Michael Enzi

Mr. ENZI

Mr. ENZI. Mr. President, I ask unanimous consent that Sergio Perez, Peter Bautz, Bill McConnaughay, and Sean O'Connor of my staff be granted floor privileges for the duration of today's session.

Mr. ENZI

Mr. ENZI. Mr. President, I thank the chairman of the committee. I thank him for his kind words, but I also thank him for his leadership on this issue. We have had a great teamwork effort both between the Senators and between the staff. This isn't something that just came together a couple of weeks ago. This is something that has been worked on for about 1\1/2\ years, with pretty constant meetings on Fridays of all of the interested groups and then stakeholders. It takes a tremendous amount of work to put something like this together and have it be in a bipartisan way like this. It is largely because it came to committee. In committee we took a look at all of the amendments that were suggested, we got the people together who had very similar amendments, and they usually were able to work out something to satisfy everybody in that instance, and we came up with a bill. As Senator Harkin mentioned, it passed 96 to 1. Anytime we get something to pass, it is kind of a landmark success. But when we get something that bipartisan, it is even more landmark. We have been trying to get this bill wrapped up before the Supreme Court decision came out on health care. The reason we have been trying to do that is, who knows what it is going to say or what kind of ideas people will come up with when that happens. This is a group of 100 idea generators, so we wanted this cleared up by that time. We are on a path to get that done right now and a path that will keep the people employed who are taking a look at new drugs and devices and generics and biosimilars and continue to get those on the market so people will have the latest innovations. One of the things we included in the bill was some use of foreign clinical trials if they were approved by the FDA, and that should even speed up the process. Of course, when we went to conference there were a lot of things people wanted to have that they brought up as amendments. It is very critical in the bill, and we get some of them and we don't get others. I know Senator Alexander played a huge role; he had seven items in the bill and we got six of them. Senator Burr had 12 items in the bill, and we got 11 of them. I have to mention, of course, that the one we did not get is a particularly important but particularly difficult issue that is going to take more time to get worked out. It is one that deals with drug distribution security, and that is something we cannot avoid. We have to do it. But it is going to take longer to work that out. It deserves some extra time and some more understanding on both sides of the aisle on that one and in a number of different States. It doesn't just involve the Senate; it doesn't just involve the drug companies; it also involves the whole chain that these things have to go through, including the local pharmacist whom we don't want to overload with work, and the people who have to transport these drugs whom we don't want to overload with work or make it extremely complicated when they cross different State lines and have to do different kinds of reporting. Senator Isakson had four amendments, and we were able to get three of them. Senator Paul had two, and we got one. Senator Hatch had six, and he got all of them. Senator McCain had two, and we got one. Senator Roberts had two, and we got both of those. Senator Murkowski had two, and we got both of those. Senator Kirk had two, and we got one of those. Senator Grassley had two, and we got one of those. Senator Portman had two, and we got both of those. And Senator Coburn had two, and we got one of those. Senator Corker had two, and we got both of those. So there are a lot of things we did on the Senate side that became possible on the House side. There are a number of things they did on the House side that we couldn't agree with on this side either. But we did reach agreement--and we reached it in pretty much record time. We now have a bill that can go ahead and be passed and go to the President for signature to assure that the level of safety we have in our drugs not only continues but improves, and drugs can get on the market faster than they had before by streamlining the process and also making sure there are better foreign inspections so the ingredients that go into the drugs don't cause problems. So this legislation reauthorizes the Food and Drug Administration's user fee program, and it ensures that Americans get better access to safe innovative medicines and medical devices. It will make significant changes. It will improve the FDA's review and approval of new drugs and devices. Unfortunately, FDA's current process for reviewing and approving medical devices too often creates delay and unpredictability. This in turn threatens patient access to the best possible treatments for their conditions. In some cases, this has forced American patients to travel overseas to obtain access to lifesaving new devices that FDA has not approved in the United States. The bill goes a long way toward solving these problems and makes the most significant changes to the law of governing FDA's review of devices in decades. This bill will speed the approval of devices by reducing the redtape associated with the ``least burdensome'' standard that FDA uses to approve such devices. The bill will also make it easier for FDA to approve devices for patients with rare diseases who might not otherwise be able to have their conditions treated most effectively. It will also enable FDA to expedite safety determinations, to resolve appeals, and to improve their postapproval surveillance activities to detect problems as they occur. It is not good enough to get them approved, we also want them watched after they are approved, and this will do it. The bill also contains important reforms to foster drug innovation and patient access to new therapies. It modernizes the accelerated approval pathway for drugs to reflect advances in science over the past 20 years. It formalizes a new process to expedite the development and approval of breakthrough therapies. These changes are particularly important for patients with rare diseases where there are no therapies available, and it is not feasible or ethical to require large conventional clinical trials. Nobody wants to be the one who is a test case when there might be something that would work for them, and there aren't the sizes of the populations to do the conventional clinical trial anyway. The patient community strongly supports these improvements because these will save lives. The bill also contains important reforms that will help mitigate the problems associated with drug shortages. It will require better coordination within FDA as well as the other Federal agencies such as the DEA. It will also allow FDA to move faster, to take actions, and to address shortages through expedited reviews and approvals. The bill also makes important changes to how FDA uses Risk Evaluation and Mitigation Strategies, REMS. REMS play a critical role in protecting patients and public health and this bill includes a provision that clarifies the process for modifying REMS--especially with regard to minor modifications. The provision in the bill being passed today does not change Congress' expectation that a non-minor modification will generally be based on the best available science including an assessment demonstrating that the modification is necessary or appropriate. Nor does the clarification indicate that a modification should be approved if it would reduce the REMS' effectiveness in addressing the drug's known risks. The bill follows what I call the 80 percent rule. When we focus on 80 percent of the issues on which we can reach agreement rather than focusing exclusively on the parts and the issues we can never resolve, we can achieve amazing results. Over 1 year ago staff began to work on identifying the 80 percent. A group of staff from Republican and Democratic offices on the Health, Education, Labor, and Pensions Committee began a series of standing meetings and proceeded to meet every week for several months. They met with stakeholders and discussed policy solutions that each member thought would solve the problem. After much discussion of the benefits, costs, and possible unintended consequences, members agreed on a list of policy concepts. If there was not a consensus on a particular policy, it wasn't included. This is the 80 percent rural in action. As this process has progressed, my staff also met with the Republican staff on the Health Committee for at least 2 hours every week to keep them informed and to seek their input. I also personally met with the members of the committee before markup to ensure I understood their priorities. This bill reflects the work of every member of the Health, Education, Labor, and Pensions Committee. All of them have at least one provision included in this legislation. Many members of the committee worked with us to find consensus measures that addressed their priorities as well. As I mentioned, not everyone got everything they wanted. We did, however, find the 80 percent of each solution that we could all agree would help solve the problem, and the bill passed the committee by a voice vote. This legislation could be a model for how the process can and should work regardless of the political environment. We followed this model as we transitioned from the committee process to the Senate floor. We worked with members who filed amendments in committee to address some of the concerns in the manager's amendment. We also worked with Members who filed amendments on the Senate floor. We did the same thing in our discussions with the House. You can see that the results are very positive. We preserved and we improved policies to foster drug innovation and patient access, and to promote accountability and transparency at the FDA. We also made significant improvements to the Senate's medical device reforms for startup and emerging growth companies, and with respect to the 510(k) process. We thank Senator Harkin for his tireless effort on this bill. I know he spent countless hours and attended dozens of meetings, working with Senators and stakeholders and advocates to address their concerns. This bill would not have had such broad bipartisan support without all of his work. Senator Harkin's staff has also worked tirelessly on this bipartisan bill. Their knowledge, professionalism, their graciousness were instrumental in addressing all of the issues in this bill. They worked many late evenings, they worked through weekends, they worked through countless working group discussions to be able to get the bill where it is today. Specifically, I want to recognize Elizabeth Jungman, Bill McConagha, Kathleen Laird, and Kate Wise for all their work. I thank Pam Smith, Senator Harkin's staff director, for her leadership getting this bill to the finish line. I especially want to recognize Jenelle Krishnamoorthy, whose organization and diplomatic skills helped us resolve the most difficult challenges and made sure that the priorities of all the members of the committee are reflected in the bill. I also wish to thank the staffs of the Legislative Counsel, the Congressional Budget Office, and the Federal Drug Administration for all of their technical assistance. Again, there are people in those groups who had to work through the weekends when we were finishing up. Finally I would thank my staff--Keith Flanagan, Melissa Pfaff, Grace Stuntz, Katy Spangler, Rob Walton, and my health policy director, Chuck Clapton. I would be really remiss if I didn't thank my staff director Frank Macchiarola for his work on this bill, especially as the bill progressed through the HELP Committee, the Senate floor, and discussions with the House. My staff has been working around the clock for many days, for weeks, and for months. I sincerely appreciate their dedication to getting this bill passed and for helping to work with the 80-percent rule. I urge my colleagues to support this bipartisan bill that makes important changes to the FDA and I ask them to support this process that expedites getting the conference done. We will have a real and meaningful impact on millions of American patients. I yield the floor.

Mr. ENZI

Mr. ENZI. Madam President, I have come to the floor to speak in favor of Senator Rubio's amendment No. 2166, the Rewarding Achievement and Incentivizing Successful Employees Act, known as the RAISE Act. It is a catchy title, and sometimes here in Congress catchy bill titles can be very misleading. Sometimes the bill title means the exact opposite of what the bill would do, such as the Employee Free Choice Act, which actually would have taken away the right to make a free choice through a secret ballot. But in this case, I congratulate my colleague Senator Rubio for a title that conveys precisely what the amendment aims to do. The RAISE Act would allow employers to give employees raises, bonuses, incentive payments, and other monetary rewards whenever they are earned, whether the union boss approves or not. As all of us know, we are in extremely difficult economic times. Unemployment has been above 8 percent for over 40 months, now and a striking number of individuals are dropping out of the workforce altogether. When we do recover, as I know we will, we are likely to face a skills gap that will further hamper hiring and growth. One of the keys to our economic recovery is the health of small businesses. For small businesses to reach their full potential, and grow into job-creating machines, they need the flexibility to maintain and attract the key employees who will get them there. Any small businessperson will tell you that their employees are their most important asset. They literally make the difference in whether the business succeeds or fails. Once your company is unionized, you learn one way or another that it is now an ``unfair labor practice'' under section 8(a)(5) of the National Labor Relations Act to give an employee a raise or a bonus or an incentive or even a gift card for a job well done without the approval of the union boss. All compensation issues must be negotiated with the union, which allows the union to take credit for securing the raise. We have come across scores of cases where employers wanted to thank employees for good customer service, impressive sales growth, or attract employees to fill a critical manpower shortage, and the National Labor Relations Board, NLRB, penalized the employer for it. In a time of global competition, the last thing we need is a Federal agency punishing companies for trying to perform better by rewarding employees. Believe it or not, there is opposition to this amendment. At least four of our largest labor unions AFL-CIO, AFSCME, SEIU, and the International Brotherhood of Teamsters--have opposed allowing employers to give raises. Critics of this bill have said that if employers want to be able to reward employees beyond the union-approved wage floor, they can negotiate that provision into their contract. This is true. An employer can make the ability to incentivize employees one of their ``asks'' in negotiations, and they probably have to give up something else in order for the union to agree to that. But it is also true that getting such a provision in the bargaining agreement is not enough to protect employers from a charge of unfair labor practice from the union and penalty from the NLRB. In my research on this issue, I came across several cases where employers had negotiated a raise clause, but since the collective bargaining agreement expired and was in renegotiation, the NLRB ruled that the provision did not apply. Let me cite an example from just a few years ago. A Montana water and mineral drilling company had negotiated a contract clause with their union to ensure that union-negotiated wages were only a floor and superior wages could be given with or without the consent of the union. When the company's orders increased, the company wanted to share the profits and decided to give employees unilateral raises, increase the per diem for meals, and raise the clothing and safety allowance reimbursement by 167 percent. But the union objected, and the NLRB agreed and stopped the raises. Why? Because although the company had negotiated the right to give raises, they were currently in the process of renegotiating their collective bargaining agreement and there had been no explicit extension of the clause allowing for superior wages and benefits. O'Keefe Drilling, Case 19-CA-29222(2005) Unfortunately, this is not an isolated case. NLRB has repeatedly punished employers in similar situations. An Oregon newspaper publisher had historically offered commission for sales of certain long-term advertisements. As it was adapting to having an online edition, it decided to qualify internet ad sales for commissions, as well, and added signing bonuses for new advertising clients. Although the newspaper had specifically negotiated for a contract provision allowing it to pay wages in excess of the established wage, the bargaining agreement was in renegotiation. The NLRB sided with the union. Register-Guard, 339 NLRB 353 (2003) The fact that raise provisions are negotiated into union contracts negates another criticism I have heard about this proposal. Some say that it would allow an employer to favor employees based on gender or race. This is entirely false--all race, sex, national origin and religion Federal discrimination statutes are and would remain in full effect. I would like to share a few more examples of why this legislation will not just benefit American workers but everyone who relies on the services they provide. For example, there is a great deal of concern about the quality and availability of health care services in this country. You would think that any Federal agency would congratulate hospitals that strive to improve the service they provide. Unfortunately, that was not the case in these two examples. During the nationwide nursing shortage we experienced in the last decade, a nonprofit New Mexico hospital was desperate for nurses. It was concerned about the ability to provide care and comply with mandatory staffing levels, so the hospital decided to offer $8000 signing bonuses and $2000 relocation bonuses. These generous bonuses were available for new applicants as well as current nurses--union members--who transferred to fill critical needs. But the union objected and the hospital was ordered to stop offering bonuses. St. Vincent Hospital, Case 28-CA-19039(2004) In another case, a Brooklyn hospital was concerned about poor reviews of their nursing staff from patient satisfaction surveys, which had been an ongoing problem. The hospital decided to reward its best nurses, so it honored high- performing nurses with a breakfast, a pin, and gave them $100 gift cards since it was the winter holiday season. Unfortunately, the union objected to this honoring of exceptional nurses and filed charges with the National Labor Relations Board. Although these nurses earned $67,000 to $150,000 a year, the NLRB found that the gift card was not a one-time, de minimis gift but, rather, should be considered compensation and should have been a subject of negotiation with the union. The hospital was banned from giving such bonuses again. Brooklyn Hospital Center, Case No. 29-CA- 29323(2009) Clearly something has gone very wrong here, and I want to thank Senator Rubio for offering us the ability to make it right. The ability to reward and incentivize employees is critical to the success of any enterprise. Instead of fixating on who gets credit for anything beneficial, our national labor-management policy should be to strengthen unionized and nonunionized businesses and encourage job creation. This will be good for all Americans, no matter what their union membership status. I urge the Senate to support the Rubio amendment and adopt this commonsense change to allow American companies and their employees to thrive.

Mr. ENZI

Mr. ENZI. Mr. President, I rise to express my support for legislation that will force a partial cease-fire in the Obama administration's war on coal. If we move forward with Senator Inhofe's resolution of disapproval, we will end one of the most egregious rules promulgated by an administration that, in the words of President Obama, hopes to see the price of electricity necessarily skyrocket. Coal is our Nation's most abundant energy resource. It provides approximately half our Nation with low-cost, reliable electricity. In my State of Wyoming, more than 6,800 people are employed directly by the coal industry. They make an average salary of more than $77,000 each year, which is $35,000 more than the average wage in the State. When we count those employed directly and indirectly, nearly 30,000 people in Wyoming depend on the coal mining industry for jobs. Nationwide, the numbers are much larger. The coal industry employs 136,000 people directly, with an average salary of $73,000 per year. For every coal mining job in the United States, we see 3.5 jobs created in another part of the economy. Simply put, the coal industry puts people to work. In an economy that is struggling to recover, the coal industry provides high-paying jobs for workers in Wyoming and in other States such as West Virginia, Pennsylvania, and Virginia. Coal provides low-cost electricity across the country that can power our Nation's manufacturing base. It provides high-paying jobs across the country at a time when our Nation's unemployment rate is at an unacceptable 8.2 percent, and the most recent jobs report shows no signs that the economy is recovering. With the tremendous benefits coal can provide, it is so puzzling to me that the administration seeks to end our use of this important, affordable energy source. Since being sworn into office, President Obama's rulemaking machine released rule after rule designed to make it more expensive to use coal. The administration's greenhouse gas standard would make it impossible to build a new coal-fired powerplant in the United States. The stream buffer zone rule would make it more difficult to mine coal. Those are just 2 of the 11 regulations the President is considering that would grievously wound the coal mining industry and hurt an already ailing economy. In total, the regulations could cost up to $130 billion to retrofit existing coal-fired powerplants and could, by some estimates, lead to shutting down as much as 20 percent of the existing coal-fired powerplant fleet. Today, we have a chance to stop one of those regulations. In February, the EPA finalized a standard that requires a strict reduction in air emissions from electric generating utilities. It is known as the Utility MACT rule. Similar to many of the rules coming from the EPA, the costs of this regulation are great and the benefits are limited. EPA estimates that the rule would create between $500,000 and $6 million in benefits related to mercury reductions, at a cost of nearly $10 billion annually for implementation of the rule. The cost-benefit ratio, assuming the EPA's best-case scenario, is 1,600 to 1. These costs will be passed on to consumers and will result in higher electricity prices. According to the Industrial Energy Consumers of America, a nonpartisan association of manufacturing companies with more than 650,000 employees, these increased costs will lessen competitiveness, threaten U.S. manufacturing jobs, and make our electric grid less reliable. It is everything not to like in a policy-- all costs, no benefits. National Economic Research Associates has studied the Utility MACT rule and found it would cause between 180,000 and 215,000 job losses by 2015. Further, it found that the Utility MACT rule would increase electricity rates by 6.5 percent on average and by as much as 19.1 percent in some areas of the country. An average household could see their electricity bills go up by at least $400 per year--a cost that will disproportionately impact those with lower fixed incomes, such as many older Americans. This resolution is the best opportunity to begin fighting back against President Obama's war on coal. By passing S.J. Res. 37, we can take a stand against this administration's goal of higher electricity costs. I plan to vote for Senator Inhofe's resolution and urge my colleagues to do the same. I yield the floor and reserve the remainder of the time.

Mr. ENZI

Mr. ENZI. Mr. President, I thank my colleague from Minnesota for her comments. This is an amendment that has come up on a regular basis-- always started from New Hampshire, always defeated by the Senate. I encourage my colleagues to table Reid amendment No. 2393. This measure is known as Senator Shaheen's amendment to phase out the Federal Sugar Program. First, I would like to commend Chairwoman Stabenow and Ranking Member Roberts for their work on the underlying bill. They proved that the Agriculture Committee is able to take a serious look at the farm bill programs and improve what is working while cutting what is not. The Sugar Program is an excellent example of what works in the farm bill. Since its early years, the Sugar Program has evolved to ensure that beet and cane growers can continue to provide the United States with a safe and reliable source of sugar products. I underscore ``reliable'' because sugar is a unique commodity. Not only are sugar crops extremely limited in their seasons, but an added component is that both sugar beets and cane must be processed immediately after harvest. Processing involves what is essentially a refinery. In Wyoming we have three facilities that process sugar, all of which are grower owned and operated. People can always tell its October back home when the large piles of sugar beets begin to appear outside the sugar plants. Workers race to produce raw sugar before the beets go bad. Any number of complications can spoil the crop and put the sugar refineries out of business. Such unique conditions produce risk that is not common with other agricultural commodities. Because much of the year's sugar is produced in such a small window, a sugar program is needed to stabilize the price of sugar through the entire year. This policy benefits the very people who opponents of the Sugar Program wish to protect. With stability in the sugar markets confectioners, food manufacturers, and beveragemakers have a steady supply of quality sugar without wild price swings. Not only are U.S. sugar prices stable under the program, but the United States offers sugar users some of the lowest prices in the developed world. I also wish to add that the U.S. Sugar Program works to ensure that other nations have access to sugar markets. Some claim the U.S. Sugar Program is a protectionist policy. This could not be more false. Mr. President, 17 of the largest sugar exporting countries in Africa, Asia, the Caribbean, Central America, and South America have all expressed support for the U.S. Sugar Program. As a matter of fact, the United States is the second largest net importer of sugar behind only Russia. The program is operated to ensure that we fulfill our trade obligations, especially within the WTO, and continues to provide a sugar market for developing nations wishing to export their product. Finally, the U.S. Sugar Program has been run for the past 10 years at zero cost to the U.S. taxpayers, and the U.S. Department of Agriculture predicts it will remain that way in its current form for at least 10 more. As other colleagues have mentioned, this is all while the U.S. sugar industry has helped to generate nearly $20 billion in annual economic activity in our country. Wyoming offers just a few examples of how much of an economic impact the sugar industry has on rural communities across our Nation. As I mentioned, the growers and local communities in my State own the plants that refine the raw sugar we use every day. Those plants produce jobs and keep economic activity local. With all the inherent risks in sugar production, these communities are able to continue providing the United States with a safe and reliable supply of sugar for the United States. The U.S. sugar policy not only helps growers but keeps prices low for consumers. Some American food manufacturers will claim that it is the price of sugar causing them to shed jobs or move overseas. However, sugar represents only a small portion of the input costs that go into food production. Instead, it is the cost of labor, environmental standards, and regulatory burdens that play the biggest role in whether U.S. firms can compete with food markets overseas. In recent years, U.S. candy production has actually gone up, and the U.S. Sugar Program has played its role by keeping prices stable. With that, I ask my colleagues to table amendment No. 2393 and keep the programs that work in this farm bill. I yield the floor.

Mr. ENZI

Mr. ENZI. Mr. President, when the Senate rejected this legislation 20 months ago in a bipartisan vote it did so for the right reasons. The fact is, discriminatory pay practices are already illegal, and properly so. Congress has put two laws on the books to combat such discrimination--Title VII of the Civil Rights Act of 1964 and the Equal Pay Act of 1963. These are both good laws that have been well-utilized to combat discrimination where it exists, and I support full enforcement of those laws. When a female or male employee is being paid less simply because of gender it must be corrected and penalized. According to the Equal Employment Opportunity Commission, EEOC, employees received more than $150 million through successfully-resolved Title VII and EPA discrimination claims last year, the largest amount awarded in 15 years. I am confident that there is no member of this Senate who would tolerate paying a woman less for the same work simply because she is a woman. As husbands, fathers and mothers of working women, I believe we all recognize the gross inequity of discrimination in pay based on gender. But what the majority is trying to push through here today is of a very different nature. The so-called Paycheck Fairness Act is misnamed. It should actually be called a Profiteering Trial Lawyers Bonanza bill. The primary beneficiary of this legislation will be trial lawyers. They will be able to bring bigger class action lawsuits without even getting the consent of plaintiffs, and they will have the weapon of ``uncapped damages'' to force employers to settle lawsuits even when they know they have done nothing wrong. The litigation bonanza this bill would create would extend even to the smallest of small businesses, only further hampering the lagging economic recovery. With unemployment trending back up to 8.2 percent, this is simply not a chance we can afford to take. When the Senate last rejected this bill, unemployment had been above 8% for 20 months. Now, it has doubled to 40 months, and it is trending higher. If we include the significant numbers of people that have simply dropped out of the workforce, the unemployment rate is over 14 percent. The United States is in very dangerous territory right now. This is not the time to pass this harmful legislation. There are a number of other concerning provisions of this bill, such as authorizing the government to require reporting of every employer's wage data by sex, race and national origin. Had this bill gone through committee mark up under regular Senate order, we may have been able to address some of these concerns. But this bill, like so many others this Congress, has circumvented regular order. The Senate rejected this identical bill on a bipartisan basis 20 months ago because it will insert the Federal Government into workplace management decisions like never before. This intrusion will benefit trial lawyers and harm job growth and employment, which will affect both women and men. Supporters of the bill cite wage data that the Bureau of Labor Statistics itself says ``do not control for many factors that can be significant in explaining earning differences.'' In fact, studies show that if you factor in observable choices such as part-time work, seniority and occupational choice, the pay gap stands between 5 to 7 percent. Some of these choices are simply personal prerogative, and I would not question the choices that anyone makes with regard to family obligations, job security and the quality of fringe benefits such as health, retirement and childcare. But to a large extent this remaining gap is due to occupational choice. It is unfortunate that this Congress has not done more to foster a job growth environment and improve job training programs like the Workforce Investment Act that could prepare more women to enter higher earning occupational fields. Surely this would be a more reasonable solution than a trial lawyer bonanza sure to disadvantage all employers and depress job growth to the disadvantage of all employees. I ask unanimous consent to have printed in the Record letters of opposition to S. 3220. I urge my colleagues to oppose this motion.

Mr. ENZI

Mr. ENZI. Madam President, I yield the Senator from Kentucky the time he is already entitled to.

Mr. ENZI. Mr. President, I rise in opposition to the McCain amendment No. 2107, which would facilitate the importation of prescription drugs from Canada. We are not talking about bus trips of seniors to reputable brick-and-mortar pharmacies right across the border. We are talking Canadian Internet pharmacies, which may not even be in Canada, which pose a significant threat to American patient safety. This amendment would require the Food and Drug Administration to allow individuals to import prescription drugs into the United States from Canada, notwithstanding any other provision of the Federal Food Drug and Cosmetic Act. Drugs that supposedly come from Canada can originate in any country in the world, and merely be shipped to the United States from Canada. Canadian law does not prohibit the shipment of drugs from any country into Canada and then into the United States. They do not care. In 2005, FDA conducted an investigation of drugs that American patients thought they were ordering from Canada. Eighty-five percent of the drugs represented as coming from Canada actually came from 27 other countries. A number of drugs were found to be counterfeit. A letter from Assistant Deputy Minister of Health, Canada, to the U.S. Surgeon General again said that Canada does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future. The pending amendment would allow importation from Canadian Internet pharmacies. Canadian Internet pharmacies openly acknowledge they obtain most of their drugs from other countries. The specific language of the pending amendment gives rise to the additional safety concerns. For example, it will not prevent the importation of drugs that need special handling, such as refrigerated or photosensitive drugs. It would not prevent the importation of special drugs, such as those inhaled during surgery or administered intravenously. The pending amendment would not require Canadian wholesalers that would be involved in the importation to be licensed or registered in any way. There would be a list but not a licensing or registration. Do we want anyone, even someone under investigation or with a suspended or revoked license, to be in the business of importing drugs, given the well-known risks? FDA advises consumers that some imported drugs, including those that bear the name of U.S.-approved products, may, in fact, be counterfeit versions that are unsafe or completely ineffective. You know, they can have all of the ingredients to it, but if it is not put together the right way, it will not even dissolve as it goes through the body, and therefore there would be no benefit from that drug, even though it looked like the real thing, it tasted like the real thing, it went down like the real thing. But if it is not the real thing, it can cause some real trouble with people's health. This is not a hypothetical concern. Last year Homeland Security Secretary Napolitano testified that counterfeit drugs are a growing problem. Two months ago, FDA testified about the dangers of purchasing counterfeit, unapproved, or diverted prescription drugs on line. My colleague Senator Mikulski has highlighted the growing involvement of organized crime in this area. Prescription drug counterfeiting can be dramatically more profitable than narcotic smuggling. Imported drugs pose additional dangers because their labels may lack important information or warnings. FDA advises consumers that an imported medication may lack information allowing patients to be promptly and correctly treated for dangerous side effects. We know imported drugs pose severe risks to American patients. The FDA and the Department of Health and Human Services have repeatedly said they cannot assure the safety of imported drugs. A side-by-side amendment that we used to put on this all the time was that you could import drugs as long as the Secretary of Health and Human Services said it was safe. Well, there hasn't been a Secretary of Health and Human Services who has been willing to sign that drugs imported from anywhere--even Canada--are safe. FDA's Web site advises consumers that imported drugs--including drugs imported from Canada--may not have been manufactured under quality assurance procedures designed to produce a safe and effective product. That is the FDA Web site. The Federal Food, Drug, and Cosmetic Act represents over 100 years of lawmaking to protect the public health. It gives the FDA authority to make sure drugs are properly approved, manufactured, labeled, shipped, handled, and stored, that factories are inspected, and that numerous other protections are in place for American patients. Adopting this amendment would endanger American patients, and I therefore urge my colleagues to oppose it. There is a lot more that could be said. I have been saying this for years and trying to find a way it could be done. At the present time, the safety of it makes me oppose this particular amendment. They keep revising the amendment. It is still online and everybody knows how things online can be redone. They talked about putting an official seal on each Web site, but I know fourth graders who can duplicate any seal you can put on the Internet. Any list can be changed--and who checks lists, anyway? The problem is not knowing where the drugs come from that go through Canada to the United States. If they are counterfeit, they can sell them for less. The Canadian secretary of health also doesn't want to be the pharmaceutical supplier to the United States. They have a little different system up there. It is a way of driving prices down, which is something we would not stand for in the United States, a mechanism where they have to bid on the drugs. The people who make hard medicine bid against each other, and your doctor might prefer the one that doesn't win the bid. That is how they drive the price down. It is probably something we would not allow in the United States. I ask my colleagues to oppose the amendment. I yield the floor.

Mr. ENZI. Mr. President, while I agree with much of what the Senator has said, I hope this doesn't encourage other partisan diatribes to come to the floor when we are on a bipartisan bill and trying to solve getting necessary pharmaceuticals to the market as soon as possible. We have a limited time of debate, and we need to stay on the subject. So I hope others are not encouraged to come down to counter anything they may have heard or to make different charges. We have some time left on Bingaman and some others, but I hope we can move forward on the bill. I yield the floor to the Chair.

Mr. ENZI. Madam President, I rise today to oppose the amendment addressing the patent settlements for generic claims. I am sympathetic to the intent of the sponsors of this amendment. I believe that some drug patent settlements may be improper and could be unfairly increasing drug prices for consumers. If that is in fact happening, we should stop the bad settlements and encourage the ones that work. The problem with this amendment, however, is that its scope is much broader and could lead to unintended consequences that could harm consumers and increase costs. That is why I must oppose it. The amendment uses a machete when a scalpel might solve the problem. Not all patent settlements are abusive. They do not all lead to higher costs. In fact, some settlements can actually expedite generic drugs coming to market. According to one recent study by RBC Capital Markets, patent settlements helped expedite 24 of the 37 most recent generic drug approvals. The amendment would allow competing generic manufacturers, in certain cases, to share the 180 days of exclusivity provided under the drug patent law known as Hatch-Waxman. This period of exclusivity was intended to create a market incentive for generic manufacturers to be the first to file a generic drug application with FDA. The amendment is intended to discourage generic manufacturers from reaching settlements with brand manufacturers to delay generic competition. Unfortunately, it may also have the unintended consequence of discouraging generic competition generally. The Hatch-Waxman statute, which first established our current system of brand and generic drug approvals, was a careful compromise of competing interests. It struck a balance between encouraging research and development of new cures and promoting competition to lower costs. By all accounts, this law has been a success. Our Nation leads the world in the creation of new drugs and therapies that improve the lives of countless patients across the world. At the same time, generic drugs have promoted competition and lowered costs to American patients. According to one recent estimate, generic drugs have saved the American health care system over $930 billion over the last decade. This amendment would disrupt that system and reduce the incentives that currently encourage manufacturers to file generic drug applications with the FDA. Allowing competitors to share the 180 days of exclusivity will undermine the market incentives for manufacturers to make such filings. It will also create uncertainty about whether generic manufacturers will ultimately be able to recoup their investments and could mean that there will be fewer generic drugs. That is why the generic drug manufacturers oppose this amendment. While I genuinely appreciate the desire to prevent abusive settlements, I believe that we must be very careful in disrupting a system that has worked so well for patients and consumers. We should hold hearings in the HELP Committee to hear from all of the stakeholders who have a role in this system. We need to learn how any proposal will impact the incentives to encourage competition. We also need to learn how any proposed solutions will affect settlements and patent litigation. This is clearly an important and very complex issue, but this amendment could have serious and detrimental consequences for patients. This is why I would urge my colleagues to oppose this amendment. I yield the floor.

Mr. ENZI. Madam President, I yield 3 minutes to the Senator from Tennessee.

Mr. ENZI. Madam President, I yield 5 minutes to the Senator from Ohio.

Mr. ENZI. Madam President, I ask unanimous consent that when we begin the next vote, Senator Paul, who has 7 minutes left on his item, be given 2 minutes so he may explain his bill in exchange for those 7 minutes.

Mr. ENZI. Mr. President, I would oppose this amendment. We do need to combat health care fraud, but this amendment goes too far in several aspects. First and most important, it would discourage any settlement agreements. People would fight it to the death if they are going to lose their exclusivity. Second, as drafted, the amendment would require companies to forfeit exclusivity anytime there is a civil or criminal liability under the Federal Food, Drug, and Cosmetic Act. It is disproportionate. This could be triggered by a misdemeanor. In addition, such liability may not reflect fraud. The amendment would discourage the development of new cures for patients. If manufactures know they could lose exclusivity for even minor infractions, they will not invest the millions of dollars necessary to create new lifesaving therapies for patients. I ask that the Senate oppose the amendment. I yield the floor.

Mr. ENZI. To receive accelerated approval, the managers' amendment requires that FDA determine that a surrogate or clinical endpoint is reasonably likely to be predictive of an effect on clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality as of the time of granting accelerated approval and the standards under section 505(c) of the FDCA or section 351(a) of the Public Health Service Act are met. In meeting such a requirement, it is appropriate for the Secretary to seek data and information to show that the surrogate or clinical endpoint is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. I would just like to reiterate that nothing in these amendments to section 506(b) is intended to alter the FDA's historical practice of utilizing unvalidated surrogates to grant accelerated approval in appropriate cases or its practice of granting traditional approval under section 505(b) based on validated surrogates in appropriate cases.

Mr. ENZI. Madam President, the chairman has said it well. We appreciate the bipartisan spirit in which people have participated, especially in committee for a year and a half, working out amendments, working out ideas, and coming up with a bill that had a good consensus. I appreciate the action on the Senate floor, the people who were willing to do time limits on their amendments, and how quickly we have gotten through the votes. I particularly want to thank the chairman for the way he has handled this in committee and the process since then. We had a couple of issues that were outstanding and those got worked out. I also want to thank the staffs on both sides. Their dedication for a year and a half is what made this happen, and we have some outstanding staff on both sides. Every member of the committee and every committee member's staff helped on this one, and that makes a difference. So I ask everyone to support the bill. I yield the floor.

Mr. ENZI

Mr. ENZI. Mr. President, I wish to provide a few comments regarding the introduction of the Bison Legacy Act. Senator Tim Johnson of South Dakota and I are introducing this legislation today because of the significant role the North American Bison has played in the history of our Nation. This bill honors that legacy by designating the bison as the national mammal of the United States. The bison has been integrally linked to the economic and spiritual lives of many Native American tribes over the centuries. Since our frontier days, the bison has become a symbol of American strength and determination. The Department of Interior has depicted the bison on its official seal for 94 years and the buffalo nickel played an important role in modernizing our currency in the early 20th century. At one point in American history, bison were brought in to graze outside the original Smithsonian building here in Washington, DC. I must also add that my home State of Wyoming is one of three states that recognize the bison as its official state mammal and has honored an image of a bison on the Wyoming state flag since it was first adopted in 1917. Today, thousands of American bison freely roam Yellowstone and Grand Teton National Park in Wyoming. The bison is also important to our state's economic well-being with a growing number of ranchers raising bison for consumers all over the world. This bill is supported by a wide variety of stakeholders. I want to recognize the National Bison Association who represents the interests of the bison ranchers in nearly every single State. Also behind this bill is the Intertribal Bison Council supporting the cultural role the bison has played in Native American history. Finally, there is the Wildlife Conservation Society who wishes to honor the restoration of bison in North America since the 19th century. I ask my colleagues to help me support and pass this legislation honoring the bison and designating it as our national mammal. The bison has and will continue to be a symbol of America, its people and a way of life.

Mr. ENZI

Mr. ENZI. Mr. President, I wish to provide a few comments regarding the introduction of the Bison Legacy Act. Senator Tim Johnson of South Dakota and I are introducing this legislation today because of the significant role the North American Bison has played in the history of our Nation. This bill honors that legacy by designating the bison as the national mammal of the United States. The bison has been integrally linked to the economic and spiritual lives of many Native American tribes over the centuries. Since our frontier days, the bison has become a symbol of American strength and determination. The Department of Interior has depicted the bison on its official seal for 94 years and the buffalo nickel played an important role in modernizing our currency in the early 20th century. At one point in American history, bison were brought in to graze outside the original Smithsonian building here in Washington, DC. I must also add that my home State of Wyoming is one of three states that recognize the bison as its official state mammal and has honored an image of a bison on the Wyoming state flag since it was first adopted in 1917. Today, thousands of American bison freely roam Yellowstone and Grand Teton National Park in Wyoming. The bison is also important to our state's economic well-being with a growing number of ranchers raising bison for consumers all over the world. This bill is supported by a wide variety of stakeholders. I want to recognize the National Bison Association who represents the interests of the bison ranchers in nearly every single State. Also behind this bill is the Intertribal Bison Council supporting the cultural role the bison has played in Native American history. Finally, there is the Wildlife Conservation Society who wishes to honor the restoration of bison in North America since the 19th century. I ask my colleagues to help me support and pass this legislation honoring the bison and designating it as our national mammal. The bison has and will continue to be a symbol of America, its people and a way of life.

Mr. ENZI

Mr. ENZI. On this amendment, I appreciate the concern, the interest, and the effort the Senator from Illinois has gone to on this bill. But in looking at it, there is still a couple of steps missing if this were to become law. Yes, it would provide a lot of information to the FDA. It would, in fact, flood them with information, and I think we would flood them with more information than they could possibly process. But that part doesn't even bother me. What bothers me is how we get that information to the consumer. It is the consumer that needs to know what they are drinking, eating, and everything else. That is why we provide labeling on a lot of things. But even the things we already provide labeling on, the consumer doesn't necessarily pay attention to it. Probably the people who need to pay the most attention to it don't pay any attention to it. So just making this information available to the FDA doesn't get it to the point where the consumer can know. Of course, anytime we start talking in this area, people get worried about the amount of regulation we put on things they consider to be very important to them and can do no harm. The right way to address this important issue is for the HELP Committee to have hearings and work together, as we have done on this bill, to find common ground on the policy. When we find common ground, as we have on this FDA bill, then we can get something done. But I think this is a little premature. So I hope people will not support this amendment at this time. I yield the floor, and I reserve the remainder of my time.

Mr. ENZI. Mr. President, I appreciate the concern by the Senator from Vermont, but I have to oppose the amendment, No. 2109, because of some of the unintended consequences it will have. This amendment would require drug companies to forfeit exclusivity for certain violations of the Federal Food, Drug, and Cosmetic Act and other laws. ``Exclusivity'' means exclusive market rights granted by the Food and Drug Administration upon approval of a drug. It may or may not run concurrently with a patent. Exclusivity is a very important type of intellectual property protection. Without it, innovators cannot predictably obtain returns on their drug development investments. The stated purpose of the amendment is to combat healthcare related fraud. The premise is, if companies know their profits are at risk, they will be strongly discouraged from engaging in fraudulent activity. But this amendment is counterproductive: It will make it more costly for law enforcement to fight fraud and could hurt patients. Congress is also thinking of ways to improve healthcare antifraud programs. For example, in a recent open letter to the health care community, six members of the Senate Finance Committee, led by Chairman Baucus and Ranking Member Hatch, announced a bipartisan effort to solicit ideas from the healthcare community on ways to reduce healthcare waste, fraud and abuse. Estimates of the amount of fraud and misspending in Medicare and Medicaid vary widely, from $20 billion to as much as $100 billion. To address this problem, the six Senators solicited ideas on program integrity and fraud and abuse enforcement reforms. This sort of constructive search for real solutions is long overdue. Healthcare fraud is a serious problem, and I strongly agree that the Congress should develop substantive solutions to it. The problem here is, the pending amendment does not really tackle the problem of fraud. Instead, the amendment uses a blunt instrument--revocation of exclusivity--to punish an incredibly broad range of legal violations. This amendment would discourage settlements in fraud cases. A settlement agreement concerning a listed violation would trigger forfeiture. If a company knows that settlement would trigger a result that could cost it hundreds of millions of dollars, it will be less likely to settle. This will make it harder for the government to settle cases, and increase the backlog of cases waiting for trial. It also creates the risk that a fraudster could prevail or appeal, and prevent the prosecutor from pursuing other cases. Settlement is an important tool in a prosecutor's toolkit. It enables them to pursue a higher volume of cases, while still obtaining sizable judgments to deter future fraud. In fiscal year 2011, the Departments of Justice and Health and Human Services together recovered nearly $4.1 billion in taxpayer dollars through healthcare anti-fraud prevention and enforcement efforts. The ability to settle claims contributed substantially to this achievement by allowing the government to pursue a higher volume of cases. Within the Federal Food, Drug, and Cosmetic Act itself, there are already robust standards and enforcement tools concerning industry marketing and communications, and interactions with healthcare providers and professionals. The False Claims Act and strong anti-kickback laws are also on the books already. This amendment will also discourage manufacturers from developing new cures. It creates tremendous uncertainty about whether investors can obtain returns on their drug development investments. If a trivial violation of FDA's detailed, elaborate regulations could put the entire investment in a drug at risk, it will discourage investment in new treatments. This would severely threaten biomedical investment and jobs. More importantly, it would lead to fewer life-saving therapies for patients. This amendment could produce absurd results. For example, the amendment would revoke exclusivity for a civil judgment concerning adulteration of a drug. A drug is considered adulterated if a manufacturer violates FDA's current Good Manufacturing Practices, known as cGMPs. There is no intent requirement, and no minimum number of inspection requirements to trigger liability. Some examples of cGMP violations include: Washing and toilet facilities are not easily accessible to working areas; adequate lighting is not provided in all areas; laboratory records do not include complete records of the periodic calibration of laboratory instruments. It obviously does not make sense to strip drug companies of exclusivity for violations like this, which do not reflect fraudulent intent. It is disproportionate and counterproductive. Again, I strongly agree that healthcare fraud is a significant problem. The best way to solve it is through robust enforcement of the many current laws on point, and continuing to work with the health care community to find effective solutions. That would be going through committee hearings as well. The pending amendment would not reduce fraud. On the contrary, it would frustrate the government's current anti-fraud efforts, and ultimately harm patients and taxpayers alike. I encourage a ``no'' vote on this amendment. I yield the floor and reserve the remainder of our time.

Mr. ENZI. Madam President, I thank the Senator for his comments and his insight and his idea. I appreciate that we are not going to be voting on this one right away because I think this needs a little time to germinate. I think it is something that, as people look at it and think about it, they will recognize the value there would be if we had more insight into what the negotiations were--not just on this but perhaps on regulations that are being done as well. I want to thank the Senator, though, for the way he has dug into the entire user fee bill and made some very substantial changes in a number of other places. I do not know of anybody who works as hard on the medical issues as does Senator Burr, and understands it, and gets into some of the details. And, of course, he worked all of these when he was in the House and now works them in the Senate, and is our foremost expert on any of the pandemic issues and was very successful earlier in the year in getting that bill through the Senate. He has been very cooperative on the other amendments which are now a part of the bill that we will not be voting on because they are already in there. I appreciate this one more suggestion and suggest that is something we should take a look at. I yield the floor and reserve the remainder of the time.

Mr. ENZI. Mr. President, I would echo the comments of the chairman, and I, too, thank the Senator from Maryland for his amendments. I think everybody appreciates both those amendments and, hopefully, they will become a part of this bill. I also appreciate all those who have come to speak this afternoon. I know there are still probably a couple of controversial amendments on which Senators should come and speak, and then we might have the possibility of moving some things up a little bit tomorrow so we can get this bill finished expediently. So I hope if anyone has an amendment, they will come and use their time. I think we have a few minutes in opposition perhaps to two of the amendments that have been debated so far. But that is it, and then I think there are three controversial ones that are left to be debated. One of those has a significant amount of time allocated to it, but the others are limited to 30 minutes equally divided. So I hope we can take care of some more of those this evening and get started on votes as soon as possible. I yield the floor, and I suggest the absence of a quorum.

Mr. ENZI. I thank the Senator from Colorado, Mr. Bennet, for his comments, but he sold himself pretty short on the influence on this bill. He has worked dramatically on every portion of this bill and made some significant contributions that are now a part of the bill. He didn't have to do amendments at this point because he got them all in. That was very important across-the-aisle work that the Senator did by working with a number of people on both sides of the aisle and being faithful and helping committee and staff members, not to mention all the committee meetings held on Fridays throughout the year. This bill wouldn't have been possible without the Senator's efforts.

Mr. ENZI. Mr. President, it was my understanding that because of the special event tonight, we were going to be out of here at 6 pm. I am not sure what leadership has in mind at this point.

Mr. ENZI

Mr. ENZI. Mr. President, I am proud to submit a resolution today to designate Saturday, July 28, 2012 as National Day of the American Cowboy. My late colleague, Senator Craig Thomas, began the tradition of honoring the men and women known as ``cowboys'' seven years ago when he introduced the first resolution to designate the fourth Saturday of July as National Day of the American Cowboy. I am proud to carry on Senator Thomas's tradition. The resolution celebrates the history of cowboys in America and recognizes the important work today's cowboys are doing in the United States. The cowboy Spirit is about honesty, integrity, courage, and patriotism, and cowboys are models of strong character, sound family values, and good common sense. The first cowboys relied on hard work and persistence to make their living in a tough country. Today's cowboys haven't changed all that much from the first wranglers and ranch hands who started herding cattle on the Great Plains. Cowboys continue to make important contributions to our economy, Western culture and my home State of Wyoming today. They live and work in every State to manage nearly 100 million cattle. Cowboys work hard, but they also play hard. Rodeo is a sport that tests skill with a rope or challenges a cowboy's ability to stay on the back of bucking rough stock for 8 long seconds. Rodeos across the nation draw millions of fans every year. This year's resolution designates July 28, 2012, as the National Day of the American Cowboy. I look forward to celebrating this day, and I hope my colleagues will join me in recognizing the important role cowboys play in our country.