DEPARTMENT OF HOMELAND SECURITY APPROPRIATIONS ACT, 2007 -- (Senate - July 11, 2006)
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Mr. VITTER. Mr. President, I ask unanimous consent that reading of the amendment be dispensed with.
The ACTING PRESIDENT pro tempore. Without objection, it is so ordered.
The amendment is as follows
(Purpose: To prohibit the United States Customs and Border Protection from preventing an individual not in the business of importing a prescription drug from importing an FDA-approved prescription drug)
On page 127, between line 2 and 3, insert the following:
Sec. 540. None of the funds made available in this Act for United States Customs and Border Protection may be used to prevent an individual not in the business of importing a prescription drug (within the meaning of section 801(g) of the Federal Food, Drug, and Cosmetic Act) from importing a prescription drug that complies with sections 501, 502, and 505 of such Act.
Mr. VITTER. Mr. President, the goal of this amendment is very straightforward. It is about breaking down the artificial barrier that prevents many Americans, including many seniors, from obtaining safe, FDA-approved, and affordable prescription drugs.
It is no secret that Americans pay more for their medicine than any other citizen in the world, of any other industrialized country. Yet our country is the biggest marketplace for these drugs in the world. Our seniors are buying their medicine in Canada as a result of that and in some other countries simply because it is cheaper. There is no other reason. Yet we see an increasing ratcheting up by Customs and protection agents in an effort to seize these personal legal medicines from Americans who are crossing from Canada back to the United States.
That is why I bring my amendment to the floor--to stop this idiocy and lunacy. My amendment is simple. Stop that escalating practice by the Customs and Border Protection of seizing personally used, FDA-approved medicines from American citizens reentering the country. My amendment would do this by simply prohibiting funds from being used for this Customs and Border Protection activity.
Let me reiterate some very important things about this amendment.
First of all, it would do nothing more and nothing less than allow our own citizens who are reentering our own country to be able to possess FDA-approved prescription medicines for their own personal use with a legitimate doctor's prescription.
That brings up a second very important point. When we talk about prescription drug imports, there are really two types that we often talk about and deal with: commercial imports by wholesalers, huge quantities brought in for the purpose of resale in this country, and personal imports by consumers.
My amendment is simply about personal imports by consumers. We are not talking about huge quantities. We are not talking about resale within the United States.
Third, my amendment is limited to FDA-approved drugs. There is this erroneous notion that sometimes comes up in this reimportation debate that somehow we are bypassing the entire FDA approval process, that somehow we are throwing out the window that entire process by which the FDA approves certain drugs after rigorous testing and analysis. None of that is true, particularly with regard to my amendment, because, again, my amendment only applies to FDA-approved drugs.
Fourth and finally, my amendment only applies to citizens who have a valid doctor's prescription to obtain these drugs. What could be simpler and make more sense than simply allowing American citizens who possess these legal drugs that they obtain with a doctor's prescription, FDA-approved for their own personal use, not huge quantities, to allow them to possess these legal drugs as they reenter their own country, the United States of America?
This amendment would not legalize reimportation full-scale. It would not legalize wholesale reimportation. It would not get into so many of the more controversial aspects of the issue. It would simply say we are not going to allow Customs and Border Patrol to ratchet up this activity by taking away seniors' drugs as they come into our country.
I think it is very significant and noteworthy that this sort of reimportation measure has enormous support certainly in this country but also in the Congress.
I want to point out some specific legislative history that demonstrates this support.
Congress has shown support for this in numerous ways, including very recently. First of all, my amendment was passed in the House. A nearly identical version of the amendment was offered by Representative Emerson of Missouri. That amendment was attached to this very same appropriations bill in subcommittee, and it survived the entire process going through the committee process and the floor.
That amendment is identical to the amendment which I am presenting on the Senate floor today. It passed through the entire House process with very strong support.
There are other instances that show very strong bipartisan support for this sort of measure. Recently, the House passed an Agriculture appropriations bill. There was also a significant reimportation provision put on that bill and included on the bill in the committee process, at the committee stage of consideration of the bill. That underlying bill, including that very important reimportation amendment, was passed overwhelmingly in the full Chamber by the full House by a vote of 378 to 46. I thank my House colleagues, Representative Emerson and Representative Gutknecht and many others for their leadership in this regard.
Finally, an entire freestanding bill has been passed through the House before on this issue, the Pharmaceutical Market Access Act. That was in 2003, and by a vote of 243 to 186 after, I might add, the most intense lobbying in the House that I ever experienced because I was a Member of the House at that time--lobbying by the pharmaceutical companies against this bill. That freestanding bill passed the House by a very significant vote, 243 to 186.
I note that bill was far broader than the personal reimportation amendment which we have on the floor today.
Again, it demonstrates the significant bipartisan support all of these reimportation measures have, certainly in the country at large, including in the Congress.
Finally, I note another victory we had not too long ago with regard to trade language. There was the very worrisome practice up until recently that the administration's U.S. Trade Representative would negotiate into many bilateral trade deals language which effectively barred reimportation from the other country--the trading partner. This was very unfortunate because it was closing the door to reimportation before it even had been opened by the Congress through trade negotiation.
Because of this very unfortunate practice, many of us in Congress, the House and the Senate, went to the administration and expressed our concern. Even more importantly, we brought language in the form of an amendment and attached it to an appropriations bill. That language said: Stop doing this; you cannot do it; it is ridiculous to negotiate free-trade agreement barriers to reimportation. We passed that language into law. I worked with my Senate colleague from Michigan on that issue. Many like-minded House colleagues worked on it in the House. We passed that into law. Most recently, the administration has acknowledged they will end this practice once and for all of negotiating this antireimportation language in trade agreements.
There is enormous support for this type of measure in the country. There is also significant bipartisan support for this in the Congress, as has been demonstrated many previous times.
In this discussion, we should focus on the individuals--particularly the seniors--who are compelled to cross the border in many instances to get affordable prescription drugs. We should not focus on the wishes, the pleas, and the intense lobbying by the drug companies. Seniors face enormous hurdles as they face their declining years with the escalating costs of prescription drugs. We should not add this additional hurdle to the list, with Customs and Border Patrol agents forcibly seizing legal, FDA-approved medicines procured with a doctor's prescription as seniors come back across the border.
Finally, in closing, as we think about this amendment, we should also consider what the true priorities of the Customs and Border Patrol should be. We are at war. It is a different type of war than we have ever faced before--a war on terror. That war has been brought to our own shores by very evil-focused people who came into this country illegally. We face new escalating threats, including potential threats from weapons of mass destruction. Our borders are a very important battleground in that war on terror. Yet in this new post-September 11 context, we will devote significant resources, significant focus on stripping seniors of prescription drugs they have gotten with a doctor's prescription, FDA-approved drugs, for their own personal use, with no wholesalers and no resale. That is a ridiculous policy for the Customs and Border Patrol to continue.
In the post-September 11 world, we should demand that Customs and Border Patrol focus on the true priorities we face in the war on terror. Stripping these small amounts of prescription drugs from the hands of seniors, which are attained with a prescription, which are FDA approved, which are for personal use, which are not for resale, not for wholesale, not obtained by wholesalers, should not be a priority of the Customs and Border Patrol.
In closing, let me again thank my colleague from Florida, Senator Nelson, who will speak in a few minutes. Also, I thank the Senator from Oklahoma, Mr. Coburn, for cosponsoring this amendment with me, and all of my colleagues who have worked on this issue, including many House Members.
Each year, millions of Americans who cannot otherwise afford their prescription drugs go into Canada with a doctor's prescription, buy FDA-approved drugs, and take them back into our country. We should not sick the police, the Customs and Border Protection agents on them, particularly in a post-September 11 world when that agency in particular has far more important priorities.
I urge all of our colleagues in the Senate to support this simple, straightforward amendment. It is the right thing to do on this issue. It is the right thing to do with regard to setting the right priorities of Customs and Border Patrol.
Mr. GREGG. Will the Senator yield?
Mr. VITTER. I am happy to yield.
Mr. GREGG. To understand the amendment, would this amendment cover purchases over the Internet or purchases by mail order?
Mr. VITTER. It would cover any purchases which are subject to seizure by Customs and Border Patrol. I don't offhand know if those purchases are ordinarily subject to that seizure. I believe most of what we are talking about is personal seizure at border checkpoints when individuals are crossing back into the country, but the amendment would cover any potential seizure by Customs and Border Patrol.
Mr. GREGG. If the Senator will yield further, I think he may have answered the question. As I understand it, it does cover Internet purchases and purchases by mail order. Customs has jurisdiction over those should they come across the border.
Mr. VITTER. If they are subject to that seizure, yes, as I stated, the amendment would cover that.
Mr. GREGG. Mr. President, if the Senator will further yield, it would also apply to purchases that could come from any country--we are not just talking about Canada? For example, purchases from England, they could come from India, they could come from Cuba, they could come from Libya, they could come from even states that have been identified as terrorist states?
Mr. VITTER. In its present form, the amendment would cover any country. We have a change in the amendment we are submitting to the desk to exclude a certain list of countries, including most of the countries the Senator mentioned.
Mr. GREGG. I ask further, would it exclude India?
Mr. VITTER. No, it would not.
Mr. GREGG. Would it exclude Pakistan?
Mr. VITTER. No, it would not.
Mr. GREGG. Would it exclude Brazil?
Mr. VITTER. No, it would not.
Mr. GREGG. If I could ask further, the FDA position, as I understand it, is that drugs which are unapproved for sale which come across the border violate the FDA approval. The Senator, in his statement, referred many times to ``FDA-approved drugs.'' As I understand the process today, the FDA views any drug purchased outside the United States, distributed outside the United States, as being unapproved for sale and therefore not meeting FDA standards. Is that not a correct analysis of the FDA view of how it views drugs that come into this country?
Mr. VITTER. I think it is an exactly correct analysis of the FDA view based on the fact that the FDA, at least in this administration, is completely against reimportation, so they have defined FDA approval to specifically exclude reimportation.
Mr. GREGG. That is correct. But if the Senator would yield further, the Senator is making a point in his statement that these would be FDA-approved drugs the people are purchasing when, in fact, they are not FDA-approved drugs because no drug that is imported into the United States, distributed outside the United States, can receive FDA approval under their rules because the FDA decided they cannot certify the efficacy and safety of those drugs. Isn't that the FDA position today?
Mr. VITTER. The FDA position is exactly as the Senator says. They are against reimportation, so they have defined FDA approval on technical grounds to exclude by definition anything that comes in from other countries. The point of my remarks is that these are exactly the same as FDA-approved drugs.
Mr. GREGG. If I could inquire further, that is the essence of the difference. The FDA does not deem them to be exactly the same because the FDA cannot certify their efficacy and safety. That is why the FDA has said that because they are not manufactured here, because they do not have control over the manufacturing process, because they do not know how they have been adulterated or may or may not have been adulterated or how they have been synthesized, they are not going to approve drugs coming into this country. So there is a significant difference between what someone buys overseas and what someone buys in America.
Mr. VITTER. If I could respond, in claiming my time, I disagree with that wholeheartedly.
Yes, the FDA has refused to take any action to do that. Can they? Absolutely, they can. Is it possible to do that, particularly in the modern age of packaging technology? Absolutely.
Most of the drugs we are talking about, in fact, are manufactured either in this country or in the same manufacturing points as the drugs that are bought in this country. So I disagree with the premise the Senator has laid out. But that is certainly the FDA's position, not to attempt to do any of that and to be completely, 1,000 percent opposed to reimportation.
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Mr. GREGG. Mr. President, if I might renew my question, the Senator from Florida may not have been in the Senate when I asked, Does this apply to Internet purchases, and the answer is yes; does it apply to mail order purchases, and the answer is yes; does it apply to countries such as India, Brazil, Pakistan, and the answer is yes. I understand the Senator from Louisiana will modify the amendment to take off a list of countries that it would not apply to, terrorist nations such as Sudan and I guess Cuba.
I renew my question because I am not sure the Senator from Florida was dispositive on it, which is, Shouldn't this amendment be directed at the FDA because to direct it at Customs and Border Patrol means that Customs and Border Patrol will be stopped from basically taking the drug which comes into this country, which FDA has now declared it cannot certify the efficacy and safety of, taking that drug, sending it over to FDA, and having the FDA evaluate it? Customs and Border Patrol has no expertise in evaluating efficacy and safety of drugs. For all we know, the drug that is being ordered over the Internet under the Senator's amendment could be anything. It could be claimed to be Lipitor, but it could be rat poisoning.
In fact, recent anecdotal studies have shown something like 80 percent of the drugs coming in through the Internet do not meet the standards they claim they do meet.
So why would you amend this bill to put Customs and Border Protection in the untenable position of having to basically release drugs to come into this country, which the FDA says it cannot claim are safe, when you have not put in the higher regime requirements of having the FDA come in and determine whether those drugs are safe?
Mr. VITTER. Mr. President, I would respond to the chairman by saying that amendment after amendment after amendment has been directed at the FDA to do the right thing and create a sensible regime with regard to this issue, and the FDA is flatout opposed to this and has made no effort in that regard, even though there is clearly the technical capability to do that through packaging technology and the like. So this is an effort to make the entire administration--all aspects that need to be involved--do the right thing.
But to say we have not asked the FDA to do this is ludicrous. We have been trying to drag them--kicking and screaming--to do the right thing for several years now. In fact, while they hide behind these safety arguments, I am afraid they are allowing safety issues to go by unaddressed.
In fact, this practice is common. Whether this amendment goes on this bill, whether this activity of Customs and Border Protection continues, one thing is certain: Seniors will import, for personal use, prescription drugs from Canada and elsewhere. That will go on, to a very significant extent.
Even if this amendment does not pass, Customs and Border Protection will never round up all of those drugs. This is a common and a growing practice because of the price issue.
So the question is: When is the FDA going to wake up and truly address these concerns that the chairman brings up with some sensible regime? This amendment is designed to force them in that direction.
But to suggest we have not asked them to do this, that we are going to the wrong agency, is a little silly because we have been asking them to do this for several years now. And we renew that request now.
Mr. GREGG. If the Senator will yield for one last question, and then, obviously, the Senator from Florida wants to be heard on the subject. But it is not silly because basically the fact pattern that is going to be created--were this amendment adopted and if it became law, without any directive to the FDA they have to step forward and actually evaluate these drugs to see if they meet safety and efficacy standards--the practical effect of this amendment would be that Customs and Border Protection could not stop any drugs coming into this country from other countries. That would include countries such as Pakistan and India and other countries which have some serious issues as to the efficacy and safety of those drugs.
In fact, if I were a creative terrorist, I would say to myself: Hey, listen, all I have to do is produce a can here that says ``Lipitor'' on it, make it look like the original Lipitor bottle--which is not too hard to do--fill it with anthrax and have a bunch of people from the United States order it who might be affiliated with me and import it that way into this country--or anything else they want to use in a biological way.
Here we are telling Customs and Border Protection that their job is to ratchet down on the capacity of terrorists to use entry ports into this country. And what you are saying in this amendment is: You, Customs and Border Protection, are not going to be allowed to evaluate anything that comes into this country which has a seal which makes it look like it is an FDA-type of drug. And the FDA will not have reviewed it. So nobody will have reviewed it.
So I think what you are creating--in your attempt to push FDA into doing something you feel they are not doing that they should do, you have targeted the wrong agency, and you are actually creating a massive hole in our capacity to secure or borders and protect ourselves.
Mr. VITTER. Mr. President, reclaiming my time, let me respond to the chairman's remarks with two comments. First of all, the FDA--right now, today, this hour, as we speak--has all the authority it needs to take any of the actions the chairman has described. It does not need any additional directive or authority. It has that authority. So the suggestion that somehow we need to act toward the FDA to give it that authority before it can move is absolutely not the case. In fact, we have been trying to get the FDA to act in this regard for several years because there are legitimate safety issues that should be met.
Secondly, I compliment the chairman for trying to figure out a scenario in which this is a true top priority of Customs and Border Protection in a post 9/11 world. I just do not think it adds up, though. I do not think, with all the border security and terrorist threats we face as a nation, allowing the Customs and Border Protection agents to continue--to even escalate--their practice of taking away small amounts of prescription drugs from seniors crossing back from Canada, et cetera, is the right thing to do, is a right priority for Customs and Border Protection.
With that, Mr. President, I yield back my time and look forward to the comments from my amendment cosponsor, the Senator from Florida.
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Mr. VITTER. Mr. President, at this point I would like to revise my amendment with the language which is at the desk.
The PRESIDING OFFICER. The Senator has the right to modify his amendment.
The amendment (No. 4548), as modified, is as follows:
On page 127, between line 2 and 3, insert the following:
Sec. 540. None of the funds made available in this Act for United States Customs and Border Protection may be used to prevent an individual not in the business of importing a prescription drug (within the meaning of section 801(g) of the Federal Food, Drug, and Cosmetic Act) from importing a prescription drug from Canada that complies with the Food, Drug, and Cosmetic Act.
Mr. VITTER. Mr. President, as modified, as the subcommittee chairman indicated, this will limit the effect of the amendment to transactions involving Canada only.
Having done that, let me close with a few remarks. First, I appreciate the offer and the commitment of the Senator from New Hampshire to work on this issue because, in fact, if he truly has these safety concerns he was outlining--I tend to think the nature of some of these scenarios he outlined were overly dramatic and not very well grounded in reality, but if he thinks these scenarios are accurate, then we need to act. The FDA needs to act today because even if my amendment is defeated--and I am very hopeful it will not be; I am very hopeful it will get a resounding vote on the Senate floor--even if it is defeated, these transactions are going on every day in the thousands.
The Senator knows that Customs and Border Patrol will never stop all of these personal-use medicines from coming into the country. So this is going on every day, thousands upon thousands of cases a day. Therefore, if there are safety issues involved--and there are some--the FDA needs to act now and we need to act now to put a regime in place.
Unfortunately, many of us, including myself, including the Senator from North Dakota and others, have tried over and over and have been blocked procedurally from moving that type of legislation to the Senate floor. That, as the Senator from North Dakota indicated, is what provoked this amendment. But I welcome the offer and the commitment of the Senator from New Hampshire to work in conference to put a full-blown regime together with regard to reimportation, and I welcome us bringing, either through this vehicle or through a stand-alone measure, this important debate to the Senate floor.
There are some safety issues, but those issues exist even if my amendment is defeated. Those issues exist because those transactions are going on every day, and they are growing in number because of the huge price disparity between the cost of drugs in the United States and the cost of those same FDA-approved equivalent drugs in places such as Canada.
Defeat of this amendment will not take care of those issues. The only thing that will take care of those issues is action, long overdue action by the FDA--and they have the authority now--or action by us in the Congress to put together an entire reimportation regime. I look forward to doing that. It is long overdue. It is important because of the very safety issues the Senator from New Hampshire outlines. It is also important because of the tremendous price pressure our constituents are under because we, unfortunately, labor under the highest prescription drug prices in the world, even though we offer the manufacturers the largest marketplace for those very same drugs in the world.
I yield back my time and look forward to the adoption of this amendment.
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Mr. VITTER. Mr. President, I rise in support of this amendment. I thank Senators Nelson and Coburn and others for their support.
This is very simple and straightforward. It will simply say in the post-9/11 world to Customs and border security that they should not be spending precious time and precious resources confiscating prescription drugs from seniors as they come back into this country from Canada. That is the only thing the amendment does. It is only about Canada. It is only about the personal use of prescription drugs. It doesn't involve wholesale, and it doesn't involve large quantities which can be resold in this country. It is only about FDA-approved drugs or their equivalent or what would be FDA-approved drugs if FDA did not define their approval process to specifically exclude drugs from other countries.
I ask for strong support of this very commonsense amendment.
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