Pharmaceutical Market Access Act of 2003

Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 335 and ask for its immediate consideration.

Mr. Speaker, for the purpose of debate only, I yield the customary 30 minutes to the gentlewoman from New York (Ms. Slaughter), pending which I yield myself such time as I may consume. During consideration of this resolution, all time yielded is for the purpose of debate only.

Mr. Speaker, the resolution before us is a well-reasoned rule providing for consideration of H.R. 2427, the Pharmaceutical Market Access Act of 2003. This rule waives all points of order against consideration of the bill and provides 1 hour of debate, evenly divided and controlled by the chairman and ranking minority member of the Committee on Energy and Commerce or their designees.

The rule also provides that during consideration of the bill, notwithstanding the operation of the previous question, the Chair may postpone further consideration of the bill to a time designated by the Speaker.

Finally, Mr. Speaker, this rule provides for one motion to recommit.

Mr. Speaker, I rise today to introduce the rule for H.R. 2427, the Pharmaceutical Market Access Act of 2003. The fact that this legislation is on the floor today demonstrates the willingness of the House Republican leadership to deal with contentious issues publicly on this House floor and to allow democracy to work by giving every Member an opportunity to cast their vote on an important issue and issues that are important to them and the American public.

But, while I believe that the underlying legislation that we will bring to the floor later is well-intentioned, it is also deeply flawed and puts the health and well-being of the American public at great risk. Congress needs to find a way to provide affordable prescription drugs to all Americans. This, however, is not the way to do it.

Mr. Speaker, the problems with this legislation can be divided into three main categories. First, safety; second, fairness; and, lastly, legal liability.

On the topic of safety, H.R. 2427 is certain to harm Americans in a number of ways. First is the issue of

verifiability. Today, on nearly every single East Asian street corner, an American traveler can pick up for only a few dollars what looks like at first inspection to be a Polo shirt that would retail in American stores for around $50. However, as anyone who has ever bought one of these shirts has learned, perhaps the hard way, after a few washings, these shirts fade, rip and generally fall apart. But I believe the consumer knew what the consumer was buying at the time that they bought it.

H.R. 2427 would open American consumers of prescription medicine up to this same kind of potential scam by allowing them to be ripped off by offering an inferior product that looks like the genuine article, but with life or death consequences not associated with purchasing illegal leisure wear. The difference here is that the consumer does not know what they are purchasing. The other can be verified and they know for sure.

I believe that the health and well-being of American drug consumers is all too important to allow them to be taken advantage of in this fashion by passing a law that would allow clever black market manufacturers with the capability to make superficially similar reproductions of prescription drugs and to pass them off as the real thing to unsuspecting American consumers.

Of course, the difference here is that when you buy that shirt on the street corner, you know that what you are buying is probably a fake and it will fall apart after a few washings, whereas our Nation's seniors and other prescription drug buyers will think that they are getting the real thing, a mistake that could have dangerous or even fatal consequences.

Another safety issue raised by this legislation is that it leaves us utterly defenseless if a health safety crisis caused by substandard or fake imported medicine is discovered. The bill would remove 16 important provisions in the U.S. law which currently protect American consumers from unsafe, counterfeit and substandard imported medicines.

For example, importation would be required under H.R. 2427 even if the Secretary of Health and Human Services believes it would pose ``an additional risk to the public health and safety.''

To demonstrate the full nature of this threat, an analogy can be drawn with yet another health crisis that happened recently. Earlier this year, when there were concerns about Mad Cow Disease in cattle from Canada that might make it its way into the United States, the Food and Drug Administration took immediate action to close the border to Canadian beef. Likewise, we need the same kind of protection for counterfeit prescription drugs that may be making their way across the border. Unfortunately, this legislation provides no protection.

The removal of these important safety provisions will lead to an influx of counterfeit and dangerous medicines into the United States. I believe that our public health and safety officials should have the right to close our borders to counterfeits and to importers who counterfeit prescription drugs. However, once again, H.R. 2427 would strip the ability of the Department of Health and Human Services to suspend reimportation of specific products or from specific importers, even if the agency discovers a pattern of counterfeits.

Existing law already allows for reimportation of prescription drugs when the health and safety of Americans can be ensured.

This bill would change that and allow importation even when health and safety could not be assured.

This legislation says that safety, in essence, does not matter. But I do say that safety matters, and it should matter whether we are talking about the beef we eat or the prescription drugs that we take.

Finally, this legislation poses a safety risk to consumers because it prevents consumers from being able to guarantee the source or effectiveness of their prescription drugs. In fact, in a letter to the gentleman from Louisiana (Mr. Tauzin), chairman of the Committee on Energy and Commerce, the Commissioner of the Drug Administration, Dr. Mark McClellan stated that this legislation would ``create a wide channel for large volumes of unapproved drugs and other products to enter the United States that are potentially injurious to the public health and that pose a threat to the security of our Nation's drug supply.''

A real live example of this case is of an Internet-based counterfeit drug provider, TrustedCanadianPharmacy.com, that claims to be the most trusted pharmacy in Canada. The site is actually registered in Barbados which, I believe, is an island off Venezuela, not a Canadian province. The products from this site could be imported into America fraudulently, with consumers believing that they were getting reimported drugs through Canada. That is why the Canadian Government has ``never stated that it would be responsible for the safety and quality of prescription drugs exported into the United States, or any country, for that matter.''

The second set of problems created by this legislation relates to fairness, both to American consumers and to the developers of the new and innovative drugs of tomorrow. If Congress were to pass this legislation, America would be justified in importing the practices of those countries that coerce drug innovators into providing their lifesaving products at below market rates. These other countries get these anticompetitive prices for medicine by blackmailing drug innovators with the threat of breaking their patent rights and illegally transferring their intellectual property to a domestic manufacturer if they refuse to concede in providing their drugs at an artificial, nonmarket rate.

As it currently stands, American prescription drug consumers already subsidize the anticompetitive practices of countries with socialized medical schemes, and I believe that is unfair. However, the answer to this problem is not to import the price controls and strong-armed tactics of the European Community. It is to address the issues through trade negotiations and the enforcement of legal mechanisms to protect American manufacturers' intellectual property.

By being unfair to the producers of these innovative medicines, H.R. 2427 also has shortcomings that consumers need from these medicines to live healthy, productive, and pain-free lives. Importing the socialist price controls of other nations will create a disincentive for drug companies to reinvest in new drug research and development, and could set back the search for cures for breast cancer, AIDS, and a number of other deadly diseases for decades by starving the private sector of these funds and the incentives that it needs to conduct this ongoing, time-consuming, and often unprofitable research. In fact, in a letter to House Speaker Dennis Hastert, the National AIDS Treatment Advocacy Project noted that ``It is foolhardy for Congress to double NIH research and then launch hasty reimportation schemes that will undermine the entire drug development process by opening the floodgates to counterfeits which will destroy the value of intellectual property.''

Finally, this legislation raises a number of complicated and troubling legal issues. For example, if a consumer who purchases a tampered or counterfeit medicine gets sick or simply does not get better because they are taking a counterfeit placebo, where do they turn for legal relief? Will they sue the drug manufacturer of the real drug who had nothing to do with the counterfeit product consumed? Will they sue the doctor who prescribed the medicine, thinking that their patient will be using the real or true product? Will they sue the pharmacy that reimported it? How about the hospital or medical complex where the doctor has that practice?

There is no telling how great the overall drain on these productive and helpful industries could be as a result of being in court with these tort claims arising from this faulty reimportation scheme, nor is there any indication of how much this inefficiency will increase the health care and insurance costs of every American.

Mr. Speaker, this legislation would create a congressionally mandated litigation disaster that has the potential to destroy the viability of health care and insurance in America.

I would like to close by listing just a few of the organizations who oppose

this bill: the American Medical Association, the United States Chamber of Commerce, the Hispanic Business Roundtable, the Leukemia and Lymphoma Society, the Society for Women's Health Research, the Seniors Coalition, 50 Plus, the National Alliance for the Mentally Ill, and the National Prostate Center Coalition. These are simply a few of the 200 organizations that have looked at this underlying legislation and wish to make their words known that they do not support the underlying legislation.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentlewoman from Girardeau, Missouri (Mrs. Emerson).

Mr. Speaker, I yield 2 minutes to the gentleman from Surf Side, Texas (Mr. Paul).

(Mr. PAUL asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I yield 2 minutes to the gentleman from Pennsylvania (Mr. Toomey), one of the brightest young Members of Congress that we have.

Mr. Speaker, I yield 2 minutes to the gentleman from Nebraska (Mr. Bereuter).

(Mr. BEREUTER asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I yield 1 minute to the gentlewoman from Kentucky (Mrs. Northup).

Mr. Speaker, I yield 2 minutes to the gentleman from Minnesota (Mr. Gutknecht), who is the author of this legislation.

Mr. Speaker, I would like to let the minority know that I have two additional speakers, but I would like for them to feel free to run down their time and then just before the gentlewoman from New York closes, we will have one speaker for 1 minute and then we will close; and if we could proceed under that agreement.

Mr. Speaker, I yield 1 minute to the gentleman from Morristown, New Jersey (Mr. Frelinghuysen).

(Mr. FRELINGHUYSEN asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I would like to inquire and confirm that I have 4\1/2\ minutes remaining.

Mr. Speaker, I have one other speaker for about 4 minutes, and then I will consume the last 30 seconds. So I will let the gentlewoman decide if she would like to finish and then we will close.

Mr. Speaker, before I begin, I want to thank my colleague from Texas not only for his generosity of providing this time, but for the passion that he brings to education and to working families of all ilks, and the eloquence he brought to the words about the importance of education as the stepladder to the American dream.

So I want to thank him now for the generosity he provided so I can be with my family this evening and catch the last flight, and for his passion and tireless work on behalf of all Americans. Texas is lucky to have you as a Representative and a voice; not only a vote, but a voice for their values.

Mr. Speaker, about 2 weeks ago a number of us came to the floor to speak on market access, and that is the ability of Americans to purchase medications anywhere in Canada, Ireland, England, France, Germany, Italy, wherever they get the cheapest price.

Since the last time that my good friend from Minnesota and I were here, there was a report yesterday by Families USA that ABC news covered and the Wall Street Journal covered, and I would like to bring that statistic to the attention of the American people. It reaffirmed a disturbing trend about skyrocketing prescription drug prices in the United States.

On average, the prices of the 50 drugs most commonly prescribed to seniors increased at a three-and-a-half times rate of inflation. The total spending of senior citizens on prescription drugs rose an estimated 44 percent from 2000 to 2003, when inflation was only running at collectively over those periods of time of 6 percent. Now we are projected to spend over the next 10 years $1.8 trillion by our seniors on their medications, and yet when we think about those dollars, the American elderly spend somewhere between 30 to 300 percent higher in prices than the senior citizens of France, England, Germany, Canada, Denmark, any of the G-8 countries and our colleagues in Europe.

My good friend from Minnesota has brought a bill into play that allows our American consumer, our American elderly, our businesses and, most importantly, our taxpayers to get the use of market forces to reduce those prices, bring real competition and the close market that our pharmaceutical companies have brought and bring competition that would save billions of dollars to the consumer and, most importantly, to the taxpayer.

To me, if we are going to have the largest expansion of an entitlement in 40 years, spend $400 billion, you would think you would want to get the taxpayer the best price, but the pharmaceutical companies have done a pretty good job of playing the political system to their benefit, and they have tried to prevent us from getting this bill to the floor, because if we got the bill to the floor, they would know what happens.

In my view, this is not only good for the seniors, they would get good prices, but it would be fair to the taxpayers who are going to be asked to pay this bill.

So my friend from Minnesota has a wonderful bill. I think he has been here many times to explain his chart about

comparative prices. I would like to yield now some time to him to talk, and then I would like to ask some questions, if he does not mind.

I yield to the gentleman from Minnesota.

Those are the same drugs? I did not mean to interrupt my colleague. Same medication, nothing different?

I yield to the gentleman from North Carolina.

(Mr. JONES of North Carolina asked and was given permission to revise and extend his remarks, and include extraneous material.)

Mr. Speaker, reclaiming my time, you should take a little solace in the fact that they have decided to go to scare tactics because they know this is not about price controls. This is about letting the market determine the price that we can pay, and they are scared of the free market. This is a large company that has a captive market and is scared of the forces of the free market to determine the best price. So they have decided to through a few Members try to play the worst and ugliest of politics because on the merits they cannot win it, and I compliment you for having the courage to stand by your principles.

I would like to make a note to something earlier that our good friend the gentleman from Minnesota (Mr. Gutknecht) said which deals with the fact that we are Democrats and Republicans here. We give different views on different subjects, but the fact is what has brought us here is our common principles and our common values, and this is a bipartisan issue because we jointly think that our seniors should not be paying the highest price, and our taxpayers should not be asked to pay the highest price when you can get lower prices.

As our colleague from Minnesota showed with that chart, although people cannot see the specific numbers, they get the basic gist that there is a 700-buck spread for the same drugs you buy in Germany versus what we buy here.

You do not have to have a party difference to understand it is fundamentally wrong. It is not right, and we cannot ask the taxpayers as we embark maybe on the largest expansion of an entitlement program in 40 years to foot a bill that would be, in my view, the greatest, largest fleecing of America in front of the naked eye.

So the pharmaceutical companies have decided to engage in this scare tactic because on the merits and on the ground they cannot win this.

I would like to ask one question because they are engaged in one other subject up here. If the gentleman from Minnesota (Mr. Gutknecht) could walk the folks through that are watching the notion of safety, just to walk them through this, because that is another scare tactic. This is the first of many salvos. We are not done with their attacks, if you do not mind me interrupting, but I would like you to walk the public through the issue of safety.

Mr. Speaker, I appreciate that. So what you are saying is that unless it is FDA-approved, it cannot come in, and it is FDA- approved, meaning the Food and Drug Administration, which is the overseer, the czar of what is safe, approves it, then it can be purchased through the Internet or overseas and brought into the United States, because, as you said earlier, it is manufactured at the same facilities. So there is really no pricing differences except they get price differences there than here. So they are FDA-approved.

Mr. Speaker, both of my colleagues we were talking a little earlier; and perhaps you could address the question, what do you think, given they have projected, I think it is $1.8 trillion over the next 10 years that seniors will be spending on medications, but if we had access to this bill and it was in place, what would be the savings to both the elderly as well as to the taxpayer, projected?

The truth is, Mr. Speaker, that we had an original bill that was going to use market forces to

bring competition between generic medications versus name-brand medications. That was projected to save the taxpayers and the consumers and the elderly $65 billion over 10 years. This concept, following that same principle of competition as the price reducer, let the market determine best price, would bring, I think the gentleman just said, a little over a half trillion dollars to the consumers, the elderly, over the next 10 years. It is using market forces.

Bringing that competition to bear on the market, that would bring prices down, and no longer would the American elderly and the American taxpayer be seen as the profit guinea pig for our pharmaceutical companies. They are making up the difference where they cannot get it in Germany or in England. They are making it up, the price difference, their profit margins, on our elderly. Therefore, our taxpayers are being asked to foot the bill in one of the largest fleecings of the American people we will ever see.

The principles of competition will bring prices down, I think. Pharmaceutical companies have gamed the system from the patent laws, the laws as it relates to competition and globalization, and through the tax laws. As my colleagues know, we had a provision which was to allow the NIH to recoup 10 percent on any drug that was developed and brought to market through NIH dollars. My view is anything below 30 percent in the private market is considered dumb money. The taxpayers, all the cancer drugs, all the AIDS drugs on the market were developed with taxpayer-based research. We should be recouping a minimum of 10 percent to the taxpayers. The NIH would be a self-funded agency in 10 years.

But the core of what we have, the biggest dollar saver is the gentleman's amendment that we are honored to be cosponsors of. Again, this is not price control; it is choice. If you bring choice to bear in the market, consumers will flock to the lowest price, and I think that is the basic principle why you have Democrats and Republicans ready to vote for this, if we could get it to the floor.

Well, Mr. Speaker, before I try to catch that last flight, when I was running for office and I was in Six Corners Jewel, which is our big grocery store with the Osco, on Irving and Organza, seniors would come out and show me what they were paying and they told me the stories about how they cut their medications in half, or a husband would skip a month so his spouse could take her medications. And the first thing they said is, you have to make this affordable. I have to be able to pay for this. They would talk about that, and ask me to make sure that whatever we did, we did not mess with their private plans. But then they would say, please, add a prescription drug benefit to Medicare.

In my view, if we are on the doorstep of adding that benefit, let us ensure, because it is the first thing they have all said to every one of us who has gone to meet with them, we have to make these drugs affordable. They cannot afford these prices. They would tell me, look, somehow last month my month's supply was $70 and this month it is $96, and nothing has changed. Nothing. If we brought competition, something would change.

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.

Mr. Speaker, I yield myself 3\1/2\ minutes.

(Mr. DINGELL asked and was given permission to revise and extend his remarks.)

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

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. Speaker, I yield 1 minute to the distinguished gentleman from New York (Mr. Towns), my good friend.

Mr. Speaker, I yield 2 minutes to the distinguished gentlewoman from California (Ms. Eshoo).

Mr. Speaker, I yield 2\1/2\ minutes to the distinguished gentleman from New York (Mr. Meeks).

Mr. Speaker, how much time remains?

Mr. Speaker, I am low on time and I would reserve.

Mr. Speaker, I yield 1 minute to the distinguished gentlewoman from the Virgin Islands (Mrs. Christensen), my good friend.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 1 minute to the distinguished gentleman from North Carolina (Mr. Price).

Mr. Speaker, I yield the balance of my time to the distinguished gentlewoman from Colorado (Ms. DeGette).

Mr. Speaker, I thank the gentleman from Texas for yielding me the 30 minutes, and I yield myself such time as I may consume.

(Ms. SLAUGHTER asked and was given permission to revise and extend her remarks.)

Mr. Speaker, after listening to my colleague, I can hardly believe that this is the same bill that passed the House twice. I had no idea that the Canadians were posing such a danger to us. That is really quite frightening. It strikes me, I think probably the danger is that the drug companies think that they may lose some research money; but since a great deal of it comes from the taxpayers of the United States, I do not know why they are so worried.

But anyway, Mr. Speaker, we are here again today with a rule that silences debate and deliberation. Late last night, along party lines, the Committee on Rules passed a closed rule for this bill. The closed rule prohibits anyone from offering amendments, including the gentlewoman from Missouri, who is, in large part, responsible for the consideration of this important legislation. The floor procedure muffles the voices of millions of Americans suffering under the outrageous cost of prescription drugs. And each side, for and against, deserves equal time and equal treatment.

Mr. Speaker, we are fortunate to live in an age when the wonders of science produces medicines that cure illness and improve the quality of life. Yet, the promise of the wonder drug is meaningless if you cannot buy them. The soaring costs of prescription drugs is a cancer on the body politic, threatening public health and our health care system. Prescription drug spending is the fastest growing component of health care spending. This spreading affliction harms everyone: seniors, working families with children, and small businesses that are doing everything they can to provide medical insurance for their employees.

A few years ago as a temporary Band-Aid, I organized a bus load of seniors to travel to Canada to purchase medications at a fraction of the cost charged in American markets. We had far more people interested than we could accommodate on our trip, but those who went saved anywhere from $100 to $650 on 3-month supplies of medication.

Right now, 10 million Americans are looking outside of the United States for affordable medicines. My constituents continue to write to me desperately looking for information on how to buy cheaper prescription drugs from Canada.

The U.S. market constitutes half of the worldwide revenue of pharmaceutical corporations. In 2001, for every dollar earned by the top 10 largest drug makers, 60 cents came from the U.S. market. U.S. consumers are routinely charged 20 to 80 percent more for prescription drugs than consumers in other industrialized nations.

If a woman from Niagara Falls fills a prescription at a pharmacy near her home, she could pay 67 percent more than she would if she crossed the Whirlpool Bridge and filled her prescription in Ontario. Tamoxifen is a highly effective, state-of-the-art medicine used in breast cancer therapy. An average prescription costs $340 in the United States, $340. In Canada, the same prescription is $40. Women in the United States should not have to pay 750 percent more for this lifesaving medicine.

People with diabetes and high cholesterol and arthritis and osteoporosis and other chronic illnesses should not be forced to buy needed prescription drugs at inflated prices just so that the pharmaceutical company executives can enjoy gargantuan profits. H.R. 2427 could reduce an average drug price by 35 percent and reduce drug spending by $635 million over 10 years.

The impact of these drug prices is particularly harsh on older Americans. Seniors disproportionately rely on prescriptions, and many have no drug coverage. It is estimated about one-third of the Medicare beneficiaries have no drug coverage at all, and others have partial coverage. Seniors are forced to pay most or all of their drug costs out-of-pocket.

Due to the ever-increasing costs, many older Americans go without filling prescriptions. Disturbingly, a study found that many seniors with serious health problems reported that they skip doses to make prescriptions last longer. According to a study released just today, African American Medicare beneficiaries age 65 and older are more than twice as likely as white beneficiaries to fail to fill prescriptions merely because of the cost.

The opponents of the legislation have put forth several arguments against drug reimportation. And, after hearing some of these arguments, I feel like I should call my friends and my colleagues across Lake Ontario and warn them about the grave danger posed by the prescriptions in their medicine cabinets.

But the fact is that drugs from Canada are safe. If the U.S. was faced with a medical crisis and a shortage of medicine to deal with it, I assure my colleagues we would not hesitate a second to import the drugs we needed from Canada to save our population.

Opponents claim that drug reimportation will result in a boom of counterfeit drugs. But the vast majority of counterfeit operations have been broken up here in the United States, not Canada, perhaps because the unaffordable cost of drugs in the U.S. creates a market for cheaper and sometimes counterfeit drugs.

Opponents are also saying that lower drug prices will impede research. The U.S. taxpayer already pays for much of the research through the National Institutes of Health, and the pharmaceutical industry remains by far the most profitable sector in the United States' economy. From 1994 to 1998, the after-tax profits averaged 17 percent, compared to 5 percent for all other industries. The high drug prices in the United States enabled pharmaceutical companies to spend more on marketing and administration than on research. And in the year 2000, the pharmaceutical industry spent more than $15 billion on marketing.

A few years, Schering-Plough spent more money marketing Claritin than Coca Cola spent advertising Coke, and more than Anheuser-Busch promoting Budweiser beer. The pharmaceutical companies have the funds necessary to continue research to discover the next breakthrough treatment, but consumers do not have the funds to buy the medicine at the inflated prices.

Some opponents of drug reimportation question the safety and efficacy of medicines brought into the United States. The underlying bill restricts the exporting countries to other industrial nations like Canada, Australia, New Zealand, and the countries of the European Union. And the United States imports guns, it imports explosives, it imports lethal chemicals and uranium and food and medical devices like pacemakers and heart valves. If we can safely and effectively import these, we can safely import prescription drugs.

The technology to ensure the safety and efficacy of imported medicines exists; we just need to use it. Even the Federal Government shops for pharmaceuticals in foreign markets. When the Federal Government needed additional doses of Anthrax vaccine after our domestic supplies had run out, where do you suppose the Pentagon bought the vaccine? From Canada.

Mr. Speaker, H.R. 2427 is an effective remedy for the crippling cost of prescription drugs and is an immediate treatment that benefits seniors, working families, and small businesses. In the end, the only loser is the inflated profits of the cash-rich pharmaceutical industry. We can and we must do better for the American people. We owe it to them to pass this legislation for the third time.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentleman from Massachusetts (Mr. McGovern).

Mr. Speaker, I yield 2 minutes to the gentleman from Oregon (Mr. DeFazio).

Mr. Speaker, I yield 2 minutes to the gentleman from Ohio (Mr. Brown).

Mr. Speaker, I yield 2 minutes to the gentleman from Vermont (Mr. Sanders).

Mr. Speaker, may I inquire how much time is remaining on both sides?

Mr. Speaker, I yield 1 minute to the gentleman from New Jersey (Mr. Pallone).

Mr. Speaker, I yield 1\1/2\ minutes to the gentleman from Maine (Mr. Allen).

That is fine, Mr. Speaker. We would be happy to do that.

Mr. Speaker, I yield 1 minute to the gentleman from Maryland (Mr. Wynn).

(Mr. WYNN asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I yield 1\1/2\ minutes to the gentleman from Michigan (Mr. Dingell).

(Mr. DINGELL asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I yield 2 minutes to the gentleman from New Jersey (Mr. Menendez).

Mr. Speaker, I am pleased to yield 1 minute to the gentleman from Ohio (Mr. Kucinich).

Mr. Speaker, may I inquire of the time, please.

Mr. Speaker, I yield 2 minutes to the gentleman from Illinois (Mr. Emanuel).

Mr. Speaker, I am pleased to yield 2 minutes to the gentleman from Massachusetts (Mr. Tierney).

(Mr. TIERNEY asked and was given permission to revise and extend his remarks.)

Mr. Speaker, will the gentleman yield?

Mr. Speaker, I want to thank the gentleman from Illinois, and I want to make a special point. This is time on the Democrats today. We have Democrats and Republicans that are agreed on this because, as I said in the past, this is not a matter of right versus left. It is a matter of right versus wrong, and it is simply wrong to require that Americans pay the world's highest prices for prescription drugs, even though we are the world's best customers.

In virtually every other area that you can imagine, the best customers get the best prices, but that is not true in prescription drugs, and I began to research this story about 5 years ago, and the more I learned, the more upsetting and compelling this story really is.

The story is that Americans are really held captive, and anytime you have a captive market, it is absolutely predictable that you are going to see the world's highest prices.

I want to give you a few examples from this chart. I apologize, this chart is kind of hard to read, but I will show you some of the examples, and I will give you the total, because I was in Germany 2 months ago, and we bought 10 of the most commonly prescribed prescription drugs. What you see here on the chart is the prices that we paid in Munich, Germany, and what those prices would be for the same drugs, same quantities, same milligrams, here in the United States. Let me give you a few of those examples.

This is a drug called Coumadin. It is a blood thinner, actually developed at the University of Wisconsin veterinarian schools, and actually originally developed as a rat poison, but in the United States, this box of drugs would sell for $89.95. In Germany we bought the drug for $21.

Here is another drug, Glucophage, made by Merck. It is a very effective drug for diabetes. A 30-tablet, 850-milligram package in the United States, $29.95. You can buy that same package, this package of drugs we bought in Munich, Germany, for $5.

The story goes on. Zocor, commonly prescribed drug, a very effective drug, the United States price, $89.95. You can buy that drug in Germany for $41.20.

The grand total of these 10 drugs in Germany was $373.30 American, but if we went down to buy them here in Washington, D.C., or almost any city in America, the price would be $1,039.65.

In fact, in many of the cases, I believe these drugs were made in the same plants, and they are shipped around the world.

All we really are saying in our bill is let us do with prescription drugs essentially what we do with every other product, and that is allow market forces to work to make certain that Americans are not held captive, and as I have said, I think Americans should pay their fair share, but I do not think we should be required to subsidize the starving Swiss.

We also have a colleague with us tonight, my good friend from North Carolina (Mr. Jones) who has joined us tonight, and he has been a strong proponent of opening markets and finding ways to get cheaper prescription drugs not just for senior citizens, but for all Americans. Ultimately we are going to have a prescription drug benefit for the taxpayers as well, and I would yield, if I could, a few minutes to the gentleman from North Carolina.

Mr. Speaker, if the gentleman would continue to yield, I thank the gentleman from Illinois, and I thank my colleague from North Carolina as well.

One of the arguments that they are making is this is not safe, you cannot be reimporting or importing or opening markets to these drugs. And once again, let me say, first of all, we are only talking about FDA-approved drugs from FDA-approved facilities, number one.

Number two, what more and more of the companies are coming out with, and we require in our legislation, and that is, they begin to develop counterfeit-proof packaging, tamper-proof, counterfeit-proof packaging.

The other thing people need to understand is we are not saying people have to do this. This is their option. We want to make certain that they are not treated like common criminals, because right now seniors are doing this. There was a study done by a University of Texas professor. A million Americans right now are crossing the border to buy their prescription drugs, and they have no assurance, no tamper-proof packaging, and worse than that, they are treated like common criminals by their own government.

So we want to make it safer. We actually want to put in a regimen, a plan, so that people can do this and their pharmacists can do this, because my vision is people ought to be able to go to the local pharmacist, and he ought to be able to shop for the best price on the best drugs. It is called parallel trading. That is what they do in Europe, and it is why they get cheaper prices than we do here in the United States.

We are concerned about safety, too. I do not want people dying from taking contaminated drugs, but remember this: Every day we import thousands of tons of food. Last year we imported 318,000 tons of plantains, and so if someone wants to tamper with things that go into people's mouths, they are more likely to do it with food products than they are with something that comes in a tamper-proof, counterfeit-proof package.

We are only talking about FDA drugs, and more importantly than that, you are correct. There are only, as I am told, about 600 facilities in the world that can produce FDA-approved drugs, and so that is the only drugs that we would permit, and we believe that a program can be established very easily using modern technology so that we can be as certain that these drugs are, in fact, Coumadin or Glucophage from an FDA-approved facility.

We can be just as assured of that even if we get the drugs from Geneva, Switzerland, or from right down the street. We want safe drugs. We want seniors to be safe. And I think we have the plan that will do that.

Mr. Speaker, the gentleman is correct. The Congressional Budget Office, which are our official bean counters, if you will, have estimated that seniors in the United States over the next 10 years will spend $1.8 trillion on prescription drugs. We can see by this chart, and I think we were very conservative, we estimate that if we simply open markets, as we do with plantains and with prunes and with pork bellies, if we just open up the markets as we do with everything else, we will see prices in the United States drop by at least 35 percent. Well, 35 percent of $1.8 trillion is $630 billion that we will save American consumers and/or taxpayers.

If I can give just one more example. We had an Inspector General who testified before the Committee on the Budget just yesterday, her name was Dara Corrigan, and she estimated, and these are her numbers not mine, but her numbers were that last year Medicare through the hospitals bought $8.2 billion worth of prescription drugs. If they could have bought those drugs at the same price that the VA buys those drugs, her estimate was that taxpayers would have saved $1.9 billion last year.

Now, my assertion is that if we open up the markets, we are going to save the VA, we are going to save Medicare, we are going to save Medicaid, we are going to save consumers, we are going to save corporations.

Last year, General Motors spent $1.3 billion on prescription drugs. Imagine how much they could save if they had access to world market prices.

I would just simply say that I hope we can have a vote. This is the people's House. Vox popolurum est vox dei, the voice of the people is the voice of God. There is where the people's business should be done. Occasionally we have partisan differences and we vote differently, but this is one that crosses party lines. It is not a matter of right versus left; it is right versus wrong. It is wrong for Americans to be held captive.

Absolutely. I know the gentleman wants to catch his plane, but I just want to say this. Regardless of what happens in the next week or two, we are not going to go away. This issue will not go away. We will stay here, on a bipartisan basis, every night for the next 6 months, 9 months, 3 years. We are not going away. The issue is not going to go away.

There is no way that our leadership, the administration, the FDA, the drug companies can defend a situation where Americans pay two and a half times more for the same drugs than our counterparts in Germany. I am not going to give up, my colleagues here tonight are not going to give up, and God bless you all.