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CITIZENS UNITED IS DOING TO OUR
DEMOCRACY.
AND WITH THAT, MR. PRESIDENT, I
WOULD YIELD THE FLOOR.
MR. PRESIDENT?
MR. PRESIDENT, IT IS MY
UNDERSTANDING I AM TO BE
AT 2:00, AND WE'RE AT
ABOUT 2:01, FOR TEN MINUTES, AND
I KNOW THE LEADER WILL HAVE
SOMETHING TO SAY ABOUT 2:15 IN
REGARDS TO THE PROGRESS OF THIS
THE
SENATOR IS RECOGNIZED CHT.
SO MUCH.
MR. PRESIDENT, I RISE TODAY TO
SPEAK ON THE LEGISLATION THAT IS
ACTUALLY BEFORE US, AS OPPOSED
TO THE TOPIC BEFORE.
SAFETY AND INNOVATION ACT WE ARE
CURRENTLY DEBATING.
NOTIONTHIS LEGISLATION INCLUDES MANY
OTHER IMPORTANT PROVISIONS
MEMBERS SHOULD KNOW WHAT'S IN
THIS BILL AND JUST HOW IMPORTANT
THESE PROVISIONS ARE.
LANGUAGE TO PERMANENTLY
REAUTHORIZE PEDIATRIC RESEARCH
INCENTIVES, PROGRAMS TO
INCENTIVE ANTIBIOTIC RESEARCH
AND DEVELOPMENT, AND MORE
TRANSPARENCY AND ACCOUNTABILITY
FOR THE F.D.A. AND STAKEHOLDERS,
WILL ADDRESS DRUG
THAT IS A BIG PROBLEM NOT ONLY
IN URBAN AREAS BUT IN THE RURAL
HEALTH CARE DELIVERY SYSTEM,
EVERY STATE, EVERY SENATOR ROT
TO BE AWARE OF THAT.
IT.
IN PLAY I JOINED SENATORS REID,
MURRAY, ALEXANDER IN INTRODUCING
THE BETTER PHARMACEUTICALS AND
DEVICES FOR CHILDREN ACT.
THAT'S THE BPDCA -- I DON'T
THINK THAT MAKES A VERY GOOD
TO TRY IT.
BACK IN 1997, CONGRESS PASSED
THE BEST PHARMACEUTICAL FOR
CHILDREN ACT, WHICH ACKNOWLEDGED
THE IMPORTANCE OF ENSURING
MEDICATIONS WERE EFFECTIVE AND
SAFE FOR CHILDREN BY PROVIDING
AN INCENTIVE FOR PHARMACEUTICAL
COMPANIES TO INVEST IN PEDIATRIC
RESEARCH.
AND IN 2003, WITH THE PASSAGE OF
THE PEDIATRIC RESEARCH EQUITY
ACT, WHY, CONGRESS REQUIRED THAT
THE PHARMACEUTICAL COMPANIES TO
ENGAGE IN THESE STUDIES.
NOW, THESE BILLS ARE OFTEN
REFERRED TO AS THE CARROT AND
THE STICK APPROACH FOR PEDIATRIC
DRUG DEVELOPMENT.
NOW, I PREFER CARROTS TO STICKS
AROUND HERE, ESPECIALLY
MANDATES.
BUT THEY HAVE PROVEN OVER TIME
TO WORK, THE CARROT-AND-STICK
ARE APPROACH.
SINCE THE ENACTMENT OF THESE
LAWS, APPROXIMATELY 426 DRUG
LABELS HAVE BEEN REVISED WITH
IMPORTANT PEDIATRIC INFORMATION,
AND THE NUMBER OF OFF-LABEL
DRUGS USED IN CHILDREN HAS
DECLINED FROM 80% TO 50%.
THAT'S CERTAINLY GOOD NEWS.
IN 2007, A COMPLEMENTARY
INITIATIVE TO PROMOTE THE
DEVELOPMENT OF PEDIATRIC MEDICAL
DEVICES -- THAT'S THE PEDIATRIC
MEDICAL DEVICE SAFETY AND
IMPROVEMENT ACT WAS ENACTED.
NOW, THIS LAW HAS RESULTED IN A
FIVEFOLD INCREASE IN THE NUMBER
OF SMALL-MARKET MEDICAL DEVICES
DESIGNATED FOR PEDIATRIC USE.
NOW, THE BETTER PHARMACEUTICALS
AND DEVICES FOR CHILDREN ACT
WILL PERMANENTLY EXTEND THESE
WORTHWHILE PROGRAMS WHILE
PROVIDING SOME REAL
PREDICTABILITY AND
ACCOUNTABILITY FOR PEDIATRIC
DRUG AND MEDICAL DEVICE
THE LEGISLATION ALSO INCLUDES
THE GENERATING -- PARDON ME, THE
GENERATING ANTIBIOTIC INCENTIVES
ACT.
I JOINED WITH SENATORS
BLUMENTHAL AND CORKER IN
SUPPORTING THIS BILL AS OF LAST
YEAR.
THIS TITLE CONTAINS PROVISIONS
THAT AIM TO BOOST DEVELOPMENT OF
PRODUCTS TO TREAT SERIOUS AND
LIFE-THREATENING INFECTIONS,
SOMETHING THAT IS A GROWING
PROBLEM IN ALL OF OUR HOSPITALS.
IT PROVIDES MEANINGFUL MARKET
INCENTIVES AND REDUCES -- GET
THIS -- REDUCES REGULATORY
GLORY BE.
HERE'S A BILL THAT ACTUALLY
REDUCES REGULATIONS, TO
ENCOURAGE DEVELOPMENT OF NEW
WHY?
WELL, THE ANTIBIOTIC PIPELINE
HAS SLOWED, MR. PRESIDENT, TO AN
ALARMING RATE.
ACCORDING TO THE F.D.A., THE
APPROVAL OF SUCH DRUGS HAS
DECREASED BY 70% SINCE THE
MID-1980'S.
THIS IS UNACCEPTABLE.
THE DEVELOPMENT OF JUST ONE NEW
TEN YEARS.
WE MUST ACT NOW TO AVOID A
POTENTIAL HEALTH CARE CRISIS.
NOW, WHEN I'M BACK IN KANSAS --
AND I KNOW WHEN OTHER SENATORS
ARE BACK IN THEIR STATES -- AND
TALKING TO FOLKS ABOUT HEALTH
CARE, I OFTEN HEAR ABOUT THE
PROBLEM WITH SHORT DRUGGAGES.
NOW, WHEN A PROBLEM EXISTS IN AN
URBAN SET, SIMPLY MULTIPLY THAT
TEN TIMES AND THAT'S WHAT WE
HAVE IN OUR RURAL AREAS.
THIS IS A CRISIS.
AS DIFFICULT AS IT IS TO HEAR
FROM MY HOSPITAL ADMINISTRATORS
AND PHARMACISTS IN KANSAS ABOUT
THE DIFFICULTIES THEY ARE HAVING
IN ET GETTING DRUGS TO FILL
PRESCRIPTIONS, NOTHING COMPARES
TO THE PATIENTS WHO CAN'T GET
THEIR DRUGS, WHO CAN'T GET THEIR
TREATMENT, WHO ARE SCARED ABOUT
THEY CAN'T GET
TO SHORTAGES.
THIS IS UNACCEPTABLE.
THIS IS WHY I JOIN THE TOGETHER
WITH NUMBER OF MY COLLEAGUES TO
WORK TOGETHER TO SEE IF WE COULD
COME TO A BIPARTISAN CONSENSUS
ON A WAY TO ALLEVIATE AT LEAST
SOME OF THE BURDEN THAT DRUG
SHORTAGES DO CREATE.
THE LEGISLATION NOW REQUIRES
REPORTING ON DRUG SHORTAGES BUT
ALSO -- ALSO -- IT DOES PROVIDE
SOME TRANSPARENCY AND
ACCOUNTABILITY IN THE HOPE THAT
WE CAN GET TO THE ROOT CAUSE OF
NOW, NOT EVERYTHING IN THIS
LEGISLATION IS WHAT I WOULD HAVE
DONE IF I HAD MY CHOICE.
THAT'S OBVIOUSLY THE CASE WITH
EVERY SENATOR ON EVERY MAJOR
BILL THAT WE MUST MAKE DECISIONS
ON.
BUT I AM CERTAIN THAT MANY OF MY
COLLEAGUES ON THE HELP COMMITTEE
ARE THINKING THE SAME THING, BUT
I THINK WE ARE PLEASED THAT WE
WERE ABLE TO COME TO A
BIPARTISAN CONSENSUS ON THIS
LEGISLATION, AND IN ADDRESSING
MANY OF THE ISSUES THAT ARE
AFFECTING KANSANS AND THE REST
OF AMERICANS.
I JUST TALKED TO A FELLOW ON THE
TELEPHONE LAST NIGHT THAT SAID,
WHY CAN'T YOU ALL WORK THOUGHT?
WHY CAN'T YOU PASS SOMETHING IN
A BIPARTISAN WAY?
THIS LEGISLATION IS A GOOD
EXAMPLE OF EXACTLY WHAT THAT
GENTLEMAN WAS TALKING ABOUT,
WHAT A LOT OF AMERICANS ARE
CONCERNED ABOUT.
IN THAT REGARD, I REALLY WANT TO
THANK CHAIRMAN HARKIN, RANKING
MEMBER ENZI FOR AWFUL THEIR WORK
-- FOR ALL OF THEIR WORK, FOR
ALL OF THE WORK BY THEIR STAFFS
AND OUR STAFFS IN PUTTING
TOGETHER IN IMPORTANT PIECE OF
THIS TOOK A LONG TIME.
IT TOOK A LOT OF EFFORT, A LOT
OF HARD WORK.
THEIR COMMITMENT TO A BIPARTISAN
PROCESS AND THEIR WILLINGNESS TO
COMMUNICATE WITH ALL THE MEMBERS
OF THE HELP COMMITTEE HAS LED US
THROUGH A RELEVANTLY
NONCONTENTIOUS MARKUP AND I HOPE
THE SAME WILL HAPPEN AS WE
FLOOR.
I YIELD BACK MY TIME.
I I NOTE THE
ABSENCE OF A QUORUM -- OH.
THANK YOU,
MR. PRESIDENT.
I THANK MY COLLEAGUE FOR
MANNER.
I'M HERE TO TALK ABOUT LITTLE
BIT ABOUT THE CLOSE ACT AND
CITIZENS UNITED.
YOU'VE HEARD US TALK ABOUT THE
NEED FOR FULL DISCLOSURE OF
MONEY DONATED TO CAMPAIGNS.
IT IS TIME FOR CONGRESS TO STOP
STALLING AND LET THE AMERICAN
VOTERS FIND OUT WHERE THE MONEY
BEING SPENT ON ELECTIONS IS
EXPHG FROM ONCE AND FOR ALL --
IS COMING FROM ONCE AND FOR ALL.
ALL OF OUR PREDICTIONS OF THE
AFTERMATH OF THE FLAWED CITIZENS
UNITED DECISION ARE COMING TRUE.
THIS DECISION HAND ADD MEGAPHONE
TO THE WEALTHIEST VOICES AMONG
US AND STRAPPED A MUZZLE ON
EVERY OTHER AMERICAN.
SURE, AVERAGE AMERICANS CAN TALK
TO ONE ANOTHER BUT NOT SPENDING
$10 MILLION ON TV ADS, AND WE
KNOW WHAT KIND OF AFFECT THAT
HAS.
IF ANYTHING, THE SITUATION IS
EVEN WORSE THAN WE COULD HAVE
POSSIBLY ANTICIPATED BECAUSE
UNLIMITED SPENDING BY JUST A
HANDFUL OF JUST THE WEALTHIEST
AMERICANS HAS MADE TRUE
DEMOCRACY IN DANGER, A TRUE
DEMOCRACY OF ONE PERSON, ONE
VOTE, OF TRUE EQUALITY --
WORRISOME WHEN YOU HAVE SUCH
HUGE AMOUNTS OF MONEY BEING
SPENT BY SO FEW PEOPLE WHO SEEM
TO SPEAK WITH ONE VOICE AND ONE
CONCERTED POINT OF VIEW.
THE LIST OF THE TOP DONORS TO
SUPERSUPER PACS READS LIKE A WHO'S
WHO OF THE RICHEST PEOPLE IN
AMERICA.
THE CONTRIBUTIONS TO SUPERPACS
THAT WERE RELEASED IN THE MOST
RECENT DISCLOSURE REPORTS ARE
ASTONISHING.
SIX-FIGURE SUMS SEEM LIKE POCKET
CHANGE NOW COMPARED WITH TODAY'S
TREND OF SEVEN- AND EIGHT-FIGURE
DONATIONS.
TOP TOP
DONOR TO THE GROUP THAT RAN
SMEAR ADS QUESTIONING JOHN
KERRY'S MILITARY SERVICE IN
WHEN YOU ADD UP HIS DONATIONS TO
SUPER PACS THIS CYCLE, WE HAVE
ALMOST $14 MILLION OF POLITICAL
INFLUENCE FROM JUST ONE MAN.
SIMMONS.
WHEN YOU COMBINE HIS PERSON ALDO
NATIONS WITH THE CORPORATION HE
OWNS WITH HIS WIFE, YOU GET
CONTRIBUTIONS OF $17 MILLION TO
SIX DIFFERENT SUPER PACS.
AND BECAUSE DISCLOSURES TO THE
FEDERAL ELECTION COMMISSION ARE
ONLY MADE PUBLICLY AVAILABLE
ONCE A MONTH, THIS PAINTS A
FRACTION OF THE PICTURE OF TOTAL
SUPER PAC SPENDING AND THE
REPORTS DON'T EVEN ADDRESS
SPENDING THROUGH SO-CALLED
NONPROFIT ORGANIZATIONS, ORGANIZATIONS.
AS WE ALL KNOW, 501-C-4
ORGANIZATIONSORGANIZATIONS ARE ABLE TO SERVE
AS CONDUITS FOR HUGE SUMS OF
ANONEANONYMOUS FUNDING.
THEY FUNCTION THE SAME AS THE
SUPER PACS EXCEPT THEY CAN'T SAY
VOTE FOR OR VOTE AGAINST.
BUT THEIR EFFECT ON CAMPAIGNS
OBVIOUSLY INTENDED IS JUST AS
REAL.
IT DOESN'T STOP AT THE FEDERAL
LEVEL.
WE'RE ALSO SEEING THE CONCERN
OVER CORPORATE SPENDING AT THE
STATE LEVEL THROUGH THE MONTANA
PARTNERSHIP v. ATTORNEY
GENERAL BULLOCK.
THIS CASE HINGES ON A CHALLENGE
TO MONTANA'S MONTANA'S CENTURY-OLD
CAMPAIGN LAW.
IN FACT, THE FUND RAISERS IN
THIS CASE, A GROUP CALLED
AMERICAN TRADITION PARTNERSHIP,
SOLICITS CONTRIBUTORS BY
SECRECY.
IN THEIR PROMOTIONAL LITERATE A
TOUR THEY PROMISE DONORS "WE'RE
NOT REQUIRED IT PROMOTE THE NAME
OR THE AMOUNT OF ANY
CONTRIBUTION WE RECEIVE."
SO IF YOU DECIDE TO SUPPORT THIS
PROGRAM, NO POLITICIAN, NO
BUREAUCRAT, NO RADICAL
ENVIRONMENTALIST WILL EVER KNOW
YOU HELPED MAKE THIS PROGRAM
POSSIBLE."
IT IS NO SURPRISE, GIVEN
MOUNTING CONCERN ABOUT THE
CORRUPTING EFFECT OF UNLIMIT AND
OFTEN ANONYMOUS CAMPAIGN
SPENDING ON OUR DEMOCRACY, THAT
SO MUCH INDIVIDUALS AND GROUPS
HAVE FILED AMICUS BRIEFS IN THIS
CASE, INCLUDING SENATORS
WHITEHOUSE AND McCAIN, SEVERAL
HOUSE DEMOCRATS, AND DOZENS OF
OTHERS URGING THE COURT TO
UPHOLD MONTANA'S 100--YEAR-OLD
LAW.
WE CANNOT SIT IDLY BUY AND WATCH
OUR DEMOCRACY GO FOR SALE TO THE
HIGHEST BIDDERS.
FULL DISCLOSURE, THE KIND THAT
THE DISCLOSE ACT OF 2012
REQUIRES, IS SO NECESSARY TO
SHED LIGHT ON WHICH GROUPS AND
INDIVIDUALS ARE FUNDING OR
ELECTIONS.
TO KEEP SOME MOD MODICUM OF FAITH
THAT THE VOTERS AT LEAST KNOW
WHAT'S GOING ON.
IN 2010, THE ORIGINAL DISCLOSE
ACT PASSED THE HOUSE, HAD
WIDESPREAD SUPPORT FROM THE
BUT FAILED TO GAIN CLOTURE BY
ONE VOTE BECAUSE NOT ONE
REPUBLICAN WAS WILLING TO STEP
ACROSS THE AISLE AND DO WHAT
CLEARLY THE AMERICAN PEOPLE
REGARD IS THE RIGHT THING.
WELL, NOW THERE'S NO EXCUSE.
WE'VE REMOVED THE ORIGINAL
PROVISIONS THAT MY REPUBLICAN
COLLEAGUES MOST OBJECTED TO.
ALL THARMS THAT REMAINS IS DISCLOSURE.
THE TIME TO ACT IS NOW WHILE
AMERICA'S RICHEST BILLIONAIRES
CAN ATOURED TO KEEP CONTRIBUTING
MILLIONS OF DOLLARS TO SUPER
PACS AND 501-C'S, AMERICA CANNOT
AFFORD TO BE KEPT IN THE DARK
ANY LONGER.
MR. PRESIDENT, I YIELD THE
FLOOR.
THE
CLERK WILL CALL THE ROLL.
QUORUM CALL:
CALL:
MR. PRESIDENT?
THE
MAJORITY LEADER IS RECOGNIZED.
I ASK UNANIMOUS
CONSENT THE CALL FOR THE QUORUM
BE TERMINATED.
WITHOUT
OBJECTION.
THE MAJORITY LEADER IS
MR. PRESIDENT, THE
FIRST THING WE'RE GOING TO TALK
ABOUT, I'VE HAD CONVERSATIONS
OVER THE LAST FEW DAYS, IN FACT
A LONGER PERIOD OF TIME THAN
THAT, WITH SENATORS VITTER AND
SENATOR COBURN, SENATOR JOHNSON,
SENATOR SHELBY AND OTHERS ON
FLOOD INSURANCE.
LIKE A LOT OF THINGS THAT
HAPPEN, THIS HAS BECOME CRITICAL
THAT WE DO SOMETHING ON FLOOD
IT AFFECTS ALMOST SIX MILLION
PEOPLE, AND WE NEED TO GET
SOMETHING DONE ON A MORE
PERMANENT BASIS.
THERE'S BEEN A GENERAL
AGREEMENT -- WE DON'T HAVE IT IN
WRITING YET BUT I WANT TO MAKE
SURE THE RECORD IS CLEAR HERE ON
THE FLOOR WHAT MY INTENTION IS.
IS THAT WE WOULD HAVE A 60-DAY
SHORT-TERM EXTENSION, AND THAT
EXTENSION THERE WOULD BE
LANGUAGE FOR THE DURATION OF 60
DAYS THAT WOULD INCLUDE IN THAT
THE SECOND-HOME SUBJECT THAT'S
PART OF THE UNDERLYING BILL THAT
SENATOR COBURN HAS FOCUSED ON.
THAT WOULD BE FOR 60 DAYS.
THEN I WOULD BE HAPPY TO MAKE A
STATEMENT HERE ON THE FLOOR
TODAY DURING THE NEXT WORK
PERIOD THAT WE WILL MOVE TO THAT
BILL, THE FLOOD INSURANCE BILL,
SO THAT WE WOULD HAVE THE
OPPORTUNITY TO MAKE IT
PERMANENT.
IT'S VERY IMPORTANT WE DO THAT,
WITH THE ECONOMY BEING SUCH AS
IT IS, WE CAN'T IN THIS AREA,
AND PROBABLY OTHERS, BUT THIS
ONE, WE CAN'T HAVE SHORT-TERM
EXTENSIONS THAT DOESN'T ALLOW
PEOPLE TO DO WHAT THEY NEED TO
DO.
40,000 HOMES A DAY GO THROUGH A
PROCESS WHERE THEY HAVE TO HAVE
IF THERE IS NO FLOOD INSURANCE,
THAT'S 40,000 LOANS EVERY DAY
THAT WILL NOT BE APPROVED.
SO, SENATORS JOHNSON AND SHELBY
HAVE DONE GOOD WORK TO NARROW
DOWN THE LIST OF AMENDMENTS THAT
WE WOULD HAVE TO CONSIDER WHEN
THE SENATE TAKES UP THIS
LONG-TERM FLOOD INSURANCE BILL.
IT'S MY UNDERSTANDING THERE ARE
A DOZEN OR SO AMENDMENTS, SIX,
EIGHT ON EACH SIDE.
I HOPE WE CAN DO THAT.
IF WE CAN'T DO THAT, WE'RE GOING
TO HAVE TO GO TO THE BILL
ANYWAY, AND I WANT TO MAKE SURE
THAT SENATOR VITTER, WHO IS ON
THE FLOOR TODAY, UNDERSTANDS
THAT THAT'S MY UNDERSTANDING OF
THINGS THAT HE AND I HAVE TALKED
ABOUT THE LAST COUPLE OF WEEKS.
MR. PRESIDENT?
THE
SENATOR FROM LOUISIANA.
MR. PRESIDENT, I
THANK THE DISTINGUISHED MAJORITY
LEADER VERY MUCH FOR THIS
IMPORTANT ANNOUNCEMENT AND THIS
PLAN, AND IT CERTAINLY MEETS --
MR. PRESIDENT, IT'S
MY UNDERSTANDING THAT HE WAS
GOING TO ASK ME A QUESTION,
BECAUSE I DON'T WANT TO LOSE THE
FLOOR.
I HAVE NO
INTENTION OF HIS LOSING THE
I JUST WANT TO THANK HIM FOR THE
ANNOUNCEMENT, AND FROM MY
PERSPECTIVE, IT MEETS THE TWO
MAIN GOALS WE'VE BEEN IN SEARCH
OF.
FIRST OF ALL, MAKING SURE IN THE
SHORT TERM THERE IS NOT A LAPSE
OF THE PROGRAM.
THAT WOULD BE DISASTROUS.
THAT WOULD CANCEL, AS THE
THOUSANDS OF GOOD CLOSINGS,
REALLY PUT A HICCUP IN THE
ECONOMY FOR NO GOOD REASON.
AND IN ADDITION, GET TO A
PERMANENT BILL IN THE NEXT WORK
PERIOD.
SO I APPRECIATE THE LEADER'S
ANNOUNCEMENT, AND I WOULD ALSO
NOTE, AS HE DID, THAT THERE'S
BEEN GREAT WORK AND GREAT
PROGRESS IN NARROWING THE FIELD
OF RELEVANT AMENDMENTS.
I CERTAINLY HOPE THAT LEADS TO A
LIMITED AND REASONABLE NUMBER OF
THE FLOOR.
I UNDERSTAND WHAT HE SAID ABOUT
IF THAT BECOMES UNWIELDY, WE'LL
JUST PROCEED WITH THE BILL AS
IS.
BUT CERTAINLY IT'S MY
EXPECTATION -- I'LL CONTINUE TO
WORK ON THAT AMENDMENT LIST SO
THAT WE HAVE A REASONABLE
OPPORTUNITY FOR RELEVANT
MR. PRESIDENT?
THE
MAJORITY LEADER.
REPUBLICAN LEADER IS ON THE
WE'VE WORKED VERY HARD TO ARRIVE
AT THIS POINT, I'M GOING TO ASK
THIS CONSENT AGREEMENT.
I APPRECIATE EVERYONE'S HELP,
AND IT TAKES EVERYONE'S HELP TO
GET TO WHERE WE ARE.
THAT'S WHY WE CALL THEM
UNANIMOUS CONSENT AGREEMENTS.
I ASK UNANIMOUS CONSENT THAT THE
ONLY FIRST-DEGREE AMENDMENTS IN
ORDER TO THE BILL THAT'S NOW
PENDING BEFORE THE SENATE BE THE
BINGAMAN 2111,
McCAIN 2107 --
UNDER
THE PREVIOUS ORDER THE MOTION TO
PROCEED TO S. 3187 IS AGREED TO.
THE CLERK WILL REPORT.
CALENDAR NUMBER
400, S. 3187, A BILL TO AMEND
THE FEDERAL FOOD, DRUG AND
COSMETIC ACT TO REVISE AND
EXTEND THE USER FEE PROGRAMS FOR
PRESCRIPTION DRUGS AND MEDICAL
DEVICES, AND SO FORTH AND FOR
OTHER PURPOSES.
UNDER
THE PREVIOUS ORDER, AMENDMENT
NUMBER 2122 IS AGREED TO.
THE MAJORITY LEADER.
MR. PRESIDENT.
I'M SORRY I GOT AHEAD OF CHAIR A
LITTLE BIT.
I ASK UNANIMOUS CONSENT THAT THE
ONLY FIRST-DEGREE AMENDMENTS IN
ORDER TO THE BILL BE THE
FOLLOWING: BINGAMAN 2111,
2108
MURKOWSKI, CARDIN 2141, GRASSLEY
21221, 2129, MANCHIN 2151,
PORTMAN 2146 AS MODIFIED.
PORTMAN 2141 AS MODIFIED.
REED OF RHODE ISLAND 2126,
COBURN 2131, DURBIN 2137, PAUL
4143 AND BURR 2130, THAT THERE
BE NO SECOND-DEGREE AMENDMENTS
IN ORDER PRIOR TO THE VOTES OR
RELATION THERE TO.
THAT THERE BE NO POINTS OF
ORDER, MOTIONS OR POINTS OF
ORDER TO THE AMENDMENTS OF THE
BILL OTHER THAN THE BUDGET
POINTS OF ORDER AND APPLICABLE
MOTIONS TO WAIVE OR MOTIONS TO
TABLE.
THAT THERE BE UP TO 30 MINUTES
OF DEBATE ON EACH OF THE
AMENDMENTS WITH THE EXCEPTION OF
THE McCAIN AMENDMENT WHICH
WILL HAVE TWO HOURS OF DEBATE,
60 MINUTES ON THE BILL, WITH ALL
TIME EQUALLY DIVIDED IN THE
USUAL FORM.
AND AT 2:00 P.M. ON THURSDAY,
MAY 24 ALL DEBATE PAOEUPL BE
CONSIDERED IS -- TIME BE
CONSIDERED EXPIRED AND THE
SENATE PROCEED TO VOTES, THAT
MINUTES OF DEBATE
EQUALLY DIVIDED IN THE YOU'RE
FORM PRIOR TO EACH VOTE -- IN
THE USUAL FORM PRIOR TO EACH
VOTE, THAT ALL AFTER THE FIRST
*** TEN MINUTES -- VOTE BE
TEN MINUTES.
60-AFFIRMATIVE VOTE THRESHOLD
BINGAMAN 2111, SANDERS 2109,
MURKOWSKI 2108.
UPON DISPOSITION OF THE
AMENDMENTS THE SENATE PROCEED TO
VOTE ON PASSAGE OF THE BILL AS
AMENDED.
THAT UPON DISPOSITION OF S. 3187
THE SENATE PROCEED TO THE
CONSIDERATION OF CALENDAR NUMBER
365, 2343, THAT THE ONLY
AMENDMENT IN ORDER TO THE BILL
BE AN AMENDMENT FOR THE
REPUBLICAN LEADER OR HIS
DESIGNEE, THE TEXT OF WHICH IS
IDENTICAL TO 2366, THAT THERE BE
TEN MINUTES OF DEBATE ON THE
AMENDMENT AND THE BILL EQUALLY
DIVIDED BETWEEN THE TWO LEADERS
DESIGNEES PRIOR TO A
VOTE ON THE McCONNELL OR
DESIGNEE AMENDMENT, AND NO
AMENDMENT BE IN ORDER TO THE
McCONNELL OR DESIGNEE
AMENDMENT, THAT NO MOTIONS OR
POINTS OF ORDER BE IN ORDER TO
THE AMENDMENT OR THE BILL OTHER
THAN THE BUDGET POINTS OF ORDER
WAIVE.
THAT UPON DISPOSITION OF THE
AMENDMENT THE SENATE PROCEED TO
VOTE ON PASSAGE OF THE BILL AS
AMENDED, IF AMENDED, THAT THE
AMENDMENT AND THE BILL BE
SUBJECT TO A 60-VOTE THRESHOLD,
THAT IF THE BILL DOES NOT
RECEIVE 60 AFFIRMATIVE VOTES
S. 2343 BE RETURNED TO THE
CALENDAR AND THE MOTION WITH
RESPECT TO S. 2343 BE WITHDRAWN.
THERE OBJECTION?
WITHOUT OBJECTION, SO ORDERED.
SO, MR. PRESIDENT,
WE'RE GOING TO HAVE VOTES ON
THESE AMENDMENTS.
IT'S MY UNDERSTANDING THAT
THERE'S TIME, 30 MINUTES PER
AMENDMENT.
AND WE NEED TO GET AS MUCH OF
THAT DONE TODAY AS POSSIBLE.
EVENT FOR SPOUSES
TONIGHT, SO WE'RE GOING TO HAVE
TO -- WE'RE NOT GOING TO BE
WORKING LATE INTO THE NIGHT.
WE HAVE TOMORROW TO FINISH THIS.
WE SHOULD BE ABLE TO DO THAT.
I HOPE WE CAN.
I HOPE IT DOESN'T SPILL IN --
THERE IS NO REASON IT SHOULD
SPILL OVER UNTIL THE NEXT DAY.
WE'RE GOING TO ALSO HAVE VOTES
ON THE REPUBLICAN STUDENT LOAN
LEGISLATION AND ON OURS.
THAT'S WHAT WE'RE DOING THE NEXT
THE
REPUBLICAN LEADER.
LET ME JUST ADD
I THINK THIS IS A GOOD AGREEMENT
THAT ALLOWS US TO GO FORWARD ON
THE F.D.A. BILL WITH APPROPRIATE
AMENDMENTS AND ALSO ALLOWS AN
OPPORTUNITY FOR THE SENATE TO
THE STUDENT LOANS.
I WOULD JOIN THE MAJORITY LEADER
IN ENCOURAGING PEOPLE TO DO
THEIR DEBATE TODAY OR IN THE
MORNING, BECAUSE ONCE WE GET
INTO THE VOTES TOMORROW
THEY'LL BE DEALT WITH
IN RAPID SUCCESSION.
A SENATOR: MR. PRESIDENT?
THE
SENATOR FROM UTAH.
MR. PRESIDENT, I RISE
TO DISCUSS MY AMENDMENT THAT
WOULD REPEAL THE COSTLY
COUNTERPRODUCTIVE MEDICAL DEVICE
TAX IN PRESIDENT OBAMA'S HEALTH
IN THE MAD SCRAMBLE TO FIND
MONEY TO PAY FOR HIS
$2.6 TRILLION HEALTH SPENDING
LAW, THE PRESIDENT AND HIS
DEMOCRATIC ALLIES CREATED A
NUMBER OF NEW TAXES THAT SERVE
NO PURPOSE OTHER THAN TO FUEL
THIS NEW SPENDING.
ECONOMICALLY, THESE TAXES ARE A
WILL UNDERCUT JOB CREATION
AND THEY WILL INCREASE COSTS FOR
PATIENTS.
THE NEW 2.3% TAX ON MEDICAL
DEVICE MANUFACTURERS WHICH KICKS
IN AT THE BEGINNING OF NEXT YEAR
IS PARTICULARLY ONEROUS.
FOR THAT REASON, LAST YEAR I
IT.
THAT BILL, THE MEDICAL DEVICE
ACT, SAYS AN INNOVATION
PROTECTION ACT, S. 17, HAS BEEN
COSPONSORED BY 25 OF MY
THEY UNDERSTAND THAT ALL OF
OBAMACARE NEEDS TO GO.
THE PRESIDENT'S HEALTH CARE LAW
IS NOW OVER TWO YEARS OLD AND IT
IS NOT AGING WELL.
EVEN BEFORE OBAMACARE BECAME
LAW, THE AMERICAN PEOPLE MADE
THEMSELVES ABSOLUTELY CLEAR THAT
THEY WANTED NOTHING TO DO WITH
THIS WASHINGTON TAKEOVER OF THE
NATION'S HEALTH CARE SYSTEM.
THE PRESIDENT AND HIS ADVISORS
REFUSE TO FACE REALITY, TELLING
RELUCTANT DEMOCRATS THAT ALL IS
WELL IN SPITE OF THE TEA PARTY
TOWN HALLS.
ACCORDING TO THE PRESIDENT AND
CONGRESSIONAL DEMOCRAT
LEADERSHIP, AS SOON AS THE
LEGISLATION BECAME LAW,
AMERICANS WOULD COME TO EMBRACE
THE WONDERFUL BENEFITS BESTOWED
ON THEM BY THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES.
IT HAS NOT QUITE TURNED OUT THAT
WAY.
POLL AFTER POLL SHOWS THAT
SUBSTANTIAL MAJORITIES OF
AMERICANS CONTINUE TO OPPOSE THE
LAW AND FAVORITES FULL REPEAL.
THE MAJORITY OF DEMOCRATS THINK
THAT THE LAW IS
UNCONSTITUTIONAL.
IN A MATTER OF WEEKS, THE
SUPREME COURT MIGHT ISSUE A COUP
TO THE GOVERNMENT.
WHATEVER THE SUPREME COURT DOES,
I WANT TO BE CLEAR ABOUT
SOMETHING -- ALL OF OBAMACARE
NEEDS TO GO.
IT NEEDS TO BE PULLED OUT ROOT
AND BRANCH.
THE ENTIRE THING NEEDS TO BE
REPEALED.
THAT SAID, SOME PARTS OF THE LAW
STAND OUT FOR THEIR
WRONG-HEADEDNESS.
THE INDIVIDUAL MANDATE AND
MEDICAID EXPANSIONS ARE FLAT OUT
UNCONSTITUTIONAL.
THE IPAB, THE CLASS ACT, THE
MEDICARE CUTS AND EMPLOYER
MANDATE ALL DESERVE HONORABLE
POLICY.
AND AMONG THE MOST
COUNTERPRODUCTIVE PARTS OF THE
ARE THE OVER $500 BILLION IN
NEW TAXES AND PENALTIES.
THE MEDICAL DEVICE TAX SITS AT
THE TOP OF A LIST OF FOOLISH NEW
OBAMACARE TAXES AND MY
COLLEAGUES WHO HAVE SUPPORTED S.
17 AND THIS AMENDMENT UNDERSTAND
THE CRITICAL IMPORTANCE OF
ELIMINATING IT.
I WANT TO THANK IN PARTICULAR MY
COLLEAGUE SENATOR BROWN FROM
MASSACHUSETTS AND SENATOR TOOMEY
FROM PENNSYLVANIA WHO HAVE
SPOKEN ON THIS ISSUE AND
UNDERSTAND COMPLETELY THE
DEVASTATION THAT THIS TAX WILL
CREATE FOR PATIENTS AND FOR
EMPLOYERS THAT PROVIDE GOOD JOBS
FOR COMMUNITIES IN THEIR STATES.
THANKS TO OBAMACARE, MEDICAL
DEVICES WILL GET HIT WITH A
$28 BILLION TAX.
AND SO WE ARE CLEAR ABOUT WHAT
THESE MEDICAL DEVICES ARE.
THEY INCLUDE SURGICAL TOOLS, BED
PANS, WHEELCHAIRS, STETHOSCOPES
AND COUNTLESS OTHER PROJECTS
THAT PATIENTS AND DOCTORS RELY
ON EVERY DAY.
SURGICAL MASKS, GLOVES, BLOOD
PRESSURE MONITORS, SCISSORS,
NEEDLES, LIGHTS, STENTS,
PACEMAKERS, SCALES, SCALPELS,
ANKLE, KNEE AND HIP BRACES AND A
LOT MORE.
THE COST OF ALL THESE PRODUCTS
IS GOING UP, THANKS TO THIS TAX.
SOMEBODY IS GOING TO HAVE TO PAY
FOR IT, AND THAT SOMEBODY IS THE
ALREADY OVERBURDENED AMERICAN
TAXPAYER AND MIDDLE-CLASS
BREADWINNER.
THE PRESIDENT AND HIS SUPPORTERS
SEEM TO THINK YOU CAN SIMPLY TAX
CORPORATIONS AND INDIVIDUALS
WITH IMPUNITY AND FACE NO
ADVERSE ECONOMIC CONSEQUENCES.
YET, ECONOMISTS UNDERSTAND THAT
WHEN YOU TAX THESE COMPANIES,
EMPLOYEES WILL PAY FOR IT IN
LOWER WAGES, THE UNEMPLOYED WILL
PAY FOR IT WITH A JOB THAT WAS
NEVER CREATED AND PATIENTS WILL
PAY FOR IT WITH HIGHER HEALTH
CARE COSTS.
WHATEVER ECONOMIC CIRCUMSTANCES,
THIS TAX IS BAD NEWS BUT IT IS
PARTICULARLY FOOLISH GIVEN THE
PRECARIOUS STATE OF OUR ECONOMIC
RECOVERY.
THE PRESIDENT ONCE LIKED TO TOUT
ALL OF THE JOBS CREATED OR SAVED
BY HIS OVER $800 BILLION
STIMULUS BILL, YET BY SUPPORTING
THE MEDICAL DEVICE TAX, THE
PRESIDENT AND HIS ALLIES HAVE
SHOWN A REAL DISREGARD FOR GOOD,
HIGH-PAYING AMERICAN JOBS.
MEDICAL DEVICE COMPANIES EMPLOY
NEARLY HALF A MILLION PEOPLE.
THEY PAY A SALARY THAT IS NEARLY
AVERAGE.
THESE MANUFACTURERS ARE SMALL
BUSINESSES THAT WE MUST BE
CULTIVATING IN OUR ECONOMY IS
GOING TO RECOVER AND WE'RE GOING
TO BRING -- AND WE'RE GOING TO
BE SUCCESSFUL IN BRINGING DOWN
UNEMPLOYMENT.
ROUGHLY 80% OF MEDICAL DEVICE
COMPANIES HAVE FEWER THAN 50
EMPLOYEES.
98% HAVE FEWER THAN 500
EMPLOYEES.
OBAMACARE'S $28 BILLION TAX HIKE
ON THESE MANUFACTURERS WILL DO
NOTHING TO IMPROVE HEALTH CARE,
BUT IT WILL DO PLENTY TO
UNDERCUT THE VIABILITY OF THESE
COMPANIES THAT PROVIDE GOOD
WAGES AND GOOD OPPORTUNITIES FOR
AMERICAN FAMILIES.
ACCORDING TO ONE RECENT
ANALYSIS, THE MEDICAL DEVICE
INDUSTRY PROVIDED JOBS TO
409,000 EMPLOYEES IN 2009, YET
THIS TAX COULD RESULT IN JOB
OF 43,000.
AND IT WILL HIT CERTAIN STATES
HARDER THAN OTHERS --
CALIFORNIA, FLORIDA, ILLINOIS,
MASSACHUSETTS, MINNESOTA, NEW
JERSEY, NEW YORK, OHIO,
PENNSYLVANIA AND WISCONSIN.
MY STATE AS WELL, THE STATE OF
UTAH.
THE PRESENCE OF MEDICAL DEVICE
MANUFACTURERS IS SIGNIFICANT IN
ALL OF THESE STATES.
THIS NEW TAX WILL ROUGHLY DOUBLE
THE DEVICE INDUSTRY'S TOTAL TAX
BILL AND RAISE ITS AVERAGE
EFFECTIVE CORPORATE INCOME TAX
RATE TO ONE OF THE HIGHEST
EFFECTIVE TAX RATES FACED BY ANY
INDUSTRY IN THE WORLD.
THE PRESIDENT AND HIS ALLIES
FREQUENTLY ATTACK INDUSTRIES
THAT CHOOSE TO MOVE THEIR
OPERATIONS OVERSEAS, BUT THEY DO
NOT SEEM TO GRASP THAT THEIR
POLICIES ARE DRIVING THESE
INDUSTRIES TO DO JUST THAT.
WITH THE ONSET OF THIS NEW TAX,
U.S. DEVICE MANUFACTURERS ARE
INCREASINGLY LIKELY TO CHOOSE
PLANTS IN THE UNITED STATES AND
REPLACE THEM WITH PLANTS IN
FOREIGN COUNTRIES.
TO ANOTHER REPORT BY
THE LEWEN GROUP, THE AMERICAN
TECHNOLOGY INDUSTRY CONTRIBUTES
CONTRIBUTES $382 BILLION IN
ECONOMY EVERY YEAR.
AND PRESIDENT OBAMA IN THE
MIDDLE OF THE WEAK ECONOMY,
FACING HIGH RATES OF
JOBLESSNESS, HAS DECIDED TO
ATTACK THAT INDUSTRY.
IT'S BEWILDERING TO ME.
AND INDUSTRY THAT PAYS WORKERS
ON AVERAGE $84,156, 1.85 TIMES
THE NATIONAL AVERAGE, HAS BECOME
A VICTIM OF THE PRESIDENT'S
DESIRE TO PAY FOR HIS NEW HEALTH
SPENDING LAW.
OR BETTER PUT, THOSE WORKERS AND
THE FAMILIES THEY SUPPORT BECOME
THE VICTIMS OF THE PRESIDENT'S
HEALTH SPENDING LAW.
IN MY OWN HOME STATE OF UTAH,
THE DEVICE TAX IS AN ISSUE OF
THERE ARE OVER 120 MEDICAL
DEVICE COMPANIES IN MY HOME
STATE OF UTAH.
AS THE UTAH TECHNOLOGY COUNCIL
WROTE IN A LETTER TO ME, THESE
COMPANIES -- QUOTE -- "ARE A
VIBRANT PART OF THE UTAH
ECONOMY, PROVIDING HIGH-PAYING,
HIGH-TECH JOBS FOR CITIZENS OF
UNQUOTE.
THEY CERTAINLY ARE ALL OF THAT.
THEY ARE UNDER ASSAULT AS A
RESULT OF THIS TAX.
TARGETED FOR NOTHING OTHER THAN
THEIR SUCCESS AND THE FACT THAT
THEY WERE A SO-CALLED
STAKEHOLDER THAT COULD PAY ITS
SO-CALLED FAIR SHARE TO
SUBSIDIZE THE PRESIDENT'S HEALTH
SPENDING BONANZA.
MR. PRESIDENT, I REQUEST THAT
THAT LETTER BE INCLUDED IN THE
RECORD AT THIS POINT.
WITHOUT
OBJECTION.
JUST YESTERDAY, THE
GOVERNOR OF UTAH, THE HONORABLE
GARY HERBERT, SENT A LETTER TO
CONGRESS ADDRESSING THE NEGATIVE
ECONOMIC IMPACT THIS TAX WILL
HAVE ON OUR STATE.
HE WROTE -- QUOTE -- "AS THE
GOVERNOR OF A STATE WITH A
SIGNIFICANT CONCENTRATION OF
MEDICAL TECHNOLOGY
MANUFACTURERS, I BELIEVE THIS
TAX COULD HARM U.S. GLOBAL
COMPETITIVENESS, STUNT MEDICAL
INNOVATION AND RESULT IN THE
LOSS OF TENS OF THOUSANDS OF
UNQUOTE.
NOW, THERE IS LITTLE DOUBT THAT
THE PRESIDENT'S MEDICAL DEVICE
TAX, ONE THAT UNFORTUNATELY
RECEIVED THE VOTE OF EVERY
DEMOCRAT IN THE SENATE, WILL DO
JUST THAT.
KILL JOBS AND UNDERCUT OUR
ECONOMY.
MR. PRESIDENT, I ASK THAT
GOVERNOR HERBERT'S LETTER BE
POINT.
WITHOUT
OBJECTION, SO ORDERED.
MR. PRESIDENT, THE
PRESIDENT'S HEALTH CARE LAW IS A
TRAVESTY.
THE AMERICAN PEOPLE KNOW IT.
THEY THINK THAT IT IS
FUNDAMENTALLY ILLEGITIMATE,
UNCONSTITUTIONAL TO ITS CORE AND
ENACTED OVER THE DEEP AND LOUD
OBJECTIONS OF CITIZENS AND
TAXPAYERS.
ALL 2,700 PAGES OF THAT LAW MUST
BE STRICKEN FROM THE U.S. CODE
ONE WAY OR ANOTHER.
ELIMINATING ITS MEDICAL DEVICE
TAX IS ABSOLUTELY ESSENTIAL.
IT IS CRITICAL FOR OUR STATES,
FOR OUR ECONOMY AND FOR
AMERICA'S FAMILIES AND WORKERS.
I ASK FOR MY COLLEAGUES TO JOIN
THE REPEAL EFFORT, AND I THANK
MY COLLEAGUES WHO HAVE ALREADY
JOINED AS COSPONSORS.
MR. PRESIDENT, I WOULD LIKE TO
BRIEFLY TOUCH ON ONE OTHER ISSUE
THAT IS OF GREAT IMPORTANCE TO
ME AND TO THE PEOPLE OF UTAH AND
OTHERS ALL OVER THE COUNTRY.
OVER 150 MILLION AMERICANS
REGULARLY CONSUME DIETARY
SUPPLEMENTS AS A MEANS OF
IMPROVING AND MAINTAINING THEIR
THE PASSAGE OF THE DIETARY
SUPPLEMENT HEALTH AND EDUCATION
ACT OR DSHEA, IN 1994 BROUGHT
CLARITY, PREDICTABILITY AND A
BETTER UNDERSTANDING OF WHAT THE
F.D.A. EXPECTED FROM INDUSTRY
AND VICE VERSA.
DSHEA PROVIDES AN APPROPRIATE
STRUCTURE THAT BALANCES THE
RISKS AND BENEFITS TO CONSUMERS
WITH CONTINUED ACCESS AND
UNFORTUNATELY, MY COLLEAGUE FROM
ILLINOIS, SENATOR DURBIN, HAS
FILED AN AMENDMENT TO THE
CURRENT BILL THAT WOULD UNDO
THAT WELL-BALANCED APPROACH.
AS THE AUTHOR OF DHEA, ALONG
WITH MY DEAR FRIEND AND
COLLEAGUE, SENATOR HARKIN IN THE
SENATE, I STRONGLY OPPOSE HIS
AMENDMENT.
IT WOULD REQUIRE FACILITIES
ENGAGED IN THE MANUFACTURING,
PROCESSING, PACKAGING AND
HOLDING OF DIETARY SUPPLEMENTS
TO REGISTER WITH THE F.D.A.,
PROVIDED WITH A LIST OF ALL
INGREDIENTS AS WELL AS A COPY OF
THE LABELING FOR EACH DIETARY
SUPPLEMENT PRODUCT.
ADDITIONALLY, THE FACILITIES
MUST ALSO REGISTER WITH RESPECT
TO NEW, REFORMULATED AND
PRODUCTS.
WHILE I APPRECIATE MY
COLLEAGUE'S COMMITMENT, HIS
AMENDMENT IS BASED ON THE
MISGUIDED PRESUMPTION THAT THE
CURRENT REGULATORY FRAMEWORK FOR
DIETARY SUPPLEMENTS IS FLAWED
AND THAT THE F.D.A. LACKS
AUTHORITY TO REGULATE THESE
PRODUCTS.
THIS IS SIMPLY NOT THE CASE.
PREVIOUS F.D.A. COMMISSIONERS,
INCLUDING DOCTORS JANE HENNEY,
MARK MCCLELLAND, MARK CRAWFORD
AND ANDY VONASHENBACH AND
DR. JOSH SHARPSTING HAVE ALL
AGREED THAT DSHEA PROVIDES A
SUFFICIENT LEVEL OF OVERSIGHT
FOR THIS INDUSTRY.
UNDER DSHEA, CONGRESS SET OUT A
LEGAL DEFINITION OF WHAT COULD
BE MARKETED AS A DIETARY
SUPPLEMENT AND SAFETY STANDARDS
THAT PRODUCTS HAVE TO MEET.
IT ALLOWED THE F.D.A. TO DEVELOP
GOOD MANUFACTURING PRACTICE
AND CLARIFIED WHAT
TYPES OF CLAIMS COULD BE MADE.
AND IT PROVIDED THE SECRETARY OF
HEALTH AND HUMAN SERVICES WITH
THE AUTHORITY TO IMPOSE AN
IMMEDIATE BAN ON ANY DIETARY
SETTLEMENT THAT POSES AN
IMMINENT RISK TO PUBLIC HEALTH.
DSEA ALREADY PROVIDES THE
SECRETARY WITH ENFORCEMENT TOOLS
OF SEIZURE, INJUNCTION OR
CRIMINAL PROSECUTION FOR
INGREDIENTS THAT POSE AN
UNREASONABLE RISK OF ILLNESS OR
INJURY, ARE POISONOUS OR
DELETERIOUS, CONTAIN UNAPPROVED
DRUGS OR FOOD ADDITIVES OR FAIL
TO MEET GOOD MANUFACTURING
PRACTICE STANDARDS.
FURTHERMORE, UNDER THE DIETARY
SUPPLEMENT AND NONPRESCRIPTION
DRUG CONSUMER PROTECTION ACT, A
MANUFACTURER, PACKER OR
DISTRIBUTOR WHOSE NAME APPEARS
ON THE LABEL IS REQUIRED TO
REPORT A SERIOUS ADVERSE EVENT
RELATED TO THE USE OF A
SUPPLEMENT WITHIN 15 BUSINESS
DAYS TO H.H.S., SUBMIT ANY
RELATED MEDICAL INFORMATION
ONE YEAR OF THE
INITIAL REPORT WITHIN 15
BUSINESS DAYS, MAINTAIN RECORDS
RELATED TO EACH REPORT FOR SIX
YEARS AND PERMIT INSPECTION OF
SUCH RECORDS.
TO ME, THAT SOUNDS LIKE A WHOLE
LOT OF REGULATION.
THE F.D.A. ALREADY HAS A
TREMENDOUS AMOUNT OF REGULATORY
OVERSIGHT AND ENFORCEMENT TOOLS
WHEN IT COMES TO DIETARY
SUPPLEMENTS.
YESTERDAY, INSTEAD OF URGING
F.D.A. TO USE ITS CURRENT
ENFORCEMENT AUTHORITY TO FIND
AND PUBLISH THOSE COMPANIES THAT
ARE NOT FOLLOWING THE LAW,
SENATOR DURBIN'S AMENDMENT
SERVES TO PUNISH ALL RESPONSIBLE
MANDATE.
SHOULD I SAY MANDATES.
FINALLY, I WOULD BE REMISS IF I
POINT.
SENATOR DURBIN'S AMENDMENT WOULD
HAVE THE DEVASTATING EFFECT OF
PILING ON MORE WORK FOR AN
UNDERFUNDED AGENCY ALREADY
KEEP ABOVE WATER
WITH ITS CURRENT CORE
RESPONSIBILITIES.
LET ME JUST SAY THIS.
BEFORE WE PASSED DSHEA, THERE
BASICALLY WAS NO REGULATION OVER
THIS INDUSTRY.
WE BROUGHT TOGETHER, SENATOR
HARKIN AND I, THE WHOLE DIETARY
SUPPLEMENT INDUSTRY TO GET
BEHIND DSHEA.
THEY ARE BEHIND IT.
IT TOOK OVER TEN YEARS TO GET
THE GOOD MANUFACTURING PRACTICES
COMPLETED BY F.D.A.
MORE THAN TEN YEARS, AS A MATTER
OF FACT.
BUT WE PROVIDED FOR THEM AND HAD
AGREEMENT.
WE PROVIDE ALL THE TOOLS THAT
ARE NECESSARY TO SUPERVISE AND
REGULATE DIETARY SUPPLEMENTS,
AND TO NOW ADD OTHER OBLIGATIONS
ONTO THIS INDUSTRY IS JUST PLAIN
NOT RIGHT.
I HOPE MY COLLEAGUES IN THE
UNITED STATES SENATE AND THE
HOUSE OF REPRESENTATIVES WILL
RECOGNIZE THAT THIS IS AN
OVERREACH AND NOT PUT UP WITH
WE'RE NOT GOING TO PUT UP WITH
BE VOTING AGAINST
SENATOR DURBIN'S AMENDMENT AND I
URGE ALL OUR COLLEAGUES TO DO
THE SAME.
I'D LIKE TO PAY TRIBUTE TO MY
COLLEAGUE, SENATOR HARKIN FROM
IOWA.
HE WORKED ASSIDUOUSLY ON THIS
BILL ALONG WITH ME.
WE WORKED ALL THE WAY THROUGH
THE SENATE ON A NUMBER OF
OCCASIONS, WE'VE IMPROVED THE
BILL FROM TIME TO TIME, WE'VE
GONE ALONG WITH THE
IMPROVEMENTS, WE'VE DONE
EVERYTHING WE CAN TO PROTECT THE
AMERICAN CITIZENS, EVERYTHING
THAT SHOULD BE DONE, NOTHING
FURTHER NEEDS TO BE DONE.
THIS IS AN INDUSTRY THAT REALLY
DESERVES SUPPORT, NOT
CONDEMNATION.
AND SENATOR HARKIN HAS BEEN
THERE EVERY STEP OF THE WAY.
HE'S A CHAMPION FOR THE DIETARY
SUPPLEMENT INDUSTRY, AS AM I.
BODY.
I THINK IT'S TIME TO QUIT TRYING
TO OVERREGULATE EVERYTHING TO
DEATH AND CAUSE THE COST TO GO
UP BY LEAPS AND BOUNDS.
DIETARY SUPPLEMENTS ARE NOT
INEXPENSIVE TODAY ALTHOUGH THEY
ARE A LOT LESS EXPENSIVE THAN
THEY WOULD BE IF WE KEEP PILING
ON THESE REGULATIONS.
AND FRANKLY, WE BELIEVE THAT WE
HAVE ALL OF THE NECESSARY
LANGUAGE IN LAW TODAY TO PROTECT
THE AMERICAN PUBLIC FROM
DELETERIOUS DIETARY SUPPLEMENTS
AND WE'VE AGAIN F.D.A., THE
FOOD AND DRUG ADMINISTRATION,
ALL THE AUTHORITY THEY NEED,
AND EVERY F.D.A. COMMISSIONER
HAS MET WITH ME, AS I RECALL,
SINCE DSHEA WAS PASSED IN 1994
AND HAVE SAID THAT THEY HAVE
ENOUGH TOOLS TO BE ABLE TO
SUPERVISE THIS INDUSTRY PROPERLY
AND THAT THEY DON'T REALLY NEED
ANYTHING MORE.
TO MAKE A LONG STORY SHORT,
AGAIN, THIS IS AN OVERREACH BY
OUR COLLEAGUE, SINCERE THOUGH
HE MAY BE, IT'S IMPORTANT
TO -- AND AS IMPORTANT AS HE
MAY BE AND I HOPE HE WILL
WITHDRAW HIS AMENDMENT SO WE
DON'T HAVE TO GO THROUGH THIS
AGAIN.
BUT IF HE WON'T, AND I -- THEN
I HOPE ALL OF OUR COLLEAGUES ON
BOTH SIDES OF THE AISLE,
A BIPARTISAN
EFFORT, ON BOTH SIDES OF THE
AISLE WILL RISE UP AND SAY WE'VE
HAD ENOUGH OF THIS AND LET'S
VOTE THESE KIND OF AMENDMENTS
DOWN.
WITH THAT I YIELD THE FLOOR
TO -- I YIELD THE FLOOR.
MR. PRESIDENT?
SENATOR FROM IOWA.
I WANT TO THANK THE
SENATOR FROM UTAH FOR HIS
CONCLUDING REMARKS REGARDING THE
AMENDMENT THAT WILL, I ASSUME
WILL BE OFFERED, IT'S CLEAR TO
ILLINOIS.
I JUST WANT TO, AGAIN, THANK
SENATOR HATCH FOR HIS GREAT
LEADERSHIP ON THE ISSUE OF
MAKING SURE THAT THE AMERICAN
PEOPLE CAN HAVE ACCESS TO
HEALTHY, LIFE-SUPPORTING
VITAMINS, MINERALS,
SUPPLEMENTS, WITHOUT HAVING IT
TO GO THROUGH UNTOLD PROCESSES
AND REVIEWS AND APPROVALS BY
F.D.A. AND ALL THAT KIND OF
REGULATION.
WAS THE LEADER ON
THE DSHEA BILL WHEN WE PASSED IT
I WAS HAPPY TO WORK IN TANDEM
WITH HIM ON THAT.
AND IT HAS PROVEN THROUGH THE
YEARS TO BE OF GREAT SUCCESS FOR
THE AMERICAN PEOPLE.
THE AMERICAN PEOPLE ALL OVER
THIS COUNTRY TAKE VITAMINS AND
SUPPLEMENTS, THEY'RE
HEALTHIER, THEY WANT TO TAKE
CHARGE OF THEIR OWN HEALTH AND
THEY'RE LIVING HEALTHIER BECAUSE
OF THIS.
I JUST -- I SAY TO MY FRIEND
FROM UTAH, I HEARD THE SENATOR
FROM ILLINOIS YESTERDAY HERE ON
THE FLOOR, GIVE A VERY
IMPASSIONED SPEECH ABOUT A VERY
SAD CASE, A YOUNG WOMAN WHO
EVIDENTLY CONSUMED SOME ENERGY
DRINKS WITH A LOT OF CAFFEINE,
SAD STORY.
A VERY SAD STORY.
BUT AS SAD AS THAT IS, YOU
KNOW, YOU CAN'T -- YOU JUST
CAN'T KEEP PEOPLE THAT ABUSE
THINGS.
I'VE SAID THERE ARE PEOPLE WHO
DIE EVERY YEAR FROM ASPIRIN
POISONING, THEY TAKE TOO MANY
ASPIRIN.
SO, YOU KNOW, A REASONABLENESS
HAS TO ENTER INTO THIS.
WE HAVE -- WE'VE WORKED
TOGETHER TO MAKE SURE THAT THE
LABELS ARE GOOD ON ALL OF THESE
THINGS, THAT PEOPLE KNOW WHAT'S
IN THEM, THAT F.D.A. HAS THE
AUTHORITY AS THE SENATOR SAID.
THE F.D.A., EVERY COMMISSIONER
SAID THEY HAVE THE AUTHORITY TO
KEEP DANGEROUS PRODUCTS OFF THE
SHELVES AND REMOVAL
THEMSELVES -- REMOVE THEM FROM
THE SHELVES.
THEY HAVE ALL THAT AUTHORITY.
SO, YOU KNOW, THESE CASES LIKE
SENATOR DURBIN BROUGHT UP,
THEY'RE SAD, VERY SAD AND YOU
WISH IT WEREN'T SO.
BUT I DON'T THINK THAT THAT
LENDS ITSELF THEN TO OVERTURNING
WHAT HAS BEEN WORKING NOW FOR 18
YEARS.
WORKING WELL FOR THE AMERICAN
PEOPLE.
SO I -- I JUST JOIN WITH THE
SENATOR FROM UTAH.
I WOULD HOPE THAT THE AMENDMENT
MIGHT BE -- MIGHT NOT COME UP.
BUT IF IT DOES, IT DOES.
AND I'M SURE THERE WILL BE SOME
DEBATE ON IT.
BUT I WOULD JOIN WITH THE
SENATOR FROM UTAH IN URGING ALL
MEMBERS OF THE SENATE TO -- TO
VOTE THAT AMENDMENT DOWN IF THE
AMENDMENT DOES COME UP, I
WOULD -- I WOULD MOVE TO TABLE
THAT AMENDMENT, BY SAY TO MY
FRIEND FROM UTAH, AND HOPEFULLY
THAT WE CAN APPROACH THIS IN A
MUCH MORE JUDICIOUS,
RESPONSIBLE, THINKING MANNER.
I WOULD JUST SAY TO MY FRIEND
FROM UTAH AND I KNOW HE
AGREASE -- AGREES WITH ME ON
THIS.
I'M SURE WE'RE NOT TAKING THE
POSITION NOTHING CAN EVER BE
CHANGED AND WE'VE CHANGED DSHEA
TO MAKE IT WORK BETTER BUT WE'VE
DONE IT AFTER DUE DELIBERATION
AND THOUGHTFULNESS AND COMMITTEE
HEARINGS AND GOING THROUGH THE
PROCESS TO SEE JUST WHAT THIS
ACCESS TO
THESE PRODUCTS BY THE AMERICAN
PEOPLE TO MAKE SURE THAT WE KEEP
THE INTENT OF DSHEA THERE.
SO, AGAIN, I'M MORE THAN
WILLING AS CHAIRMAN OF THE
COMMITTEE, SENATORS -- USED TO
BE CHAIRMAN OF THE COMMITTEE,
WAS CHAIRMAN AT THAT TIME AND
RANKING MEMBER.
THAT WE'RE ALWAYS WILLING TO
LOOK AT THESE THINGS AND TAKE A
HEARING ON IT AND GET
INFORMATION.
SO, AGAIN, I JUST THANK THE
SENATOR FROM UTAH, HE'S BEEN A
GREAT LEADER ON THIS AND I
APPRECIATE HIS --
I APPRECIATE HIS
LEADERSHIP ON THIS MATTER.
I KNOW SENATOR DURBIN IS VERY
SINCERE BUT MY GOSH, THERE'S
ENOUGH REGULATION AND REGULATORY
AUTHORITY IN THIS BILL AND
INCLUDING THE AMENDMENTS THAT
WE'VE ADDED VOLUNTARILY OVER THE
YEARS TO RESOLVE ANY PROBLEM
THAT EXISTS.
AND FRANKLY, I HOPE EVERYBODY
WILL VOTE AGAINST THE DURBIN
AMENDMENT.
THANK YOU.
I THANK THE SENATOR
FROM UTAH.
MR. PRESIDENT, I --
HOW MUCH TIME IS
REMAINING ON THE BILL?
ON
GENERAL DEBATE, 24 1/2 MINUTES.
I RESERVE THE
BALANCE OF MY TIME ON THE BILL.
I WOULD ASK IF SENATOR DURBIN IS
ON THE FLOOR, IF YOU'D LIKE TO
BRING UP YOUR AMENDMENT THEN AND
WE COULD BEGIN DEBATE ON THE
AMENDMENT.
THE
SENATOR FROM IOWA HAS THE FLOOR.
AGAIN CONSUMING MY TIME ON THE
MINUTES LEFT.
THAT IS
CORRECT.
I WOULD JUST MAKE A
THE BILL.
I'VE TALKED ABOUT IT IN THE
PAST, I DON'T MEAN TO TAKE TOO
MUCH TIME BUT I WANT EVERY
SENATOR TO KNOW THAT WE ARE NOW
ON THE F.D.A. REAUTHORIZATION
BILL.
THIS IS REAUTHORIZING THE
PRESCRIPTION DRUG USER FEE, THE
MEDICAL DEVICE USER FEES, THEN
WE ARE AUTHORIZING A NEW
PROGRAM, THE GENERIC DRUG USER
FEE,
NOW.
THERE ARE 30 MINUTES OF DEBATE
ON EACH AMENDMENT THAT HAS BEEN
LISTED, SENATORS KNOW WHO THEY
ARE AND WHAT THOSE AMENDMENTS
ARE.
I JUST WANT TO MAKE IT VERY
CLEAR THAT THE UNANIMOUS CONSENT
THAT WE JUST ADOPTED SAYS THAT
ALL DEBATE TIME WILL EXPIRE AT
2:00 P.M. TOMORROW.
AT 2:00 P.M. TOMORROW.
SO I SAY TO SENATORS IF YOU WANT
TO TAKE YOUR 30 MINUTES AND
DEBATE YOUR AMENDMENT, NOW IS
THE TIME TO DO IT.
IF YOU WAIT TOO LONG, 2:00 WILL
COME TOMORROW, YOU WON'T HAVE
THE TIME AND YOU'LL BE LIMITED
TO ONE MINUTE.
THERE WILL BE TWO MINUTES ON
EACH AMENDMENT AFTER THAT, SO
YOU'D BE LIMITED TO JUST ONE
THOSE WHO HAVE AMENDMENTS AND
WISH TO DISCUSS THEM, YOU'RE
GUARANTEED AT LEAST 30 MINUTES
BUT ALL TIME RUNS OUT AT
2:00 P.M. TOMORROW.
I SAY TO SENATORS, AGAIN, IF
YOU'D LIKE TO TALK ON YOUR
AMENDMENT AND MAKE YOUR POINTS,
NOW'S THE TIME TO DO IT, THIS
AFTERNOON.
SO, MR. PRESIDENT, I YIELD THE
FLOOR.
MADAM PRESIDENT?
THE
SENATOR FROM ILLINOIS.
I HAVE AN AMENDMENT
PENDING AND I CALL UP AMENDMENT
2124.
WILL REPORT.
THE SENATOR FROM
ILLINOIS, MR. DURBIN, PROPOSES
AMENDMENT NUMBERED 2127.
THE
SENATOR IS RECOGNIZED.
VERY STRAIGHTFORWARD.
I'M NOT GOING TO ASK FOR A SHOW
OF HANDS AMONG MONICA SENATORS
OR STAFF, HOW MANY OF US GOT UP
AND TOOK A VITAMIN PILL BUT I'LL
SAY THIS SENATOR DID.
I DIDN'T HAVE A PRESCRIPTION FOR
MY VITAMIN PILL, I BOUGHT IT
VOLUNTARILY, I DON'T KNOW IF IT
DOES ANY GOOD BUT IT'S MY
DECISION.
I THINK THAT'S A GOOD THING.
THE FOOD AND DRUG ADMINISTRATION
IS AN AGENCY WHICH TAKES A LOOK
AT WHAT WE BUY AND WHAT WE
CONSUME.
RESPONSIBILITY.
WHEN IT COMES TO CERTAIN THINGS
LIKE PRESCRIPTION DRUGS, THEY
TEST THEM.
MAYBE THE PHARMACEUTICAL COMPANY
ACTUALLY DOES THE TESTING BUT
F.D.A. MONITORS TO MAKE SURE
THAT WHAT IS GIVEN TO YOU BY
YOUR DOCTOR IS SAFE, WON'T KILL
YOU, AND EFFECTIVE, DOES WHAT
IT SAYS IT'S GOING TO DO.
SAME THING TRUE FOR
OVER-THE-COUNTER DRUGS.
THE FOOD AND DRUG ADMINISTRATION
HAS THAT RESPONSIBILITY.
AND WHEN IT COMES TO THE
INGREDIENTS, THE DOSAGE, THOSE
SORTS OF THINGS ARE ESTABLISHED
THROUGH THE FOOD AND DRUG
ADMINISTRATION BASED ON
DISCLOSURES BY THE COMPANIES,
TESTING, EXPERIENCE, IT'S ALL
THERE.
BUT THERE'S ANOTHER WORLD OUT
THERE, COMPLETELY DIFFERENT
WORLD CALLED DIETARY SUPPLEMENTS
WHICH INCLUDES THE VITAMIN PILL
I TOOK THIS MORNING AS DID THE
THAT ISN'T MUCH -- IS A MUCH
DIFFERENT WORLD.
IT IS A WORLD WITH LESS
DISCLOSURE, LESS TRANSPARENCY,
AND FAR LESS REGULATION.
IN FACT, IN FACT, THERE IS NO
REQUIREMENT IN THE LAW TODAY,
NONE, THAT THE PEOPLE WHO SELL
US DIETARY SUPPLEMENTS HAVE TO
REGISTER WITH THE FOOD AND DRUG
ADMINISTRATION THE NAME OF THEIR
PRODUCT, THE INGREDIENTS IT
LABEL.
THAT'S WHAT MY AMENDMENT SAYS.
WE DON'T REQUIRE ANY TESTING BY
DIETARY SUPPLEMENT COMPANIES.
WE DON'T REQUIRE ANY ASSERTIONS
OF SAFETY.
JUST SIMPLY THAT THEY REGISTER
WITH THE F.D.A. THAT THEY'RE
SELLING IN AMERICA.
SO THAT TO ME SEEMS LIKE A
PRETTY BASIC THING.
AND IT ISN'T MY IDEA.
IT ISN'T AN ORIGINAL IDEA.
IT COMES FROM A REPORT FROM THE
GENERAL ACCOUNTABILITY OFFICE IN
HERE'S WHAT THEY RECOMMENDED
AFTER THEY MADE A REVIEW OF THE
SAFETY ISSUES WITH THE FOOD AND
TO IMPROVE THE INFORMATION
AVAILABLE TO F.D.A. FOR
IDENTIFYING SAFETY CONCERNS AND
BETTER ENABLE F.D.A. TO MEET ITS
RESPONSIBILITY TO PROMOTE THE
PUBLIC HEALTH, WE, THE
G.A.O., RECOMMEND THAT THE
SECRETARY OF DEPARTMENT OF
HEALTH AND HUMAN SERVICES DIRECT
THE COMMISSIONER OF THE F.D.A.
TO REQUEST AUTHORITY TO REQUIRE
DIETARY SUPPLEMENT COMPANIES TO
IDENTIFY THEMSELVES AS A DIETARY
SUPPLEMENT COMPANY, AS PART OF
EXISTING REGISTRATION
REQUIREMENTS AND UPDATE THIS
INFORMATION ANNUALLY, PROVIDE A
LIST OF ALL DIETARY SUPPLEMENT
PRODUCTS THEY SELL AND A COPY OF
THE LAIBILITIES AND UPDATE THIS
INFORMATION ANNUALLY AND REPORT
ALL ADVERSE EVENTS RELATED TO
THE DIETARY SUPPLEMENTS.
IN OTHER WORDS, DID YOU TAKE
THE PILL AND GET SICK.
DOES THAT SEEM LIKE AN ONEROUS,
HEF-HANDED, BIG-GOVERNMENT,
OVERREGULATION OF AN INDUSTRY?
REMEMBER, THE DIETARY
SUPPLEMENT COMPANIES ARE NOT ALL
BASED IN THE UNITED STATES.
THERE ARE PRODUCTS SITTING ON
THE SHELF WHICH IF YOU DON'T
LOOK CAREFULLY YOU MAY NOT KNOW
COME FROM A LOT OF OTHER
COUNTRIES, INCLUDING CHINA.
SO DO WE WANT TO KNOW?
WHEN YOU GO IN THE VITAMIN
STORE, WOULD YOU LIKE TO KNOW
THAT THE COMPANY THAT'S SELLING
YOU WHATEVER IT IS IS AT LEAST
REGISTERED IN THE UNITED STATES?
IS THAT TOO MUCH TO ASK, THAT
IF YOU'RE GOING TO SELL THE
PRODUCT IN THE UNITED STATES,
YOU HAVE TO REGISTER WITH THE
F.D.A. AND TELL WAS THE
INGREDIENTS ARE?
THAT TO ME SEEMS PRETTY BASIC
AND I'LL BET YOU 99% OF AMERICAN
PEOPLE THOUGHT I THOUGHT THEY
ALREADY DID THAT.
NO, THEY DON'T.
NO REQUIREMENT IN THE LAW.
DIETARY SUPPLEMENT IS OUTSIDE
THE LAW.
LET ME TELL YOU DIETARY
SUPPLEMENTS GO BEYOND THE
VITAMIN PILL.
YESTERDAY I TOLD THE STORY ON
THE FLOOR, 16-YEAR-OLD GIRL IN
HAGERSTOWN, MARYLAND, SHE
EVER SEEN THEM?
WHEN YOU GO IN THE STORE YOU SEE
COKES AND ALL THOSE THINGS AND
THERE'S A MONSTER ENERGY DRINK.
THERE.
SHE DRANK TWO OF THEM AND DIED.
KILLED HER.
CARDIAC ARREST.
I MET WITH HER MOM YESTERDAY.
SHE SAID I RAN IN THERE, HER
BOYFRIEND SAID SHE STOPPED
BREATHING WHILE WEECHG TV.
THEY TOOK HER TO THE HOSPITAL,
GOT HER BACK TO LIFE FOR A
LITTLE WHILE AND SHE LINGERED
AND DIED A FEW DAYS LATER.
IT WAS A DIETARY SUPPLEMENT.
IS IT TOO MUCH TO ASK THE
COMPANY MAKING THE MONSTER
ENERGY DRINK TO REGISTER WITH
THE F.D.A. AND TELL US WHAT THE
INGREDIENTS ARE IN THAT DRINK?
IS THAT THE HEAVY HAND OF
GOVERNMENT?
I DON'T THINK SO.
BECAUSE HERE'S A WHAT WE FOUND.
SOMETIMES INGREDIENTS THAT MAY
APPEAR TO BE BENIGN AND OKAY
TODAY TURN OUT TO BE DANGEROUS
WHEN YOU LOOK AT THEM MORE
CAREFULLY AND MORE CLOSELY AND
MAYBE MORE DANGEROUS FOR PEOPLE
WHO ARE YOUNGER OR PREGNANT OR
IN A COMPROMISED IMMUNE
SITUATION.
SO THIS AMENDMENT BASICALLY SAYS
AMERICAN CONSUMERS HAVE THE
RIGHT TO KNOW THAT THE DIETARY
SUPPLEMENT SITTING ON THE SHELF
HAS AT LEAST SHOWN UP AND
REGISTERED WITH THE F.D.A.
I HEARD SENATOR HATCH AND
SENATOR HARKIN SAY THIS JUST
GOES TOO FAR.
IT'S TOO MUCH TO ASK.
I THINK THEY'RE WRONG.
MANUFACTURERS ALREADY, SOME
SAY, ALREADY VOLUNTARILY
PROVIDE PRODUCT LABELS THIS TO
THE NATIONAL INSTITUTES OF
IT'S TRUE BUT IT'S A VOLUNTARY
SYSTEM.
GOOD ACTORS SHARE THEIR LABELS
WITH THE N.I.H. BUT THE BAD
ACTORS DON'T.
N.I.H. IS IN THE PROCESS OF
BUILDING A LABEL DATA BASE THAT
CURRENTLY HAS 7,500 --
7,500 -- DIETARY SUPPLEMENT
LABELS.
DO YOU KNOW HOW MANY PRODUCTS
ARE ON THE MARKET?
THEY HAVE 7,500 BE LABELS.
75,000.
75,000.
SO 10% OF VOLUNTEERING THIS
SO TO SAY THE N.I.H. ALREADY HAS
THE INFORMATION IS 90% WRONG.
REQUIRING REGISTRATION THEY SAY
OF THESE LABELS IS JUST TOO MUCH
WORK FOR THE F.D.A.
AS A MATTER OF FACT, THE F.D.A.
RESPONDED TO THE G.A.O.
RECOMMENDATION AND SAID WE AGREE
THE AGENCY'S ABUILT TO ENSURE
THE SAFETY OF DIETARY
SUPPLEMENTS USED BY CONSUMERS
WOULD BE IMPROVED IF F.D.A. HAD
MORE INFORMATION ON THE IDENTITY
OF FIRMS MARKETING DIETARY
SUPPLEMENTS AS WELL AS THE
IDENTITY AND COMPOSITIONS OF THE
PRODUCTS THEY MARKET.
THE F.D.A.
SAID WE WANT THIS INFORMATION TO
KEEP AMERICANS SAFE.
SO TO ARGUE THAT THIS IS A
BURDEN WE SHOULDN'T PUT ON THE
F.D.A., THEY ASKED FOR IT.
THE OTHER THING IS ABOUT HOW
MANY SUPPLEMENTS ARE BEING SAID
IN THE UNITED STATES.
I SAID 5,000.
THAT WAS THE ESTIMATE IN --
I SAID 75,000.
THAT WAS THE ESTIMATE IN 2008.
THE NUMBER I'M AFRAID IS MUCH
AND IN TERMS OF HOW MANY COME ON
THE MARKET EACH YEAR, IT'S JUST
A GUESS -- IT'S A WILD GUESS
BECAUSE IT'S THE WILD WEST, IT'S
AN OPEN MARKET.
ANY COUNTRY THAT WANTS TO EXPORT
THEIR DIETARY SUPPLEMENT TO THE
UNITED STATES, WHETHER IT'S FROM
CHINA OR INDIA OR AFRICA OR
EUROPE OR MEXICO, BE MY GUEST.
YOU DON'T EVEN HAVE TO SHOW UP
AND REGISTER WITH 9 F.D.A.
IT'S A --
REGISTER WITH THE F.D.A.
IT'S A SIMPLE AMENDMENT.
IT JUST SAYS IF YOU WANT TO DO
BUSINESS IN THE U.S., SELL YOUR
DIETARY SUPPLEMENT, TELL US WHO
YOU ARE, TELL US WHAT IT LOOKS
SAYS.
IT'S NOT TOO MUCH TO PROTECT
FAMILIES FROM HARMFUL
I RESERVE THE BALANCE OF MY
TIME.
MR. PRESIDENT, I ASK UNANIMOUS
CONSENT THAT THE TIME SENATOR
HATCH USED BE COUNTED
RETROACTIVELY AGAINST THE TIME
IN OPPOSITION TO MY AMENDMENT
NUMBER 2127.
WITHOUT
OBJECTION.
SO ORDERED.