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What we are doing here, and what history is going to tell us we have done, is that we have increased the risk
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Mr. Speaker, the result of that is going to be that we are going to be compelled at some time in the not-distant future, after we have seen what is going to occur under this legislation, to come back and address something which could have been handled better if the rule had permitted the consideration of the amendment which the gentleman from Arkansas (Mr. BERRY), the gentleman from Vermont (Mr. SANDERS), and the gentlewoman from Missouri (Mrs. EMERSON) would have offered to the people of this country and upon which we might have done a better job of legislating in the overall public interest.
Mr. Speaker, I regret what we are doing. We will be sorry.
Mr. Speaker, I rise in opposition to H.R. 3240, because, although it seems benign, it would hurt the enforcement of laws ensuring the safety and efficacy of imported drugs.
The Prescription Drug Marketing Act came into being after an investigation that revealed serious irregularities with respect to adulterated and counterfeit drugs from abroad. Recent investigations of Internet Web sites indicate there is still cause for concern. Significant quantities of prescription drugs from every source around the globe are entering this country on a daily basis through the U.S. mail. In fact, just last year the U.S. Customs agency had a more than 400 percent increase in the amount of pharmaceutical drugs they found being sent into this country from abroad. In many cases, these drugs arrive in unmarked plastic bags, with no indications of what they are, where they came from, or even how they should be taken. Are they real? Who knows? Are they adulterated? Who knows? Can they cause harm? Who knows? What we do know is that there was a problem with certain drug sources when we first looked into this matter more than decade ago, and there continues to be a problem today.
I do want to acknowledge the beneficial aspects of the bill before us. Lack of access to medically necessary prescription drugs is a real problem faced by millions of Americans. I command my colleague, Mr. GUTKNECHT, and all who will support him today, for recognizing that the price Americans pay for drugs is too high. But, first and foremost, the PDMA is a public health and safety law. We should therefore tread carefully before changing it. I am greatly concerned that the bill before us has not been the subject of hearings, or a thorough examination about why the Food and Drug Administration (FDA) sends warning letters to consumers that may be engaged in potentially risky behavior. This bill may make it very difficult for the FDA, as a practical matter, to provide thousands of consumers with a warning regarding what may be potentially risky behavior. I speak not only about the person that drives across to border to Mexico, but also to the numerous individuals now purchasing their drugs from one of hundreds of Internet sites that now exist.
I am open to a careful review and revision of PDMA for the purpose of creating a paradigm for drug importation that is safe for our consumers while facilitating access to the international market prices at which many commonly prescribed prescription drugs are available. But this bill, and this process, do not have my support.
[Time: 00:10]
Mr. COBURN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I would just like to make note of the fact that the wonderful Food and Drug Administration bureaucracy that we have seen built over the last 40 years, the average price to get a drug through that organization is $450 million, of which only $50 million is allocated for safety, $400 million for efficacy for a Food and Drug Administration to tell somebody where to put a bathroom in a plant, and bureaucratic overregulation.
So when we talk about how effective it is, it is important to know what portion of the costs are really on safety and that portion which is not associated with safety.
Mr. Speaker, I yield 3 minutes to the gentleman from Montana (Mr. HILL).
Mr. HILL of Montana. Mr. Speaker, I thank the gentleman from Oklahoma for yielding me the time, and I thank the gentleman from Minnesota (Mr. GUTKNECHT) for bringing this measure before the House. I am proud to be a sponsor of the bill and to stand here to support it.
We just spent I think about 12 hours debating Medicare reform and prescription drugs. Regardless of where my colleagues were on the final vote, I think that everybody in this House should be happy with the fact that the Congress has finally got on record that it is going to do something to try to help senior citizens with prescription drugs. I know that everybody here is hopeful that we can get a bill that the Senate can pass and the President can sign to do that.
But we have a big problem in this country, and that is the soaring cost of pharmaceutical drugs. The General Accounting Office estimated the bill we just passed will reduce the price of prescription drugs to seniors by 25 percent, perhaps as much as 39 percent. But I am concerned whether that will become a reality as a consequence of that bill. Drugs are going up at the rate of four times the rate of inflation. Last year, almost 10 percent, the price of pharmaceutical drugs went up.
The irony is that, in my State of Montana, people can go right across the border, and they can buy these same prescription drugs for 56 percent less in Canada. The reason is that the FDA, in essence, has created a barrier so that Montanans cannot purchase drugs. They cannot purchase their pharmacy needs in Canada.
Now, the irony of all this is that we have the North American Free Trade Agreement. We have below-cost, cheap cattle pouring across the border in Montana, over a million of them last year. We have below-cost wheat pouring across the Montana border taking away our markets. Cheap cattle and cheap grain come across the border, no problem at all.
As a matter of fact, I do not know if the Members of the House realize it, but cattle, swinging carcases, come into this country from Canada, and they have a USDA stamp on them that says that they are inspected and graded by the U.S. Department of Agriculture even though they are not because the NAFTA agreement says that they can do that.
Now, Montanans would like to have a little benefit from NAFTA. They would like to buy their medicines from Canada as well. The irony is that ag producers who are being forced to sell their products below cost are saying, buck it up. You cannot compete in this marketplace.
Yet, the FDA has, in essence, protected, created a protected market for one of the wealthiest industries in this country, in the world, in the pharmacy companies here in this country.
So what the Gutknecht bill basically says is, no, we are not going to do that anymore. We are going to try to induce competition by allowing people to buy their medications elsewhere.
The gentleman from Vermont (Mr. SANDERS) is absolutely correct. This does not just apply to retail. The bill of the gentleman from Minnesota (Mr. GUTKNECHT) basically applies only to retail trade and pharmaceutical drugs. It ought to apply to the wholesale as well so that our local pharmacists can buy from any distributor anywhere in the world.
Now, the gentleman from Michigan (Mr. DINGELL) raised a concern about the safety issue. But what we have to realize is that these are the exact same formulations that are licensed in the United States. They are produced in exactly the same plants as they are that come into the United States. They are in the same package.
I urge my colleagues to support this bill and also support the bill of the gentleman from Vermont (Mr. SANDERS).
Mr. BROWN of Ohio. Mr. Speaker, how much time is remaining on each side?
The SPEAKER pro tempore (Mr. PEASE). The gentleman from Ohio (Mr. BROWN) has 4 1/2 minutes remaining. The gentleman from Oklahoma (Mr. COBURN) has 6 minutes remaining.
Mr. BROWN of Ohio. Mr. Speaker, I reserve the balance of my time.
Mr. COBURN. Mr. Speaker, I yield myself 2 1/2 minutes.
Mr. Speakers, one of the ironic things about today's debate is the debate was about whose prescription drug bill would do the problem. We had a debate about the wrong problem. The problem is the lack of price competition in the pharmaceutical industry. For if prices were not rising, seniors would not be screaming, and we would not be addressing this issue at all, putting the risk of the Medicare program
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It is interesting to note that we have a President that is screaming for a prescription drug bill, and his own Justice Department will not even answer letters requesting an investigation into the antitrust activities of the pharmaceutical industry.
It is interesting to note that politics has reigned supreme in the debate about pharmaceutical and Medicare drug benefit when, in fact, we can accomplish a limitation on advertising, we can accomplish setting in force of motion of the very administrative agencies that are already in place to assure the American people that we do not have monopolies and we do not have price gouging and we do not have price fixing.
It is to be noted that the FTC has already received two consent decrees from two large pharmaceuticals manufacturers, one of which was paying $60 million a year to another pharmaceutical company not to bring a drug to market, consequently costing American consumers for $250 million for that drug alone. That drug was a calcium channel blocker known as diltiazen.
Another one, Hytrin, used for prostatic hypertrophy and hypertension, same thing, $15 million a month paid to another pharmaceutical company so they will not bring a drug to market.
We have collusion, and we have lack of competition. Until we address that, we will not be good stewards of the Medicare program. We will not be good stewards, whatever drug benefit we offer.
The other point that I would make, as we have done in every other area of Medicare, because we have not been good stewards, we are going to cost shift. We are going to lower the prices. Under the Democrat plan or the Republican plan, the prices for Medicare seniors will go down. But that price, if we do not work on the industry, will cost shift to the private sector.
So we are going to raise taxes on everybody else, their cost of health care, to supplant the lack of the proper benefits in Medicare.
Mr. Speaker, I reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker, I yield 4 1/4 minutes to the gentleman from Pennsylvania (Mr. KLINK) who has worked hard for a prescription drug benefit for Medicare beneficiaries.
Mr. KLINK. Mr. Speaker, I would start off by thanking the gentleman from Ohio for yielding me the time, even though the hour is late, and I would like to compliment the gentleman from Minnesota (Mr. GUTKNECHT) for his bill.
However, I must rise in opposition to H.R. 3240 because, while it seems harmless, and I laud the goal in the end of making sure that we can get the most fair price for drugs for all of our senior citizens, in fact for all of our citizens, this bill may seem harmless, but it could very seriously undercut the Food and Drug Administration's ability to warn the public that they are importing something that may not, in fact, be real.
The gentleman from Montana (Mr. HILL) I will tell him I wished I had the same surety that he does that these drugs were made in the same factory. We have seen with a lot of the investigations that we have done that, in fact, we have seen adulterated products. We have seen products that are not what they purport to be.
My colleagues may not realize it, but the Internet has become the new frontier for international drug purchases. Anyone with a computer and a mouse can click on a site, and one does not even need prescriptions, one does not need a doctor's okay, one just gets the drugs, and who knows where they are shipped from.
One recent investigation that we had in the Committee on Commerce of Internet pharmaceutical sales shows that buying drugs on-line can really be the on-line equivalent of trick-or-treating on Halloween in a very dangerous neighborhood. The drugs are often shipped in unmarked packages. There are no indications of strength or quality, no way of knowing what the products are, no way of knowing where they came from, no way of knowing who handled them, where they were stored or even what is in them.
We have seen reports in the news of arrests that were made for smuggling in fake Viagra. We have seen accounts of arrests being made for selling fake Xenical that was made only from starch and a small amount of an antiasthmatic drug. We have seen reports of fake ampicillin and AZT made from starch and anti-mold powder.
How prevalent are these bogus drugs? Well, the fact of the matter is we do not know. That is the frightening thing about all of this. Much of our investigation has focused on what the Federal Government is doing to protect consumers from unknowingly being harmed by something they import from one of these rogue sites.
Now, we have got to remember the Prescription Drug Marketing Act, which regulates the import of pharmaceutical products, was enacted in response to a lot of problems people had when they unknowingly imported drugs that were being adulterated or counterfeit drugs from abroad.
The gentleman, who had spoken earlier about the importation of food, one of the problems that he and I have both had with NAFTA and with GATT and with some of these other agreements is that we know that food has been brought into this country that was bad.
[Time: 00:20]
We have seen strawberries in Michigan that have caused kids to get very sick. We have seen meat products that have come in that have caused people to get sick. We have seen vegetables and fruits that come in with DDT and other kinds of things sprayed on them that we could not get away with here. So we know that the safety of food has been a problem, and the safety of drugs has been a problem too.
I want to get where the author of this bill is trying to get, but I do not think this is the way to get there. We want to help the FDA be better. They are not perfect. The reality is that this piece of legislation, with virtual conveyor belts at every international airport coming in, with these drugs being shipped by the Internet , if it were just Canada, we could deal with that, because their system is very similar to ours. The problem is we are talking about Africa and Asia and South America and central America and all of these islands nations. These drugs are being set up and manufactured all over the place, and some are real, some are not. We do not know what we are getting into.
What the gentleman is doing here, we are putting unrealistic burdens on an FDA that we have found out in the Committee on Commerce that they cannot deal with the problem as it is now. They do not have enough people to deal with what is coming in now. And the communications between the FDA and Customs is horrible, and the public is at risk already.
We cannot make it more at risk. We all want to get senior citizens access to cheaper drugs. I have concerns about the potential unintended regulatory consequences of this bill. If this bill dealt only with imports from countries like Canada, we would not have a problem. I think we need to amend the Prescription Drug Marketing Act. I wish we that we had had hearings on this bill. I wish we had had a chance to talk more about it. I am not prepared tonight to gamble with the safety and efficacy of the drugs coming into this country.
Mr. BROWN of Ohio. Mr. Speaker, I have no further requests for time, and I yield back the balance of my time.
Mr. COBURN. Could I inquire of the Chair the time remaining.
The CHAIRMAN. The gentleman from Oklahoma (Mr. COBURN) has 3 1/2 minutes remaining.
Mr. COBURN. Mr. Speaker, I yield 3 1/2 minutes to the gentleman from Minnesota (Mr. GUTKNECHT).
Mr. GUTKNECHT. Mr. Speaker, first of all, I want to clarify something. Section 3 of our bill says including a pharmacist or wholesale importer. We want our local pharmacies to be able to set up correspondent relationships.
In terms of the whole issue of people getting bad drugs, I mean, the truth of the matter is, this is happening now; and the reason is because of these huge differentials. We have tried now for 2 years to work with the FDA to come up with a plan so that we can bring down these barriers to local pharmacists and HMOs.
Let me give an example. One of the HMOs in Minneapolis, they did a study on their own, and if they could buy their drugs from Winnipeg, if they could realize half of the savings that
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We want to work with the FDA, but for 2 years the FDA has basically refused to return our phone calls. Mr. Speaker, there is a crisis out there; but the crisis is price. I am not here tonight to beat up on the pharmaceutical companies. The truth of the matter is they are going to charge as much as they can. I mean, shame on the pharmaceutical companies, yes, for what they are charging; but shame on the FDA for letting them get away with it, and shame on us for not doing something about it.
Now, this bill is not perfect, and I understand that we should be going further; but I think that is as far as we can get this year, or at least in the next several weeks. As we go forward, perhaps in the Senate, perhaps in conference committee, sometime perhaps before we get it to the President's desk, maybe we can strengthen it this year. And if the FDA does not respond appropriately, I guarantee I will be back next year and we will be fighting for even stronger legislation. Because this idea that American consumers should pay $30.25 for Coumadin when consumers in Switzerland pay $2.85 for the same drug, that is simply wrong. And shame on us if we let that continue.
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