Congressional Record December 9, 2009 S12786-S12787

Transcription

1 Congressional Record December 9, 2009 S12786-S12787 Mr. MENENDEZ. I thank the distinguished chairman of the Senate Finance Committee for yielding me the time. Madam President, I rise in strong opposition to the Dorgan amendment to allow the importation of drugs from 32 different countries in the world into the medicine cabinets of American families. I believe that is, at its core, a regressive amendment. This amendment, however well-intentioned, reminds me of a time when the lack of sufficient regulation allowed people to sell snake oil and magic elixirs. Let's not relive that history. Let's learn from it. I am sure many in this Chamber remember a time when the doctor would give us a prescription, we would take that to the local pharmacy, and the one thing we never did was question what was in the bottle. Now, with this amendment, we would not be so certain. We would not be sure that what is in the bottle is what we think it is. We would not be so certain from where it came. It could be directly from countries all over the world--lithuania, Estonia, Latvia, the Czech Republic, or any 1 of 28 other countries, and I will speak to that. Yes, I have heard they are part of the European Union, but I will talk about what the European Union just said about their challenges with counterfeit drugs. Or maybe they will come indirectly from any number of countries that have proven to make tainted medicine; those who are not part of the European Union but who are counterfeiting their drugs into the European Union, getting into their supply chain and ultimately getting to us, if we were to allow it to happen. We would not be absolutely sure of the conditions under which they were manufactured, whether they are safe to use, or where their ingredients originated. Health care reform and lowering costs does not mean we should roll the dice with the health and safety of the American people. I appreciate my colleagues' interest in bringing lower cost drugs to the market. In fact, I agree with them. But we cannot risk the health and safety of the American people in order to do it, and I am afraid this amendment would do just that. We have heard a lot about the FDA--the Food and Drug Administration. Yes, they are the ones who safeguard Americans from having the wrong type of drugs get into our marketplace or making sure the right type of drugs are approved and the wrong ones stay out. I have heard the stories of Americans searching for affordable prescription drugs and either going online to get them or traveling sometimes. But we have to ensure the drugs they buy are not counterfeit, not tainted, not substandard, and that they are what the doctor ordered and will work.

2 This amendment would undo current safety protections that ensure that patients are getting prescription medications that are the same in substance, quality, and quantity their doctor has prescribed. So let's see what the FDA said. In a letter from the Food and Drug Administration issued the other day to one of our colleagues in the Senate, Commissioner Hamburg said there are four potential risks to patients, in her opinion, that have to be addressed. First, she is concerned that some imported drugs may not be safe and effective because they were not subject to a rigorous regulatory review prior to approval. Second, she says the drugs ``may not be a consistently made, high quality product because they were not manufactured in a facility that complied with appropriate good manufacturing procedures.'' Third, the drugs ``may not be substitutable with the FDA approved products because of differences in composition or manufacturing.'' And, fourth, the drugs simply ``may not be what they purport to be'' because inadequate safeguards in the supply chain may have allowed contamination or--worse-- counterfeiting. In addition, the FDA's letter went on to cite significant ``safety concerns related to allowing the importation of nonbioequivalent products... and confusion in distribution and labeling between foreign products and the domestic product.'' The FDA is also concerned it does not have clear authority over foreign supply chains. In other words, there is a very real risk that imported drugs either would not make us better or, yes, could very well make us worse. One reason we never question what is in the bottle when we go to the pharmacy to fill our prescription is because the U.S. drug supply system is a closed system. That is why it is one of the safest in the world. Everyone in the system is subject to the FDA's oversight--to these very standards--and to strong penalties for failure to comply with the law. The FDA would have to review data to determine whether the non-fda-approved drug is safe, effective, and substitutable with the FDA-approved version. In addition, the FDA would need to review drug facilities all over the world to determine whether they manufacture high-quality products consistently. It is clear that keeping our drug supply safe--in a global economy in which we cannot affect the motives and willingness of others to game the system for greed and profit--is a monumental task. It is not simply allowing for the importation of lower cost medications, as the proponents of this amendment would have us believe. It will require a global reach, extraordinary vigilance, and a serious investment to enforce the highest standards in parts of the world that have minimal standards now, so we don't have to ask which drug is real

3 and which is counterfeit; so we don't have to wonder, if the packaging looks the same: Is it approved Tamiflu or is it counterfeit Tamiflu? The packaging looks the same, but is the content the same? One is approved; one is counterfeit. When the swine flu was coming through and everybody started trying to get hold of Tamiflu, what did they do? They went online and got counterfeit Tamiflu which didn't do the job. In this photo, the answer is no. One is real, one is counterfeit. You can't tell the difference. Is this helping people save money, if they just paid for a counterfeit product? No. Is this an effective treatment for a contagious H1N1 flu, if you have just been fooled by a counterfeit bottle of Tamiflu because you thought it was cheaper? No. How is this in the best interest of the American people? Here is another example--lipitor. Can you tell which is counterfeit or approved Lipitor? They look the same. Americans who purchase them are told they are the same, but how do you tell the difference? Most people can't. So they will go about their normal routine each morning taking the so-called Lipitor, thinking they are treating their high blood pressure, but really they are walking around with the same silent killer and not taking the appropriate medication for it. Another example, Aricept, a drug to slow the progression of Alzheimer's disease-- something my mother was taking when she was alive. Can you tell the difference between the pills in this photo? No. And that is the problem. The global economy opens global possibilities to counterfeiting these drugs. It opens the potential for these drugs--or the ingredients used in these drugs--to find their way from nation to nation, from Southeast Asia where the problem is epidemic to one of the 32 nations listed in the amendment that supposedly are safer, and then ultimately into American homes. That is a gamble we cannot afford to take. We should not have to wonder what is in the bottle. Americans suffering from Alzheimer's should not have to wonder if the drug they are taking is real or counterfeit. By the time they figure that out, buying a drug either online or abroad that is counterfeit or not of the same substance or of a different dosage, it could be too late to help reverse the damage, as was promised. One final example, Celebrex, used to treat arthritis and chronic pain. Can you tell the difference between these pills? No, and neither would those who continue to suffer if they are scammed into buying the counterfeit version. One is approved, one is counterfeit. I fully appreciate my colleagues' desire to keep the cost of prescription drugs down, but our first task is to protect the safety of Americans and to prevent counterfeit drugs from infecting the American market.

4 The real problem is bringing down the cost of prescription drugs as part of overall health care reform, and the real solution is expanding access to affordable drugs in the United States. I have heard several of my colleagues refer to 9 percent increases. What they fail to mention is the deep discounts the industry provides, particularly to the government and other entities, against that increase. They do not do that because, of course, it doesn't serve their purpose. In this fight to create affordable drugs in the United States, I take a back seat to no one. But at the same time, I strongly believe we cannot roll the dice with the health and safety of the American people. This amendment is that roll of the dice. We should never put Americans in the position of having to worry about whether their medicine will make them better or worse. We should never put Americans in a position of wondering is that a real pill or is that a poison pill? To see what happens if we allow importation we only need to look to the European Union. One of my colleagues earlier today used it as an example as to why we should pass this amendment. But I listened to the words of the European Union, and I hear quite the opposite. Earlier this week, the European Union Commissioner in charge of this issue said: The number of counterfeit medicines arriving in Europe... is constantly growing. The European Commission is extremely worried. To quote another section of the statement: In just 2 months, the European Union seized 34 million fake tablets at custom points in all member countries. This exceeded our worst fears. It went on to say: Every fake 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 illness with a real drug. I expect the EU will agree in 2010 that a drug's journey from manufacture to sale should be scrutinized carefully. He goes on to talk about other safeguards. So, in fact, the very essence of what some claim is the very reason we should allow importation, the European Union is saying, quite to the contrary, that they think this is a huge problem for them and, in fact, what seems to be an action that would not hurt someone can actually mean the difference between life and death.

5 I don't want American families to see those fears come to life. Yes, counterfeit drugs may happen, but if we pass the amendment, we just open the floodgates. The European Union's experience only proves my concerns, not alleviates them like some others suggest. A $75 counterfeit cancer drug that only contains half of the dosage that a person has been prescribed and needs does not save Americans money and certainly is not worth the price in terms of dollars or risk to life. Let's not now open national borders to insufficiently regulated drugs from around the world. Finally, in a different dimension, I think safety is utmost, but at a time of joblessness in this country, I don't want to offshore those jobs abroad to allow contaminated and counterfeit prescription drugs to come into this country. We are attacking the one last major research and manufacturing entity in the United States, one that has been at the forefront of the health care reform effort and put $80 billion of its own money in for reform. I want to see more partners like that in this process. Let's reject this amendment. Let's keep our drug supply one of the safest in the world. I yield the floor.