SERVICE MEMBERS HOME OWNERSHIP TAX ACT OF 2009--Resumed
Mr. President, I offer time to my colleague from New Jersey, Senator Menendez--up to 11 minutes. Mr. President, I yield 1 more minute to the Senator. Mr. President, I call up amendment No. 3156--it is at the desk--and I ask for its…
Mr. President, I offer time to my colleague from New Jersey, Senator Menendez--up to 11 minutes.
Mr. President, I yield 1 more minute to the Senator.
Mr. President, I call up amendment No. 3156--it is at the desk--and I ask for its immediate consideration.
Mr. President, I ask unanimous consent that reading of the amendment be dispensed with.
Mr. President, I rise today because one thing we have to do as we progress with this health care reform bill is to make sure prescription medicine in our country is safe and affordable. I thank my colleague from New Jersey for his excellent review of the conditions that cause us to add this amendment to Senator Dorgan's amendment that would allow potentially unsafe prescription drugs to be shipped across our borders and directly into the medicine cabinets of homes throughout America.
I want to be clear, the effect of this plan Senator Dorgan has offered could be catastrophic. That is why President Obama's administration has written to the Congress expressing its serious concerns with the Dorgan amendment.
I appreciate the efforts to try to lower prescription drug prices. After all, that is what we are doing with the whole health reform review--trying to get costs reduced so everyone can have safe and affordable health care. We want to make sure people do not harm their health with any shortcuts.
We all want Americans to stay healthy and still have some money left in their pockets. But as much as we want to cut costs for consumers, we cannot afford to cut corners and risk exposing Americans to drugs that are ineffective or unsafe.
The fact is, this is a matter of life and death. The European Commission just discovered that counterfeit drugs in Europe are worse than they feared. In just 2 months--and I know Senator Menendez made reference to this as well--the EU seized 34 million fake tablets, including antibiotics, cancer treatments, and anticholesterol medicine.
As the industry commissioner of the EU said:
Every faked drug is a potential massacre. Even when a
medicine only contains an ineffective substance, this can
lead to people dying because they think they are fighting
their illnesses with a real drug.
Americans buy medicine to lower their cholesterol, fight cancer, and prevent heart disease. Imagine what would happen to a mother or a child if they start relying on medicine imported from another country only to find out years later that the drug was a fake. Imagine the heartbreak that might ensue if the medicine Americans were taking was found to be harmful. The fact is that drugs from other countries have dangerously high counterfeit rates and importation could expose Americans to those drugs.
Under the Dorgan amendment, drugs would be imported from former Soviet Union countries where the World Health Organization estimates that
over 20 percent of the drugs are counterfeit. Under the Dorgan amendment, drugs that originate in China could find their way into our homes. We know that China has been the source of many dangerous products in recent years, from toys laced with lead to toothpaste made with antifreeze.
If we are going to trust drugs from other countries, we need to be absolutely certain we are not putting Americans' lives at risk. That is why the Food and Drug Administration went on record to express its concerns with the Dorgan amendment. They say:
There are significant safety concerns related to allowing
the importation of non-bioequivalent products, and safety
issues related to confusion in distribution and labeling of
foreign products and the domestic product that remain to be
fully addressed in the amendment.
That is from the FDA Commissioner Margaret Hamburg.
There are problems associated with the possibility of drugs coming to this country that are way different than that which is expected to be used in the treatment of sickness.
President Obama's FDA Commissioner also wrote and said that importing drugs presents a risk to patients because the drug may not be safe and effective, may not have been made in a facility with good manufacturing practices, and may not be the drug it claims to be.
In light of the serious concerns raised by the Obama administration, I am offering an amendment to require that the Department of Health and Human Services certify that the drugs are safe and will reduce costs before they are imported. My amendment is a commonsense bipartisan alternative to the Dorgan amendment. In fact, it is the exact same language as the Dorgan importation amendment, but with the certification requirement that is so important to ensure safety.
If we are going to allow the importation of drugs from other countries, we have to be certain they are safe and affordable. With this amendment, I would be in support of the Dorgan amendment. Only certification by health experts will provide that assurance. I urge my colleagues to support my amendment and oppose the Dorgan amendment.
We have no way of knowing what the working conditions might be like in a plant or a facility, or the sanitary conditions, in other countries, or whether in the process of packing and shipping temperatures might not be appropriate for the product to arrive without deterioration. Thusly, again, I stress--bring in what you want, just make sure it is safe for the people. There is no moment in the discussion we have had about the health care reform bill that says, Look, you can save money by taking a chance on a shortcut here or a shortcut there. Absolutely not. We wouldn't think of proposing anything such as that, and we ought not to be proposing it here now.
I yield 5 minutes to my colleague from North Carolina.
No objection.
Mr. President, I believe my colleague from North Dakota intends to make further remarks. How much time do we have on our side, please?
Thirteen minutes.
Mr. President, if Senator Dorgan is here, then we are trying to accommodate a colleague who wishes to speak on this. How much time is left on the Dorgan side?
Mr. President, we heard about what is happening in the EU having to do with the question of whether drugs are counterfeit and the serious consequences of having people take medication that is not what it is supposed to be--the consequences of something like that, especially interfaced with other products.
There was a news report last week that was printed in Yahoo News. They quote the Industry Commissioner of the European Union--the program in Europe that controls drug safety or at least attempts to. We see that the European Union has expressed concern about the situation they see there. The Commissioner, Mr. Verheugen, said he expected the EU to take action to fight the menace of fake pharmaceuticals. Then he said he thought the EU would agree, in 2010, that a drug's journey from manufacture to sale should be scrutinized carefully and there will be special markings on the packages.
There is a lot of concern about this, and we ought not to dash willy- nilly through here without understanding what the consequences of fake medication might be. I wish to see our people pay as little as they can to get the medicines they need. Part of that has to include a safety factor. As I said earlier, we would not suggest anything in the health reform bill that would take a shortcut and disregard safety. I have a letter that was sent from the Department of Health and Human Services, which I quoted a little bit ago. They say the letter is being sent on the amendment filed by Senator Dorgan. The administration supports this program, which I agree to, to buy safe and effective drugs from other countries and included $5 million in our 2010 budget.
They go on to say--and this is from the Commissioner of Food and Drugs--that:
Importing non-FDA-approved prescription drugs presents four
potential risks to patients that must be addressed: (1) the
drug may not be safe and effective because it was not subject
to a rigorous regulatory review prior to approval; (2) the
drug may not be consistently made, high quality product
because it was not manufactured in a facility that complies
with appropriate good manufacturing practices; (3) the drug
may not be substitutable with the FDA-approved product
because of differences in composition or manufacturing; and
(4) the drug may not be what it purports to be, because it
has been contaminated or is a counterfeit due to inadequate
safeguards in the supply chain.
I ask unanimous consent that this letter, sent to Senator Tom Carper, from the Department of Health and Human Services, be printed in the Record.
Mr. President, I will now suggest the absence of a quorum and ask unanimous consent that it be charged equally to both sides.
You have considerably more based on--
Yes, I withdraw the request.
Mr. President, there was an objection to having the time equally divided expressed by the Senator from Iowa before.
How much time is available on our side, Mr. President?
Seven?
Mr. President, I, too, have people who want to speak to the issue. If we can equally divide the quorum call, that is all right with me. I have no objection.
Will the Senator yield for a question?
I know Senator Dorgan very well. He is a man of great principle and skill, I might say. But I say the list of aberrations, the lack of care about the various products--the toys, wallboards, and food--I have had a great interest in those items. It is interesting that it is being suggested by the Senator from North Dakota that is an acceptable standard and we ought to go ahead and continue it.
The question is whether, if you think that casual standard for bringing in food and other products is acceptable--
--therefore, we ought to do the same with drugs?
Mr. President, I think we have some time available. I wish to continue with some remarks. I thank the Senator from Kansas for his remarks and his concern also about the efficacy and the safety of drugs that might reach our citizens.
I listened carefully to the remarks of my colleague from North Dakota. He said the principal focus of our amendment is to protect the profits of the drug companies. No, I want to protect the health and well-being of American citizens. I look at an industry that has prolonged life expectancy, has made life more productive and pleasant for many whose disabilities may have them imprisoned in their homes.
We look at what has happened over the years, where treatment for conditions such as malaria, polio, smallpox were discovered, and antibiotics and chemotherapy have continued to be developed, primarily by American drug companies. Those are the companies that have the reputation for bringing the best products to market, the most carefully scrutinized, and most effective. What I want is for those companies to continue to be developing drugs that will extend wellness and will continue to improve longevity. I want these products to be available more reasonably, more cheaply--more affordably.
I had an experience in my life--people have heard me talk about this at times--whereby my father got cancer, was disabled with cancer when he was 42 years old. Our family was virtually bankrupt as a result of the cost for drugs and hospital services and physicians, so I know how costly they are. My father had cancer then, and I have seen what has happened now, with the opportunities for some optimism in situations where cancer develops. We are looking to make these drugs more available, more affordable.
The thing that strikes me, as we review where we are in the development of a new health plan or a reform of the existing health programs, and I hear the criticism coming from people who have indicated they do not support more available health products, I think about what happens when votes come about that move the health care bill along. There is absolute obstinacy that prevails with many of our friends on the Republican side.
I look at what good, proper products can do and the hope we have for childhood diseases that are so painful to see. We look for improvements in those--whether it is autism or diabetes or other conditions. We want desperately for companies in this country of ours to continue to develop drugs to treat them--or companies anywhere. But when they come to this country we have to know they are safe because there is nothing that can excuse the sacrifice of safety, for whatever discounts you might get on the product, products that, as has been noted, can kill you if they are the wrong formula or contaminated product.
Our differences between the Dorgan and Lautenberg amendments boil down to one word: safety. Knowing that when you open the bottle, that when you take the liquid, you are not doing something or your children or your loved ones are not doing something that harms their health. We owe them that feeling of security and comfort as they try to cure themselves from sickness or disease. That is what we are looking at here. I hope my colleagues will stand up and say no, don't let these products come in without the tightest scrutiny that can be developed; without the most secure process of production and shipment that can be exercised.
I yield the remainder of my time.
Madam President, this is a simple solution to a complicated problem. My amendment contains the Dorgan amendment. The work done by our friend from North Dakota is significant. But what it did not have is a guarantee, as much as possible, that the product was safe; that there were no counterfeits, that there were no mixtures of things that might not work well with other drugs.
My amendment adds a simple requirement that imported drugs be certified as safe by the Health and Human Services Secretary. I hope we will be able to pass this, which will include the Dorgan amendment, to make sure the products that get here are safe, no matter what the price will be. If it is not safe, it is worthless. We want to be sure every product that reaches our shore is safe to take and will be sold at a more reasonable cost.