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EFFORT TO REDUCE THE COST OF
PRESCRIPTION DRUGS FOR
MADAM PRESIDENT, I YIELD THE
FLOOR AND SUGGEST THE ABSENCE --
I YIELD THE FLOOR.
A SENATOR: MADAM PRESIDENT?
THE
SENATOR FROM MASSACHUSETTS.
PRESIDENT.
I THANK THE GENTLEMAN FOR
YIELDING.
I'M PLEASED AS WELL THAT THE
SENATE IS MOVING THIS WEEK TO
CONSIDER THE F.D.A. SAFETY AND
INNOVATION ACT.
A VERY IMPORTANT PIECE OF
LEGISLATION THAT WILL HELP
ENSURE AMERICANS HAVE ACCESS TO
SAFE, INNOVATIVE MEDICAL
TREATMENTS BY GIVING THE F.D.A.
THE RESOURCES IT NEEDS TO REVIEW
NEW PRODUCTS AS SAFELY AND AS
QUICKLY AS POSSIBLE, WHILE ALSO
GIVING THE INDUSTRY THE
CERTAINTY IT NEEDS TO CONTINUE
INVESTING IN NEW RESEARCH AS I
TRAVEL AROUND MASSACHUSETTS, THE
NUMBER-ONE ISSUE I FIND IS THAT
LACK OF REGULATORY CERTAINTY AND
SOMETIMES TAX CERTAINTY, SO THIS
IS CERTAINLY A STEP IN THE RIGHT
DIRECTION.
I'M PLEASED THAT THIS
LEGISLATION TAKES MANY STEPS TO
STRENGTHEN THE MEDICAL
INNOVATION INDUSTRY IN THE
UNITED STATES.
I HAVE CHAMPIONED ONE SUCH
PROVISION WITH SENATORS McCAIN
AND CASEY THAT WILL SMOOTH THE
REGULATORY PATH THAT I
REFERENCED EARLIER FOR NEW
MODERATE RISK MEDICAL DEVICES.
THE UNDERLYING BILL BEFORE US
NEEDS TO BE PASSED AS QUICKLY AS
POSSIBLE TO GUARANTEE THAT
REGULATORY CERTAINTY AT THE
AND ITS
STAKEHOLDERS.
HOWEVER, I'M DISAPPOINTED THAT
THE SENATE HAS NOT YET TAKEN THE
TIME TO ADDRESS THE KEY AREA OF
CONCERN RELATING TO THIS BILL,
AND THAT'S THE NEW MEDICAL
DEVICE EXCISE TAX.
THE NEW 2.3% TAX ON MEDICAL
DEVICE SALES THAT WAS IMPOSED IN
THE FEDERAL HEALTH CARE LAW WILL
COST OUR ECONOMY THOUSANDS OF
JOBS AND LIMIT AMERICANS' ACCESS
TO THE MOST GROUND-BREAKING
STATE-OF-THE-ART MEDICAL DEVICES
WHICH MANY PEOPLE NEED.
FOR THE PAST 18 MONTHS, I HAVE
BEEN PUSHING FOR THE SENATE TO
CONSIDER A MEDICAL DEVICE TAX
REPEAL BILL THAT I INTRODUCED
BACK IN FEBRUARY OF 2011, ONE OF
THE FIRST BILLS THAT I
INTRODUCED, AND TODAY I ALONG
WITH OTHERS WILL BE INTRODUCING
AN AMENDMENT TO REPEAL THIS
JOB-KILLING TAX, A TAX WHICH
WILL IN FACT DRIVE UP THE COST
OF HEALTH CARE AND CARE FOR
PATIENTS AND MAKE OUR WORKERS
COMPETITIVE.
I CAN TELL YOU IN MASSACHUSETTS,
WE HAVE OVER 400 MEDICAL DEVICE
COMPANIES.
WE'RE AN INNOVATIVE STATE.
THE ABILITY TO HAVE
COMPANIES LIKE THIS IN
MASSACHUSETTS EMPLOYING NEARLY
25,000 WORKERS AND CONTRIBUTING
OVER $4 BILLION TO OUR ECONOMY,
AND THAT IS OBVIOUSLY A
SUBSTANTIAL INDUSTRY IN
MASSACHUSETTS, AND IT AFFECTS
EACH AND EVERY PERSON THROUGHOUT
THIS COUNTRY INDIRECTLY.
IF IT GOES INTO EFFECT NEXT
YEAR, THIS HARMFUL TAX WILL PUT
AMERICAN WORKERS AT A
COMPETITIVE DISADVANTAGE AND
CHASE JOBS OVERSEAS.
THERE IS ALREADY COMPANIES THAT
HAVE BEEN OVER THE LAST YEAR AND
A HALF LOOKING OVERSEAS, ALREADY
SHIFTING THEIR STRATEGY.
WHERE IS THAT MONEY COMING FROM?
WHERE THAT 2.3% TAX THAT IN SOME
INSTANCES REPRESENTS THE ENTIRE
NET PROFIT FOR SOME OF THESE
YOUNG COMPANIES IN MASSACHUSETTS
AND THROUGHOUT THE COUNTRY.
IT WILL POTENTIALLY COST 43,000
JOBS ACROSS THE COUNTRY, WITH A
LOSS OF $3.5 BILLION IN WAGES.
I'M NOT QUITE SURE HOW THAT
MAKES SENSE IN ANYBODY'S BOOK.
MASSACHUSETTS ALONE IS EXPECTED
TO LOSE OVER 2,600 JOBS AS A
DIRECT RESULT OF THIS TAX AND UP
TO 10% OF OUR ENTIRE MEDICAL
DEVICE MANUFACTURING WORK FORCE
WILL BE AFGD.
WE CAN'T HAVE THIS TYPE OF JOB
LOSS IN OUR ECONOMY WHEN WE'RE
STILL STRUGGLING.
WE'RE A INNOVATIVE STATE.
WE HAVE OVER 400 MEDICAL DEVICE
COMPANIES IN MASSACHUSETTS.
WE DO GENERATE A TREMENDOUS
AMOUNT OF REVENUE AND THE
BILLIONS OF DOLLARS, SO WHERE
IS THIS TAX GOING TO COME FROM?
IS IT COMING FROM R & D, FROM
GROWTH, EXPANSION, HIRING,
FIRING?
NO ONE SEEMS TO KNOW.
I CAN TELL YOU THAT THE
MASSACHUSETTS COMPANIES AND
COMPANIES THROUGHOUT THE UNITED
STATES ARE DEEPLY, DEEPLY
CONCERNED ABOUT THIS.
AND I FIND IT SURPRISING AND
DISAPPOINTING THAT THERE IS NOT
A CONSENSUS TO REPEAL THE
MEDICAL DEVICE TAX WHICH WILL
AFFECT STATES ACROSS THIS GREAT
COUNTRY, WHETHER IT'S ON A BILL
OR A STAND-ALONE BILL WE NEED TO
GET IT DONE AND GET IT DONE LIKE
TRULY BIPARTISAN,
BICAMERAL MANNER ON THE 3%
WITHHOLDING, THE 1099 FIX, THE
HIRE A VETERAN BILL, THE
INSIDER TRADING BILL.
WE'VE WORKED TOGETHER IN A
DONE.
IT MATTERS A GREAT DEAL TO
MASSACHUSETTS AND SHOULD CONCERN
EVERY MEMBER OF THIS BODY.
MADAM CHAIR, I THANK YOU AND I
NOTE THE ABSENCE OF A QUORUM.
THE CLERK
WILL CALL THE ROLL.
QUORUM CALL:
THE
SENATOR FROM ILLINOIS.
I ASK UNANIMOUS
OBJECTED.
WITHOUT
OBJECTION.
I ASK TO SPEAK IN
MORNING BUSINESS.
I WITHDRAW THAT.
IT'S MY UNDERSTANDING WE'RE ON
THE F.D.A. MOTION?
THAT IS
CORRECT.
MY STATEMENT RELATES
TO THAT BILL SO I WILL SPEAK AS
PART OF THAT.
DIETARY SUPPLEMENTS HAVE BECOME
A COMMON HEALTH AID IN MEDICINE
CABINETS ACROSS AMERICA.
MORE THAN HALF OF US IN AMERICA
USE DIETARY SUPPLEMENTS
INCLUDING THIS SENATOR, WHO FOR
A VARIETY OF REASONS TAKES A
MULTIVITAMIN TABLET EVERY
MORNING.
IN SPITE OF THEIR POPULARITY,
MANY PEOPLE WOULD BE SURPRISED
TO LEARN THAT THE FOOD AND DRUG
ADMINISTRATION DOESN'T KNOW HOW
MANY DIETARY SUPPLEMENTS ARE
BEING SOLD IN THE UNITED STATES.
MOST PEOPLE DON'T KNOW THAT IF A
DATE TAXPAYER SUPPLEMENT
INGREDIENT PRESENTED SERIOUS
HEALTH CONCERNS THE FOOD AND
DRUG ADMINISTRATION DOESN'T HAVE
THE INFORMATION TO TRACK DOWN
PRODUCTS CONTAINING THE HARMFUL
INGREDIENT.
WE ASSUME IF IT'S FOR SALE IN
AMERICA, SOME GOVERNMENT AGENCY
IS TAKING A CLOSE LOOK TO MAKE
SURE THAT THAT PRODUCT IS SAFE
AND THAT WE KNOW WHAT'S INSIDE
OF IT AND THAT IT WOULDN'T HARM
A CUSTOMER, AN INNOCENT
CUSTOMER.
TURNS OUT THAT MAY BE TRUE WHEN
IT COMES TO PRESCRIPTION DRUGS
AND OVER-THE-COUNTERRER DRUGS
BUT THE -- COUNTER DRUGS BY THE
DIETARY SUPPLEMENT DRUG WORLD IS
A MUCH DIFFERENT WORLD WITH
MINIMAL REGULATIONS.
I HAVE AN AMENDMENT TO ENSURE
THE FOOD AND DRUG ADMINISTRATION
HAS THE INFORMATION IT NEEDS TO
RESPOND QUICKLY AND EFFICIENTLY
WHEN SAFETY CONCERNS ARISE
CONCERNING DIETARY SUPPLEMENTS.
THIS WOULD REQUIRE DATE TAXPAYER
SUPPLEMENT MANUFACTURERS GIVE
THE FOOD AND DRUG ADMINISTRATION
THE NAME OF EACH SUPPLEMENT THEY
PRODUCE, ALONG WITH A
DESCRIPTION, A LIST OF
INGREDIENTS, AND A COPY OF THE
LABEL.
IT'S NOT AN ONEROUS REQUIREMENT
BUT FOR THE FIRST TIME THE FOOD
AND DRUG ADMINISTRATION WOULD
LITERALLY HAVE A CATALOGUE OF
ALL THE DATE TAXPAYER
SUPPLEMENTS BEING SOLD TO
AMERICANS ALL ACROSS THE NATION.
NOW, WITH THIS INFORMATION THE
F.D.A. IS BETTER EQUIPPED TO
PROTECT CONSUMERS' HEALTH AND TO
WORK WITH MANUFACTURERS TO
ADDRESS ANY PROBLEMS IF THEY
ARISE.
THE 2009 REPORT BY THE
GOVERNMENT ACCOUNTABILITY OFFICE
FOUND THAT THE FOOD AND DRUG
ADMINISTRATION IS LIMITED IN ITS
ABILITY TO RESPOND TO SAFETY
CONCERNS BECAUSE DIETARY
SUPPLEMENT MANUFACTURERS DON'T
ALWAYS PROVIDE BASIC
INFORMATION, LIKE PRODUCT NAMES
OR LISTS OF INGREDIENTS.
THIS COMMONSENSE AMENDMENT THAT
I'M OFFERING IS SUPPORTED BY THE
CONSUMERS UNION, AND IT WOULD
GIVE THE FOOD AND DRUG
ADMINISTRATION BASIC INFORMATION
IT NEEDS TO PROTECT THE PUBLIC.
TRUST ME, IT WILL BE OPPOSED BY
CERTAIN INTEREST GROUPS.
BUT I HEARD OPPOSITION ALMOST
TEN YEARS AGO WHEN I INTRODUCED
A BILL TO REQUIRE DIETARY
SUPPLEMENT MANUFACTURERS REPORT
SERIOUS ADVERSE EVENTS, LIKE
HOSPITALIZATIONS OR DEATH TO THE
F.D.A.
THE NEED FOR MANDATORY REPORTING
OF ADVERSE EVENTS WAS
DEMONSTRATED BY INJURY AND DEATH
ACROSS THE COUNTRY CAUSED BY
POPULAR AND DANGEROUS DIETARY
INGREDIENTS LIKE EPHEDRA BEFORE
IT WAS BANNED IN THE UNITED
STATES IN 2004.
ONE OF THE VICTIMS WAS
16-YEAR-OLD SEAN RIGGINS FROM
LINCOLN, ILLINOIS, 30 MILES
FROM WHERE I LIVE IN DOWNSTATE
ILLINOIS.
HE DIED IN SEPTEMBER, 2002, A
HIGH SCHOOL STUDENT AFTER HE
TOOK SOMETHING CALLED YELLOW
IT WAS SUPPOSED TO BE AN ENERGY
BOOST AND HE WAS HEADED OFF TO
PLAY FOOTBALL.
IT CONTAINED EPHEDRA AND IT
KILLED HIM.
SHORTLY BEFORE HIS DEFT, METABA
LIFE CLAIMED TO THE PUBLIC
THAT THEY HAD NO EPHEDRA-RELATED
ADVERSE EVENT REPORTS, PERIOD.
HOWEVER A LA PLATA LAWT WAS
FILED -- A LAWSUIT WAS FILED
AND THEY WERE REQUIRED UNDER
THAT LAWSUIT TO DISCLOSE THEIR
RECORDS.
IN OCTOBER OF 2002, UNDER
PRESSURE, THEY GAVE F.D.A. OVER
13,000 EPHEDRA-RELATED ADVERSE
EVENT REPORTS.
PEOPLE HAD TAKEN THEIR
SUBSTANCES WITH EPHEDRA, GOT
SICK OR WORSE.
IN 2006, I WORKED WITH SENATOR
ORRIN HATCH OF UTAH AND TOM
HARKEN OF -- TOM HARKIN TO PASS
THE AMENDMENT WHICH MANDATES
THE FOOD AND DRUG
ADMINISTRATION.
STANDS TO REASON, IF THERE'S A
DRUG FOR SALE IN THE UNITED
STATES, DIETARY SUPPLEMENT IN
THIS CASE, CAUSES A PROBLEM,
SHOULDN'T WE KNOW ABOUT IT?
IF IF IT'S CAUSING A PROBLEM IN
A LOT OF DIFFERENT PLACES, IF
THE FOOD AND DRUG ADMINISTRATION
WILL DISCOVER IT.
SINCE THE LAW TOOK EFFECT IN
2007, DIETARY FLEMENT SPLEMENT
ADD VER EVENT REPORTS SUBMITTED
HAVE INCREASED
SEVENFOLD FROM 368 IN 2007 TO
2,473 IN 2011.
THE F.D.A. IS USING THESE
REPORTS AS PART OF A
SURVEILLANCE SYSTEM TO SIGNAL
POTENTIAL SAFETY ISSUES AND IN
SOME CASES TAKE REGULATORY
ACTION.
MANDATORY REPORTING OF ADVERSE
EVENTS WAS AN IMPORTANT STEP TO
PROTECT CONSUMER SAFETY, BUT WE
WEE NEED TO DO MORE TO ENSURE
THE F.D.A. AND CONSUMERS HAVE
THE INFORMATION THEY NEED.
MADAM PRESIDENT, THE SAD
REALITY OF THIS AMENDMENT AND
THIS ISSUE IS THAT IT TAKES A
TRAGEDY TO CATCH OUR ATTENTION.
SOMEONE HAS TO BE SERIOUSLY HURT
OR WORSE BEFORE MEMBERS OF
CONGRESS AND OTHERS WILL TAKE
NOTICE AND DO SOMETHING.
I RECENTLY LEARNED ABOUT THE
TRAGIC DEATH OF THIS BEAUTIFUL
YOUNG 14-YEAR-OLD GIRL.
HER NAME WAS ANISE FORIER FROM
MARYLAND.
SHE WAS AN HONOR STUDENT, LIKED
TO READ VAMPIRE NOVELS, WATCHED
CHICK FLICKS WITH HER MOM AND
HAD A PASSION FOR WRITING.
LAST DECEMBER, HER LIFE WAS CUT
SHORT WHEN SHE WENT INTO CARDIAC
WHAT CAUSED IT?
CAFFEINE TOXICITY.
SHE DRANK TWO 24-OUNCE MONSTER
HOURS.
AND IT TOOK HER LIFE.
THE AMERICAN ACADEMY OF PEED RAT
YATHD TRICKS RECOMMENDS THAT
ADOLESCENTS LIKE ANISE CONSUME
NO MORE THAN 100 MILLIGRAMS OF
CAFFEINE EVERY DAY.
BUT IN LESS THAN 24 HOURS SHE
HAD CONSUMED 480 MILLIGRAMS OF
THAT'S THE EQUIVALENT TO 14
12-OUNCE SODAS WITH ORDINARY
CAFFEINE CONTENT.
SHE DID IT WITH TWO DRINKS.
A RECENT REPORT BY SAM IS A --
SAMSA SHOWS THAT IT POSES
POTENTIALLY HEALTH RISKS.
IN THE GALLERY TODAY ARE MEMBERS
OF ANISE'S FAMILY.
WE JOIN THEM IN MOURNING HER
LOSS IN THE HOPE THAT HER LIFE
WILL AT LEAST GIVE US NOTICE
THAT THERE ARE THINGS WE CAN DO
TO SPARE OTHER FAMILIES FROM THE
GRIEF THAT THEIR FAMILY HAS GONE
THROUGH.
WINDY CROSSLAND IS HER MOM.
HER SISTER JADE IS HERE, HER
GRANDFATHER *** AND GRANDMOTHER
FAITH.
THEY'VE COME HERE TODAY BECAUSE
THEY ARE HOPING THAT THE SENATE
WILL HEAR ABOUT THIS AMENDMENT
AND THAT WE CAN TAKE IT UP AND
PASS IT.
HER CASE IS NOT ALONE.
EMERGENCY ROOM VISITS DUE TO
ENERGY DRINKS HAVE INCREASED
TENFOLD BETWEEN 2005 AND 2009.
FROM 1,128 IN 2005 TO 13,114
E.R. VISITS IN 2009.
ENERGY DRINKS TARGET KIDS.
WITH FLASHY ADS AND NAMES,
MONSTER, ROCK STAR, FIVE-HOUR
ENERGY DRINK.
BUT THERE ARE SERIOUS CONCERNS
ABOUT THE HIGH LEVELS OF
THESE BEVERAGES AND
HERBAL INGREDIENTS THAT CONTAIN
EVEN ADDITIONAL CAFFEINE.
THE F.D.A. -- THIS IS THE
INTERESTING THING.
IF YOU WALK IN, AS I HAVE, TO
AN ORDINARY GAS STATION,
WHETHER IT'S IN NEW HAMPSHIRE OR
IN ILLINOIS, AND YOU SEE THE
COOLER THERE WITH THE DRINKS IN
IT, AND THEN YOU'LL SEE SOME
OTHERS ON COUNTERS, YOU MIGHT
ASSUME, WELL, THEY'RE ALL
SUBJECT TO THE SAME LEVEL OF
BUT IT'S NOT TRUE.
IF YOU'RE TALKING ABOUT ORDINARY
BEVERAGES, SODAS, THEY'RE
CHARACTERIZED AS FOOD, AND THEY
ARE SUBJECT TO CERTAIN
LIMITATIONS BY THE F.D.A.
HOWEVER, IF YOU LOOK AT THE
FINE PRINT -- AND YOU BETTER
LOOK CLOSELY BECAUSE IT'S VERY
TINY, YOU MAY FIND THIS IS
BEING CHARACTERIZED AND
SUPPLEMENT.
BY CHANGING, PUTTING THOSE TWO
WORDS ON THE LABEL, THEY ESCAPE
REGULATION.
SO WE LIMIT THE CAFFEINE IN AN
ORDINARY SODA POP, FOR EXAMPLE,
A CEEL, BUT WHEN IT COMES TO
THE DIETARY SUPPLEMENT SIDE OF
THE STORY, THERE ARE NO
THAT'S WHY THIS POOR YOUNG
LADY, THIS POOR YOUNG GIRL,
WAS A VICTIM BECAUSE OF THE HUGE
AMOUNT OF CAFFEINE THAT WAS
CONSUMED IN THE NAME OF A
DIETARY SUPPLEMENT.
THE F.D.A. HAS THE AUTHORITY TO
REGULATE CAFFEINE LEVELS IN
BEVERAGES, AND TO REQUIRE
BEVERAGE MANUFACTURERS TO PROVE
THE ADDITIVES THEY PUT INSIDE
THAT CAN OR BOTTLEER SAFE.
-- ARE -- BOTTLE ARE SAFE.
BUT MOST AVOID IT BY CALLING
THEIR PRODUCTS DIETARY
I DEFY YOU TO WALK INTO A STORE
AND LOOK AT THAT CASE OF ALL THE
THINGS YOU CAN BUY AND PICK OUT
THE ONES THAT ARE REGULATED BY
THE F.D.A. AND THOSE THAT
AREN'T.
YOU'RE GOING TO HAVE TO STUDY
LONG AND HARD, AND LOOK CLOSELY
AT THE LABELS TO FIGURE IT OUT.
IS THAT FAIR TO CONSUMERS?
IS IT FAIR TO FAMILIES AND
PARENTS THAT WE DON'T HAVE EVEN
BASIC OVERSIGHT AND REGULATION
OVER PRODUCTS THAT CAN LITERALLY
HARM OR TAKE THE LIFE OF A
BEAUTIFUL YOUNG GIRL LIKE THIS?
THE AMENDMENT I'M OFFERING WOULD
ENSURE THAT THE F.D.A. KNOWS
ABOUT ALL OF THE ENERGY DRINKS
BEING SOLD IN THE UNITED STATES
AND MAY PROVIDE INFORMATION
ABOUT INGREDIENTS THAT COULD
HELP THE AGENCY ADDRESS
POTENTIAL SAFETY CONCERNS.
NOW, MOST DIETARY SUPPLEMENTS
SAFE.
AND ARE USED BY MILLIONS OF
AMERICANS AS PART OF A HEALTHY
LIFESTYLE.
SOME INGREDIENTS MAY BE SAFE FOR
THE GENERAL POPULATION BUT MAY
BE RISKY FOR KIDS, PREGNANT
WOMEN, OR PEOPLE WITH A HEART
CONDITION, OR CERTAIN --
TAKING CERTAIN PRESCRIPTION
DRUGS.
FURTHERMORE, IN SPITE OF THE
MANY RESPONSIBLE DIETARY
SUPPLEMENT COMPANIES, SADLY,
THERE IS A MURKY MARKET SPACE
OUT THERE WHERE SOME BAD ACTORS
ARE SELLING POTENTIALLY
DANGEROUS PRODUCTS, SOME OF
THEM IMPORTED INTO THE UNITED
STATES, WHICH LITERALLY DO NOT
EVEN DISCLOSE THEIR INGREDIENTS
ACCURATE WAY.
THIS AMENDMENT WILL TAKE AN
IMPORTANT STEP TO PROTECT THE
PUBLIC HEALTH BY REQUIRING
DIETARY SUPPLEMENT MANUFACTURERS
TO SUBMIT BASIC INFORMATION TO
THE F.D.A. THAT WOULD HELP THE
AGENCY IDENTIFY SAFETY ISSUES
AND RESPOND MORE QUICKLY.
NO ONE WANTS TO LEARN OF THE
DEATH OF ANOTHER 16-YEAR-OLD WHO
LOVED TO PLAY FOOTBALL OR OF
THIS WONDERFUL YOUNG 14-YEAR-OLD
GIRL WHO LOVED WATCHING MOVIES
WITH HER MOM.
WE CAN HELP PREVENT THESE
TRAGEDIES BY REQUIRING THAT
BETTER INFORMATION IS REPORTED
TO THE F.D.A. WHEN THESE DIETARY
SUPPLEMENTS GO ON THE MARKET.
MADAM PRESIDENT, I YIELD THE
FLOOR.
THE
SENATOR FROM GEORGIA.
AS A MEMBER OF THE
HEALTH, EDUCATION, LABOR, AND
PENSION COMMITTEE I RISE FOR A
BRIEF SPEECH BUT I WANT TO BEGIN
BY THANKING CHAIRMAN HARKIN,
RANKING MEMBER ENZI, THE ENTIRE
STAFF OF THE HELP ME AND MY
STAFF WHO HAVE HELPED SO MUCH ON
THIS LEGISLATION WHICH IS SO
PEOPLE.
THIS IS A CHANCE WHERE WE HAVE A
BIPARTISAN EFFORT IN THE UNITED
STATES SENATE TO DO SOMETHING
CONSTRUCTIVE AND MEANINGFUL AND
I COMMEND BOTH OF THEM ON THEIR
WORK.
THERE ARE COMPONENT PARTS OF
THIS LEGISLATION I WANT TO
ILLUMINATE FOR JUST A SECOND
BECAUSE I HAD A LOT TO DO WITH
THEM BECAUSE THEY'RE VERY
IMPORTANT.
ONE DEALS WITH THIRD PARTY
LOGISTICS PROVIDERS.
AS THE CHAIR IS AWARE AND THE
SENATE IS AWARE WE HAVE A
PLACEHOLDER IN IN THE MANAGER'S
AMENDMENT FOR THIRD PARTY
TRAIS.
IT'S THE MECHANISM OF TRACKING
THE DRUG FROM ITS ORIGIN TO THE
INDIVIDUAL USING THE DRUG TO
SECURITY.
BUT THERE ARE THIRD-PARTY
LOGISTICS CARRIERS TO DELIVER AN
AWFUL LOT OF CONTENT LIKE FED EX
AND U.P.S. WHO OPERATE IN ALL 50
STATES AND WE OUGHT TO HAVE A
TOO-STATE SEAMLESS DELIVERY
RATHER THAN 50 STATES ALL HAVING
REGULATORY AUTHORITY.
SO MY FIRST MESSAGE TODAY TO
SEND TO THE CONFEREES WHEN THE
IS ULTIMATELY REPORTED
IS TO TAKE THESE PLACEHOLDERS ON
THESE THIRD PARTY PROVIDERS AND
IN THE TRACK AND TRACE
REGULATIONS WE PROVIDE A
SEAMLESS POLICY.
IT'S VERY IMPORTANT TO OUR
COUNTRY AND TO THE
PHARMACEUTICAL INDUSTRY AND
MOSTLY IT'S VERY IMPORTANT TO
THOSE OF US WHO CONSUME THOSE
SECONDLY, THERE IS ANOTHER
PROVISION CALLED THE MEDICAL GAS
ACT, GAS SAFETY ACT, WHICH WAS
INCLUDED IN THIS LEGISLATION AND
I AM VERY GRATEFUL THAT THE
MANAGERS OF THE LEGISLATION
AGREED TO PUT IT IN THE BILL
BECAUSE IT'S EQUALLY IMPORTANT
FOR OUR PEOPLE IN THIS COUNTRY.
BUT I WANT TO MAKE SURE ONE
THING IS UNDERLINED.
MEDICAL GASES ARE CRITICALLY
IMPORTANT TO SUSTAIN LIFE,
GASES LIKE OXYGEN, LIKE NIGHT
TRUSS OXIDE, CALLED BY LAUGHING
BUT I WANT TO MAKE SURE AS WE GO
THROUGH THIS PROCESS WE HAVE A
SYSTEM WHERE MEDICAL GASES THAT
HAVE STOOD THE TEST OF TIME
REMAIN AVAILABLE THROUGH MEDICAL
USE AND BRAND-NEW MEDICAL
PRODUCTS THAT HAVE NEVER BEEN
THROUGH THE TESTING TIME GO
THROUGH AN APPROPRIATE F.D.A.
REVIEW WHICH IS WHAT THE
ORIGINAL ACT, THE MEDICAL GAS
SAFETY ACT INCLUDED, AND WANTED
TO BE INCLUDED IN THIS
LEGISLATION.
UNANIMOUS CONSENT THAT THE
STATEMENT BOTH ON MEDICAL GAS
AND THE STATEMENT ON THIRD-PARTY
LOGISTICAL PROVIDERS BE INCLUDED
IN ITS TOTALITY FOR THE RECORD.
OBJECTION.
A SENATOR: AND I COMMEND THE
CHAIRMAN AND RANKING MEMBER
AGAIN ON THEIR SERVICE AND THE
FINE WORK ON THE F.D.A. BILL.
AND I YIELD BACK AND SUGGEST THE
ABSENCE OF A QUORUM.
THE CLERK
WILL CALL THE ROLL.
QUORUM CALL:
QUORUM CALL:
CALL:
MR. PRESIDENT?
I ASK FURTHER PROCEEDINGS UNDER
WITH.
WITHOUT
OBJECTION.
MR. PRESIDENT --
MR. PRESIDENT, I ASK CONSENT
THAT MY STATEMENT THAT I'M ABOUT
TO GIVE APPEAR AS IF IN MORNING
BUSINESS BUT NOT CONNECTED TO
THE MOTION AT HAND.
OBJECTION.
MR. PRESIDENT,
LAST WEEK OUR NATION LOST ONE OF
ITS MOST DETERMINED AND
COURAGEOUS ADVOCATES FOR THE
RIGHTS OF PEOPLE WITH
DISABILITIES: KATIE BECK KET.
I'M PROUD TO SAY KATIE WAS A
NATIVE IOWAN, BORN IN 1978 AND
CONTRACTED VIRAL ENCEPHALITIS.
SHE HAD A SEIZURE AND WENT INTO
COMA FOR TEN DAYS.
THIS ILLNESS CAUSED DAMAGE TO
HER BRAIN WHICH LEFT HER
PARALYZED AND UNABLE TO BREATHE
ON HER OWN.
KATIE WAS PLACED ON A
VENTILATOR, WAS FED USING A
TUBE.
INITIALLY COMING OUT OF THE COMA
SHE COULD NOT MOVE AT ALL.
SLOWLY MUCH OF THE PARALYSIS
RECEDED BUT SHE WAS NOT ABLE TO
BREATHE ON HER OWN UNTIL SHE WAS
TWO YEARS OF AGE.
DURING THAT TIME SHE LIVED ON A
PEDIATRIC INTENSIVE CARE UNIT.
HER FAMILY WANTED HER OUT OF THE
HOSPITAL AND WANTED HER HOME.
BY HER THIRD BIRTHDAY KATIE'S
PRIVATE INSURANCE REACHED ITS
TKHR-RBS 1 MILLION CAP -- $1
MILLION CAP AND BEGAN TO RECEIVE
DOCTORS DETERMINED SHE COULD
LEAVE THE HOSPITAL WITH PROPER
SUPPORTS AT HOME.
HOWEVER, HERE'S THE CATCH:
MEDICAID REFUSED TO PAY FOR SUCH
EVEN THOUGH IT WOULD COST
ONE-SIXTH AS MUCH AS HOSPITAL
CARE.
MEDICAID WOULD PAY FOR
INSTITUTIONAL CARE BUT NOT FOR
IN HER OWN HOME.
SHE ONLY RECEIVED CARE AT A
IT COVERED.
SO KATIE'S PREDICAMENT BEGAN TO
RECEIVE ATTENTION.
THANKS TO THE INTERVENTION OF
MANY PEOPLE INCLUDING
THEN-CONGRESSMAN TOM TOCKE, WHO
WAS KATIE'S CONGRESSMAN AT THAT
TIME, WHO BEGAN TO SPEAK OUT
ABOUT THIS AND WHO BROUGHT IT TO
THE ATTENTION OF THEN-PRESIDENT
RONALD REAGAN, AND MANY IN
CONGRESS, AND BECAUSE OF THAT
PRESIDENT REAGAN SPOKE OUT ABOUT
THIS, AND A NEW HOME AND
COMMUNITY-BASED WAIVER WAS
CREATED TO ALLOW CHILDREN IN
KATIE'S SITUATION TO RECEIVE
THEIR CARE AT HOME RATHER THAN
IN HOSPITALS.
THIS NEW PROGRAM WAS CALLED THE
KATIE BECKETT WAIVER.
AT THE TIME IT WAS THOUGHT THE
PROGRAM WOULD BENEFIT ONLY A FEW
HUNDRED CHILDREN.
SINCE 1982, OVER HALF A
MILLION CHILDREN HAVE BENEFITED
FROM THE KATIE BECKETT WAIVER
INCLUDING 11,000 IN IOWA.
KATIE AND HER FAMILY WERE TRUE
PIONEERS IN CHANGING THE
INSTITUTIONAL BIASES IN MEDICAID
AND PERMITTING CHILDREN WITH
DISABILITIES TO RECEIVE SUPPORTS
AND SERVICES IN THEIR OWN HOMES
RATHER THAN A HOSPITAL, NURSING
SETTING.
SO UNDER THE NEW PROGRAM, KATIE
WENT HOME ALMOST THREE FULL
YEARS AFTER SHE WAS ADMITTED.
AT THAT TIME SHE WAS ABLE TO BE
OFF HER VENTILATOR FOR SIX HOURS
A DAY.
SO WHAT HAPPENED AFTER HER
WELL, SHE STARTED SCHOOL.
WHILE HER FELLOW STUDENTS
CONSIDERED HER DIFFERENT BECAUSE
OF HER MEDICAL CONDITION, SHE
NEVER NEEDED SPECIAL EDUCATION
SERVICES.
AT AN EARLY AGE SHE BECAME A
PASSIONATE ADVOCATED FOR HOME
AND COMMUNITY-BASED CARE.
WHILE IN HIGH SCHOOL SHE
TESTIFIED BEFORE CONGRESS, MET
WITH GOVERNORS AND, AS I SAID,
STATES.
SHE SERVED AS AN INTERN AT
EXCEPTIONAL PARENT MAGAZINE,
LIVING IN BOSTON.
THAT SUMMER BETWEEN HER JUNIOR
AND SENIOR YEAR OF HIGH SCHOOL,
KATIE LEARNED TO MANAGE HER OWN
MEDICAL CARE, DIRECTING THE
NURSE WHO IS PROVIDED HER
VENTILATOR.
KATIE CONSIDERED ADVOCACY TO BE
HER VOCATION AND CHOSEN PATH.
IN PARTICULAR, HELPING TO RAISE
THE CONSCIOUSNESS OF OTHER YOUNG
PEOPLE ABOUT DISABILITY ISSUES.
EVEN THOUGH SHE FOUND THIS WORK
REWARDING, SHE SOMETIMES FELT
UNCOMFORTABLE IN THOSE
PRE-A.D.A. DAYS, AS WE SAY,
PRE-AMERICANS WITH DISABILITIES
ACT, TO BE SINGLED OUT BECAUSE
OF HER DISABILITY.
ALL SHE WANTED WITH WAS, AS SHE PUT
IT, TO FIT IN AND BE NORMAL.
HER FIRST JOB WAS AT A MUSIC
STORE AT A LOCAL JOB.
SHE GOT THE JOB BY VIRTUE OF HER
KNOWLEDGE AND INTEREST IN MUSIC.
BUT AS KATIE SAID -- QUOTE --
SOUL."
SO SHE LOOKED FOR WORK THAT
WOULD ALLOW HER TO HELP OTHER
PEOPLE.
SHE HAD BEEN VOLUNTEERING AT THE
LOCAL YWCA IN THE SECONDHAND
SHOP THAT SUPPORTED THE ONLY
HOMELESS SHELTER FOR WOMEN AND
CHILDREN IN EASTERN IOWA AND WAS
THEN HIRED FOR THE RECEPTIONIST
JOB AT THE Y.
THE SKWROP TITLE RE -- THE JOB
TITLE RECEPTIONIST DID NOT
DESCRIBE HER TRUE JOB
RESPONSIBILITIES.
*** ASSAULT VICTIMS.
SHE HELPED WITH THE NEUTRAL
EXCHANGE PROGRAM WHERE DIVORCED
OR SEPARATED PARENTS COULD DROP
OFF THEIR CHILDREN WITHOUT
HAVING TO ENCOUNTER EACH OTHER.
SHE LEARNED TO QUICKLY ASSESS
THE NEEDS OF OTHERS AND TO HELP
CONNECT THEM TO APPROPRIATE
SERVICES AND SUPPORTS.
SHE ALSO HELPED WITH THE
SUPERVISORSED VISITATION
PROGRAM -- SUPERVISED VISITATION
PROGRAM AND WAS SOON PROMOTED TO
THAT PROGRAM.
LATER KATIE WORKED WITH HER
MOTHER, JULIE BECKETT TO HELP
ESTABLISH THE KIDS AS
SELF-ADVOCATES NETWORK, A GROUP
DESIGNED TO HELP CHILDREN AND
YOUTH WITH SIGNIFICANT MEDICAL
NEEDS TO SPEAK UP FOR THEIR OWN
CARE AND SUPPORT.
WORKING THROUGH FAMILY VOICES,
ANOTHER ORGANIZATION SPEARHEADED
BY JULIE BECKETT, KATIE HELPED
TO TEACH HUNDREDS OF YOUNG
PEOPLE HOW TO ADVOCATE FOR THEIR
OWN HEALTH CARE.
SHE SERVED AS A SENATE APPOINTEE
ON THE TICKET TO WORK AND THE
WORK ADVISORY PANEL WHICH
PROVIDED ADVICE TO THE SOCIAL
SECURITY ADMINISTRATION, THE
PRESIDENT AND CONGRESS ON WORK
INCENTIVES, EMPLOYMENT AND OTHER
ISSUES FACING PEOPLE WITH
DISABILITIES.
KATIE BECKETT GRADUATED FROM
MOUNT MERCY COLLEGE IN CEDAR
RAPIDS, IOWA, IN 2001.
SHE TOOK WRITING COURSES IN
KIRKWOOD COMMUNITY COLLEGE.
SHE WAS CLOSE TO COMPLETING A
A SERIES OF ILLNESSES OBLIGED
HER TO PUT OFF RETURNING TO
COLLEGE AND TAKE THE CLASSES
NECESSARY TO BECOME A TEACHER.
KATIE TREASURED THE FREEDOM TO
ENGAGE IN THE KINDS OF
ACTIVITIES SO MANY OF US TAKE
FOR GRANTED, INCLUDING EATING AT
RED LOBSTER, GOING TO THE
SHOPPING MALL, AND RECENTLY
MOVING IN TO HER OWN APARTMENT.
KATIE WILL BE GREATLY MISSED BY
SO MANY PEOPLE ALL ACROSS
SHE WILL BE REMEMBERED FOR HER
DETERMINED ADVOCACY AND THAT OF
HER FAMILY, WHICH HAS CHANGED
COUNTLESS LIVES FOR THE BETTER.
SHE INSPIRED A WHOLE GENERATION
OF YOUNG PEOPLE WITH
DISABILITIES BY SHOWING THAT AN
ORDINARY PERSON CAN ACCOMPLISH
EXTRAORDINARY THINGS THROUGH
PERSISTENCE.
MR. PRESIDENT, DR. MARTIN LUTHER
KING JR. ONCE SAID "LIFE'S MOST
URGENT AND PERSISTENT QUESTION
OTHERS?"
DURING HER MEMORABLE BUT VERY
SHORT LIFETIME, KATIE ANSWERED
THAT QUESTION IN POWERFUL WAYS.
AS AN AGENT FOR CHANGE AND A
DETERMINED ADVOCATE.
HER LIVING LEGACY IS THE PROGRAM
THAT BEARS HER NAME: THE KATIE
BECKETT WAIVER WHICH WILL
CONTINUE TO IMPROVE THE LIVES OF
CHILDREN AND YOUNG PEOPLE WITH
DISABILITIES FAR INTO THE
FUTURE.
MR. PRESIDENT, I SEE MY
COLLEAGUE FROM IOWA HERE, WHO
HAS ALSO BEEN A FRIEND OF THE
BECKETTS, HAS BEEN VERY
SUPPORTIVE OF KATIE AND HER WORK
AND JULIE BECKETT, AND THIS HAS
TRULY BEEN A BIPARTISAN,
BICAMERAL SUPPORT FOR THIS
WONDERFUL, WONDERFUL FAMILY.
KATIE'S FUNERAL IS THIS FRIDAY.
WE'RE ALL GOING TO MISS HER.
AS I SAID, WHEN YOU MET KATIE
BECKETT, YOU WERE INSPIRED TO DO
MORE THAN YOU THOUGHT YOU COULD
SHE WAS A WONDERFUL, WONDERFUL
AND IT'S JUST TRAGIC THAT HER
LIFE CAME TO, CAME TO SUCH A
SHORT CLOSE JUST LAST WEEK.
REMEMBERED.
AS I SAID, SHE CHANGED SO MANY
LIVES IN THIS COUNTRY, SO MANY
LIVES FOR THE BETTER.
WITH THAT, MR. PRESIDENT, I
YIELD THE FLOOR.
MR. PRESIDENT?
THE
SENATOR FROM IOWA.
I THANK MY
COLLEAGUE FROM IOWA FOR HIS VERY
NICE REMARKS ABOUT KATIE