WE PLACE ON THE CITIZENS RECEIVING SAFE AND EFFECTIVE PRODUCTS
           FREE FROM ADULTERATION AND MISBRANDING. DATING FROM THE 1906
           PURE FOOD AND DRUG ACT THROUGH THE 1938 FEDERAL FOOD AND
           COSMETIC ACT, THE 1963 EFFICACY AMENDMENTS AND THE 1988
           PRESCRIPTION DRUG MARKETING ACT, OUR NATION HAS DEVISE ADD MORE
           OR LESS CLOSED REGULATORY SYSTEM THAT ENSURES THAT DRUG
           PRODUCTS WILL BE CAREFULLY CONTROLLED FROM THE MANUFACTURER TO
           THE PATIENT'S BEDSIDE. IF WE'RE OPEN -- IF WE OPEN UP OUR

           BOARDERS TO A NEW PLETHORA OF DRUG REIMPORTS, WE NEED TO BE
           ABSOLUTELY CERTAIN THAT WE HAVE NOT UNDERMINED THE INTEGRITY OF
           THIS REGULATORY SYSTEM BY ADMITTING PRODUCTS, IMPROPERLY
           MANUFACTURED, TRANSPORTED OR STORED. A PILL MAKE LOOK LIKE THE
           RIGHT ITEM BUT NOT CONTAIN THE RIGHT CONCENTRATION OR NO
           MEDICATION AT ALL. WE MUST NOT ALLOW THE AMERICAN PUBLIC TO
           FALL PREY TO COUNTERFEIT SO-CALLED GRAY MARKET PRODUCTS. THESE
           ARE PRODUCTS THAT CAN BE MADE TO LOOK EXACTLY LIKE THE REAL

           THING AND MAY COMPLY WITH OR ATTEMPT TO COMPLY WITH REQUIREMENT
           OF THE ACTUAL APPROVED PRODUCT BUT WHICH DO NOT COMPLY WITH THE
           LEGAL REQUIREMENT OF A LICENSE FROM THE PATENT HOLDER. IN SHORT
           A PIRATED PRODUCT. NOW WHILE THERE IS CLEAR AND OBVIOUS HEALTH
           DANGER TO AN ADULT RATED NONCONFORMING PRODUCT THERE IS A GREAT
           DETRIMENT TO THE AMERICAN PUBLIC IF THE UNSCRUPULOUS ARE
           ALLOWED TO REIMPORT AMERICAN INVENTIONS BACK INTO AMERICA
           WITHOUT COMPENSATETH THE INVENTOR. FEW WILL BE ABLE TO PUT UP

           FRONT CAPITOL, BHLS OF DOLLARS IN THIS CASE TO DEVELOP A DRUG
           IF ANOTHER PARTY CAN MAKE AND SEMI-THE DRUG WHILE UNDER PATENT
           PROTECTION. IT TAKES AN AVERAGE OF 15 YEARS AND HALF A MILLION
           DOLLARS TO CREATE ONE OF THE BLOCKBTER DRUGS. SO WE HAVE TO BE
           CAREFUL. KEEP IN MIND AS CHAIRMAN. THE SENATE JUDICIARY
           COMMITTEE I HAVE A SPECIAL OBLIGATION WITH RESPECT TO
           INTELLECTUAL PROPERTY LAWS THAT WE NOT GO DOWN ANY PATH THAT
           CAN BE SEEN AS INVITETH THE DEVELOPMENT OF A GRAY MARKET FOR
           PRESCRIPTION DRUGS. AFTER ALL, A FAKE ROLEX MAY BE RIGHT TWICE

           A DAY, BUT A BAD COPY OF A GOOD DRUG CAN KILL YOU. AND THIS IS
           SOMETHING THAT WE HAVE BEEN TO BEER MORE CONCERNED ABOUT AROUND
           HERE. WE CAN'T JUST DO WHAT LOOKS TO BE GOOD BUT IF ESSENCE CAN
           KILL PEOPLE. ONE OF THE GREAT ACCOMPLISHMENTS OF A 1995 GATT
           TREATY WAS TO PUT INTERLENGTH WAM PROPERTY PROTECTION FRONT AND CENTER?
           THE TRADE RELATIONSHIP WITH THE DEVELOPING WORLD. MANY
           COUNTRIES ARE NOTORIOUS FOR LAX TREATMENT OF COPYRIGHT
           VIOLATION BY THEIR CITIZENS. WHEN THE INCONVENIENCE IS
           EXAPPROPRIATED IT IS AMERICAN INVENTORS AND AMERICAN CONSUMERS

           WHO SUFFER. THE UNITED STATES CANNOT AND SHOULD NOT ALLOW FREE
           RIDERS AROUND THE WORLD. ESSENTIALLY TO FORCE THE AMERICAN
           PUBLIC TO UNDERWRITE A DISPROPORTIONATE AMOUNT OF THE RESEARCH
           AND DEVELOPMENT THAT RUTS IN THE NEXT GENERATION BREAK THROUGH
           PRODUCT. WHERE IS THE PHARMACEUTICAL INDUSTRY IN CANADA?
           WHERE IS IT IN MEXICO?
           THEY HAVE PRICE CONTROLS AND NOBODY IS GOING TO INVEST THE
           MONEY INTO DEVELOPING THESE LIFE SAVING AND COST SAVING DRUGS
           OVER THE LONG RUN IN THOSE COUNTRIES WITH PRICE CONTROLS.
           WEAPON HAVE HAD MANY DEBATES OVER PRICE CONTROLS AND I REMEMBER

           THOSE DAYS WHEN SENATOR PRYOR AND I WERE ON THIS FLOOR ARGUING
           BACK AND FORTH ABOUT PRICE CONTROLS AND FORTUNATELY THE SENATE
           IN ITS WISDOM DECIDED NOT TO GO FOR PRICE CONTROLS. THIS IS
           STEP NUMBER ONE, TWO, THREE AND FOUR TOWARDS PRICE CONTROLS
           THAT WILL STULT SFI ONE OF THE MOST IMPORTANT INDUSTRIES IN
           AMERICA AT A TIME WHEN WE JUST MAPPED THE HUMAN GENOME AND WE
           ARE AT A POINT WHERE WE CAN CREATE MORE LIFE SAVING DRUGS,
           MAYBE AT EVEN A GREATER COST BUT NEVERTHELESS AT A GREATER

           HEALTH CARE COST SAVINGS THAN EVER BEFORE. NOW, ONE HAS ONLY TO
           READ A COLLECTION EVER THE SECTION 301 REPORTS OF THE OFFICE OF
           THE UNITED STATES TRADE REPRESENTATIVE TO GET A FEEL OF JUST
           HOW PREVALENT SUCH INTELLECTUAL PROPERTY THEFT IS WORLDWIDE. I
           TOOK THE TIME TO PRESENT THIS BACKGROUND BECAUSE I THINK THE
           JEFF ORDER-DORGAN AMENDMENT REQUIRES SUCH ANALYSIS. I WILL BE
           THE FIRST TO ADMIT THE AMENDMENT AT FIRST BLUSH SEEMS QUITE
           SIMPLE AND APPEAL. WHAT COULD BE THE MATTER WITH A RESUME THAT
           ESSENTIALLY SAYS DRUGS OBTAINED FROM OUTSIDE THE UNITED STATES

           HAVE PRICES LOWER THAN U.S. PRICES CAN BE RESOLD IN THE U.S.
           PRESUMABLY IN A MANNER THAT PLACES APPRECIATE TOWER LOWER
           PREVAILING U.S. PRICES. YET I RECALL H.L. MENKEN OBSERVATION.
           THERE IS ALWAYS AN EASY SOLUTION TO EVERY HUMAN PROBLEM. NEAT,
           PLAUSIBLE AND WRONG. I TOO JOIN MANY OF MIRE CONSTITUENTS IN
           UTAH AND OTHERS ACROSS THE COUNTRY IN QUESTIONING WHY OUR
           CITIZENS ARE PAYING HIGHER DRUG PRICES THAN THOSE WHO LIVE IN
           OTHER COUNTRIES. WHILE I RECOGNIZE THAT THERE ARE COMPLEX
           ECONOMIC POLITICAL AND SOCIAL SFAK TORS AT PLAIN, THAT

           PARTIALLY EXPLAIN WHY THE DRUG COMPANY WOULD CHARGE LESS NOR A
           DRUG COMPANY IN A DID HE SAY CITY TUTE REGION IN SUB-SAHARAN
           AFRICA, IT IS MORE DIFFICULT TO UNDERSTAND WHY A DRUG COSTS
           LESS NN TIJUANA MEXICO THAN SAN DIEGO, CALIFORNIA. SOME P SOME
           NATIONS SIMPLY CANNOT AFFORD THE DRUGS. DRUGS COST LESS IN SOME
           COUNTRIES FOR THE SAME REASON THAT REAL ESTATE COSTS LESS IN
           SOME STATES. SOME NATIONS IMPOSE PRICE CONTROLS, AND I THINK I
           HAVE MADE THAT POINT. THIS IS A VERY SERIOUS ISSUE. WEAPON

           SHOULD NOT BE ALLOWING A GREAT MARKET TO DEMOCRAT. WEAPON
           SHOULD NOT BE ALLOWING THE INSCRUB LUST TO COME INTO OUR
           COUNTRY AND EXPLOIT THE SICK AND NEED I AND THOSE WHO ARE
           HOPING NOR A LOWER COST SET OF DRUGS WHEN THEY ARE NOT GOING TO
           GET IT. I HAVE TO SAY WHEN THIS DEBATE HAPPENED IN THE HOUSE,
           MY DEAR FRIEND, CONGRESSMAN JOHN DINGLE WHO PLAYED A TREMENDOUS
           ROLE IN HEALTH CARE ALL THESE YEARS I HAVE BEEN IN THE
           CONGRESS, STOOD UP AND ARGUED AGAINST THIS. HE LOST IN THE
           HOUSE BUT HE SHOULD HAVE WON. I WOULD ASK UNANIMOUS CONSENT
           THAT HIS LETTER BE PLACED IN THE RECORD AT THIS POINT, AND AS

           WELL, THE NATIONAL WHOLE SEEM DRUG I ASSOCIATION LETTER WHERE
           THEY BEG US NOT TO PASS THIS TYPE OF LEGISLATION BECAUSE OF THE
           HARM IT COULD CAUSE TO THE AMERICAN PUBLIC. AND TO THE AMERICAN
           CONSUMER.
           

           THE PRESIDING OFFICER: IT WILL BE MADE A PART OF THE RECORD.
           

           MR. HATCH: I DEBATED THE ISSUE OF PRICE CONTROLS MANY TIMES SO
           I WON'T SPEND ANYMORE TIME ON THE ISSUE OF PRY CONTROLS BUT IT
           DOESN'T MAKE SENSE AND THAT'S WHAT WE ARE HEADED TOWARDS. THE
           GREATEST INDUSTRY IN OUR COUNTRY THAT HAS THE GREATEST
           POTENTIALS TO DO THE GREATEST AMOUNT OF GOOD TO BRING HEALTH
           CARE COST DOWN IN THE END EVEN THOUGH IT IS TREMENDOUSLY
           EXPENSIVE TO DEVELOP THESE DRUGS, IT IS GOING TO BE FLATTENED
           BY THIS TYPE OF LEGISLATION, WELL-MEANING, WELL INTENTIONED,
           AND ABSOLUTELY DESTRUCTIVE TO OUR INNOVATIVE INDUSTRIES IN THIS
           PARTICULAR COUNTRY. WE HAVE TO FIND A WAY AROUND THIS DRUG

           PRICE PROBLEM IN THIS COUNTRY WITHOUT CREATING A GRAY MARKET IN
           THESE PARTICULAR GOOD AND SERVICES. THERE HASN'T BEEN ONE DAY
           OF HEARING ON THIS PARTICULAR -- ON THIS PARTICULAR PROBLEM.
           NOW HOW CAN WE GUARANTEE THAT FOREIGN GOVERNMENT PRICE
           CONTROLLERS WILL NOT SET AN ARTIFICIALLY LOW PRICE ON SOME NEW
           ALZHEIMER'S DRUG. CAN WE BE SURE THIS WON'T HAVE THE UNINTENDED
           BUT REAL RIPPLE EFFECT OF CONVINCING COMPANY OFFICIALS TO --
           

           THE PRESIDING OFFICER: THE SENATOR HAS USED HIS TEN MINUTES.
           

           MR. HATCH: CAN I ASK UNANIMOUS CONSENT TO TAKE ONE ADDITIONAL
           MINUTE WITH AN ADDITIONAL MINUTE GIVEN TO THE OTHER SIDE?
           
           

           THE PRESIDING OFFICER: WITHOUT OBJECTION, SO ORDERED.
           

           MR. HATCH: CAN'T BE WE SURE THIS WON'T HAVE THE RIPPLE EFFECT
           OF CONVINCING COMPANY OFFICIALS TO FOREGO RESEARCH ON THIS NEW
           CLASS OF DRUGS FOR NEAR THAT IN CONJUNCTION WITH THE NEW
           LIBERAL REIMPORT POLICY THEY WILL NOT BE ABLE TO RECUE THEIR
           INVESTMENT?
           LET US HOPE THE FUTURE DOES NOT COME TO DOWN AT THAT P -- DOWN
           TO A CHOICE BETWEEN TWO LOUSY ALTERNATIVES, A HOB SONS CHOICE.
           GREAT DRUGS NOT WIDELY AFFORDABLE ARE DRUGS ABANDONED DUE TO
           MINIMAL PROJECTED REVENUES. I CAN TELL YOU GIVEN MY WORK IN THE

           AIDS EPIDEMIC BETWEEN EXPENSIVE DRUGS AND NO DRUGS, EXPENSIVE
           DRUGS IS A BETTER PROBLEM TO HAVE. WE ARE IN DANGER OF LOSING A
           TREMENDOUSLY INNOVATIVE AND EFFECTIVE AND PRODUCTIVE INDUSTRY
           THAT HAS MADE THE AMERICAN NATION THE LEADER IN HEALTH CARE
           THROUGHOUT THE WORLD. AND THIS TYPE OF AN AMENDMENT, I THINK,
           WILL UNDER UNDERMINE EVERYTHING THAT WEAPON HAVE BEEN DOING ALL
           THESE QUEERS THAT REALLY HAVE BENEFITED, HAS BENEFITED THE
           WHOLE WORLD. I ASK UNANIMOUS CONSENT THAT THE BALANCE OF MY
           REMARKS BE PLACED IN THE RECORD AT THIS POINT.
           

           THE PRESIDING OFFICER: WITHOUT OBJECTION.
           

           MR. HATCH: I YIELD THE FLOOR. A SENATOR: MR. PRESIDENT?
           
           

           THE PRESIDING OFFICER: THE SENATOR FROM VERMONT.
           

           MR. JEFFORDS: I WOULD LIKE TO POINT OUT WE HELD A HEARING ON
           THIS YESTERDAY, SO I WANTED TO CORRECT MY GOOD CHAIRMAN OF
           THAT. I YIELD FIVE MINUTES TO THE SENATOR FROM NEW YORK.
           

           MR. MOYNIHAN: THANK YOU, MR. PRESIDENT.
           

           THE PRESIDING OFFICER: THE SENATOR FROM NEW YORK.
           

           MR. MOYNIHAN: I VERY MUCH APPRECIATE THE COURTESY OF MY FRIEND
           FROM VERMONT, BECAUSE I AM GOING TO RISE -- I RISE TO SUPPORT
           THE VIEWS OF MY FRIEND FROM UTAH, WHO HAS JUST BEEN SPEAKING TO
           CAREFULLY ABOUT THE MATTER OF PRICE CONTROLS. SIR, I DON'T
           EXPECT TO HAVE ANY CONSIDERABLE INFLUENCE ON WHAT WE DO TODAY
           BUT I WOULD LIKE IN A VERY SHORT ORDER TO MAKE -- TO TRY TO PUT

           WHAT WE ARE DOING IN A PERSPECTIVE. THIS BEGAN FOR ME DURING
           THE HEARINGS OF THE FINANCE COMMITTEE ON THE HEALTH CARE
           LEGISLATION SUBMITTED TO US BY THE ADMINISTRATION IN 1994
           199446789 AT ONE HEARING, A PROFESSOR, CHARLES FAY HI, FORMED
           HAM UNIVERSITY SPEAKING FOR THE CATHOLIC HEALTH ASSOCIATION
           SAID WHAT WE ARE WITNESSING IN THE COUNTRY WAS THE COMMODITY IF

           I INDICATION OF MEDICINE. -- COMMODIFICATION. DOWN AT THE HEAD
           OF THE TABLE AT THE UCLA HOSPITAL SAID CAN I GUY E. GIVE YOU AN EXAMPLE?
           IN SOUTHERN CALIFORNIA WE NOW HAVE A SPOT MARKET FOR BONE
           MARROW TRANSPLANTS. THIS THOUGHT STAYED WITH ME. THAT MARKET
           NORSES WERE BEGINNING TO SHAPE DECISIONS IN HEALTH MATTERS AS

           THEY HAD NOT DONE BEFORE. IT WAS PARTICULARLY POIGNANT THAT THE
           FIRST INSTITUTIONS THAT WOULD HAVE TROUBLE IN THIS NEW
           SITUATION WOULD BE THE MEDICAL SCHOOLS, THE TEACHING HOSPITALS
           WHICH AS ECONOMISTS SAY ARE PUBLIC GOODS. EVERYONE BENEFITS
           FROM PUBLIC GOODS, SO NO ONE WILL PAY FOR IT. NO ONE HAS AN
           INCENTIVE TO DO, AND WE ARE SEEING THIS ALL OVER THE COUNTRY IN

           A SHORT SIX YEARS. AND NOW TODAY WE ARE SEEING ANOTHER
           PHENOMENON OF A MARKET THAT COMES INTO BEING AS RAILROADS DID,
           AS WHALE REFINERIES DID, OIL PRODUCERS, AS HAS BEEN GOING ON
           THROUGH THE HISTORY OF FREE MARKETS AND FREE ENTERPRISE, WHICH
           IS PRICE CONTROLS. THERE IS SOMETHING ABOUT OUR POLITICAL
           SYSTEMS IN THE WEST THAT RESPOND TO THE CREATION OF NEW MARKETS

           AND THE SEEMING RISE IN PRICES IN THOSE MARKETS WHEN IN FACT
           QUALITY RISES, THAT SAYS PERHAPS WE CAN CONTROL THIS BY
           CONTROLLING THE PRICE. IT ALWAYS FAILS, MR. PRESIDENT. IT IS
           THE ONE THING YOU CAN SAY WITH A LARGE DEGREE OF CONFIDENCE,
           THAT IN THE 20TH CENTURY, THIS EFFORT ALWAYS FAILS. SOMETIMES
           IT FAILS BY PRODUCING BLACK MARKETS WHERE THE LAWS ARE NOT
           OBEYED, OTHERS BY SIMPLY DEPRESSING THE QUALITY OF THE PRODUCTS

           IN THE MARKET. THAT IS WHAT WE HAVE TO WATCH FOR HERE IN THE
           MAIN. WE ARE DEALING WITH THOROUGHLY RESPONSIBLE ORGANIZATIONS.
           THE PFIZER CORPORATION, OF MY CITY OF NEW YORK, BEGAN WORK IN
           BROOKLYN IN 1849. DEVELOPED THE FIRST TREATMENT FOR PARASITIC
           WORMS IN THE MID-19TH CENTURY WHEN THAT WAS A RAMPANT ENDEMIC
           DISEASE. IT HAS SINCE GONE ON TO DO OTHER EXTRAORDINARY THINGS.

           IT WAS THE FIRST MAJOR PRODUCER OF PENICILLIN IN THE UNITED
           STATES, WHICH WAS THE DRUG OF SUCH ENORMOUS CONSEQUENCE IN THE
           SECOND WORLD WAR, THE FIRST TIME WE HAVE BEEN ABLE TO DESTROY
           CELL IN A BODY WITHOUT DESTROYING OTHERS. AND TODAY THE PFIZER
           HAS 12,000 RESEARCHERS WORKING. THEY HAVE A BUDGET, SIR A
           BUDGET OF $4.7 BILLION. LARGER THAN THE NATIONAL INSTITUTES OF

           HEALTH. I SAY, SIR, PUT -- IMPOSE PRICE CONTROLS, WHICH ALWAYS
           SEEM LIKE A GOOD IDEA AT THE TIME, AND IN A SHORT ORDER THERE
           WILL BE NO SUCH BUDGET. A PERIOD OF ENORMOUS INNOVATION, VERY
           RECENT IN THE HISTORY OF MEDICINE, WILL COME TO A CLOSE. I SEE
           MY TIME HAS COME TO A CLOSE, SIR. I WOULD ASK IF I MAY TO
           INCLUDE IN THE RECORD AT THIS POINT THE PAPER I GAVE THE
           CARTWRIGHT LECTURE AS REPRINTED IN THE JOURNAL ACADEMIC

           MEDICINE, THE JOURNAL OF THE ASSOCIATION OF AMERICAN MEDICAL
           COLLEGES.
           

           THE PRESIDING OFFICER: WITHOUT OBJECTION IT WILL BE MADE A PART
           OF THE RECORD.
           

           THE PRESIDING OFFICER: I THANK THE CHAIR. I THANK MY FRIENDS

           FOR YIELDING ME TIME. MR. JEFFORDS: MR. PRESIDENT?
           
           

           THE PRESIDING OFFICER: THE SENATOR FROM VERMONT.
           

           MR. JEFFORDS: I YIELD TO THE SENATOR FROM MINNESOTA FOUR
           MINUTES.
           

           THE PRESIDING OFFICER: THE SENATOR FROM MINNESOTA.
           

           MR. WELLSTONE: I THANK THE SENATOR FROM VERMONT. I AM VERY
           PLEASED TO BE INVOLVED IN WORKING ON THIS LEGISLATION WITH HIM
           AND OTHER LEGISLATION WITH SENATOR DORGAN. TO MY COLLEAGUE FROM
           UTAH, IF YOU READ THE AMENDMENT CAREFULLY, ALL COLLEAGUES THAT
           ARE GOING TO VOTE, WE ARE VERY CLEAR ON PROTECTIONS. WE ARE
           VERY CLEAR. IF THE SAFEGUARDS AREN'T IN PLACE THEY CAN'T BE
           REIMPORTED. THAT'S CLEAR LANGUAGE. WHAT ARE SOME OF THE
           PRECTIONS?
           STRICT F.D.A. OVERSIMT. PROOF OF F.D.A. APPROVAL OF IMPORTED ME

           SINCE. ONLY LICENSED PHARMACIST AND WHOLE SEEM LETTERS CAN
           IMPORT MEDICINES FOR RESEEM. I AM PORMTERS WILL HAVE TO MOMENT
           REQUIREMENT FOREHAND
{END: 2000/07/19 TIME: 16-45 , Wed.  106TH SENATE, SECOND SESSION}