Prescription Drug User Fee Amendments Of 2007
Mr. President, I ask unanimous consent that Senator Boxer from California be recognized for 15 minutes, obviously as the next Democratic speaker following my presentation. Mr. President, I have come to the floor to talk about the…
Mr. President, I ask unanimous consent that Senator Boxer from California be recognized for 15 minutes, obviously as the next Democratic speaker following my presentation.
Mr. President, I have come to the floor to talk about the underlying bill that is being considered, a piece of legislation to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions and so on. It may be that there will be an agreement by which I and some others who will offer legislation or an amendment to deal with the issue of prescription drug prices will do that at another time and not on this bill. If that is the case, I am fine with that. I understand there are discussions underway now. I would be perfectly amenable to not offering an amendment on this legislation and instead having an opportunity to offer it at a different time. That amendment is about the reimportation of prescription drugs.
Let me talk just a little about this issue. This is an issue which is getting a gray beard these days because it has been around so long with so many promises to be able to take it up here in the Congress. We have 33 cosponsors on a piece of legislation that would try to break the back of the pricing monopoly that exists with the pharmaceutical industry for prescription drugs in our country. The fact is, the American consumers are charged the highest prices for prescription drugs anywhere in the world. The highest prices for prescription drugs are charged to the American consumer. It is not right. It is not fair. It ought to stop. We do have price controls on prescription drugs in our country; they are just controlled by the pharmaceutical industry. That is why we have the highest prices in the world.
Mr. President, I ask unanimous consent to show a couple of bottles of medicine.
Mr. President, these two bottles of medicine are Lipitor. Lipitor is a very common prescription drug used by many Americans to reduce cholesterol. As you can see, this drug, Lipitor, is made in Ireland, as a matter of fact, and then imported into this country by the pharmaceutical industry. From Ireland it is sent many places, but in this case the bottle in my left hand was sent to Canada, and the bottle in my right hand was sent to the United States. Same bottle, same pill, slightly different color on the front of it. It is an FDA- approved medicine produced in an FDA-approved plant in Ireland and then sent to Canada and the United States.
The difference? No difference--same plastic in the bottle, same medicine inside--except the price. The Canadian pays $1.83 per tablet, and the American pays $3.57--96 percent more. Let me say that again: No difference, same medicine, same bottle, same price, made in the same plant, FDA approved. Difference? The American consumer is told: Guess what, we have a special deal for you, you get to pay 96 percent more for the same medicine.
Is this unusual? No, it is not. I sat on a hay bale one day at a farm with an old codger. He was in his eighties. This is in North Dakota. He said: You know, my wife has been fighting breast cancer. She has fought this now for 3 years. We have gone to Canada. We had to go to Canada to get the medicine, to buy Tamoxifen, and the reason we had to drive to Canada every 3 months or so to get the medicine is we save 80 percent by buying it in Canada. We cannot afford the price in the United States. We can't afford the price to have my wife fight this breast cancer.
The question is, Is it just Canada? No, not at all, but let me at least describe the situation with the United States and Canada. I could put up the chart with Italy, Spain, Germany, France, England--I could put up this chart with virtually every country because the U.S. consumer pays the highest prices in the world.
Lipitor, I just described it; Plavix, we pay 46 percent more; Prevacid we pay 97 percent more; Zocor, 31 percent more, Nexium, 55 percent; Zoloft, 52 percent more. The list goes on and on, as you might imagine.
We have a population that receives a lot of benefit from miracle drugs. There are prescription drugs that allow you to manage your disease without having to go to an acute care bed in a hospital. It is a wonderful thing.
A substantial portion of the research to develop those drugs is done in the National Institutes of Health, paid for by us. We turn that research over to the prescription drug industry, they produce medicine from it, and then they sell us the medicine.
Another body of research is done by the prescription drug industry themselves. They spend a lot of money on that. They also spend a lot of money on advertising and promotion. Now, anyone who was standing in front of a mirror this morning brushing their teeth, shaving, perhaps getting ready for work and had their television on, one of those little television sets, if they have one, anyone who was engaged in doing that probably saw a television commercial. It said this: You should go ask your doctor whether the purple pill is right for you. It didn't necessarily tell you what the purple pill was for; it just says you need to talk to your doctor to see if you should have the purple pill.
It also makes you want to run out and say: Hey, what is this purple pill? Maybe I should have some of those purple pills, without knowing what they are for. It goes on all day, every day, advertising directly to consumers for medicines that can only be prescribed by a doctor for a prescription saying: Go talk to your doctor. Wouldn't you like some of these pills? We have an unbelievable amount of promotion and advertising with respect to prescription drugs. That is another issue. I believe there is only one other industrialized country that allows that; that is New Zealand. But that is another issue for another time.
The issue is pricing. I have described what is happening with respect to pricing. This is Canada, but I can describe it for other countries as well. The percent of adults, ages 19 to 64, not filling a prescription because of cost, 43 percent of the uninsured in this country--that is 45, 46 million--do not take their medicine because they do not have the money. They say it costs too much.
The result? Well, often many of them will end up in the priciest kind of health care, some kind of an acute care bed through an emergency room in a hospital.
The legislation we have developed in Congress is bipartisan. It stretches from--I shouldn't say stretches because I am not describing the polls in Congress. But we have Ted Kennedy, Democrat; Chuck Grassley, Republican; Debbie Stabenow, Democrat; John McCain, Republican; back and forth. Bipartisan support for a piece of legislation we have crafted very carefully that says: Why shouldn't the American people be able to take advantage of FDA-approved drugs by reimporting them from another country where that same drug is sold for a fraction of the price? Why shouldn't the global economy work for consumers as well? This is bipartisan legislation that has substantial areas of safety built into it, so there is no safety issue. This is from Dr. David Kessler, who was head of the FDA for 8 years, 1990 to 1997. ``The Dorgan-Snowe bill''--Olympia Snowe is the principal cosponsor, along with me and many others who have worked on this-- Senator Stabenow and Senator McCain and others for a long time, Senator Kennedy.
The Dorgan-Snowe bill provides a sound framework for
assuring that imported drugs are safe and effective. Most
notably, it provides additional resources to the agency to
run such a program, oversight by the FDA of the chain of
custody of imported drugs back to the FDA-inspected plants, a
mechanism to review imported drugs to ensure that they meet
FDA's approval standards, and the registration and oversight
of importers and exporters to assure that the imported drugs
meet these standards and are not counterfeit.
Let me show you where your prescription drugs come from. The pharmaceutical industry is engaged in a full court press with Members of this Chamber. They have a fair number of friends in this Chamber who would want to help them derail this legislation and continue to be able to charge the highest prices to the American consumer.
Lipitor comes from Dublin, Ireland. Nexium comes from France. Of course, these are all imported by the pharmaceutical manufacturers themselves. Any one of these--Vytorin, Singapore, Italy, the United Kingdom; Actos comes from Osaka, Japan. All of these are made in other countries, brought back to this country, and, by the way, sold in every other country in most cases for a lower price than when they are sent back to this country by the manufacturer.
The legislation we have introduced is very simple. It gives the American consumer the opportunity to take advantage of lower prices for an FDA-approved drug; in many cases, by the way, a drug that was created with the very research that the American people paid for through the National Institutes of Health.
Some have said, as a result of the pharmaceutical industry's entreaties here, well, this can't be done safely. It cannot be done safely. Well, apparently, they do it safely. The chain of custody, for example, in Canada is virtually identical. I had a quote that I do not have here. I had a quote from Dr. McClelland, the former head of the FDA, virtually identical chain of custody from Canada as opposed to the United States between the pharmaceutical manufacturer, the wholesaler, and the retailer.
So is the chain of custody in Canada safe with respect to prescription drugs being sold to Canadian consumers? The answer is yes. So why would you not be able to establish a regime, just as they have in Europe for many years, called parallel trading? This is not new. If you are in Europe and you are living in Germany and want to buy a prescription from Spain, or living in Italy and find a prescription drug priced lower in France through a parallel trading system, you can easily do that.
To my knowledge, we have testimony from one of the people involved. To my knowledge, there have been no issues of safety at all. They have done it for 20 years. Are those who oppose this saying, well, the Europeans are smarter than we are, they can do it but we can't? I don't understand that. That is not the case. I don't understand that.
This is a very simple case. We propose an amendment that would allow drug reimportation and would make it safe. That is the fact.
We understand that the pharmaceutical industry does not like it. That is a fact, too. I understand why they don't like it.
Suppose I were running a pharmaceutical company and had the ability to price however I wanted to price inside the United States, one of the most important markets in the world, perhaps the most important market in the world, and I would have no competition from lower prices because I was able to keep that out. I understand why they would like to keep that deal working for them, but it does not work for the American people. It is not fair for the American people; it just isn't.
That is why we have put together a bipartisan piece of legislation, the Dorgan-Snowe bill, that is supported by Republicans and Democrats, which now has 33 cosponsors. It is one that should pass in the Senate. The House has already passed a similar piece of legislation in the last session. I believe, finally, given a fair opportunity--and I believe we will be given that fair opportunity whether it is on this bill or perhaps with some consent to do it on another bill, I believe we will get this done.
This is important. There are some things we do that are not very important at all. My criticism--it is a great privilege to serve here. My criticism of this place is from time to time we treat the light way too seriously, and we treat the serious far too lightly. This is a serious issue that deserves to be treated seriously.
It has been around for a long time. We have not had a vote on it only because we have been blocked by, I would say, Senator Frist, the majority leader, for a long time, despite what I thought and my colleagues thought was a representation by him that he would allow us to have this on the Senate floor. He continued to block it.
I understand the pharmaceutical industry is pulling out all of the stops. They have a full court press, trying to find as many Members of the Senate as they can who will stand up for their current pricing strategy. And they will find a few, no question about that. I think there are some Members of the Congress who like the pricing strategy of saying let's price drugs so that the American people pay the highest prices in the world. But I am very anxious to get them here to the floor to debate them on that subject because they are wrong. It is just wrong. It is wrong to do this to the American people.
One final point. I don't disrespect the pharmaceutical industry. I say good for you when you produce a miracle drug, a lifesaving drug. But miracle drugs offer no miracles to people who can't afford to buy them. My problem with the pharmaceutical industry is the pricing strategy, the pricing strategy which says to the American people: You pay the highest prices in the world, and there is nothing we will let you do that can alter that. That is wrong. That is why I and others come to the floor of the Senate to say let's fix this. Not later, let's fix this now.
Mr. President, I yield the floor.