Providing for consideration of 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.

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, 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 offer a motion to recommit.

Most vigorously so, Mr. Speaker.

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, 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.

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.

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.

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

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. 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. 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. 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. 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. Speaker, I am pleased to yield 1 minute to the distinguished gentleman from Illinois (Mr. Crane).

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.)

Will the Speaker announce how much time remains.

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.)

Mr. Speaker, I yield 1 minute to the gentleman from Texas (Mr. Sessions).

Mr. Speaker, I am pleased to yield 1 minute to the gentleman from California (Mr. Gary G. Miller).

Mr. Speaker, may I inquire once again as to the time allocations.

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

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. 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. Speaker, I demand a recorded vote.

Mr. Speaker, I thank the gentleman for yielding me time.

Mr. Speaker, I rise in support of the rule, but I also strongly support the bill itself, H.R. 2427. And I would like to advise other Members here that I approach all legislation the same way. I look at it through two prisms. One, I look to see if it promotes freedom, and the other I look to see if it conforms to the Constitution.

Every piece of legislation I look at it in this manner. Now, the sad part is I do not get to vote for many bills. They come up short on quite a few occasions. So I want to thank the gentleman from Minnesota (Mr. Gutknecht) and the gentlewoman from Missouri (Mrs. Emerson) for giving us a bill tonight that I can vote for enthusiastically. I finally found one, and I thank them very much.

But in looking at the particular bill, one of the specific reasons why I oppose it, is I came to Congress opposing all welfare. Some people oppose welfare for the poor, but they support welfare for the rich. Others support welfare for the rich, but not for the poor; and some people support both kinds of welfare. I do not support any kind of welfare. This bill is needed to stop the indirect welfare through regulation for the rich and the pharmaceutical corporations. This is corporate welfare. That is one of the strong reasons why I am opposed to that.

I also believe in freedom of choice. People have the right to make their own choices. We do not need to promote the nanny state. People are wise enough and cautious enough to make their own choices. Today we had two votes on free trade legislation. They were promoting international trade agreements, but done in the name of free trade. Why do we have free trade legislation, so-called? To lower tariffs, to lower prices to the consumer. But those very same people who worked so hard on free trade legislation are saying now we cannot allow the American people the option of buying drugs from other countries and saving money.

I urge all my colleagues to support H.R. 2427.

Mr. Speaker, I am pleased to be an original cosponsor of H.R. 2427, the Pharmaceutical Market Access Act, because I believe it is an important bill that will benefit all Americans. As my colleagues are aware, many Americans are concerned about the high cost of prescription drugs. These high prices particularly affect senior citizens who have a greater than average need for prescription drugs and a lower than average income. Of course, some of these seniors may soon have at least part of their prescription drug costs covered by Medicare.

However, the fact that Medicare, that is already on shaky financial ground, will soon be

subsidizing prescription drug costs makes it more important than ever that Congress address the issue of prescription drug costs. Of course, Congress's actions should respect our constitutional limits and not further expand the role of government in the health care market.

Fortunately, there are a number of market-oriented policies Congress can adopt to lower the prices of prescription drugs. This is because the main reason prescription drug prices are high is government policies, that give a few powerful companies monopoly power. For example, policies restricting the importation of quality pharmaceuticals enable pharmaceutical companies to charge above-market prices for their products. Therefore, all members of Congress who are serious about lowering prescription drug prices should support H.R. 2427.

Opponents of this bill have waged a hysterical campaign to convince members that this amendment will result in consumers purchasing unsafe products. Acceptance of this argument not only requires ignoring H.R. 2427's numerous provisions ensuring the safety of imported drugs, it also requires assuming that consumers will buy cheap pharmaceuticals without taking any efforts to ensure that they are buying quality products. The experience of my constituents who are currently traveling to foreign countries to purchase prescription drugs shows that consumers are quite capable of purchasing safe products without interference from Big ``Mother.''

Furthermore, if the supporters of the status quo were truly concerned about promoting health, instead of protecting the special privileges of powerful companies, they would be more concerned with reforming the current policies that endanger health by artificially raising the cost of prescription drugs. Oftentimes, lower income Americans will take less of a prescription medicine than necessary to save money. Some even forgo other necessities, including food, in order to afford their medications. By reducing the prices of pharmaceuticals, H.R. 2427 will help ensure that no child has to take less than the recommended dosage of a prescription medicine and that no American has to choose between medication and food.

Other opponents of this bill have charged that creating a free market in pharmaceuticals will impose Canadian style price controls on prescription drugs. This is nonsense. Nothing in H.R. 2427 gives the government any additional power to determine pharmaceutical prices. H.R. 2427 simply lowers trade barriers, thus taking a step toward ensuring that Americans pay a true market price for prescription drugs. This market price will likely be lower than the current price because current government policies raise the price of prescription drugs above what it would be in the market.

Today, Americans enjoy access to many imported goods which are subject to price controls, and even receive government subsidies, in their countries of origin. Interestingly, some people support liberalized trade with Communist China, which is hardly a free economy, while opposing H.R. 2427! American policy has always been based on the principle that our economy is strengthened by free trade even when our trading partners engage in such market distorting policies as price controls and industrial subsidies. There is no good reason why pharmaceuticals should be an exception to the rule.

Finally, Mr. Speaker, I wish to express my disappointment with the numerous D.C.-based ``free-market'' organizations that are opposing this bill. Anyone following this debate could be excused for thinking they have entered into a Twilight Zone episode where ``libertarian'' policy wonks argue that the Federal Government must protect citizens from purchasing the pharmaceuticals of their choice, endorse protectionism, and argue that the Federal Government has a moral duty to fashion policies designed to protect the pharmaceutical companies' profit margins. I do not wish to speculate on the motivation behind this deviation from free-market principles among groups that normally uphold the principles of liberty. However, I do hope the vehemence with which these organizations are attacking this bill is motivated by sincere, if misguided, principle, and not by the large donations these organizations have received from the pharmaceutical industry. If the latter is the case, then these groups have discredited themselves by suggesting that their free-market principles can be compromised when it serves the interests of their corporate donors.

In conclusion, Mr. Speaker, I once again urge my colleagues to show that they are serious about lowering the prices of prescription drugs and that they trust the people to do what is in their best interests by supporting H.R. 2427, the Pharmaceutical Market Access Act.