to codify our fundamental right to open
pharmaceutical markets and allow seniors to keep more of their hard-
earned dollars in their pockets. This is our opportunity to give
pharmaceutical companies the leverage that they need to knock down
barriers, and more importantly, to knock down price controls. In the
long run, this will be better for pharmaceutical companies and better
for American consumers. I commend Mr. Gutknecht for being a champion
of this important issue and I urge my colleague to support this effort.
Mr. KNOLLENBERG. Mr. Speaker, I rise today to urge my colleagues to
protect the well-being of the American people by voting against H.R.
2427, the Pharmaceutical Market Access Act, which would allow the re-
importation of drugs.
It is estimated that more than 10 percent of drugs worldwide are
counterfeit, and in some countries, more than half the drug supply is
fake. We have seen in this country the tragic consequences of
counterfeit drugs.
For example, many American AIDS and cancer patients were victims of a
counterfeit version of the injectible medication, Procrit. Hawked as
the life-prolonging Procrit, the counterfeit drug proved to be lethal,
non-sterile tap water. How many more cases like this will we experience
with re-importation?
In fact, multiple FDA commissioners have declared, ``Consumers are
exposed to a number of potential risks when they purchase drugs from
foreign sources.''
I sincerely appreciate my colleagues' efforts to make prescription
drugs more accessible. However, this pursuit of accessibility
compromises the health and safety of American citizens. I encourage all
my colleagues to ensure the safety of our citizens by voting against
H.R. 2427.
The SPEAKER pro tempore (Mr. LaHood). All time for debate has
expired.
Pursuant to House Resolution 335, the bill is considered read for
amendment, and the previous question is ordered.
The question is on the engrossment and third reading of the bill.
The bill was ordered to be engrossed and read a third time, and was
read the third time.
Motion to Recommit Offered By Mr. Dingell
Mr. DINGELL. Mr. Speaker, I offer a motion to recommit.
The SPEAKER pro tempore. Is the gentleman opposed to the bill?
Mr. DINGELL. Most vigorously so, Mr. Speaker.
The SPEAKER pro tempore. The Clerk will report the motion to
recommit.
The Clerk read as follows:
Mr. Dingell of Michigan moves to recommit the bill, H.R.
2427, to the Committee on Energy and Commerce.
The SPEAKER pro tempore. Without objection, the previous question is
ordered on the motion to recommit.
There was no objection.
The SPEAKER pro tempore. The question is on the motion to recommit.
The motion to recommit was rejected.
The SPEAKER pro tempore. The question is on the passage of the bill.
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
[[Page H7611]]
Recorded Vote
Mr. TAUZIN. Mr. Speaker, I demand a recorded vote.
A recorded vote was ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, this 15-
minute vote on passage will be followed by a 5-minute vote on the
motion to instruct on H.R. 1308, if ordered.
The vote was taken by electronic device, and there were--ayes 243,
noes 186, not voting 6, as follows:
[Roll No. 445]
AYES--243
Abercrombie
Ackerman
Aderholt
Allen
Baca
Baird
Baldwin
Ballance
Bartlett (MD)
Bass
Becerra
Bell
Bereuter
Berkley
Berry
Bishop (GA)
Bishop (NY)
Blumenauer
Bono
Boozman
Boswell
Boucher
Boyd
Brady (PA)
Brady (TX)
Brown (OH)
Brown (SC)
Brown, Corrine
Brown-Waite, Ginny
Burton (IN)
Capito
Capps
Capuano
Cardoza
Carson (IN)
Case
Castle
Clay
Conyers
Cooper
Costello
Cramer
Crowley
Culberson
Cummings
Davis (AL)
Davis (CA)
Davis (IL)
Davis (TN)
Davis, Jo Ann
DeFazio
Delahunt
DeLauro
DeMint
Deutsch
Dicks
Doggett
Doyle
Duncan
Edwards
Ehlers
Emanuel
Emerson
Engel
Evans
Everett
Fattah
Filner
Flake
Forbes
Frank (MA)
Franks (AZ)
Frost
Garrett (NJ)
Gilchrest
Gonzalez
Goode
Goodlatte
Gordon
Green (TX)
Grijalva
Gutknecht
Harman
Hastings (FL)
Hastings (WA)
Hayworth
Hensarling
Hinchey
Hinojosa
Hoeffel
Hoekstra
Holden
Hooley (OR)
Hoyer
Hunter
Hyde
Inslee
Israel
Istook
Jackson (IL)
Jackson-Lee (TX)
Janklow
Jenkins
Johnson (CT)
Jones (NC)
Jones (OH)
Kanjorski
Kaptur
Kennedy (RI)
Kildee
Kilpatrick
Kind
King (IA)
Kingston
Kleczka
Kolbe
Kucinich
LaHood
Lampson
Langevin
Lantos
Larsen (WA)
Larson (CT)
LaTourette
Leach
Lee
Levin
Lewis (GA)
Lipinski
Lowey
Lucas (KY)
Lynch
Majette
Maloney
Manzullo
Markey
Marshall
McCarthy (NY)
McCollum
McDermott
McGovern
McHugh
McInnis
McKeon
McNulty
Meehan
Mica
Michaud
Miller (MI)
Miller (NC)
Miller, George
Mollohan
Moore
Moran (KS)
Moran (VA)
Murtha
Musgrave
Myrick
Nadler
Napolitano
Neal (MA)
Neugebauer
Northup
Oberstar
Obey
Olver
Ortiz
Osborne
Otter
Owens
Pallone
Paul
Pelosi
Peterson (MN)
Peterson (PA)
Petri
Platts
Pomeroy
Rahall
Ramstad
Rangel
Rehberg
Renzi
Reyes
Rodriguez
Rohrabacher
Ross
Roybal-Allard
Royce
Ruppersberger
Ryan (OH)
Ryan (WI)
Sabo
Sanchez, Linda T.
Sanders
Sandlin
Schakowsky
Schiff
Schrock
Scott (VA)
Sensenbrenner
Serrano
Shadegg
Shaw
Shays
Sherwood
Shuster
Simpson
Skelton
Slaughter
Smith (MI)
Smith (NJ)
Snyder
Solis
Spratt
Stark
Stenholm
Strickland
Stupak
Tancredo
Taylor (MS)
Taylor (NC)
Thornberry
Tierney
Toomey
Turner (TX)
Udall (NM)
Van Hollen
Velazquez
Vitter
Wamp
Waters
Watson
Watt
Weiner
Wexler
Wicker
Wilson (NM)
Wolf
Woolsey
Wu
Wynn
Young (FL)
NOES--186
Akin
Alexander
Andrews
Bachus
Baker
Ballenger
Barrett (SC)
Barton (TX)
Beauprez
Berman
Biggert
Bilirakis
Bishop (UT)
Blackburn
Blunt
Boehlert
Boehner
Bonilla
Bonner
Bradley (NH)
Burgess
Burns
Burr
Buyer
Calvert
Camp
Cannon
Cantor
Cardin
Carson (OK)
Carter
Chabot
Chocola
Clyburn
Coble
Cole
Collins
Cox
Crane
Crenshaw
Cubin
Cunningham
Davis (FL)
Davis, Tom
Deal (GA)
DeGette
DeLay
Diaz-Balart, L.
Diaz-Balart, M.
Dingell
Dooley (CA)
Doolittle
Dreier
Dunn
English
Eshoo
Etheridge
Farr
Feeney
Ferguson
Fletcher
Foley
Fossella
Frelinghuysen
Gallegly
Gerlach
Gibbons
Gillmor
Gingrey
Goss
Granger
Graves
Green (WI)
Greenwood
Hall
Harris
Hart
Hastert
Hayes
Hefley
Herger
Hill
Hobson
Holt
Honda
Hostettler
Houghton
Hulshof
Isakson
Issa
John
Johnson (IL)
Johnson, E. B.
Johnson, Sam
Keller
Kelly
Kennedy (MN)
King (NY)
Kirk
Kline
Knollenberg
Latham
Lewis (CA)
Lewis (KY)
Linder
LoBiondo
Lofgren
Lucas (OK)
Matheson
Matsui
McCarthy (MO)
McCotter
McCrery
McIntyre
Meek (FL)
Meeks (NY)
Menendez
Millender-McDonald
Miller (FL)
Miller, Gary
Murphy
Nethercutt
Ney
Norwood
Nunes
Nussle
Ose
Oxley
Pascrell
Payne
Pearce
Pence
Pickering
Pitts
Pombo
Porter
Portman
Price (NC)
Pryce (OH)
Putnam
Quinn
Radanovich
Regula
Reynolds
Rogers (AL)
Rogers (KY)
Rogers (MI)
Ros-Lehtinen
Rothman
Rush
Ryun (KS)
Sanchez, Loretta
Saxton
Scott (GA)
Sessions
Sherman
Shimkus
Simmons
Smith (TX)
Smith (WA)
Souder
Stearns
Sullivan
Sweeney
Tanner
Tauscher
Tauzin
Terry
Thomas
Thompson (CA)
Thompson (MS)
Tiahrt
Tiberi
Towns
Turner (OH)
Udall (CO)
Upton
Visclosky
Walden (OR)
Walsh
Waxman
Weldon (FL)
Weller
Whitfield
Wilson (SC)
Young (AK)
NOT VOTING--6
Ford
Gephardt
Gutierrez
Jefferson
Pastor
Weldon (PA)
Announcement by the Speaker Pro Tempore
The SPEAKER pro tempore (Mr. LaHood) (during the vote). Two minutes
are left to vote.
{time} 0251
Mr. SMITH of Texas changed his vote from ``aye'' to ``no.''
So the bill was passed.
The result of the vote was announced as above recorded.
A motion to reconsider was laid on the table.
____________________