Orrin Hatch

Mr. HATCH

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. HATCH

Mr. HATCH. Mr. President, I would like to discuss the amendment which deals with antibiotics and enantiomers, which is included in the managers' package we are adopting today. I offered this amendment at the HELP Committee markup, but withdrew it with assurances that we would work it out prior to floor action. There have been constructive discussions among all interested parties and I believe we have worked language out that is acceptable. There is a great urgency to this situation, and I want to make certain my colleagues understand it fully. The Infectious Diseases Society of America, the Alliance for Aging Research, the Institute of Medicine, the Resources for the Future, the Centers for Disease Control, and many others have been sounding the alarm about the growing threat from resistant microorganisms and the need for innovation in the area of antibiotics. Congress must listen. Nobel Laureate Joshua Lederberg said it well: We are running out of bullets for dealing with a number of (bacterial) infections. Patients are dying because we no longer in many cases have antibiotics that work. The Hatch amendment is intended to be an initial step in the fight against these resistant strains of bacteria by increasing incentives and innovation. Additionally, the language in the amendment requests FDA to work with companies to apply the Orphan Drug Act to antibiotics wherever possible. Hand-in-hand with this, it reauthorizes the Orphan Drug Act grant and contracts from fiscal years 2008 through 2012. As many of my colleagues know, this act has resulted in important medicines for rare diseases. The Hatch amendment also ensures that currently existing incentives for new drugs are available for new single enantiomers in new therapeutic areas such as Alzheimer's, cancer, and type II diabetes among others. In 1997, FDA issued a Federal Register notice acknowledging that the policy needed clarification and this amendment would do that. Let me start with the issue of antibiotics and the need for new antibiotics to fight drug-resistant infections. Many of us have become more and more concerned that there is an alarming increase in the number of drug-resistant infections--many of them serious--and we are running out of treatment options. My first chart is based on data from the Centers for Disease Control and Prevention and shows how resistant strains of infections have spread rapidly from 1980 to 2000. My colleagues, this is a very alarming trend and sadly, for all of us, the problem of resistance continues to grow. A report many of us are familiar with, Bad Bugs, No Drugs, from the Infectious Diseases Society of America, IDSA, highlights the lack of R&D for new antibiotics. Antibiotics are not profitable compared to medications that treat chronic conditions and lifestyle issues. Also, antibiotics are taken for short periods of time--unlike medications for chronic disease which may be taken daily. And, when a new antibiotic comes on the market, it is discouraged from use to avoid the development of resistance. As a result, it is fair to say that major pharmaceutical companies have not been making significant investments in antibiotics. Given that there are few, if any, antibiotics in the drug development pipeline, if Congress fails to act, we walk blindly into a future where we must fear basic infections we have long taken for granted are not a problem. Medicine changed dramatically when penicillin was discovered and physicians had a tool to treat deadly infections. Can any of my colleagues imagine life without penicillin? I am sorry to inform you, we are about there. Over the years, many infections became resistant to penicillin, but we were OK--we moved on to the next antibiotic. We had methicillin--and now serious infections are resistant to that. We should consider what the health professionals are telling us. Will we listen? We are taking antibiotics and our ability to treat bacterial infections for granted. Infectious disease doctors from all over the country have been writing to their Senators to express their support for my amendment. They tell heart-wrenching stories. Dr. Helen Boucher, a physician at Tufts Medical Center in Boston, MA, wrote to tell Congress that patients are routinely lost ``to infections caused by resistant bacteria for which we have few to no options. [They] recently lost two bone marrow transplant recipients who survived all the chemo but died of multiply-resistant gram negative infections. In both cases, [physicians] pulled an old antibiotic off the shelf and gave it as a last resort, knowing how toxic it was but having NO other options for these young people. . . .'' She wrote: As a doc and an American, it's horrifying to know that few to no companies are investing even in discovery of new antibiotics for these infections . . . just this week [she] was presented a case of a previously completely healthy 33 year-old lady who presented to the hospital in Boston with pneumonia and died within 6 hours from community-acquired MRSA. Her story and so many others that we see ALL the time, make the need for new and powerful options to treat these infections critical. Community-acquired MRSA is an infection that was historically acquired while in the hospital, but now is impacting young, healthy people. We have heard stories of high school, college and professional athletes losing their lives or careers as a result of these infections. Sadly, this infection has become far too common, difficult to treat and has few options to fight it. It can leave individuals disfigured, if they survive. In my own State of Utah, the number of children with MRSA infections at the Primary Children's Medical Center in Salt Lake City has dramatically increased since 1989. Dr. Andy Pavia of Salt Lake City told me that he ``cared for a 2 month old girl who developed MRSA pneumonia and almost died as a complication of an otherwise mild respiratory infection. She survived and will be going home to her parents, but only after 2 weeks of the most sophisticated intensive care and an additional 4 weeks of intravenous antibiotics.'' Dr. Pavia went on to explain that the Primary Children's Medical Center sees the impact of resistant bacteria almost every day. In fact, he wrote: Last week a two year old girl [who] was weeks away from being cured of Burkitt's lymphoma developed shock due to a bloodstream infection with a highly resistant strain of a gram-negative bacteria. Fortunately, the bacteria was sensitive to one remaining antibiotic. If it had been resistant, she would not have left the Pediatric ICU alive. The doctor related that MRSA is an aggressive, difficult to treat, form of staph that has spread rapidly within communities. Half of the children he sees with severe MRSA infections acquired their infection at home. This is a picture of Bryce, whose family tells a similar story. He had his first cold 2 days before Christmas. Before then, 14-month-old Bryce Smith had never been sick. At 2 a.m. on New Year's Day, his parents took him to the emergency room, where the seriousness of their son's condition became immediately apparent. An X-ray showed that Bryce had pneumonia. A CT scan showed that his right lung was filled with fluid. Four hours after arriving at the ER, Bryce was scheduled for surgery. Doctors found that a methicillin- resistant staph infection had eaten a hole through his lung. For the first 12 days that Bryce was in the hospital, the doctors didn't know whether he would live. Doctors battled to force air into the child's lungs, but as they told his mom, it was like trying to pump air into a brick. Doctors prescribed high levels of antibiotics, including vancomycin, in a desperate battle to fight the infections. For 6 weeks, the child did not wake up. During Bryce's stay in the hospital, he has suffered from several additional infections. Bryce is doing much better now, he was released from the hospital, but he still must relearn how to walk. His recovery could take several months. As of April 2007, the Smiths' total bill for Bryce's care is just under $1 million. Fortunately, the family's insurance does not have a ceiling on payments; otherwise, the Smiths say they would be in financial ruin. Bryce's ongoing care needs are decreasing, but he still has regular visits with the pulmonologist, nephrologist, and his pediatrician. He still tires out easily with exertion. The fact that children acquire this infection at home is significant because we used to only worry about it in the hospital. Last month, there were numerous articles about CDC's concern that cases of resistant gonorrhea have dramatically increased and respond to only one antibiotic. There has been much concern over the past couple months related to extensively-drug resistant--XDR-TB. Right now, there is a man in Phoenix, AZ, whom authorities took action to isolate in order to avoid the spread of the deadly XDR-TB infection he had contracted while out of the country. This comes in addition to the numerous reports of our soldiers coming home from Iraq with Acinetobactor--a resistant infection that is especially difficult to treat and the only option is a very toxic antibiotic. One doctor we have heard from, in a local community, indicated he has seen two patients just this month with infections resistant to every antibiotic currently available. That is becoming a common occurrence. Infections disease specialists can do little more than provide supportive care for those unfortunate patients. Without any new antibiotics in the pharmaceutical pipeline, there is no promise of a treatment for years to come. Whatever we do to begin to address this serious concern, we can't hope to realize the benefit for more than a decade. Drug development takes time and money. Yet few companies are willing to invest either in the area of antibiotics. I believe this chart shows that is the case. As you can see from this chart, the number of new antibacterial agents that have actually been approved is minimal. The market forces don't work well for antibiotics. When we cannot rely on the market, government has an obligation to step in. The Hatch amendment focuses on incentives for research and development of antibiotics. Specifically, my amendment: Provides equitable treatment for so-called ``old'' antibiotics; promotes communication and education of current law orphan drug incentives by directing FDA to convene a public meeting to clarify what ``bad bugs'' may qualify for orphan designation; reauthorizes the Orphan Drug grants and contracts program which expired September 30, and requires FDA to establish, update and make publicly available information on antibiotic breakpoints. This is important to assure that the antibiotics we and our children take are effective against bacterial infections and minimize the progression of resistance. Antimicrobial resistance is a public health crisis. In many ways, it is even bigger than drug safety, a point our colleague, Dr. Coburn, made at the HELP mark up. This is an issue that touches not just the old or the young, but all Americans throughout every walk of life. Antibiotics are as precious a natural resource as water is to a vibrant and healthy community and, guess what, the creek is drying up. The Hatch amendment only takes the first steps to address these issues. If we cannot work together on these more minor provisions, how will we truly combat antimicrobial resistance? What will we say to the children, soldiers, athletes, elderly and so many others that contract these deadly diseases which only years before were successfully treated with antibiotics? Are we really willing to walk away and leave nothing in our arsenal to fight these bad bugs? I would like to turn my attention now to a provision in the Hatch amendment which encourages innovation in another area. This provision provides for 5-year exclusivity for enantiomers of previously approved racemic drugs in different therapeutic areas based on new data. Enantiomers are mirror images of the same drug. You can think of them as left-handed and right-handed molecules. We now understand that, in some cases, these enantiomers have very different activity and safety profiles. In simplest terms, imagine the biological target is a glove that fits one hand better than the other. When Hatch-Waxman was passed originally, we didn't contemplate the isolation of one enantiomer from an approved drug made up of a mixture of enantiomers and its development for a new use based on all new data. But today that is exactly what is happening. Sponsors are finding new important uses for enantiomers of drugs previously approved as a mixture of enantiomers. Where FDA is requiring all new data for approval of these single enantiomers and will not allow a company to rely on any of the data submitted in the original application for the mixture of enantiomers, these single enantiomers are effectively new chemical entities and should be entitled to 5-year exclusivity. In 1997, in a Federal Register notice, FDA laid out the issue, acknowledging the lack of clarity in the law regarding 5-year exclusivity for enantiomers and the need to incentivize this type of development. FDA requested comments but never finalized a policy. The Hatch amendment makes it clear that development of an enantiomer for new use in a new therapeutic area based on new data would qualify for 5-year exclusivity. However, in order to address the potential for abuse the revised provision limits 5-year exclusivity to approvals in a new therapeutic class. As this chart states, innovation and development of enantiomers may provide treatments in cancer, Alzheimer's disease, type II diabetes. When it comes to FDA, we need to get it right. I feel we have done a lot of good with this bill, and I voted for it in committee with the understanding the issues I raised on antibiotics and enantiomers would be addressed before we reached final passage. I am glad that, as of yesterday afternoon, we have worked out all remaining concerns and I believe the chairman's commitment at the markup has been honored. I know that some were concerned about this amendment, specifically because its incentives provisions were fueled by exclusivity. With all due respect, I understand the importance of the generic drug industry. We spoke earlier about the need to get it right for follow-on biologics. But we should listen to the public health associations, who understand the need to support innovation. Indeed, the Alliance for Aging Research, Infectious Diseases Society of America, National Organization of Rare Disorders, and Immune Deficiency Foundation are dedicated to advocating for patients and doctors and improving public health in this country, and they fully support this amendment in its entirety. The Infectious Diseases Society of America represents doctors that see the threat of resistant bugs every day. They recognize the need for innovation in their therapeutic area. This isn't different than 10 years ago when the American Academy of Pediatrics argued passionately for the need for innovation in pediatric research. Some may not remember that the generic drug industry opposed that provision saying that innovation was not necessary. In contrast, I am pleased that we have achieved an agreement today that recognizes the need for this innovation in research involving antibiotics and enantiomers. Ten years ago, Congress passed the last major piece of FDA legislation, the Food and Drug Administration Modernization Act, or FDAMA. Those of us who were here then recall ever-so-vividly the infamous chart of the feet displayed with great effectiveness by our colleague Senator Kennedy. I hasten to say many have had recurring nightmares about the horror of these feet. The Senator and his very bright staff were ever-so- clever in their effective use of this chart. Today, I hope to have the same effect, although I do not wish to spawn a new generation of nightmares. I submit to my colleagues, that if we had adequate antibiotics in development, we never would have had to look at these diseased feet. With passage of my amendment today, perhaps this chart can be relegated to the Russell attic forever. In closing, I thank my colleagues for recognizing that antimicrobial resistance is not a brand issue or a generic issue. Effective treatment for Alzheimer's, cancer, or type II diabetes is not a brand issue or a generic issue. These are public health issues. I urge my colleagues to take these issues seriously and appreciate that we have joined together and not let these serious concerns fall subject to politics as usual. These are growing problems and require attention before it is too late. We need to make sure that innovation is encouraged in these areas and high scientific standards are maintained and the Hatch amendment does just that.

Mr. HATCH

Mr. HATCH. I rise to speak about the amendment I offered to S. 1082 on antibiotics access and innovation. My amendment is supported by the Infectious Diseases Society of America, IDSA, the Alliance for Aging Research, the National Organization of Rare Disorders, and the Immune Deficiency Foundation. It is intended to take initial steps to address the important issue of drug resistant microorganisms and the need for new antibiotics. Senate Health, Education, Labor, and Pensions Committee Chairman Ted Kennedy and its Ranking Member Mike Enzi have worked with me on the provision as well as Senators Burr, Brown, and Cochran. I appreciate all their efforts to address this important issue and am pleased that we have reached an agreement on language to include in S. 1082.

Mr. HATCH. Senator Kennedy has always been a leader in public health issues and I appreciate the efforts of him and his staff to address this important matter. However, I am concerned one provision of my amendment that was not included which deals with bioequivalence standards for locally-acting non-absorbed drugs. In the amendment I filed for Committee, I had asked for the Food and Drug Administration to establish a new bioequivalence standard for these drugs through a guidance allowing for transparency and a public process. The underlying bill deals with drug safety and although I am a supporter of the generic drug industry, I want to ensure that their bioequivalence standards are based on science--we need to ensure that FDA is applying high scientific standards and allowing for public input when these standards are developed by the Office of Generic Drugs.

Mr. HATCH. Yes, it is. I appreciate the remarks of the Senator from Ohio. I yield to the Senator from Mississippi.

Mr. HATCH. I thank the Senator from Mississippi for his leadership on this matter. I agree that we need to pursue this further if we don't get good answers from the FDA. The agency's lack of a response is a big concern to me. I might also add that your health advisor, Leigh Ann Ross, who is a pharmacist, has been very helpful in explaining the issues of pharmaceutical science at issue here. I also want to acknowledge the work of my colleague from Massachusetts who has shown great leadership here and his dedicated staffer, David Dorsey, who has worked tirelessly on this entire bill and this issue in particular. I also appreciate the hard work of Senator Enzi's staff person, David Schmickel, who has made great efforts to reach an agreement on this issue. We would not have been able to reach this point without Senator Kennedy's and Senator Enzi's leadership on the entire bill. In addition, I would like to acknowledge Senator Brown's health staffer, Ellie Dehoney, who has made valuable contributions to this discussion.

Mr. HATCH. I thank the Senator. I appreciate my colleagues' willingness to work with me on this important issue. Although the language on the bioequivalence issue is not in the agreed-to version of the amendment, by accepting the revised amendment, I want to make it perfectly clear that we want to have clear answers from the FDA on its current process in establishing a bioequivalence standard for locally-acting non-absorbed drugs. It is certainly not my intent or the intent of my colleagues to suggest that we have concluded the oversight of FDA on this issue. Instead, we have agreed to engage with FDA through the oversight function of the HELP Committee to ensure that the scientific standards and procedures used in establishing bioequivalence for this life-threatening antibiotic are appropriate.

Mr. HATCH. I thank the Senator from Pennsylvania and I know that he has been in communication with FDA regarding this issue. His contributions to this dialog have been considerable. I look forward to working with him, Senator Cochran and my HELP Committee colleagues in getting some answers from the FDA on this situation. Authorized Generics

Mr. HATCH. My friend from West Virginia has had a longstanding interest in looking into this issue, and I certainly don't fault his tenacity in this area. When Congressman Henry Waxman and I wrote the Drug Price Competition and Patent Term Restoration Act in 1984, our intent was to improve generic competition, while preserving the ability of brand-name manufacturers to discover and market new and innovative products. I think this legislation has worked fairly well at achieving its intended goals. I know there have been a few problems along the way, but I think we addressed many of them in the Medicare Modernization Act of 2003. In that law, Congress closed several loopholes that were delaying generic competition and hindering consumer access to lower cost generic drugs. The law also clarified the 180-day period of market exclusivity for generic manufacturers. Now, I know Senator Rockefeller is very concerned about authorized generics, and I think we should have updated data on the number of authorized generic drugs are on the market. The language already included in S. 1082 will help the Federal Trade Commission complete its authorized generics study, which I know Senator Rockefeller requested along with Senators Grassley and Leahy. I support the completion of that study; however, Congress shouldn't contemplate additional legislation before having necessary data on authorized generics. I will work with my good friend and colleague from West Virginia to ensure that the FTC has the data needed to complete its study. So, I want to let my friend from West Virginia know that I want to continue to have a dialogue about this issue.

Mr. HATCH

Mr. HATCH. Mr. President, a number of questions have been raised about how the Durbin amendment on food safety, adopted yesterday by a unanimous vote, would affect regulation of dietary supplements. I wanted to take this opportunity to clarify the record. First, let me indicate my support for the efforts of the Senator from Illinois, Mr. Durbin. The recent misfortunes with peanut butter, spinach, and pet food show me that our Nation's food safety policies are pitifully lacking. Therefore, I am supportive of Senator Durbin's work and also the considerable work of Senator Enzi and his staff to resolve problems that were found with the draft amendment. For the edification of my colleagues, section 201ff of the Federal Food, Drug and Cosmetic Act, FFDCA, contains the definition of dietary supplements. That definition includes a proviso that supplements are to be considered foods, except in the instance when a product makes a drug claim. In other words, by Federal law, dietary supplements are generally considered to be foods. It is for this reason that the language of the original Durbin amendment establishing a new adulterated food registry could have been read to apply to dietary supplements. This raised problems for me, and indeed for our colleague Senator Harkin, since we had spent more than 2 years working with Senators Durbin, Kennedy, and Enzi to draft, pass and enact the Dietary Supplement and Nonprescription Drug Consumer Protection Act, Public Law 109-462. That law authorizes a new program so that reports of serious adverse events related to the use of a dietary supplement or over-the- counter drug would be reported to the Food and Drug Administration, FDA, on a priority basis. As I said, the Durbin amendment contemplates a new adulterated food registry. Under the provisions establishing that registry, reports of adulterated foods would be made by many, if not all, of the same parties who are required to file reports of serious adverse events associated with the use of dietary supplements under Public Law 109- 462. And so passage of the Durbin amendment could be seen to supersede the law we enacted last year for supplements, which I am relieved to hear was not the intent of our colleague, Senator Durbin. Consequently, the amendment we adopted yesterday contains language that Senator Harkin and I suggested to make certain that dietary supplements would not be covered by the new food safety language and thus last year's law would not be superseded. To reassure those who are interested in the Dietary Supplement Health and Education Act, DSHEA, I wanted to take a moment to outline those changes. First, there is new language in the section establishing the adulterated food registry to express the sense of the Senate that: (1) DSHEA has established the legal framework to ensure that dietary supplements are safe and properly labeled foods; (2) the Dietary Supplement and Nonprescription Drug Consumer Protection Act has established a mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States; and (3) the adverse events reporting system under that act will serve as the early warning system for any potential public health issues associated with the use of these food products. In addition, language contained in the Durbin amendment modifies the definition of supplement contained in 201ff of the FFDCA so that supplements will not be considered foods for the purpose of the new adulterated foods registry. This in no way would alter the time-honored conclusion of the Congress that supplements are to be considered foods. On the contrary, all it would do is exempt supplements from the registry. These changes, all contained in the amendment which was approved yesterday, make clear that there are no new dietary supplement requirements in the Food and Drug Administration Revitalization Act. It is my hope this will reassure the many who have expressed concern that Congress was inadvertently repealing Public Law 109-462.

Mr. HATCH

Mr. HATCH. Mr. President, I thank my dear colleague from Tennessee for allowing me to go first, and also my two colleagues on the Democratic side, Senators Carper and Stabenow. I ask unanimous consent that Senator Alexander be permitted to go next and then Senator Carper and then Senator Stabenow.

Mr. HATCH. I think we have an agreement among the four of us.

Mr. HATCH. I would add to that request the Senator from Oklahoma after Senator Stabenow.

Mr. HATCH. Mr. President, I thank my colleagues, including the two managers of the bill on both the Democratic and the Republican side. I rise in support of the Allard amendment. I want to take a few minutes to talk about pediatric testing and research provisions included in this bill. I have strongly supported both the Best Pharmaceuticals for Children Act and the Pediatric Research Improvement Act. As my colleagues know, current law provides 6 months of exclusivity for drugs that do research and development in the area of pediatric use. I am very interested in keeping it that way. That has proven very efficacious in the Hatch-Waxman bill. It keeps companies involved in developing great drugs for children in this area. So it is a very important part of this. I was deeply involved in those negotiations in 1997 with my former colleague, our former colleague, Senator Mike DeWine. I have supported these efforts from Ohio Senator Mike DeWine that brought additional pediatric testing of prescription drugs to our attention during consideration of the FDA Modernization Act of 1997. He fought long and hard to encourage drug companies to conduct clinical trials on pediatric uses of their drugs. His efforts paid off and this program has been extremely successful. As a result, pediatric drugs are safer and more effective for children. The bill before us today reduces the 6-month exclusivity period for blockbuster drugs to 3 months. I emphasize again this market exclusivity has provided the incentive needed to increase research and development for pediatric drugs. We used the same type of an approach on the orphan drug bill many years ago. At that time there were only a few orphan drugs. Today there are over 300 being developed. It is the same principle here. The Allard amendment restores current law and provides 6 months of exclusivity for all drugs. As I mentioned last night, my good friend and colleague from Connecticut, Senator Chris Dodd, has also shown great leadership on this issue when FDAMA was being considered in 1997. He held a hearing on this issue earlier this year with his ranking Republican member, Senator Lamar Alexander, who has served long and well on this committee. That hearing was very insightful, and I believe many of us are trying to do the right thing as we reauthorize both programs. I urge my colleagues not to lose sight of the purpose of these two programs as we make decisions on this part of the bill. We want good solid information about the safest way to prescribe drugs for children. By giving companies market exclusivity to conduct clinical trials, we will know the safest dosage levels for children. So let's not lose sight of the original purpose of these programs: to help children have the safest dosages for prescriptions. Now, it is no secret I support the Allard amendment. I would just like to add a few more facts. Nearly two-thirds of the drugs prescribed for children have not been studied and labeled for pediatric use. I know the importance of accurate clinical information about a drug's use in the pediatric population. This smaller body mass and higher metabolic rates of children mean they often respond differently to drug dosing than adults do. A drug that is safe and effective in adults may not always be safe for children. The question is not whether we should study the safety of drugs for children but how we make that research happen. In 1997, Congress considered this issue and created an incentives program for companies to study the use of their drugs in pediatric populations. The program offers an additional 6-month patent protection or exclusivity to drug manufacturers to help recoup the cost of investing in these critical pediatric studies. It is a win-win situation. Drug companies have the incentive to invest time and extra resources for a small share of the market, and, more importantly, children get the research they need. The evidence is that the incentives for exclusivity should be maintained, not lowered. Despite the fact that the bill providing the incentive for pediatric studies was enacted a decade ago, nearly two- thirds of the drugs prescribed for children have not been studied and labeled for pediatric use. We have had a great deal of study about the need for this incentive and how it should work. The fact remains that there is a persistent public health need for accurate clinical information about how adult drugs will work in children. Children are not adults, for reasons that the Senator from Oklahoma, Dr. Coburn, has well explained to this body. Much of what our colleague from Connecticut, Senator Dodd, has just said underscores the need for a continued, strong, exclusivity provision. The statistics he cited about the success of this program are truly remarkable and a significant milestone in the history of public health. The only place where there seems to be disagreement on Best Pharmaceuticals for Children Act is the exclusivity period for what some define as ``blockbuster drugs.'' I know the Senator may call the 6 months period ``gouging'' but that ``gouging'' may very well be the incentive that has led to the FDA receiving more than 400 proposed pediatric-study requests and receiving 144 completed studies. Those who support the Senator's amendment--and I know it is well- intentioned--suggest that without the 6 months' incentive, the pediatric testing will still continue and will be robust. Who knows if this is true? I wonder if we want to call their bluff and take away this powerful incentive? I don't think we can take that chance.

Mr. HATCH. I am happy to discuss this issue with my colleagues. As they are aware, this has been my high priority for a number of years, given that I am the author with Representative Henry Waxman of the Drug Price Competition and Patent Term Restoration Act--or ``Hatch-Waxman''. The Schumer-Clinton bill, which I know has been introduced by Representative Waxman in the House, is an important contribution to this dialogue. I want to work to reach an acceptable compromise on an expedited basis, and it is clear to me it must be a bipartisan effort.

Mr. HATCH. I look forward to working with my colleagues to include bipartisan follow-on biologics legislation in the conference agreement on the FDA Revitalization Act. It is clear that consumers would benefit tremendously from an abbreviated pathway for consideration of biosimilar products. Any effort, though, must be based on a sound understanding of the science involved and it must contain incentives for development of the innovator products which will be copied.

Mr. HATCH. Will the Senator yield?

Mr. HATCH. Mr. President, I thank my dear friend and colleague. It is so nice of him to say that. I take tremendous interest in this bill, as I do every piece of legislation, but this bill in particular. I congratulate the chairman and the ranking member for the way they have conducted not only the committee through this process but this bill itself. I hope this bill will pass and that we can correct whatever needs to be corrected, and that we will be able to do this follow-on biological work together. If we can do that, this will be a major breakthrough bill, and will do a great deal of good for the FDA. If that happens, then I think the chairman and the ranking member deserve a great deal of credit. I am very grateful my friend from Massachusetts has been so kind to me today.

Mr. HATCH. Mr. President, to say the distinguished Senator from New York knows how to stick it to a person on the floor is all I can say. I am grateful for this friendship and grateful for his and Senator Clinton's work on this as well, and willingness to work together in a bipartisan way. This is big-time stuff. If we get it right, it will surely do a lot of good, as Hatch-Waxman has done over the last 23 years.

Mr. HATCH. My office has been inundated by calls from people throughout the country who believe that this legislation, specifically the provision establishing a Reagan-Udall Institute, will overturn the Dietary Supplement Health and Education Act of 1994. That has not been my reading of the bill, but I wonder if other Senators have heard similar concerns?

Mr. HATCH. That explanation is very helpful. What, specifically, would the role of the Foundation be with respect to dietary supplements?

Mr. HATCH. To add to that point, it seems that the language could, in fact, help dietary supplement consumers, because it would allow collaboration between government and industry to conduct research on issues that might be helpful to supplement consumers?

Mr. HATCH. I thank you for those assurances and that clarification.

Mr. HATCH

Mr. HATCH. Mr. President, I rise in support of S. 1082, the Food and Drug Administration Revitalization Act. This legislation addresses many critical issues, including the need for provide proper incentives and support for the development and review of pharmaceuticals and medical devices, including products for children, and the need for heightened efforts to assure the safety of medications. As we debate this legislation, let us remember we all have the same goals in mind. We want Americans to benefit from life-saving, life-enhancing drug and device products. We want Americans to have access to drugs that are safe and effective. We want Americans to have all the relevant safety information available on their drugs. And, indeed, we want Americans to know that the Food and Drug Administration, the agency responsible for ensuring drug and device safety, has the resources to do its job. That is what this bill is all about protecting Americans and giving the FDA the tools to do its job. The legislation before us reauthorizes both the Prescription Drug User Fee Act, better known as PDUFA, and the Medical Device User Modernization Fee Act, better known as MDUFMA. It is of critical importance that both programs be authorized by the end of the fiscal year. This legislation embodies the agreements reached by both industries and the FDA, along with refinements added by the Congress. Let me make clear that I am supportive of these reauthorizations. It is fair to say that I had reservations about PDUFA when it was enacted in 1992, questioning the wisdom of whether an industry should be required to support a governmental function. To a certain extent, I still have those reservations. That being said, it has become abundantly clear that there are not the resources in the Agriculture Appropriations bill to support these review functions absent a user fee, and thus I recognize their necessity. With regard to MDUFMA, I have been particularly concerned about the impact that user fees could have on small medical device manufacturers, many of which are located in Utah. Indeed, I am proud that there are over 100 medical device companies in Utah, companies that represent the best in American innovation. They are true world leaders in their industry. The changes made in the last reauthorization at my request, along with the new structure of the user fee in FDARA and the improved trigger provision satisfy me that the manufacturers are being fairly treated by the user fee program in this bill. And, indeed, this is a serious concern. In February of 2006, the Lewin Group prepared a report for the FDA entitled ``Medical Device Industry Perspectives on MDUFMA. That report revealed that senior industry experts felt FDA is generally doing an excellent job in premarket regulation of medical devices and that the industry was generally supportive of the purpose and goals of MDUFMA. However, key among the findings was the fact that the industry perceived little or no evidence of attaining the main intent of the program or in realizing a favorable return on investment from user fees. In fact, whenever I return to Utah to meet with medical device executives, I hear the same concern. And it is a concern I share. Indicative of that concern is the astounding fact that 70 percent of responding device manufacturers perceived that MDUFMA goals have not resulted in meaningful improvements in either the predictability or timeliness of reviews. In fact, when I reviewed the device approval times, I understood those concerns. For some classes of devices, FDA had made great progress. For others not. This was disturbing to me, since we would all hope that progress would have been made across the board. It is my hope with the new fee structure embodied in S. 1082, we will make better progress in achieving the approval time goals. I am pleased that Chairman Kennedy and Senator Enzi included provisions at my request which make certain the fees for smaller companies are affordable. Let me turn to the issue of direct-to-consumer advertising, or DTC. This is an issue on which our colleague, the senior Senator from Kansas, Mr. Pat Roberts, has shown great leadership, both in the HELP Committee, and here in the Senate Chamber. Senator Roberts has led the charge to eliminate the 2-year moratorium on prescription advertising for newly approved drugs. He has expressed constitutional concerns about such a moratorium. I share those concerns. He is right to bring this up. In general, I believe we should be guided by a very simple rule. Advertising about products the FDA regulates should be truthful and not misleading. I do understand the arguments that some in this body make with respect to pharmaceutical advertising. Some nights, when I watch television, those ads do become tiresome. But I could say that about a lot of ads. Some have argued we need to be particularly careful about what pharmaceutical advertising is allowed, because we have limited knowledge about drugs, especially when they come on the market. Those who make such arguments fail to recognize that FDARA will guarantee that consumers have access to greater clinical and safety information about medications because it gives the FDA more authority to review and react to drug safety data. User fees created by S. 1082 will bolster the FDA office responsible for reviewing drug advertisements. The FDA has told my office and others that drug manufacturers cooperate fully with the FDA when a concern is raised about an advertisement. That would be my preference for how these ads should be handled. I am hopeful we will be able to address this issue and I am encouraged by recent discussions involving the Senator from Kansas and others members of the Senate HELP Committee. The bill's drug safety provisions are probably its most important component. Indeed, shortly after the Institute of Medicine issued its report on this issue, we all began to see a floor of letters in support of efforts to improve the drug safety program. Members of the HELP Committee undertook serious discussions on how to address the problems that have been identified, and the result is this legislation developed by Senator Enzi and Chairman Kennedy. The Enzi- Kennedy bill has benefited from the guidance of our colleagues, former Chairman Gregg and Senator Burr, who have pointed out the necessity for more flexibility in determining when a risk evaluation mitigation plan--or REMS--is needed. Senator Coburn added greatly to the discussion by raising issues relating to the access of our constituents in rural areas to needed pharmaceuticals. I believe the product of these discussions strikes the appropriate balance. It requires, for example, that determining whether the FDA should further assess the safety of a drug should be based on scientific evidence. To me, that is probably the most integral part of this bill--when concerns are raised about drugs, these concerns must be based on scientific evidence and not on innuendos or hearsay. This approach allows proper evaluation of relevant information and gives the FDA greater authority to warn consumers when there are problems. In addition, the drug safety title strengthens the FDA's existing authority to monitor drugs once they have been approved by making it clear that evaluation must occur before and after approval. One of the most important components of this legislation is that more drug safety information will be made more available to the public. I believe that is an important victory for the American consumer. I also want to take a few minutes to talk about the pediatric testing and research provisions included in this bill. I have supported both the Best Pharmaceuticals for Children Act and the Pediatric Research Improvement Act. In fact, I have supported these efforts since our former colleague from Ohio, Senator Mike DeWine, brought the need for additional pediatric testing of prescription drugs to our attention during consideration of the FDA Modernization Act of 1997. He fought long and hard to encourage drug companies to conduct clinical trials on pediatric uses of their drugs. His efforts paid off and this program has been extremely successful. My good friend and colleague from Connecticut, subcommittee Chairman Chris Dodd, has also shown great leadership on this issue when FDAMA was being considered in 1997. He held a hearing on this issue earlier this year with his ranking Republican member, Senator Lamar Alexander. That hearing was very insightful and I believe that many of us are trying to do the right thing as we reauthorize both programs. I urge my colleagues not to lose sight of the purpose of these two programs as we make decisions on this part of the bill. We want good, solid information about the safest way to prescribe drugs for children. And by giving companies market exclusivity to conduct clinical trials, we will know the safest dosage levels for children. So let us not lose sight of the original propose of these programs--to help children have the safest dosages for prescriptions. I am hopeful that we will be able to work out our differences on these provisions on these very important issues. Food safety is another issue that is on nearly everyone's mind these days. When I was a kid, we were always told to eat our spinach so we could grow muscles like Popeye. Peanut butter is almost a staple for most Americans. And yet these ordinary, common foods have harmed rather than helped. Pets are getting sick and we have discovered that their food has been contaminated. Something needs to be done. I have worked with Senators Kennedy, Enzi, Durbin and Allard to figure out a constructive approach to these important issues. I think that we have made a lot of progress and I look forward continuing those discussions as the bill progresses toward enactment. One factor that is not discussed enough is the need to appropriate more funding for inspectors and inspector training, especially abroad. I can recall over a decade though when Jim Phillips, a former investigator for the FDA, brought to our attention the woefully lacking FDA resources for foreign inspections. We were shocked then, and unfortunately, we are shocked now. Today, only one percent of imported food is inspected. I believe this issue needs to be carefully reviewed by Congress so people no longer have to worry about whether food for them or their pets is safe. I offered and withdrew an amendment during the HELP Committee consideration of this bill that would address another important issue. My amendment had several provisions which encouraged innovation and development of safe antibiotics, required the FDA to convene a meeting to determine how the Orphan Drug Act should be applied to antibiotics, and reauthorized the grant programs for the Orphan Drug Act. Finally, my amendment provided for a 5-year exclusivity for enantiomers of previously approved racemic drugs if and only if, one, they are approved for new therapeutic uses and, two, a completely new data set has been created for approval of this enantiomer. It is my expectation that our current discussions on these provisions will lead toward their adoption later in the week. I also want to point out that there have been many discussions on ways to ensure that citizens' petitions do not unfairly delay generic drug approvals. I believe this is a problem, although I do not believe it is of a magnitude as some would suggest. I do not oppose making changes to ensure that any abuses in this area are stopped, as long as FDA still has the ability to do the appropriate scientific and legal review of abbreviated new drug approval applications in the timeframe it desires. Let me turn now to one provision which is not in the bill: language authorizing a pathway for the Food and Drug Administration to approve copies of biologics. This is commonly referred to as the ``biosimilars,'' ``biogenerics,'' or ``follow-on biologics'' legislation. Senator Gregg spoke so well about this subject just a few minutes ago. While language on this issue is not included in the bill we consider today, I want to make perfectly clear that it is my intention to work toward development of an acceptable compromise that can be included in the final version of FDARA and signed into law. It is my hope Senators will refrain from offering any amendments on this issue until we have time to develop consensus. And I do believe consensus can be developed without delay. It is my intention to do so. As my colleagues are aware, I am the Hatch of Hatch-Waxman. I have a serious interest in making certain the law Chairman Waxman and I developed in 1984, the Drug Price Competition and Patent Term Restoration Act, is used as the basis for development of legislation to provide an abbreviated pathway for approval of follow-on biological products. In so doing, we must make certain we include the appropriate incentives for development of those products. Indeed, that is my high priority. By any estimate, the Hatch-Waxman law has done consumers tremendous good by fostering today's modern generic drug industry. It has saved patients literally billions of dollars. Similarly, using it as a basis for development of a pathway for follow-on biologics will help consumers with access to the innovative, life-affirming biologic products. But in so doing, we must be mindful of the fact that we need to encourage and nurture the innovation that provides the biologics that the generic companies seek to copy. This is a tremendously complicated task, but it is one worth doing. In 1984, when Chairman Waxman and I undertook a series of negotiations that led to approval of the Drug Price Competition and Patent Term Restoration Act, it was a very different time. There were no cell phones, no DVDs, almost no one had a personal computer, and a stamp cost 20 cents It was a much less complicated time. Generic drugs were a small, struggling industry, with no discernible footprint in the pharmaceutical world. The innovators had yet to respond to their first paragraph IV certification. In 1984, brands versus generics largely an American endeavor. Today, the pharmaceutical market--both innovator and generic--is an international marker--for research, development and marketing. Biological products were not an issue in 1984. Today, they are becoming an increasingly larger part of pharmaceutical spending. It is my strong belief that we can learn from this experience and build another solid law that will help consumers--both by supporting the incentive to discover and develop new biologics, and by fostering a climate that will lead to lower prices. This is a classic win-win situation. And why is that so important? A February report by the Center for Medicare and Medicaid Services paints the picture very well: America's health care spending in the next 10 years will double to $4.1 trillion. Or, to look at it another way, that is 20 cents out of every dollar spent. We spend about $7,500 per capita on health care in the U.S. Yet in 2016, that will rise to an astounding $12,800 per person. Greater spending for pharmaceuticals is expected to fuel much of the increase, the report's authors concluded. And there it is in a nutshell. The good news and the bad news. Not much worries Congress more than the costs of medical care--both from the perspective of a balanced budget, and from the view of our constituents' pocketbooks. In many ways, it is an embarrassment of riches. We have exciting new therapies to treat our medical ills--new drugs, new devices, stem cell treatments. Their potential to improve human health and well-being is almost limitless. And yet the cost of those treatments, the impact they have on the budget, at times seems equally limitless. In fact, in 2005, prescription drug spending was estimated at $214 billion, a healthy amount by anyone's measure. That same year, spending on biologics was estimated at $32 billion. Since biologicals are generally more expensive products, ways to reduce their costs interest policymakers and other stakeholders in expenditure of the health care dollar, foremost among them employers, insurers, pharmacy benefits managers, and of course, the government. Comes now the generic drug industry, which has been proven to provide alternative, safe and effective therapies in a much more cost beneficial manner. We look to them to be part of the solution to this problem. And they, in turn, look to us to help them be part of that solution. It is no secret that several senators have been meeting to develop a bill that would establish a pathway for biosimilar products to be approved by the Food and Drug Administration. We had hoped to have it ready for inclusion in FDARA, but it was not, despite the talks of the four Senators. I am referring to Health, Education, Labor, and Pensions Committee Chairman Ted Kennedy, the committee's ranking Republican, Mike Enzi, Senator Hillary Clinton, and me. All members of the HELP Committee, we have worked to develop consensus on what legislation would include. Senator Kennedy and I began these talks several months ago. He is committed to developing a bill on a priority basis. Our staffs literally have been working night and day. Our work has been aided immeasurably by the leadership of Chairman Waxman, and in the Senate, Senator Chuck Schumer and Senator Clinton, who have introduced the companion to the Waxman bill. Their legislation, the Access to Life-Saving Medicine Act, H.R. 1038/S. 623, provides a solid starting point for discussions. It is an important work that has added immeasurably to the congressional dialogue. It is my hope that our discussions will also be informed by the work of Representatives Jay Inslee, Gene Green and Tammy Baldwin, who recently introduced the Patient Protection and Innovative Biologic Medicines Act of 2007, H.R. 1956, and by the views of the many, many stakeholders in this legislative effort. The time to develop a pathway for approval of biosimilar products is long past overdue. It should be our priority, and it should be our high priority, to get it done this year. But, we should get it done right. Our deliberations must be based on science. The original balance of the law must be maintained, but we must also recognize the emerging realities of this new world. And what are those realities? First, biotechnology products are not drugs; they are very complicated molecules that are not easily reproduced. An inadvertent change in the structure of that molecule can lead to very devastating consequences. Second, today, it is unlikely that any follow-on company will be able to produce an exact copy of a biotech molecule, a generic biologic if you will, at least at first. Third, because science advances, and because American researchers are very good at advancing science--stem cell research is one example that comes readily to mind--we must hold open the possibility that one day there will be true biogenerics. And we must also develop a pathway so that biosimilar products can be approved without a full biologics license application, a time-consuming and expensive process. But whatever policy we develop, it must be based on soundness of science, rather than the practicalities of politics. Fourth, we must take into account the unique nature of today's industry. This is so much more than an exercise between big Pharma and the generics, or even between big bio and the generics. Indeed, there are about 1,400 biotech companies in the United States. How many of them are profitable? Astoundingly, only 20. Many of these companies are small, with revenues of under a million dollars per year. Many do not even have a product on the market. We must examine closely the issue of who will be making biosimilars? Will it be the Barr Labs and Tevas of the world? Undoubtedly. But it may also be generic subsidiaries of innovator companies. It is also very likely to be companies in India and China. As we have seen with the recent concerns over pet food, inspecting foreign manufacturing plants has historically been a problem for the resource- constrained Food and Drug Administration. Fifth, we must use the framework of Hatch-Waxman where we can, but we must recognize there may be ways to improve it. There are obvious differences between regulating a pathway for biosimilars and for copies of chemical drugs. For example, as I mentioned, today's science will probably not allow identical copies of today's biologics. So, the concept of bioequivalence cannot be imported into this debate. Instead, we must work carefully to define biosimilarity. Another difference today is the fact that process patents are much more integrally tied to the manufacture of biologics. Current law does not require listing of process patents in the orange book. Waxman-Hatch is inherently a litigious process. But its framework-- the patent holder or drug manufacturer--v. the generic--does not easily translate to a system in which multiple patent holders may exist, including, for example, major universities and research centers. Sixth, the incentives for development of biotech products must be maintained, enhanced where it advances public policy. But at the same time, we cannot seed a new generation of roadblocks that preclude biosimilar entry. This is the nub of the key, crucial balance. Seventh, the role of the FDA must be carefully evaluated. We must empower the agency to evaluate pure, safe and potent copies of biotech products, but we must all recognize that there must be a bright line that separates a safe copy from a new product which should be subject to a full biologic license application. We need to free the agency and provide it with the flexibility to evaluate the adequacy of a biosimilar submission based on good science, but we must also recognize that, as Commissioner von Eschenbach has said, there may be some products which cannot be copied safely with today's science. Eighth, we must make certain the resources are there for the FDA to do the job right. I must note that negotiations between the agency and the pharmaceutical industry on the Prescription Drug User Fee Act reauthorization, or PDUFA, took over one year. Every indication I have is that review of a biosimilar application is very likely to be more complex and time consuming than that for a new biologics license application. There must be authority for a fee to be collected that reflects this complex workload. If we do not provide adequate resources to the FDA, then review of new products could suffer at the expense of cheaper copies as reviewers become siphoned off from new products to the biosimilars. We should not design a system in which this occurs. And I must digress at this point to underscore that the FDA is already cash-strapped and that situation simply must be corrected. The dire FDA resources issue appears to have manifested iself in such recent revelations as to the inadequacy of food inspections for some of the most ubiquitous products in American life, including pet food and peanut butter. Federal policymakers must take this into account when legislating, and the Food and Drug Administration Revitalization Act is a good place to start. Enacting follow-on biologics legislation is a top priority for me. I want us to finalize a bill on a priority basis, and it is my hope it can be included in the final version of FDARA that emerges from the conference committee. Before I close, I want to talk about one other issue that is often debated when FDA-related legislation is considered on the floor: importation of prescription drugs. This morning, I listened to our colleague, the Senator from North Dakota, Mr. Dorgan, talk about his legislation which allows prescription drugs from other countries to be imported into the United States from other countries. My colleague refers to this as drug reimportation which I believe gives people the false impression that these drugs are originally manufactured in the United States, exported to another country and then imported back to the United States. I just want to clarify that is not typically the case. In addition, I saw the Senator from North Dakota hold up two bottles of Lipitor and say that there is no difference between a drug manufactured in Ireland and a drug manufactured in the United States. He suggested that the pills may be different colors but the bottles are the same and the medicine in the bottle is the same. That may be true for the two bottles of drugs that he had on the Senate floor. But how could we be assured that is always the case? Can we always guarantee that pills in a bottle labeled from Ireland are actually manufactured in Ireland? I don't think so. This issue is the crux of the problem--unless the FDA has approved these medications, we have no way of knowing what is actually in the bottle. In fact, when I served as chairman of the Senate Judiciary Committee, I held a hearing on drug importation and this issue was raised by one of the members of the committee. At that July 14, 2004, hearing, one Senator specifically asked about a prescription drug bottle labeled as being from Canada. William Hubbard, the Associate Commissioner for Policy and Planning for the FDA, told her that even though the label said the bottle was from Canada, the FDA had no idea where that bottle had originated. In fact, at that hearing, Mr. Hubbard said: Although some purchasers of drugs from foreign sources may receive genuine product, others may unknowingly buy counterfeit copies that contain only inert ingredients, legitimate drugs that are outdated and have been diverted to unscrupulous resellers, or dangerous sub-potent or super- potent products that were improperly manufactured. Furthermore, in the case of foreign-based sources, if a consumer has an adverse drug reaction or any other problem, the consumer may have little or no recourse either because the operator of the pharmacy often is not known, or the physical location of the seller is unknown or beyond the consumer's reach. FDA has only limited ability to take action against these foreign operators. On a related issue, I would like to share Mr. Hubbard's insights on the safety of drugs that have been imported from other countries. FDA remains concerned about the public health implications of unapproved prescription drugs from entities seeking to profit by getting around U.S. legal standards for drug safety and effectiveness. Many drugs obtained from foreign sources that either purport to be or appear to be the same as U.S.- approved prescription drugs are, in fact, of unknown quality. Consumers are exposed to a number of potential risks when they purchase drugs from foreign sources or from sources that are not operated by pharmacies properly licensed under state pharmacy laws. These outlets may dispense expired, subpotent, contaminated or counterfeit product, the wrong or a contraindicated product, an incorrect dose, or medication unaccompanied by adequate directions for use. The labeling of the drug may not be in English and therefore important information regarding dosage, warnings and side effects may not be available to the consumer. The drugs may not have been packaged and stored under appropriate conditions to prevent degradation, and there is no assurance that these products were manufactured under current good manufacturing practice (cGMP) standards. When consumers take such medications, they face risks of dangerous drug interactions and/or of suffering adverse events, some of which can be life-threatening. More commonly, if the drugs are subpotent or ineffective, they may suffer complications from the illnesses that their prescriptions were intended to treat, without ever knowing the true cause. Mr. President, this was a sobering hearing and I urge my colleagues, especially those who support the importation of prescription drugs into this country, to take the time to review the testimony from the July 14, 2004, hearing. We had many witnesses who provided valuable insights on this issue. To address Senator Dorgan's other point regarding the cost of prescription drugs, I want to make one thing perfectly clear--I want Americans to have access to affordable drugs, but I also want these drugs to be safe and effective. As one of the authors of Hatch-Waxman, I understand the problem of pharmaceutical costs, and I have a record of working to find solutions. But bringing potentially unsafe medicines, medicines uncertified by the FDA, into the United States is not a solution. In conclusion, I ask my colleagues who are skeptical about this bill to reserve judgment and listen carefully to the debate. While I supported this bill when it was considered by the Senate HELP Committee 2 weeks ago, I honestly believe that members of the HELP Committee have worked hard together to make the reported bill even better. So I urge my colleagues to take the time to review the bill because there are a lot of good provisions in it. I would like to take this opportunity to recognize the hard work of the staffs of both our committee chairman, Senator Kennedy, and our ranking minority member, Senator Enzi. I would specifically like to thank Amy Muhlberg and David Dorsey for their dedication and hard work on this issue--they have been working on drug safety legislation for over 2 years and I want both of them to know how much all of us appreciate their efforts. I also want to recognize Shana Christrup and David Bowen for their leadership in helping their bosses get this bill to the floor under very difficult time constraints. All of the HELP Committee members' staff have worked long hours and many weekend hours and I just want you to know how much I appreciate all of you. Mr. President, I yield the floor.

Mr. HATCH. As usual, my dear friend from North Dakota is articulate, and he deserves to be listened to, but I disagree with him. The Dorgan amendment allows individuals to import a qualifying drug, and this will pose an overwhelming set of resource burdens for the FDA, Customs, and other agencies, especially the FDA. It would, as I have mentioned before, create very significant safety concerns. This amendment establishes a complicated system for the regulation of imported drugs. Now this system that he suggests is so vast, it would take and require a lot of money, more than all of the proposed fees could support. Where would an already strapped Federal agency such as FDA get these additional dollars? So far we have not given it to them. There have been estimates that these dollars would amount to so much that there is no way that we could give them enough money. This amendment allows foreign-imported products to be approved for distribution in the United States even when they may not be bioequivalent to the FDA-approved products. Now the reason I cite that is because the letter from the FDA, this letter was sent to the Honorable Byron L. Dorgan, Senator Dorgan. This letter was sent April 10, 2007. I ask unanimous consent that this letter be printed at the conclusion of my remarks.