John McCain

Mr. McCAIN

Mr. McCAIN. Could I explain my request to the Senator from Nevada? Could I be recognized, Mr. President?

Mr. McCAIN. I would like to speak for 5 minutes. The Senator from Alaska has indicated he will move to table the amendment. I would like 5 minutes, as the sponsor of the amendment, prior to the vote to table.

Mr. McCAIN. I yield the floor.

Mr. McCAIN. I yield the floor.

Mr. McCAIN. Mr. President, it is fine with me, whenever he wants to make the motion to table. I do have additional comments on the issue.

Mr. McCAIN. Mr. President, I send an amendment to the desk.

Mr. McCAIN. Mr. President, I ask unanimous consent that the reading of the amendment be dispensed with.

Mr. McCAIN. Mr. President, this calls for full and open competition in the case of a lease of a transport/VIP aircraft. It would address the complaints of industry with respect to the Boeing 767 tanker lease and Boeing 737 transport/VIP lease and the first five multisensor command and control aircraft, and would replace the JSTARS E-3 AWACS and the RC-135 Rivet Joint aircraft. Basically, it calls for full and open competition for these aircraft, in the case of four 737 transport aircraft, and, as I understand, prospective Boeing 767 tanker aircraft.

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. McCAIN. Mr. President, I misspoke. This amendment does not apply to the 767, only to the 737 aircraft.

Mr. McCAIN. For the benefit of my colleagues, I have one more amendment that is not agreed to and would require a rollcall vote, which I understand from the majority leader would be scheduled for tomorrow. I have a statement I would like to read concerning the pending bill and then discuss the amendment, or if the managers so choose, I would discuss the amendment first and then describe my views on the overall legislation. Mr. President, I send amendment No. 4445 to the desk.

Mr. McCAIN. Mr. President, I ask unanimous consent that the reading of the amendment be dispensed with.

Mr. McCAIN

Mr. McCAIN. Reserving the right to object.

Mr. McCAIN. I object to proceeding until I see the managers' amendment.

Mr. McCAIN. On DOD appropriations?

Mr. McCAIN. Reserving the right to object, I thank the Senator from West Virginia. We have had many occasions where late at night managers' amendments were agreed to without anyone ever having seen or heard of them. And I would still like to see the managers' amendment before some time late tomorrow night when everyone wants to get out of here and leave and I am the bad guy again. I want to see what is in the managers' amendment package. It is not an illegitimate request to see the managers' amendment package before they vote on final passage, which then puts us in the uncomfortable position of having to be delayed. I think it is a fair request on the part of the taxpayers of America to see what we are voting.

Mr. McCAIN. I don't. I would like to say, any amendment that I have will be debated and voted on. I don't have the privilege of proposing a managers' amendment.

Mr. McCAIN

Mr. McCAIN. Mr. President, the Greater Access to Affordable Pharmaceuticals Act, GAAP, provides a real opportunity to benefit all consumers of prescription drugs. In the recently concluded study of the abuses of the Hatch-Waxman act, the Federal Trade Commission concluded that there is a need for Congress to act and to act quickly to end the exploitation of loopholes in current law that has delayed the entry of generic drugs into the market. S. 812 would allow consumers earlier access to generic versions of drugs while protecting the intellectual property rights of the brand name drug innovators--a protection that is necessary for their continued investment in research and development of new and improved pharmaceuticals. S. 812 would accomplish five important objectives. First, the bill would limit the ability of brand name drug companies to delay the marketing of generic competitors. It does this by limiting brand name drug companies to only one automatic 30-month stay. Under current law, brand name drug companies can prevent generic substitutes from coming to market by suing the generics for patent infringement, thus triggering an automatic stay of up to 30 months on the FDA's approval of the generic drug. By bringing successive patent infringement suits, brand name drug companies have obtained sequential stays, and kept generics off the market much longer than 30 months. Allowing for only one automatic delay is consistent with the FTC's recent recommendations. In its report, the FTC recommended that only one stay be allowed, and noted that: prior to 1998, only 1 out of 9 blockbuster drugs products involved at least three patent lawsuits, whereas after 1998, 5 of the 8 blockbuster products involved at least three lawsuits. . . . [C]ases involving multiple patents take longer than those involving fewer patents [to resolve] the FTC wrote, and the Commission found that the multiple stacking of automatic stays delayed the approval of generic drug applications from between 4 and 40 months beyond the initial 30-month period. There is no doubt that these stays have cost consumers enormous sums of money by preventing their access to cheaper generic versions of drugs. Allowing for one 30-month stay, as S. 812 does, strikes a balance between the rights of brand name drug companies seeking to protect their legitimate patents, and the rights of consumers to access generic drugs without unreasonable delay due to ``gaming'' of the system. Second, the GAAP Act would modify the provision in current law that allows the first-to-file generic drug manufacturer an exclusive 180-day period to market its drug without competition from other generic manufacturers. The 180-exclusivity period was intended to provide a needed incentive for challenging dubious patents. Like the automatic 30-month stay, however, this 180-day exclusivity has been abused. Brand name and generic drug companies have colluded in deals in which the brand name manufacturer effectively extends its own period of exclusivity by paying the generic drug manufacturer to stay out of the market for the six months during which the generic would otherwise be able to compete. When this occurs, the brand name manufacturer wins, and the generic manufacturer wins, but consumers lose. To prevent this type of abuse, S. 812 modifies current law so that first-to-file generic manufacturers that engage in anticompetitive conduct and do not go to market, lose the privilege of the 6-month exclusivity in the generic market, and, in certain circumstances, that exclusivity ``rolls'' over to the next generic competitor. Third, the legislation would require generic drug applicants to the FDA to provide a more detailed ``paragraph IV'' filing. This means that the patent holder will not only receive a general notice that its patent is being challenged, but the generic drug applicant will be required to provide a more detailed legal basis of its assertions regarding the original patent's validity. This is an important protection for the brand name manufacturers because they will receive more information about the nature of the patent challenge as opposed to a simple notice that a generic application has been filed. Fourth, S. 812 would clarify that the FDA's existing regulations as they pertain to bioequivalence have the effect of law. Currently, bio- equivalence is demonstrated through blood level studies, and only in some circumstances has the FDA allowed for limited human data to be submitted for products where blood studies are inapplicable. S. 812 would allow the FDA to amend its regulations as necessary and clarify its authority over biological products under the Federal Food, Drug and Cosmetic Act. The fifth significant change to current law relates to how to clean up abuses of the ``Orange Book'', the manual in which the FDA lists all patents on pharmaceutical drugs. S. 812 allows generic manufacturers in certain instances to bring a cause of action to ``de-list'' or ``rename'' a drug patent. Current law provides no means for ``delisting'' a patent, although doing so can speed the marketing of generic drugs, particularly in cases involving patents that are patently frivolous and for which the brand name manufacturers clearly would not win a patent infringement suit. While purging the Orange Book of frivolous patents is important, I understand that some Senators are concerned that the new cause of action to ``delist'' will not speed the availability of generic drugs, but will lead to a snarl of litigation. I hope these concerns can be reviewed in conference. Over twenty years ago, Hatch-Waxman established the procedures for bringing generic drugs to consumers and set out to strike a balance that would allow drug innovators to protect their innovations, while allowing generic drugs easier access into the market. In large part, Hatch-Waxman succeeded in bringing new lower-cost alternatives to consumers, and encouraging more investment in U.S. pharmaceutical research and development. This has been evident in the years since the enactment of Hatch-Waxman, where research and development has increased from $3 billion to $21 billion. Loopholes in the law, however, have delayed benefits to consumers. It is time to close them. The Congressional Budget Office, CBO, recently released results of its estimate of S. 812, finding that total drug expenditures in this country over the next ten years, 203 to 2012, will be roughly $4.7 trillion. If the delays resulting from numerous lawsuits and agreements that arise under current law were eliminated, the CBO estimates that S. 812 would result in a savings of up to 7 percent, or $320 billion. For consumers, particularly seniors, the uninsured, and those on Medicare, this is a tremendous savings. Congress will improve the lives of many Americans by passing the underlying language of S. 812. I urge my colleagues to do this now.

Mr. McCAIN

Mr. McCAIN. Mr. President, I have a couple of amendments the managers have accepted, and I have another amendment that would be the subject of debate. I send those two amendments that I think are agreed to, to the desk at this time and ask for their immediate consideration, either separately or en bloc. The first amendment I would request be called up would be amendment No. 4443.

Mr. McCAIN. Mr. President, the first amendment would remove the reporting period required for the positioning of UH-60s and would allow that the report be submitted at any time. It is largely technical in nature.

Mr. McCAIN

Mr. McCAIN. Mr. President, along with Senators Schumer, Craig, and Kennedy, I rise today to introduce the ``Our Lady of Peace Act'' that has the strong support of major organizations across the political spectrum. This legislation fixes a huge hole in our system--a hole that delays legitimate firearms purchases and allows criminals and other prohibited buyers to obtain guns. The hole is the faulty records in the National Instant Criminal Background Check System, NICS. Based on a report released by Americans for Gun Safety Foundation in January 2002, Congress has learned that millions of records are missing from the NICS database. Over a 30-month period, 10,000 criminals obtained a firearm despite a background check because the records couldn't be checked properly within the 3 days allowed by federal law. In addition, thousands of other prohibited buyers will never be stopped because very few restraining orders, drug abuse or mental disability records are kept at all. This report makes it clear that if we are to be serious about stopping criminals, wife-beaters and illegal aliens from slipping through a background check, we had better fix this broken system. Better records mean more accurate background checks--checks which stop prohibited buyers while allowing legitimate buyers to be approved. And better records put the ``instant'' back into instant check, because delays occur when records have to be searched manually. In fact, the only reason why criminal background checks sometime take several days is because records have to be checked by hand instead of computer. The figure is astonishing. There are over 30 million missing records. For felony records, the typical state has automated only 58 percent of its felony conviction records. The FBI estimates that out of 39 million felony arrest records, 16 million of them lack final disposition information. Without final disposition records, background checks must rely on time consuming manual searches of courthouse files to approve or deny firearms purchases. On the issue of mental health, 33 States keep no mental health disqualifying records and no state supplies mental health disqualifying records to NICS. The General Accounting Office, GAO, estimates that 2.7 million mental illness records should be in the NICS databases, but less than 100,000 records are available, nearly all from VA mental hospitals. States have supplied only 41 mental health records to NICS. Combined with the federal records, the GAO estimates that only 8.6 percent of the records of those disqualified from buying a firearm for mental health reasons are accessible on the NICS database. In the case of drug abusers, the GAO estimates that only 3 percent of the 14 million records of drug abusers are automated, not including felons and wanted fugitives. States have supplied only 97 of those records to NICS which the GAO estimates as representing less than 0.1 percent of the total records of those with drug records that would deny them a firearm. On the issue of domestic violence, 20 States lack a database for either domestic violence misdemeanants or temporary restraining orders or both, 42 percent of all NICS denials based on restraining orders come from one State--Kentucky--which does the best job of automating TRO's from the bench. The Department of Justice estimates that nearly 2 million restraining order records are missing from the database. In the case of illegal aliens/non-immigrant status records, the GAO estimates that over 2 million illegal alien records are absent from the NICS database. Through 2001, NICS had no records of non-immigrants in the United States making it impossible to stop visitors to the U.S. on tourist or student visas from purchasing firearms. The benefits of better records are simple and important. They lead to accurate and instant background checks. Better records mean we would be able to stop far more prohibited buyers from obtaining a gun than we do now. When a restraining order, drug abuse or mental health record is missing, nothing in the NICS system indicates a reason to delay the sale and search records. NICS simply approves the transaction usually within 3 minutes. Poor records are why and this legislation will fix the system. This bill requires Federal agencies such as the Immigration and Naturalization Service, INS, and the VA to provide all records of those disqualified from purchasing a firearm to NICS. For INS, it would mean sending millions of records of those here on tourist visas, student visas, and all other non-immigrant visas to NICS. Each State would be allowed to receive a waiver for up to 5 years of the 10 percent matching requirement for the National Criminal History Improvement Grants, NCHIP, when that state automates and makes available to NICS at least 95 percent of records of those disqualified from purchasing a firearm. This bill also requires states to automate and send to NICS all disqualifying records under Federal and State law, including domestic violence misdemeanors, restraining orders, criminal conviction misdemeanors, drug abuse and other relevant records to NICS. We also provides grants of $250 million per year for 3 years to States to improve background check records, automate systems, enhance states capacities to perform background checks, supply mental health records and domestic violence records to NICS. We also give grants of $125 million per year for 3 years to States to assess their systems for rapidly getting criminal conviction, domestic violence records and other records from the courtroom into the NICS database and for improving those systems so as to eliminate the lag time between conviction and entry into NICS. Better records mean instant checks: 72 percent of background checks are approved and completed within minutes, but 5 percent take days to complete for one reason only faulty records force law enforcement into time consuming searches to locate final disposition records for felony and domestic violence convictions. It is our hope that this legislation will finally make our records system complete and totally stop prohibited buyers from gaining access to firearms while allowing legitimate buyers to be approved.

Mr. McCAIN

Mr. McCAIN. Mr. President, along with Senators Schumer, Craig, and Kennedy, I rise today to introduce the ``Our Lady of Peace Act'' that has the strong support of major organizations across the political spectrum. This legislation fixes a huge hole in our system--a hole that delays legitimate firearms purchases and allows criminals and other prohibited buyers to obtain guns. The hole is the faulty records in the National Instant Criminal Background Check System, NICS. Based on a report released by Americans for Gun Safety Foundation in January 2002, Congress has learned that millions of records are missing from the NICS database. Over a 30-month period, 10,000 criminals obtained a firearm despite a background check because the records couldn't be checked properly within the 3 days allowed by federal law. In addition, thousands of other prohibited buyers will never be stopped because very few restraining orders, drug abuse or mental disability records are kept at all. This report makes it clear that if we are to be serious about stopping criminals, wife-beaters and illegal aliens from slipping through a background check, we had better fix this broken system. Better records mean more accurate background checks--checks which stop prohibited buyers while allowing legitimate buyers to be approved. And better records put the ``instant'' back into instant check, because delays occur when records have to be searched manually. In fact, the only reason why criminal background checks sometime take several days is because records have to be checked by hand instead of computer. The figure is astonishing. There are over 30 million missing records. For felony records, the typical state has automated only 58 percent of its felony conviction records. The FBI estimates that out of 39 million felony arrest records, 16 million of them lack final disposition information. Without final disposition records, background checks must rely on time consuming manual searches of courthouse files to approve or deny firearms purchases. On the issue of mental health, 33 States keep no mental health disqualifying records and no state supplies mental health disqualifying records to NICS. The General Accounting Office, GAO, estimates that 2.7 million mental illness records should be in the NICS databases, but less than 100,000 records are available, nearly all from VA mental hospitals. States have supplied only 41 mental health records to NICS. Combined with the federal records, the GAO estimates that only 8.6 percent of the records of those disqualified from buying a firearm for mental health reasons are accessible on the NICS database. In the case of drug abusers, the GAO estimates that only 3 percent of the 14 million records of drug abusers are automated, not including felons and wanted fugitives. States have supplied only 97 of those records to NICS which the GAO estimates as representing less than 0.1 percent of the total records of those with drug records that would deny them a firearm. On the issue of domestic violence, 20 States lack a database for either domestic violence misdemeanants or temporary restraining orders or both, 42 percent of all NICS denials based on restraining orders come from one State--Kentucky--which does the best job of automating TRO's from the bench. The Department of Justice estimates that nearly 2 million restraining order records are missing from the database. In the case of illegal aliens/non-immigrant status records, the GAO estimates that over 2 million illegal alien records are absent from the NICS database. Through 2001, NICS had no records of non-immigrants in the United States making it impossible to stop visitors to the U.S. on tourist or student visas from purchasing firearms. The benefits of better records are simple and important. They lead to accurate and instant background checks. Better records mean we would be able to stop far more prohibited buyers from obtaining a gun than we do now. When a restraining order, drug abuse or mental health record is missing, nothing in the NICS system indicates a reason to delay the sale and search records. NICS simply approves the transaction usually within 3 minutes. Poor records are why and this legislation will fix the system. This bill requires Federal agencies such as the Immigration and Naturalization Service, INS, and the VA to provide all records of those disqualified from purchasing a firearm to NICS. For INS, it would mean sending millions of records of those here on tourist visas, student visas, and all other non-immigrant visas to NICS. Each State would be allowed to receive a waiver for up to 5 years of the 10 percent matching requirement for the National Criminal History Improvement Grants, NCHIP, when that state automates and makes available to NICS at least 95 percent of records of those disqualified from purchasing a firearm. This bill also requires states to automate and send to NICS all disqualifying records under Federal and State law, including domestic violence misdemeanors, restraining orders, criminal conviction misdemeanors, drug abuse and other relevant records to NICS. We also provides grants of $250 million per year for 3 years to States to improve background check records, automate systems, enhance states capacities to perform background checks, supply mental health records and domestic violence records to NICS. We also give grants of $125 million per year for 3 years to States to assess their systems for rapidly getting criminal conviction, domestic violence records and other records from the courtroom into the NICS database and for improving those systems so as to eliminate the lag time between conviction and entry into NICS. Better records mean instant checks: 72 percent of background checks are approved and completed within minutes, but 5 percent take days to complete for one reason only faulty records force law enforcement into time consuming searches to locate final disposition records for felony and domestic violence convictions. It is our hope that this legislation will finally make our records system complete and totally stop prohibited buyers from gaining access to firearms while allowing legitimate buyers to be approved.

Mr. McCAIN

Mr. McCAIN. Madam President, I rise to introduce legislation to authorize the distribution of judgement funds to eligible tribal members of the Gila River Indian Community in Arizona. Representative Hayworth recently introduced companion legislation in the House of Representatives. The Gila River Indian Community Judgement Fund Distribution Act resolves two half-century old claims by the Gila River tribe against the United States for failure to meet Federal obligations to protect the Community's use of water from the Gila River and Salt River in Arizona. The original complaint was filed before the Indian Claims Commission on August 8, 1951. In 1982, the United States Court of Claims confirmed liability of the United States to the Community, and recently the settlement of these two claims was determined to be seven million dollars. So much time has passed that the Indian Claims Commission formerly in charge of fund distributions no longer exists. However, a debt does not disappear. The judgement award has since been transferred from the Indian Claims Commission to a trust account on behalf of the Community, managed by the Office of Trust Management at the Department of Interior. This judgement award was certified by the Treasury Department on October 6, 1999 for the final portion of the litigation to the two remaining dockets of the Gila River Indian Community. Since that time, the Community has been working with the BIA in an attempt to finalize a use and distribution plan to submit to Congress for approval. As outlined in its plan, the Community has decided to distribute the judgement award equally to eligible tribal members. I ask unanimous consent to print the tribal resolution approved by the Gila River Indian Community in support of this payment plan in the Record.

Mr. McCAIN

Mr. McCAIN. Mr. President, I thank the managers of this bill for their hard work in putting forth this legislation which provides Federal funding for the legislative branch. In reviewing this bill to determine whether it contains items that are low-priority, unnecessary, wasteful, or have not been appropriately reviewed in the normal, merit-based prioritization process, I applaud the Appropriations Committee for their fiscal restraint in including a minimal number of such items. For this legislation, only two locality-specific earmarks appear to be included. The bill itself includes $200,000 for Southern Illinois University for the purpose of developing a permanent commemoration of the Lewis and Clark Expedition. And an amendment to this bill that was adopted on the Senate floor provides $500,000 for the Alexandria Museum of Art and the New Orleans Museum of Art for activities relating to the Louisiana Purchase Bicentennial Celebration. How refreshing it would be if the Appropriations Committee would demonstrate the same fiscal responsibility they showed in preparing this legislation in every one of the remaining appropriations bills. Unfortunately, this bill is the exception to the rule, because, as evidenced by the recently passed supplemental appropriations bill, the runaway pork-barrel gravy train shows no signs of slowing down on Capitol Hill. We must remember that while the amounts associated with each individual earmark may not seem extravagant, taken together they represent a serious diversion of taxpayers' hard-earned dollars at the expense of numerous programs that have undergone the appropriate merit- based selection process. During this time of mounting deficits, we must be more prudent about where we devote limited fiscal resources. I urge all my colleagues to curb the habit of directing hard-earned taxpayer dollars to locality-specific special interests.

Mr. McCAIN

Mr. McCAIN. Madam President, I rise to introduce legislation to authorize the distribution of judgement funds to eligible tribal members of the Gila River Indian Community in Arizona. Representative Hayworth recently introduced companion legislation in the House of Representatives. The Gila River Indian Community Judgement Fund Distribution Act resolves two half-century old claims by the Gila River tribe against the United States for failure to meet Federal obligations to protect the Community's use of water from the Gila River and Salt River in Arizona. The original complaint was filed before the Indian Claims Commission on August 8, 1951. In 1982, the United States Court of Claims confirmed liability of the United States to the Community, and recently the settlement of these two claims was determined to be seven million dollars. So much time has passed that the Indian Claims Commission formerly in charge of fund distributions no longer exists. However, a debt does not disappear. The judgement award has since been transferred from the Indian Claims Commission to a trust account on behalf of the Community, managed by the Office of Trust Management at the Department of Interior. This judgement award was certified by the Treasury Department on October 6, 1999 for the final portion of the litigation to the two remaining dockets of the Gila River Indian Community. Since that time, the Community has been working with the BIA in an attempt to finalize a use and distribution plan to submit to Congress for approval. As outlined in its plan, the Community has decided to distribute the judgement award equally to eligible tribal members. I ask unanimous consent to print the tribal resolution approved by the Gila River Indian Community in support of this payment plan in the Record.