Chuck Grassley

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, one of the issues that has been very much a shortcoming within the FDA besides lack of respect for the scientific process, but it is involved in the issue of this amendment as well, is whether scientists in the FDA who have the responsibility of postmarketing surveillance get the respect they ought to from the Office of New Drugs that previously had approved the drug. We have found in the case of Vioxx, in the case of antidepressants for children, and in a lot of other areas as well that this has just not been the case. My amendment will follow the Institute of Medicine recommendation and make sure there is adequate time and consideration given to postmarketing surveillance, the same as there is to the approval of the drug in the first place. So I ask for approval of this amendment. It is backed by the Institute of Medicine.

Mr. GRASSLEY. Mr. President, I will speak in favor of 1039. I have 30 seconds, did you say, or 1 minute?

Mr. GRASSLEY. Mr. President, I yield myself such time as I might consume. I only have 2\1/2\ minutes. Amendment No. 1039 On the very important amendment about making sure there is adequate cooperation and dialog between the Office of New Drugs and the Office of Postmarket Surveillance, I wish to make clear this amendment is not, as some have characterized it, about process. It seems to me this is the ultimate of insurance to do the right thing to protect the American people on the safety of drugs. It is based on so many examples I found over the last 3 years, where there was not the respect for the Office of Postmarketing Surveillance there ought to be from the Office of New Drugs. A lot of safety issues would not have gotten out if we had not had a lot of red-blooded, patriotic whistleblowers who would come to Congress, such as Dr. Graham, for instance, in the case of Vioxx, such as Dr. Mosholder, in the case of depressants for children who were committing suicide. This ended up with Vioxx coming off the market. This ended up with black-box safety measures in the case of the antidepressants. The Institute of Medicine has recognized the importance of these two groups within the FDA working very closely together on making a determination on postmarketing surveillance. That is what my amendment does. It makes sure this process works the way the Institute of Medicine indicated it should. So as you consider voting on this amendment, I ask my colleagues-- himself or herself--one basic question before voting: Since the Institute of Medicine recommends equality between the preapproval process--in other words, before a drug is marketed--and the postapproval process at the FDA, why not vote for this amendment and improve postmarketing safety for the American people? I yield the floor.

Mr. GRASSLEY. This amendment provides for the application of stronger civil monetary penalties for violations of approved risk evaluation and mitigation strategies. Currently, the bill before us contains penalties, but those penalties won't mean much to large global corporations. In fact, the penalties amount to the cost of doing business. This amendment is intended, then, to give the Food and Drug Administration, the watchdog, some bite along with its bark. There is opposition to having strong civil monetary penalties, but that does not make sense to this Senator. Even the Consumers Union supports this amendment. The reality is, drug companies provide lifesaving pharmaceuticals throughout the world. The pharmaceutical companies make miracles happen. Before a drug is approved, a drug company has an incentive to provide evidence of a drug's effectiveness to the Food and Drug Administration. Without it, they can't sell drugs in this country. However, once a drug is already being sold in the marketplace, drug companies have almost no incentive to look for and evaluate safety issues. The bottom line is, sometimes market forces guide businesses in a way that may be contrary to the public interest. We have seen this happen many times. For the Food and Drug Administration's new authorities to be meaningful in this legislation, there must be stronger civil monetary penalties in the underlying bill; hence, my amendment. Fines are nothing more than the cost of doing business, and we can't change behavior. More importantly, we can't even deter bad behavior. If a company does what it is supposed to do, a drug company doesn't need to fear any penalties. It is that simple. I ask Members of the Senate to support this amendment because it adds real teeth to the FDA's bite. I thank Senators Kennedy and Enzi for the tremendous efforts they went to in bringing this bill to the Senate floor. Again, I want to make this bill even better. They have already included several ideas Senator Dodd and I have shared with them. I reserve the remainder of my time.

Mr. GRASSLEY. This amendment is important because S. 1082 does not sufficiently address the underlying problems I have found existing at the Food and Drug Administration during my tenure as chairman of the Senate Finance Committee looking into the problems of the Food and Drug Administration, with the goal in mind that the Federal Government should only be paying for drugs that are safe. That problem is the lack of equality between the Office of New Drugs, which reviews drug applications and decides whether to approve a drug for marketing, and the Office of Surveillance and Epidemiology, the office which monitors and assesses the safety of drugs postmarketing. Many times I quote the Institute of Medicine as justification for my amendment. They recognize this problem. The Institute of Medicine recognizes joint authority between these two offices for postapproval regulatory action related to safety. Even the Consumers Union supports this amendment. Having equality between preapproval and postapproval offices at the FDA is fundamental to real reform. Concentrating on the entire life cycle of drugs is critical. After all, the vast majority of a drug's life cycle is spent postapproval. In essence, the bill before us promotes the status quo when it comes to the specific role played by the Office of Surveillance. That means the Office of Surveillance and Epidemiology will remain nothing more than a mere consultant to the Office of New Drugs. This is not acceptable. Amendment 1039 gives the Office of Surveillance sign-off authority. They are experts in postmarketing safety. Even the Institute of Medicine recognized that through their recommendations. Let me be clear: This is not the amendment Senator Dodd and I originally proposed. I still believe an independent postmarketing safety center would be best to solve the problem. But under the process, that is not going to happen. Through this amendment, at least joint postmarketing decisionmaking between the Office of Surveillance and the Office of New Drugs will allow the office with the postmarketing safety expertise to have a say in what drug safety action will be taken by the FDA. The problem is not only the FDA having enough tools--this bill gives additional tools--it is about FDA managers disregarding concerns raised by its own scientists in the Office of Surveillance and not taking prompt action. This amendment makes common sense when you weigh the evidence I presented over the last 3 years about these problems at the FDA. Opponents of this amendment say it is unnecessary because the bill includes a dispute resolution process with strict deadlines. But that process is for disputes between the FDA and the drug company, not internal disagreements between FDA offices. Getting down to brass tacks, when the office that looks at postmarketing surveillance is under the thumb of the Office of New Drugs, and the Office of New Drugs says: This drug is safe, they aren't going to want to get egg on their faces by listening to the advice of the Office of Postmarketing Surveillance. If that had been the case, Dr. Graham, in the case of Vioxx, and Dr. Mosholder, in the case of antidepressant drugs, when kids were committing suicide, would have been listened to, but they weren't until they came as whistleblowers to the Congress. We have to have it so that we have enough independent decisionmaking within the FDA to make sure these drugs are safe. This amendment provides an approach with checks and balances between the office that approves a drug for marketing and the office that watches a drug once it is on the market.

Mr. GRASSLEY. I am going to speak about amendment No. 1039. I ask unanimous consent that Senators Mikulski, Brown, Snowe, and Bingaman be added as cosponsors.

Mr. GRASSLEY. Madam President, I yield myself 5 minutes out of the 10 allotted to me.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, it is with sadness that I pay tribute today to a young man from Iowa who gave his life in service to his country. PFC Brian A. Botello was killed on April 29, 2007, while serving in Iraq as part of the 3rd Squadron, 61st Cavalry Regiment, 2nd Infantry Division. My prayers go out to his mother Karyn, in Alta, IA, and his father Tony in Michigan. They can be proud of their son's honorable service and the tremendous sacrifice he made for his country. All Americans owe a debt of gratitude to Brian Botello. His memory will live on along those other patriots who have laid down their lives for the cause of freedom. I know that Brian's loss will be felt particularly deeply in the small town of Alta where he grew up. I know that flags have been flown at half mast and everyone from his neighbors to classmates from high school to members of his church are sharing stories and grieving as they remember Brian. I hope that they are able to take comfort in the fact that Brian Botello died honorably as an American patriot and he is now in a better place.

Mr. GRASSLEY

Mr. GRASSLEY. Madam President, we have three critical votes ahead of us this afternoon. These votes mean that today is the day we show the American people whether we can really pass drug importation or whether we are just giving it lip service and nothing else. The Dorgan amendment is the moment American consumers have been waiting for and today is the day. As I said last week, the Dorgan amendment is the result of a collaborative effort by myself with Senator Dorgan and with Senator Snowe and Senator Kennedy to finally make drug importation legal in this country. This is the golden opportunity this year to get it done. Now we have heard here on the floor the concerns that some have with drug importation and drug safety. Let me tell you that this is something I take seriously. Everyone who knows me knows that I care deeply about the safety of drugs, and I would not be standing here today urging support for the Dorgan amendment if I didn't think it had the right stuff on drug safety. And it does. The fact is that the unsafe situation is what we have today. Today, consumers are ordering drugs over the Internet from who knows where, and the FDA does not have the resources to do much of anything about it. The fact is that legislation to legalize importation would not only help to lower the cost of prescription drugs for all Americans but also should shut down rogue Internet pharmacies selling unsafe drugs. The Dorgan amendment would improve drug safety, not threaten it. And it would open up trade to lower cost drugs. We see news accounts on a regular basis describing Americans who log on to the Internet to purchase drugs from Canada and elsewhere. In 2004, my staff were briefed about an investigation by the Permanent Subcommittee on Investigations for the Senate Government Affairs Committee. The Permanent Subcommittee on Investigations conducted an investigation into current drug importation. They found that about 40,000 parcels containing prescription drugs come through the JFK mail facility every single day of the year--40,000 packages each day. Now, the JFK airport houses the largest International Mail Branch in the United States, but even then it is the tip of the iceberg. Each day of the year 30,000 packages of drugs enter the United States through Miami, and 20,000 enter through Chicago. That's 50,000 more packages each day. What is worse, about 28 percent of the drugs coming in are controlled substances. These are addictive drugs that require close physician supervision. While most people are ordering their prescriptions from Canada, they are also ordering prescriptions from Brazil, India, Pakistan, the Netherlands, Spain, Portugal, Mexico and Romania. Although the Federal Food, Drug, and Cosmetic Act prohibits the importation of unapproved, misbranded, or adulterated drugs into the United States, the fact is that thousands of counterfeit and unregulated drugs are seeping through our borders. This is what is happening today. John Taylor, Associate Commissioner of Regulatory Affairs for the Food and Drug Administration, FDA, in his testimony before the House Committee on Energy and Commerce in June 2003 stated that, ``the growing volume of unapproved imported drugs, which often are generated from sales via the Internet, presents a formidable enforcement challenge.'' Despite the hard work of both the FDA and BCBP to control our borders, the importation of illegal drugs has become an unenforceable problem. That is because today, the FDA does not have the authority or the resources to do much about it. The Dorgan amendment would change that. The basic approach to assuring the drugs are safe in the Dorgan amendment which I coauthored with him--is to give FDA the ability to verify the drug pedigree back to the manufacturer, require FDA to inspect frequently, and require fees to give FDA the resources to do this. For imports by individuals from Canada, the bill requires the exporters in Canada to register with FDA and to post a bond that they will lose if they send unsafe drugs. Frequent inspections by FDA ensure compliance. For commercial imports, American wholesalers and pharmacists must register with FDA and are subject to criminal penalties if they import unsafe drugs. Again, frequent inspections by FDA ensure compliance. The bill requires manufacturers to inform FDA whether foreign drugs meet FDA standards, and if they don't, the manufacturers have to give FDA the information necessary to evaluate the safety of the drug. If a foreign drug is manufactured in a plant the FDA has not inspected, FDA can inspect it. The bottom line is the legislation gives the FDA the authority and resources it needs to implement safely the drug importation program set up under this bill. The fact is that the unsafe situation is what we have today: 40,000 drug packages coming in every day in New York, 30,000 drug packages coming in every day in Miami, and 20,000 drug packages coming in every day in Chicago. That is 90,000 packages with drugs coming in from other countries every single day. We are already saying yes to drug importation every day that we allow this unregulated and unsafe situation to exist. We say yes to it 90,000 times a day. What we need to do and what the Dorgan amendment would accomplish is giving the FDA the resources to clean up this mess. The Dorgan amendment gives the FDA the resources and authority to crack down on the unsafe and unregulated importation of drugs. That is what we need. That is one of the key reasons I have been working with Senator Dorgan and Senator Snowe and Senator Kennedy on this legislation. One of our key aims is to improve drug safety. I have been doing a lot of work in the area of drug safety, as my colleagues know, and I felt that I should talk about why the Dorgan amendment is important for improving drug safety. A vote against the Dorgan amendment is a vote in favor of the unsafe situation we have today. I must also say that a vote for the Cochran amendment is a vote to kill the Dorgan amendment. So a vote in favor of the Cochran amendment is a vote in favor of doing nothing. It is a vote for keeping the unsafe situation we have today. Congress must act now on legislation that will not only shut down rogue Internet pharmacies selling unsafe drugs to consumers but will also lower the cost of prescription drugs. Legalizing the importation of prescription drugs through a highly regulated system overseen by FDA will stem the tide of unregulated pharmaceuticals coming into the United States and create a safe and effective system for obtaining low-cost prescription drugs. The bill before us is the vehicle this year to get it done. The bill we are debating is a must-pass FDA bill. The Senate should send a strong message that we are committed to finally getting it done this year. And that is what we are working together to do today. Making it legal for Americans to import their prescription drugs is a top priority at the grassroots. It needs to be a top priority here in Washington. I have long advocated allowing American consumers access to safe drugs from other countries. I have always considered it a free-trade issue. Imports create competition and keep domestic industry more responsive to consumers. In the United States, we import everything consumers want. So that should be the case on prescription drugs. We need to do it legally and safely. We need to give the FDA the authority and resources to do it. That is what the Dorgan amendment would do. Consumers in the United States pay far more for prescription drugs than those in other counties. If Americans could legally and safely access prescription drugs outside the United States, then drug companies will be forced to reevaluate their pricing strategies. They would no longer be able to gouge American consumers by making them pay more than their fair share of the high cost of research and development. Now, it is true that pharmaceutical companies do not like the idea of opening up America to the global marketplace. They want to keep the United States closed to other markets in order to charge higher prices here. However, with the Dorgan amendment, prescription drug companies will be forced to compete and establish fair prices here in America. Now some don't want this to happen. And I want to reiterate that there is an attempt to kill drug importation as has been done many times before in this Chamber. I am referring to an amendment by my good friend from Mississippi, Senator Cochran. His amendment would require a certification about health and safety. That amendment is designed to kill drug importation once again. It is a clever amendment but it is a poison pill. Our effort develops an effective and safe system that gives Americans access to lower prices. This amendment requires that all imported drugs be approved by the FDA. The amendment sets a stringent set of safety requirements that must be met before Americans can import drugs from that country. And there are stiff penalties for violating the safety requirements. Don't be fooled by the Cochran amendment. Voting for the Cochran amendment is a vote to kill drug importation. With the Dorgan amendment, we are working to get the job done. We need to make sure Americans have even greater, more affordable access to wonder drugs by further opening the doors to competition in the global pharmaceutical industry. Americans are waiting. We must make sure they have access to affordable prescription drugs. I urge my colleagues to vote against the Cochran amendment and in favor of the Dorgan amendment.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. GRASSLEY. We have 18 minutes remaining. I yield myself 9 minutes.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, there are two amendments I am going to bring up on the bill that will be before the Senate. Amendment No. 1039, which Senators Mikulski and Brown will also be cosponsoring, provides for joint postmarketing decisionmaking between two offices within the FDA--the Office of Surveillance and Epidemiology and the Office of New Drugs. These offices would address jointly postmarketing drug safety issues. This postmarketing decisionmaking is intended to include labeling changes requiring additional postmarketing studies and restrictions on distribution and use of drugs. The joint decisionmaking would give the Office of Surveillance and Epidemiology signoff authority. This is different than its present role of being a mere consultant to the Office of New Drugs. It is very important to understand that the core of this amendment was recommended by the Institute of Medicine last fall. The other amendment is amendment No. 998, which Senator Dodd will also be cosponsoring. It provides for the application of stronger civil penalties for noncompliance with approved risk evaluation. Currently, S. 1082 contains penalties that are insignificant for large companies and amount to nothing more than the cost of doing business. This amendment is intended to give the FDA, the watchdog, some bite along with its bark. Big PhRMA doesn't like my amendments because they shake up the status quo. The status quo includes FDA's debacle, such as Vioxx and the failure of FDA to notify doctors and parents of potentially tragic effects of antidepressants on children. These amendments would make postmarketing safety concerns a forethought rather than an afterthought at the FDA. These amendments are intended to establish greater accountability, break the stronghold big PhRMA has on the FDA, and make postmarketing safety a meaningful effort at the agency. Today, through my amendments, I hope to help Senator Kennedy and Senator Enzi finish a very good job they started through the HELP Committee. S. 1082 is a first step in setting a new direction for the safety of prescription drugs. As I said the week before last, I am heartened by the fact that this bill attempts to address some of the many failures I have exposed over the last 3 years at the FDA, failures that negatively affect the core mission of the FDA. For the first time in almost a decade, we have an opportunity to reform, improve, and reestablish the FDA as what it should be: the gold standard of drug safety. The bills Senator Dodd and I have introduced in the past were intended to enhance drug and device safety and to bring transparency. Over the past two Congresses, I have worked with Senator Dodd on these bills. One of these bills asks for the creation of a new center devoted solely to postmarketing drug safety, a center that would bow to no one but the American consumer, a center that would be an independent voice for consumers, a center that would reside in the FDA and decide what to do and when to do it when an unexpected safety risk arises from a drug. There is strong opposition to such a center, I found. This is the case even though scientists and epidemiologists working in the FDA, as well as independent thought leaders, believe the Food and Drug Administration Safety Act of 2007 would prevent another Vioxx debacle. The HELP Committee incorporated certain aspects of Grassley-Dodd and Dodd-Grassley bills in the bill before us, and I thank Senator Kennedy and Senator Enzi for doing that. During floor debates, I have seen agreements and long-term commitments fall through. It is clear to me S. 1082 will never include a separate center for postmarketing safety. The way the process works will not allow a new center to be created in the FDA. That is very unfortunate. It is particularly unfortunate for our consumers. Senator Dodd and I concluded a new independent center was the best way to ensure postmarketing drug safety. But, again, there is strong opposition to such a center, despite the fact that it is the right thing to do. The wheeling and dealing and lobbying on this bill have made it impossible for a new postmarketing center to become a reality. So instead, I am here to offer a lesser amendment. It is lesser because it is not the best we can do. I know we can do better. Amendment No. 1039 has its roots in the Institute of Medicine recommendations and should be embraced by every Member. Specifically, the Institute of Medicine stated in its report: The committee recommends that CDER appoint an OSE staff member to each new drug application review team and assign joint authority to OND and OSE for the postapproval regulatory actions related to safety. Two members of the Institute of Medicine committee which issued the report reiterated recommendations in an article published last week in the Journal of the American Medical Association. In particular, they stated: The Institute of Medicine identified the imbalance in authority between the Office of New Drugs and the Office of Surveillance and Epidemiology as a major weakness in the drug safety system. In an effort to facilitate a collaborative and constructive team approach, the Institute of Medicine recommended joint authority for the Office of New Drugs and Office of Surveillance and Epidemiology in the postapproval setting. These experts noted that the FDA's response to the Institute of Medicine's recommendations ``represent incremental progress'' but suggest that the FDA failed to embrace, among other things, ``the equality between the preapproval and postapproval activity of the agency.'' Having equality between the preapproval and postapproval activities at the FDA is fundamental to real reform. It is common sense. This is especially true when we think about what we have learned from the operation of the FDA over the past few years and those shortcomings. As we debate this bill, we are going to hear a lot about the impressive Institute of Medicine study and its recommendations to improve the FDA. We have and will continue to hear Members talk about how S. 1082 addresses many of the Institute of Medicine's recommendations. However, this is one important and sweeping recommendation that is not addressed in the bill before us. Amendment No. 1039 is intended to address that shortcoming. I have seen time and again in my investigations that serious adverse effects that emerge after a drug is on the market do not necessarily get the prompt attention they deserve. They are certainly not getting the attention from the Office of New Drugs. Even the Government Accountability Office report entitled, ``Improvement Needed in FDA's Postmarket Decision-making and Oversight Process,'' stated: FDA lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues. I, for one, have seen too many people suffer from the results of the Vioxx mess. I also have heard from parents whose children committed suicide on antidepressants. This amendment is about making postmarketing safety in S. 1082 a reality, not just another byline. Identifying a safety issue after a drug is on the market is the beginning of the process of protecting the American consumer. Once the safety questions are identified, FDA needs to be empowered and willing to take action to address those questions and to ensure timely notice to doctors and consumers of new safety risks for drugs that they are already taking. Senator Enzi stated last Monday that with Vioxx, the Food and Drug Administration did not have enough tools to deal with the new risks that became evident only after Vioxx had been on the market for some time. But the problem with the Vioxx mess and the antidepressant mess wasn't only about having enough tools, it was about FDA managers disregarding the concerns raised by its own scientists in the Office of Surveillance and Epidemiology and not taking action in a timely manner. Amendment No. 1039, which is in the Institute of Medicine recommendations, is intended to curb delays when it comes to safety. I have also been told by scientists and epidemiologists working in the FDA, as well as independent thought leaders, that S. 1082 as it stands will not prevent another Vioxx debacle. They have told me that the Office of Surveillance and Epidemiology needs, at the minimum, joint postmarketing decisionmaking authority with the Office of New Drugs to ensure prompt postmarketing action. I also am afraid to say, that right now, I am at the beginning of another review that will likely lead to concerns similar to those we have seen in the past--a situation where the postmarketing adverse events are severe and the public knows nothing. The other amendment I want to talk about, amendment No. 998, is just plain common sense. For FDA's new authorities to be meaningful, there has to be strong civil monetary penalties. I hear that there is a lot of opposition to having stronger civil monetary penalties than those currently in S. 1082. But that just does not make sense to me. Over the last week I have heard members talk about giving FDA some bite. Well, let's add some teeth. Civil monetary penalties need to be more than the cost of doing business. If civil monetary penalties are nothing more that the cost of doing business, you can't change behavior and, more importantly, you can't deter intentional bad behavior. Amendment No. 998 would increase the penalties that can be imposed if companies fail to comply with the requirements of the ``risk evaluation and management strategies,'' such as labeling changes and requirements for postapproval studies or risk communication plans. These requirements are at the core of S. 1082. But, FDA cannot be an effective regulator if it's all bark and no bite. The last thing we need to do with this bill is to provide the FDA with new authorities but little enforcement capacity. That's not accountability and that won't help FDA do its job better for the American people, and it won't punish bad players. That is why amendment Nos. 1039 and 998 make sense. They fit into S. 1082 and its stated goal of promoting postmarketing safety. I again thank Senators Kennedy and Enzi for the tremendous efforts that went into bringing this bill to the floor, and I again thank them for incorporating a number of the provisions set forth in the two bills filed by Senator Dodd and me. Mr. President, I yield the floor.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, I have not had an opportunity to speak with the Senator from North Dakota. I hope I am not abusing my privilege of working with him and having some time this morning. I yield myself 7 minutes. The Dorgan amendment is the moment American consumers have been waiting for. I am here to urge my colleagues to vote for cloture so we can finally legalize drug importation. As I said yesterday, the Dorgan amendment is the result of a collaborative effort by myself, with Senators Dorgan, Snowe, and Kennedy, to finally make drug importation legal. This is a golden opportunity that we have been waiting for years to accomplish. The bill before us is the vehicle this year to get it done. The bill we are debating is a must-pass Food and Drug Administration bill. The Senate should send a strong message that we are committed to finally getting it done this year. This is what we have been working to accomplish today. Making it legal for Americans to import their prescription drugs is a top priority at the grassroots of America. It needs to be a top priority here in Washington. It is something that shows up in almost every one of my town meetings throughout Iowa. I have long advocated allowing American consumers access to safe drugs from other countries. I have always considered this more a free trade issue than I have a health or prescription drug issue. Imports create competition and keep domestic industry more responsive to consumers. In the United States--so that I explain why I consider this a free trade issue more than a health issue--we import everything. We allow everything that consumers might want to buy; based upon the quality they choose and the price they choose, we have allowed it to come into the country if Americans want to buy from overseas. Hopefully, they want to buy American-made products. But we have considered free trade something that has given consumers the best deal they can get. So why not do it for pharmaceuticals as well as any other product people want to buy? Consumers in the United States now pay far more for prescription drugs than consumers in other countries. If Americans could legally and safely access prescription drugs from outside the United States under a regulation that we established to guarantee safety, drug companies will be forced to reevaluate the price strategies that they have for American consumers. They would no longer be able to gouge American consumers by making them pay more than their fair share for the high cost of research and development. I sort out research and development because I think Canadians are getting a better deal from American pharmaceuticals. Germans are getting a better deal from American pharmaceuticals. They get such a low price. They don't pay the fair share. The American consumer of pharmaceutical products pays for most of the research and development that benefits the entire world. It is not fair to the American consumer. It is true that pharmaceutical companies do not like the idea of opening American consumption of drugs to the global marketplace. They want to keep the United States closed to other markets in order to charge higher prices here. They would argue: We have to charge higher prices here. The Government directs what we pay the consumers or charge the consumers of Germany. Well, that is not fair to the American to pay for that sort of research. However, with the Dorgan amendment--and this is what we are talking about on this important vote coming up--prescription drug companies will be forced to compete, forced to establish a fair price here in America. Some don't want this to happen. I want to reiterate that there is an attempt to kill drug importation, as has been done many times before in this Chamber. I am referring to an amendment to make sure there is certification of health and safety. That amendment is designed to kill drug importation once again. It is a clever amendment, but it is a poison pill. Our effort develops an effective and safe system. This amendment requires all imported drugs to be approved by the Food and Drug Administration. That is the right thing to do. The amendment sets a stringent set of safety requirements that must be met before Americans can import drugs into this country, and there are stiff penalties for violation. Don't be fooled by this poison pill amendment. Voting for that amendment is a vote to kill drug importation. That amendment surely will be up if we get beyond the cloture vote, the next vote. It is important that people vote for cloture. With the Dorgan amendment, we are getting the job of safety done. We need to make sure Americans have even greater, more affordable access to wonder drugs by further opening the doors to competition in the global pharmaceutical industry. We must make sure they have access to affordable prescription drugs. I urge my colleagues to vote for cloture. One additional editorial comment that is legitimate to maybe criticize Grassley for voting for this amendment but a criticism that I think I would now explain; that is, that comes from a very good fellow Member and friend of mine in the Senate who came up to me yesterday and said: Then wouldn't I be for having all restrictions against ethanol coming into this country done away with because I represent a State that is very high in ethanol. I said the answer to that is twofold: No. 1, all restrictions ought to go off when ethanol is no longer an infant industry, and it is still an infant industry. Secondly, and more importantly, there is already a free importation of ethanol in this country of up to 7 percent of our production, and we have not even reached that 7 percent importation of ethanol. I will debate that issue when the leeway within present law allows. So I do not think there is an inconsistency on my part in what I said about the free entry from the mature industry of pharmaceuticals--maybe not mature in biotechnology but surely mature in pharmaceuticals. I yield the floor.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, I am pleased to join my colleague, Senator Durbin, in introducing the Methamphetamine Production Prevention Act of 2007. Together we offer this important legislation in an effort to strengthen existing law by providing some necessary changes and updates. During my time in the Senate, I have come to the floor many times to speak about methamphetamine and how it has destroyed individuals, families, and communities across the country. The Midwest was hit especially hard by meth and the impacts of this drug were devastating to rural areas. As opposed to other illegal drugs, meth is often times home cooked and made in rural areas using ingredients that are largely available over the counter. I am proud to say that Congress has taken action to attack this problem head on by working to cut off access to these over the counter products that form the basis of the drug. Legislation such as the Combat Methamphetamine Act of 2005, Combat Meth Act of 2005, which was included into the USA Patriot Act Reauthorization in 2005 immediately impacted the production of home cooked meth. Just a week ago when I joined with Senator Feinstein in introducing two other separate bills, the Saving Kids from Dangerous Drugs Act and the Drug Endangered Children Act, I noted that because of the efforts of Congress in passing the Combat Meth Act, the number of clandestine meth lab seizures has dropped across the country. The Combat Meth Act was a tremendous step in the right direction limiting access to psuedoephedrine, PSE, the main ingredient in methamphetamine. The Combat Meth Act required this product to be removed from store shelves and placed behind the counter at pharmacies across the country. It also limited the number of products containing PSE a person could buy at once. Further, it required a logbook system be kept by pharmacies containing information regarding the individuals that purchased products containing PSE. Despite these successes, ever determined meth cooks and users have learned how to game this system and continue to produce home grown meth. The preferred method of these meth cooks is to ``smurf'' between different pharmacies for PSE products. Smurfing occurs when a person visits a number of different locations buying the legal maximum amount of PSE product at each site. The result is an amount of PSE sufficient to produce home cooked meth. Smurfing occurs because the Combat Meth Act only required that retailers keep a logbook which could be kept on paper or electronically. It did not require interoperability or electronic transmission of data. As a result, these unscrupulous individuals have learned that if they provide false information or visit multiple stores, tracking and arresting these individuals is more difficult and time consuming for law enforcement. This is especially true in metropolitan communities that share a common border, one such example is the Quad Cities on the Iowa/Illinois border. Recently, the Quad City Times highlighted the successes of the Combat Meth Act in an article titled, The Next Step in Meth War. This article detailed the efforts of a Scott County Deputy and his dedication in fighting the meth war. One noteworthy portion of this article raised a question about the lengths that were required for this deputy to do his job in combating mom and pop meth labs. The article stated, ``Now we're stuck with this image of a detective in each Iowa county sorting through thousands of paper forms.'' It read further, ``He must call county to county to find out if those purchasing the limit in Scott County might be doing so elsewhere as well.'' This statement gets right to the heart of our bill. We can't effectively combat meth if we don't close the smurfing loophole. To address this loophole, Senator Durbin and I have introduced the Methamphetamine Production Prevention Act of 2007. This legislation would revise the technical requirements of the Combat Meth Act to allow for electronic logbook systems. The bill would also create a Federal grant program for states looking to create or enhance existing electronic logbook systems. Finally, this bill would prioritize these Federal grants to states that design and implement the most effective systems for sharing information via an electronic logbook system. This legislation will take a big step forward in closing this loophole that home grown meth cooks abuse. Additionally, it does so without creating burdensome mandates upon states to meet requirements. This bill facilitates innovation and growth by offering financial assistance to states looking to create an electronic logbook system. By avoiding mandates, this legislation seeks to promote innovation and growth of electronic logbook systems. This bill has broad support from the law enforcement community and has been endorsed by the National Sheriffs' Association, the National Narcotics Officers' Associations' Coalition, National Alliance of State Drug Enforcement Agencies, the National Criminal Justice Association, the National Troopers Coalition, the National District Attorneys Association, the National Association of Counties, and the Community Anti-Drug Coalitions of America among others. As you can see, this legislation has a broad base of support. Working together, state and local governments can use this legislation and grant program to create interoperable networks that will reduce the illegal smurfing of PSE products and lead us to the goal of ending domestic production of meth. I urge my colleagues, join us in support of this important legislation and pass the Methamphetamine Production Prevention Act of 2007 and help wipe out domestic production of meth. Mr. President, I ask unanimous consent that the aforementioned article be printed in the Record.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, I am pleased to join my colleague, Senator Durbin, in introducing the Methamphetamine Production Prevention Act of 2007. Together we offer this important legislation in an effort to strengthen existing law by providing some necessary changes and updates. During my time in the Senate, I have come to the floor many times to speak about methamphetamine and how it has destroyed individuals, families, and communities across the country. The Midwest was hit especially hard by meth and the impacts of this drug were devastating to rural areas. As opposed to other illegal drugs, meth is often times home cooked and made in rural areas using ingredients that are largely available over the counter. I am proud to say that Congress has taken action to attack this problem head on by working to cut off access to these over the counter products that form the basis of the drug. Legislation such as the Combat Methamphetamine Act of 2005, Combat Meth Act of 2005, which was included into the USA Patriot Act Reauthorization in 2005 immediately impacted the production of home cooked meth. Just a week ago when I joined with Senator Feinstein in introducing two other separate bills, the Saving Kids from Dangerous Drugs Act and the Drug Endangered Children Act, I noted that because of the efforts of Congress in passing the Combat Meth Act, the number of clandestine meth lab seizures has dropped across the country. The Combat Meth Act was a tremendous step in the right direction limiting access to psuedoephedrine, PSE, the main ingredient in methamphetamine. The Combat Meth Act required this product to be removed from store shelves and placed behind the counter at pharmacies across the country. It also limited the number of products containing PSE a person could buy at once. Further, it required a logbook system be kept by pharmacies containing information regarding the individuals that purchased products containing PSE. Despite these successes, ever determined meth cooks and users have learned how to game this system and continue to produce home grown meth. The preferred method of these meth cooks is to ``smurf'' between different pharmacies for PSE products. Smurfing occurs when a person visits a number of different locations buying the legal maximum amount of PSE product at each site. The result is an amount of PSE sufficient to produce home cooked meth. Smurfing occurs because the Combat Meth Act only required that retailers keep a logbook which could be kept on paper or electronically. It did not require interoperability or electronic transmission of data. As a result, these unscrupulous individuals have learned that if they provide false information or visit multiple stores, tracking and arresting these individuals is more difficult and time consuming for law enforcement. This is especially true in metropolitan communities that share a common border, one such example is the Quad Cities on the Iowa/Illinois border. Recently, the Quad City Times highlighted the successes of the Combat Meth Act in an article titled, The Next Step in Meth War. This article detailed the efforts of a Scott County Deputy and his dedication in fighting the meth war. One noteworthy portion of this article raised a question about the lengths that were required for this deputy to do his job in combating mom and pop meth labs. The article stated, ``Now we're stuck with this image of a detective in each Iowa county sorting through thousands of paper forms.'' It read further, ``He must call county to county to find out if those purchasing the limit in Scott County might be doing so elsewhere as well.'' This statement gets right to the heart of our bill. We can't effectively combat meth if we don't close the smurfing loophole. To address this loophole, Senator Durbin and I have introduced the Methamphetamine Production Prevention Act of 2007. This legislation would revise the technical requirements of the Combat Meth Act to allow for electronic logbook systems. The bill would also create a Federal grant program for states looking to create or enhance existing electronic logbook systems. Finally, this bill would prioritize these Federal grants to states that design and implement the most effective systems for sharing information via an electronic logbook system. This legislation will take a big step forward in closing this loophole that home grown meth cooks abuse. Additionally, it does so without creating burdensome mandates upon states to meet requirements. This bill facilitates innovation and growth by offering financial assistance to states looking to create an electronic logbook system. By avoiding mandates, this legislation seeks to promote innovation and growth of electronic logbook systems. This bill has broad support from the law enforcement community and has been endorsed by the National Sheriffs' Association, the National Narcotics Officers' Associations' Coalition, National Alliance of State Drug Enforcement Agencies, the National Criminal Justice Association, the National Troopers Coalition, the National District Attorneys Association, the National Association of Counties, and the Community Anti-Drug Coalitions of America among others. As you can see, this legislation has a broad base of support. Working together, state and local governments can use this legislation and grant program to create interoperable networks that will reduce the illegal smurfing of PSE products and lead us to the goal of ending domestic production of meth. I urge my colleagues, join us in support of this important legislation and pass the Methamphetamine Production Prevention Act of 2007 and help wipe out domestic production of meth. Mr. President, I ask unanimous consent that the aforementioned article be printed in the Record.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, I am a cosponsor of Senator Dorgan's amendment called the Pharmaceutical Market Access and Drug Safety Act. We want to add the provisions on the importation of drugs to this measure. Obviously, I support that effort. That legislation is the result of a collaborative effort by this Senator, Senator Dorgan, Senator Snowe, and Senator Kennedy to finally make drug importation legal in this country. This is one effort which I hope the new Democratic Congress can finally get passed because last time, my own party did not want to see this passed, even though I worked hard to get that done. Now is the time for us to make this happen. This is a golden opportunity this year to get it done. I think we are well on the way to getting it done. I have been a longtime proponent of drug importation. In the years 2000, 2002, and 2003, I supported amendments permitting importation of prescription drugs from one country--Canada. In 2004, Senator Kennedy and I worked together on a bill that would authorize drug importation, but it did not survive the partisan politics of that year. I then introduced my own drug importation bill in 2004 with the number S. 2307. After introducing my bill, I began working in conjunction with the efforts of Senator Dorgan, Senator Snowe, and Senator Kennedy. So in this provision before us, we combined our efforts so that we could all get behind the same bill and have a better chance of getting it passed. Of course, that is where we are, working together this very minute. Making it legal for Americans to import their prescription drugs is a top priority at the grassroots level, as it shows up in my 99 town meetings I have every year in each of our 99 counties, and I have been doing that for 26 years. So I think I have a feel for what the grassroots of my State wants Congress to hear. This is one issue about which I constantly hear, although I am probably hearing it a little bit less now that we have the Part D provisions of the Medicare bill because for people who couldn't afford drugs, who maybe relied on imports or at least drugs from other countries, they are able to get them a little better through the subsidization under the Part D Program. But I still hear about this issue, and that is why I am still working to get it passed. So this needs to be a top priority in Washington as it is at the grassroots of America. I have long advocated allowing American consumers access to safe drugs from other countries, but I have not looked at this solely or even most importantly as a health issue. I have looked at it more often as a free-trade issue. Imports of any kind coming into our country create competition and keep domestic industry of all segments of our economy more responsive to the consumer, giving the consumer what they want at a price they are willing to pay and a quality they care about. In the United States, we seem to import anything that the consumer wants to buy in America, but we don't do it for pharmaceuticals. So why not, with this legislation, do for pharmaceuticals what we do for everything else American consumers want to buy? That is what breaking down the barriers to trade is all about. That is where our country has been for 50 years, breaking down barriers to trade around the world. Yet we keep this barrier up. Consumers in the United States then pay far more for prescription drugs than those in other countries. If Americans could legally and safely access prescription drugs outside the United States, then drug companies would be forced to reevaluate pricing strategies. More competition would have an impact. They would no longer be able to gouge the American consumer by making them pay more than a fair share of the higher costs of research and development, which is a resource we need for research and development, but why should just the American consumers pay for that? It is true that pharmaceutical companies do not like the idea of opening up America to the global marketplace. They want to keep the United States closed to other markets in order to charge higher prices here. However, with this amendment, prescription drug companies will be forced to be competitive and establish fair prices in America. The drug companies will try to find, of course, loopholes to protect their bottom line, but I think our amendment is comprehensive enough to keep that action illegal. It would not allow, for instance, manufacturers to discriminate against registered exporters or importers. It would prohibit drug companies from engaging in any activities to restrict, to prohibit, or to delay the importation of a qualifying drug. The amendment would give the Federal Trade Commission the authority to prevent this kind of possible abuse of the system. I also understand that there will be an attempt to kill this amendment, as it has been, I believe, in the years 2000, 2002, and 2003, by an amendment that would require a certification about health and safety. That amendment is designed to kill the underlying Dorgan amendment. It is a clever amendment and for sure can legitimately be determined to be a poison pill. Our efforts develop an effective and safe system that gives Americans access to lower prices. This amendment requires that all imported drugs be approved by the Food and Drug Administration. The amendment sets a stringent set of safety requirements that must be met before Americans can import drugs from that country. The amendment requires all exporting pharmacies and importing wholesalers to be registered with the Food and Drug Administration, as well as being inspected. It gives the authority for the FDA to inspect entire distribution chains of imported drugs, and it sets very stringent penalties for violation of the safety requirements in this bill, including criminal penalties and up to 10 years in prison. Don't be fooled by the poison pill amendment to which I just referred. Voting for that amendment is a vote to kill drug importation. With the Dorgan amendment, we are going to get this job done because we need to make sure Americans have even greater, more affordable access to wonder drugs by further opening the doors to competition in the global pharmaceutical industry. I think Americans have been waiting for this for a long period of time. When a country such as ours allows every other product to come into this country that the consumer wants for the best price and the best quality, there is no reason we should make an exception for pharmaceuticals. We must make sure they have access to these affordable prescription drugs. So I urge my colleagues to support the Dorgan amendment.

Mr. GRASSLEY. Yes.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, I ask unanimous consent that a bill introduced by me today to amend the Internal Revenue Code of 1986 to clarify student housing eligible for the low-income housing credit, and for other purposes, be printed in the Reord.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, the title of this bill, ``The U.S. Troop Readiness, Veterans' Health, and Iraq Accountability Act,'' doesn't say much for the contents of this legislation because it has gone way beyond that with a lot of material that has nothing to do with the title. The Finance Committee matters definitely don't fit into this bill. As the distinguished chairman of the Appropriations Committee, Senator Byrd has said on so many occasions the Founding Fathers vested the great power of the purse in the Congress. Likewise, the other great power, the power to raise taxes, is vested in Congress. The power of the purse, appropriations, is our power. We are directly accountable to our constituents for our spending actions. In that vein, I deeply respect the deep traditions of the Appropriations Committee. As former chairman and now ranking member of the Finance Committee, I also deeply respect the division of power. The power to tax is our power as a committee, and we are directly accountable to our constituents for our taxing actions. We should mix the jurisdiction of the two great money committees--Finance and Appropriations--rarely, if at all. It should only occur if at all when the senior members of the tax writing and appropriations committees agree. Mixing tax writing and appropriations jurisdiction should not occur. As a leadership power play, those kinds of actions demean the committees. Fortunately, the leadership respected this division of jurisdiction between the tax writers and appropriators over the last 6 years. Unfortunately, early on in the tenure of this new Democratic majority and their leadership, we have seen a dramatically different course of action for purely partisan reasons. The Democratic leadership inserted into this sensitive supplemental appropriations bill two major matters that involve Finance Committee jurisdiction. So the first lesson we have learned is that the line between the tax writing committee jurisdiction and appropriations jurisdiction will not be observed. That will only undermine each committee and break down the committee process. The second lesson is the ``I told you so.'' Shortly after the Senate acted on the minimum wage and small business tax relief bill, I said I had learned something from the Democratic leadership, as they were in the minority over the last 6 years. It was a lesson the Democrats taught us while they were in the minority. That lesson is, get a preconference agreement. Put another way, if you are in the Senate minority, as we are now, don't agree to a conference unless you secure an agreement for fair treatment in advance. That is something that worked well for the Democrats while they were in the minority, something we ought to have learned, and we have learned. Now let me say I appreciate all the consultation and courtesy that Chairman Baucus has given me. He worked with me and I worked with him to get the minimum wage, small business tax relief bill through the committee. But the composition of the final package that is before us is heavily weighted toward an extension and modification of the work opportunity tax credit--and I support that credit--and the benefits of that policy are delayed. Small businesses need tax relief to be in sync with the time of the minimum wage kicking in. Both of these outcomes do not reflect a proportionate agreement between the House and Senate bills. The arbitrary ceiling on the amount of tax relief was not a fair balance. This agreement confirms that a preconference process--learning that from the Democratic minority of the last 4 years--is necessary to ensure that a conference agreement will reflect the priorities of both bodies. I will reiterate my point to the Republican leadership again on that. This process proves that we need a preconference agreement before agreeing to go to conference in the first place. Now I will return to the substance of the deal, Mr. President. I am hearing from a lot of small business folks who are going to be paying the minimum wage. They want to retain their current workforces, hey have to look to the bottome line. They are very disappointed that the arbitrary $5 billion limit meant that important tax relief measures were tossed out. I am referring to a simplification of the cash method of accounting. That proposal would cut down on a lot of paperwork small businesses currently have to do. I'm also referring to faster depreciation rules for new restaurant buildings, and I am referring to faster depreciation rules for retailers and owner-financed building improvements. All of these proposals would help with the coming cash crunch that these small businesses will be facing. I am not hearing from a lot of the big business folks who were targeted by the loophole closers and antitax shelter measures. Because of House opposition and fealty to the $5 billion number, those reasonable revenue raisers were tossed out the window. This was a missed opportunity. It was a missed opportunity for a Congress that started with a supposed reform mission to send a message to K Street in DC and Wall Street in New York City. That message would've been simple. Don't engage in tax shelters like the so-called ``SILO'' transactions. Don't move your company headquarters offshore to minimize your American tax responsibilities like the so-called ``inversion'' transactions. For high-paid CEOS, don't rely too much on non-qualified deferred compensation arrangements. Nope, you can kiss that opportunity goodbye. When it came to the small business tax relief package, K Street and Wall Street big business won and Main Street small business lost. Not a good outcome. Hopefully, once this bill is vetoed and we return to the minimum wage/small business tax relief package, Main Street small business will come out on top. Now I am going to turn to the other Finance Committee material in this time-sensitive appropriations bill. I am referring to Medicaid proposals in the conference agreement. There is a provision in the conference agreement that would prevent CMS from implementing the cost- limitation rule. Certainly, a one-year moratorium is an improvement over the two-year moratorium that was in the bill as passed by the Senate, but the language in the bill still encourages states to push the envelope on payment schemes. If CMS gets a waiver or state plan amendment that has authority to do with the rule, I don't think CMS has the authority to turn it down. Neither does CMS. And after trying to work it out with the sponsors of the provision for the last couple of weeks, I don't think they want CMS to have any authority either. Why? This is a provision written for the benefit of a special interests so they can avoid real scrutiny of their financing arrangements. This provision will encourage states to offer payment schemes that CMS has previously disallowed as being inappropriate. It will encourage litigation if CMS tries to assert that they do still maintain jurisdiction. This is just bad public policy. The inspector general has investigated and reported to congress on why there are problems in the areas the rule addresses. We have not had the first hearing on why the rule doesn't work and must be stopped. This is a tremendous mistake and should not be in the bill. The way that this provision is paid for is equally noxious. The extension of the Wisconsin pharmacy plus waiver is an unnecessary earmark. Every State but Wisconsin has changed their pharmacy assistance program as the MMA required. But why hasn't Wisconsin? It's very simple. They want the Federal dollars that Medicaid provides and the rebates they get from drug companies. That it is an earmark is bad. But the way the language is written is really offensive. The language is written in a way that games Medicaid's budget neutrality test. It's written to guarantee that it appears to save money. The reality is that Wisconsin will be providing many poor seniors with less of a benefit than they could get through part d. Wisconsin charges greater cost-sharing than Medicare for low income seniors. It truly is another missed opportunity. They could have paid for this with a provision we would have gladly supported. But again, the special interest won out. We could have struck a provision that the House Rules Committee stuck in the tax bill in the middle of the night last December that creates an unfair advantage for certain private fee-for-service Medicare Advantage plans. Senator Baucus and I thought this was terrible policy, we said so on the floor, and have wanted to change it. Plans based in Illinois and Nevada are among the plans it advantages most. So for some reason, striking the provision didn't make it into the bill. It's a corporate giveaway that should be eliminated. Legislating to prevent CMS from cleaning up intergovernmental transfers scams on this appropriation bill sets a bad precedent. That is clear. It's legislation on Medicaid and, that is a basic part of the jurisdiction of the Finance Committee. If the Senate proceeds in this manner, then nothing then would prevent the Senate legislating changes on other Medicaid and Medicare issues on appropriation bills without the benefit of hearings or committee action on those subjects. Invading the Medicaid and Medicare jurisdiction of the Finance Committee is a mistake. It is almost impossible to cope with Medicaid and Medicare legislation on appropriation bills. These are complex issues that are best dealt with by the committee of jurisdiction. This bill is going to be vetoed. The Appropriations Committee will return to its work to fund the troops in the field. We ought to focus on that. On minimum wage/small business tax relief, we need to go to regular order. Let's arrive at a pre-conference agreement on the House and Senate bills and go to conference and hash it out with a real conference. Unlike this situation, the chairmen and ranking members of both tax writing committees should be conferees. In that setting, we can arrive at a bipartisan agreement that passes the House, Senate, and be signed by the President. On the Medicaid provision, it ought to be crafted by the committees of jurisdiction and incorporated in a vehicle controlled by those committees. After the veto, let's get this right. I would ask the leadership to get out of the way of the tax writing committees and let us do our work on our schedule in line with our committees' objectives. I yield the floor.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, I ask unanimous consent that a bill introduced by me today to amend the Internal Revenue Code of 1986 to clarify student housing eligible for the low-income housing credit, and for other purposes, be printed in the Reord.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, I am pleased to join my colleague today, Senator Feinstein, in introducing the Saving Kids from Dangerous Drugs Act of 2007. I believe we have a moral obligation in this country to ensure our young people have every opportunity to grow up without being accosted by drug pushers at every turn, whether on TV, in the movies, or on the way to school. This important legislation comes in response to the recent warnings issued by the Drug Enforcement Administration and the Office of National Drug Control Policy of candy-flavored meth and other illegal drugs being colored, packaged, and flavored in ways that appear to be designed to attract use by children and minors. As co-chairman of the Senate Caucus on International Narcotics Control, I can tell you that the most at-risk population for drug abuse is our young people. Research has shown time and again that if you can keep a child drug- free until they turn 20, chances are very slim that they will ever try or become addicted. Unfortunately, unscrupulous drug dealers are all too aware of statistics like these and have developed new techniques and marketing gimmicks to lure in younger users. As a parent and now grandparent, this is extremely worrisome. Last year, we worked to pass the Combat Meth Act into law. Since that time, the number of clandestine meth lab seizures have dropped dramatically across the country. By placing the essential ingredient pseudoephedrine behind the counter, we have lifted a heavy burden from the shoulders of our local law enforcement and made our communities a safer place to live and raise a family. In my home State of Iowa alone, the number of seizures fell a remarkable 73 percent since the sale of pseudoephearine was restricted. But as anyone can tell you, we have a long way to go. Despite our best efforts and recent success, meth continues to wreak havoc on families and communities across the country. While local ``mom and pop'' meth labs are being dismantled everywhere, drug dealers continue to look for new ways to market their poison. This legislation is intended to protect our young people by expanding existing penalties for those marketing their poison to kids. Currently Federal law enhances Federal penalties for selling drugs to anyone under the age of 21. When a violation occurs, the Federal penalties are doubled--tripled for a repeat offense--and a mandatory minimum of at least 1 year also applies. However, only the dealer who directly sells drugs to someone under 21 is subject to a double sentence. The Saving Kids from Dangerous Drugs Act would expand the circumstances under which these enhanced penalties apply. Under our bill, the enhanced penalties that already exist would also apply to anyone who ``manufactures, creates, distributes, or possesses with intent to distribute a controlled substance that is flavored, colored, packaged or otherwise altered in a way that is designed to make it more appealing to a person under 21 years of age, or who attempts or conspires to do so.'' The fight against meth and other dangerous drugs is and will continue to be an ongoing struggle. We must adapt and change our tactics just as the dealers, distributors, and pushers have changed theirs. We must do all we can to protect the most vulnerable among us and send a clear message to those wishing to prey on our youth. I ask that my colleagues join us in support of this important legislation and pass the Drug Endangered Children Act of 2007.

Mr. GRASSLEY

Mr. GRASSLEY. Mr. President, I am pleased to join my colleague today, Senator Feinstein, in introducing the Saving Kids from Dangerous Drugs Act of 2007. I believe we have a moral obligation in this country to ensure our young people have every opportunity to grow up without being accosted by drug pushers at every turn, whether on TV, in the movies, or on the way to school. This important legislation comes in response to the recent warnings issued by the Drug Enforcement Administration and the Office of National Drug Control Policy of candy-flavored meth and other illegal drugs being colored, packaged, and flavored in ways that appear to be designed to attract use by children and minors. As co-chairman of the Senate Caucus on International Narcotics Control, I can tell you that the most at-risk population for drug abuse is our young people. Research has shown time and again that if you can keep a child drug- free until they turn 20, chances are very slim that they will ever try or become addicted. Unfortunately, unscrupulous drug dealers are all too aware of statistics like these and have developed new techniques and marketing gimmicks to lure in younger users. As a parent and now grandparent, this is extremely worrisome. Last year, we worked to pass the Combat Meth Act into law. Since that time, the number of clandestine meth lab seizures have dropped dramatically across the country. By placing the essential ingredient pseudoephedrine behind the counter, we have lifted a heavy burden from the shoulders of our local law enforcement and made our communities a safer place to live and raise a family. In my home State of Iowa alone, the number of seizures fell a remarkable 73 percent since the sale of pseudoephearine was restricted. But as anyone can tell you, we have a long way to go. Despite our best efforts and recent success, meth continues to wreak havoc on families and communities across the country. While local ``mom and pop'' meth labs are being dismantled everywhere, drug dealers continue to look for new ways to market their poison. This legislation is intended to protect our young people by expanding existing penalties for those marketing their poison to kids. Currently Federal law enhances Federal penalties for selling drugs to anyone under the age of 21. When a violation occurs, the Federal penalties are doubled--tripled for a repeat offense--and a mandatory minimum of at least 1 year also applies. However, only the dealer who directly sells drugs to someone under 21 is subject to a double sentence. The Saving Kids from Dangerous Drugs Act would expand the circumstances under which these enhanced penalties apply. Under our bill, the enhanced penalties that already exist would also apply to anyone who ``manufactures, creates, distributes, or possesses with intent to distribute a controlled substance that is flavored, colored, packaged or otherwise altered in a way that is designed to make it more appealing to a person under 21 years of age, or who attempts or conspires to do so.'' The fight against meth and other dangerous drugs is and will continue to be an ongoing struggle. We must adapt and change our tactics just as the dealers, distributors, and pushers have changed theirs. We must do all we can to protect the most vulnerable among us and send a clear message to those wishing to prey on our youth. I ask that my colleagues join us in support of this important legislation and pass the Drug Endangered Children Act of 2007.

Mr. GRASSLEY. Mr. President, I am pleased to join my colleague today, Senator Feinstein, in introducing the Drug Endangered Children Act (DEC) of 2007. As U.S. Senators representing States that have been among the hardest hit by the scourge of meth, we have witnessed first hand how this horrible drug has devastated individual lives and families. We have seen the havoc wreaked on the environment as well as the child welfare system and we have listened to the horror stories of those caught in the grips of addiction. Last year we worked together in a bi-partisan effort to pass the Combat Meth Act, which was eventually included in the USA PATRIOT Act Reauthorization. The result has been a dramatic decrease in the number of clandestine meth lab seizures. While this is certainly welcome news, particularly for our first responders and local law enforcement community, last year there were over 6,400 clandestine meth lab incidents throughout the country. In my home State, we saw a 73 percent decrease in the number of meth lab incidents compared to the previous year yet there were still over 300 incidents last year alone. Clearly, the Combat Meth Act has made progress against locally produced meth, but further action is needed to fully combat this epidemic. In spite of our success and ongoing efforts to reduce the dangers from ``mom and pop'' meth labs, new and more disturbing instances of meth production, trafficking, and abuse are becoming more prevalent throughout the country. In the State of Missouri, police recently made seven meth-related arrests in just as many hours in the tiny, quiet town of Ozark. The house where these arrests were made belonged to a 45-year-old grandmother, who was baby sitting her infant grandson while his mother was away at school. Upon her arrest she admitted to using meth, but denied she was a dealer. However, while police searched the house, six more individuals were picked up on meth-related charges. When it was all said and done, three children under the age of 3 watched as the police arrested their parent or grandparent for selling or possessing this dangerous drug. Sadly, this was not an unusual incident. Since 2002, more than 12,000 children throughout the country have been affected, injured, or killed at meth lab sites and thousands more have been sent to foster homes or were victims of meth-related abuse in the home. In Iowa, the Department of Health reports that over 1,000 children over the past 4 years were classified as victims of abuse, and that nearly half of child abuse cases have been meth-related. Due to the shocking number of children that were being victimized by meth in one form or another, I joined my colleagues in supporting the ``Drug Endangered Children Act of 2005.'' This bill which passed into law as part of the USA PATRIOT Act Reauthorization, established a national grant program to support state Drug Endangered Children programs and to assist local law enforcement, medical services, and child welfare workers to ensure that victimized children would receive proper attention and treatment after living in these terrible environments. I'm pleased to report that since we implemented this grant program, a large number of communities throughout the nation have formed multi-disciplinary alliances for the benefit of drug-exposed children. There are 16 communities throughout Iowa that have taken advantage of these grants and more are in the process of planning and setting up programs. The Drug Endangered Children Act of 2007 would re-authorize this important grant program for an additional 2 years and assist States in coordinating law enforcement, medical services, and child welfare efforts, to ensure that children found in such environments receive appropriate attention and care. I am pleased to join with my colleague again as we work together to renew this wonderful and worthwhile program. I ask that my colleagues join us in support of this important legislation and pass the Drug Endangered Children Act of 2007.

Mr. GRASSLEY

Mr. GRASSLEY. I ask unanimous consent that the order for the quorum call be rescinded.

Mr. GRASSLEY. Mr. President, in his bestselling book, ``The World is Flat,'' Thomas Friedman discusses the challenges of globalism using the metaphor of the world getting flatter to describe how the breaking down of international barriers to the movement of goods, services, people, and ideas creates an intensely competitive global environment. I liked it so much, and it has so much wisdom in it. In chapter 8, entitled ``This Is Not a Test,'' Friedman says, ``If this moment has any parallel in American history, it is the height of the cold war, around 1957, when the Soviet Union leaped ahead of America in the space race by putting up the Sputnik satellite.'' Not coincidentally, the Congress passed the National Defense Education Act the following year, 1958. That act really started Federal Government involvement in education. It was designed primarily to jumpstart education in math, science, and modern foreign languages so we would be able to match and exceed the achievements of the Soviets and win the cold war. According to Thomas Friedman, to meet the challenges of what he calls ``flatism'' will require, ``as comprehensive, energetic, and focused a response as did meeting the challenge of communism.'' As I mentioned, Federal education policy started with an urgency to support and encourage students to excel in fields that were considered to be of major importance to national security during the cold war. Subsequently, Federal education policy became concerned with equity between students of different socioeconomic classes as part of President Johnson's war on poverty. Both of these dual focuses of Federal education policy, excellence and equity, are legitimate and important. However, we sometimes seem to ping pong between the two, forgetting about one in favor of the other. The No Child Left Behind Act of 2001 deepened the existing focus of the Elementary and Secondary Education Act on making sure that all students have an adequate education. Now while we don't have a single event like Sputnik to bring home to us the current challenges we face, there is a growing recognition that, for the sake of our future economic competitiveness, we cannot neglect the importance of challenging and encouraging students to excel so that they will some day be the scientists, engineers, and researchers that will create the innovations that will drive our economy. This means that we must not only help underachieving students to achieve at grade level, but we must encourage high ability students to achieve to their full potential. For years, I have been leading the charge to do a better job unlocking the tremendous potential that lies in gifted and talented young Americans. They represent a national resource that, unfortunately, too often goes untapped. Gifted students learn faster and to a greater depth than other students and often look at the world differently than other students. As a result, it takes a great deal more to keep them challenged and stimulated. If they are not sufficiently stimulated, they often learn to get by with minimum effort and adopt poor learning habits that can prevent them from achieving to their potential. In fact, many gifted and talented students underachieve or even drop out of school. Jan and Bob Davidson, from the majority leader's home State, wrote an important book called ``Genius Denied'' about how, nationwide, we are letting gifted students fall through the cracks and wasting their potential. The Belin-Blank Center in my home State of Iowa produced a report titled, ``A Nation Deceived: How Schools Hold Back America's Brightest Students.'' This situation must be reversed if America is to retain its competitive edge which, obviously, is the purpose of the very good legislation before us, led by Senators Bingaman and Alexander. I am glad that the American competitiveness bill currently before the Senate recognizes the need to do a better job of helping students to excel in fields like math, science, and critical foreign languages. However, if we want to go toe to toe with countries that place a very high value on learning, we must do more to support and encourage the best and brightest American students. My amendment would increase the fee employers pay for H1-B visas for highly skilled foreign workers to immigrate to the United States and to use that additional funding for the Jacob Javits Gifted and Talented Students Education Act. This is the only Federal program that provides funding to support programming to meet the unique learning needs of our brightest, most promising students. It funds a national research center that produces invaluable research in instructional strategies that can truly tap into the potential of gifted students as well as a small grant program to encourage such research nationwide. The Javits Act also contains a grant program to encourage greater focus in the States on meeting the needs of gifted learners, although it has been funded at levels that severely limit its effectiveness. The quality or even existence of services for gifted students varies widely among our 50 States. While the Federal Government should not assume the primary responsibility for funding gifted and talented education, just as Congress provides funding to augment State efforts to provide an equitable education for disadvantaged students and students with disabilities, the Federal Government still has a vital national interest in encouraging State efforts to fully develop the gifts and talents of American youth. The proposal that is in my amendment before the Senate would essentially charge a fee to those investing in talent from abroad and use it to invest in talent for the future here at home. Doesn't it make sense if we are using our educational system to bring students or workers over here to train them better--they take advantage of our higher education system; they take advantage of our educational system generally--wouldn't it be wise to use those resources so we can enhance the opportunity we have for our own gifted and talented students right here in the United States? We have to put more attention on education. Now, I am offering a Federal program, I know, or the expansion of a Federal program, and funding it in a way that is not appreciated by those who will soon be involved in the immigration bill that is going to be before us. They have asked I not offer this amendment, and that is why I said I would offer it and withdraw it. But I think this is a very important approach we must use if we are going to make adequate use of our own talented and our own gifted students right here at home--the homebred students whom we have--as opposed to thinking we have to rely, in the 21st century, in this great country of America, upon the talent of foreign lands. Now, there is a lot of talent in foreign lands that if we can draw upon it, we ought to draw upon it. But the fact we have to do that, or we think we are willing to submit to that sort of an approach, to advance the competitiveness of our economy in this globalization we are involved in, is a sad commentary. That is why I have offered this amendment. I want to say even though I am withdrawing it, I am doing it with the idea I am not giving up on this effort. I am going to advance this effort in other appropriate places in the legislative process in the future. Let me suggest, for those who maybe want to fight it, it is going to be in the near future. For those who maybe like it, would they join me in this effort to get this job done? Having emphasized competitiveness and everything involved in it, I want to say my philosophy of improving education in this country is not rested only upon Federal programs. I think four basic things are at the base of changing or improving our educational system, and they do not involve the expenditure of more money. It basically is a societal attitude that needs to be changed. No. 1, we have to think in terms that there is nothing wrong with homework. There are too many parents, too many teachers in this country who think, somehow, we have to eliminate homework. Secondly, we have to have the schools in this country and the parents involved think that education and book learning is more important than sports; thirdly, that weekends are not something just for leisure. Weekends have to be used for study as well. And lastly--and the one thing that is most important--parents, to a greater degree than they are presently, have to be involved and show interest in the education of their own kids, and supporting the great teachers of this country who are there doing both the job of parenting as well as the job of teaching. Those societal changes are going to do more to enhance education and the competitiveness of our economic system than anything we can do by passing any Federal program. But I think we can enhance a lot of programs, and this bill is a good step in that direction. I wish I had been able to convince the people on the Judiciary Committee that we ought to advance this amendment here at this time because it is very associated with the competitiveness of our society and the purposes of this bill. Amendment No. 914 Withdrawn But I ask unanimous consent to withdraw the amendment.