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NATIONAL CAPTIONING INSTITUTE,
INC., IN COOPERATION WITH THE
REPRESENTATIVES.
UNITED STATES HOUSE OF
ANY USE OF THE CLOSED-CAPTIONED
COVERAGE OF THE HOUSE
PROCEEDINGS FOR POLITICAL OR
COMMERCIAL PURPOSES IS EXPRESSLY
PROHIBITED BY THE U.S. HOUSE OF
REPRESENTATIVES.]
ON
THIS VOTE THE YEAS ARE 245.
THE NAYS ARE 178.
THE RESOLUTION IS ADOPTED.
WITHOUT OBJECTION, THE MOTION
TO RECONSIDER IS LAID ON THE
TABLE.
THE UNFINISHED BUSINESS IS THE
VOTE ON THE MOTION TO INSTRUCT
ON H.R. 4348 OFFERED BY THE
GENTLEMAN FROM MINNESOTA, MR.
WALZ, ON WHICH THE YEAS AND
NAYS WERE ORDERED.
MOTION.
THE CLERK WILL REDESIGNATE THE
MOTION TO INSTRUCT
CONFEREES ON H.R. 4348 OFFERED
BY MR. WALZ OF MINNESOTA.
THE
INSTRUCT.
QUESTION IS ON THE MOTION TO
MEMBERS WILL RECORD THEIR VOTES
BY ELECTRONIC DEVICE.
THIS WILL BE A FIVE-MINUTE
VOTE.
[CAPTIONING MADE POSSIBLE BY
THE NATIONAL CAPTIONING
INSTITUTE, INC., IN COOPERATION
REPRESENTATIVES.
WITH THE UNITED STATES HOUSE OF
ANY USE OF THE CLOSED-CAPTIONED
COVERAGE OF THE HOUSE
PROCEEDINGS FOR POLITICAL OR
COMMERCIAL PURPOSES IS
EXPRESSLY PROHIBITED BY THE
U.S. HOUSE OF REPRESENTATIVES.]
ON
THIS VOTE THE YEAS ARE --
ON
THIS VOTE THE YEAS ARE 386 AND
THE NAYS ARE 34, ONE VOTING
PRESENT.
WITHOUT OBJECTION, THE MOTION
TO RECONSIDER IS LAID ON THE
TABLE.
FOR WHAT PURPOSE DOES THE
GENTLEMAN FROM MARYLAND RISE?
MR. SPEAKER, THE
HOUSE IS NOT IN ORDER.
THE
GENTLEMAN IS CORRECT.
THE HOUSE IS NOT IN ORDER.
PLEASE TAKE YOUR CONVERSATIONS
OFF OF THE FLOOR.
PLEASE TAKE YOUR CONVERSATIONS
OFF THE FLOOR.
WOULD YOU PLEASE TAKE YOUR
CONVERSATIONS OFF THE FLOOR,
PLEASE?
RECOGNIZED.
THE GENTLEMAN FROM MARYLAND IS
THANK YOU, MR.
SPEAKER.
PURSUANT TO CLAUSE 6-C OF RULE
22, I HEREBY GIVE NOTICE OF MY
INTENTION TO OFFER A MOTION TO
INSTRUCT CONFEREES ON H.R.
4348.
THE MOTION TO INSTRUCT
CONFEREES READS AS FOLLOWS, MR.
SPEAKER.
I MOVE THAT THE MANAGERS ON THE
PART OF THE HOUSE OF THE
CONFERENCE ON THE DISAGREEING
VOTES OF THE TWO HOUSES ON THE
SENATE AMENDMENT TO H.R. 4348
BE INSTRUCTED TO PROCEED FROM
DISAGREEMENT TO THE AMENDMENTS
TO THE AMENDMENT OF THE SENATE.
THE
GENTLEMAN'S NOTICE WILL APPEAR
IN THE RECORD.
THANK YOU, MR.
SPEAKER.
FOR
WHAT PURPOSE DOES THE
GENTLELADY FROM TENNESSEE RISE?
THANK YOU, MR.
SPEAKER.
PURSUANT TO CLAUSE 7-C OF RULE
22, I OFFER A MOTION TO
INSTRUCT CONFEREES.
FOLLOWS.
THE FORM OF THE MOTION IS AS
I MOVE THAT THE CONFERENCE ON
THE DISAGREEING VOTES ON THE
TWO HOUSES OF THE SENATE
AMENDMENT TO H.R. 4348 BE
INSTRUCTED TO REJECT SECTION
31108 OF THE SENATE AMENDMENT
RELATED TO DISTRACTED DRIVING
GRANT OTHER THAN THE MATTER
PROPOSED TO BE INSERTED AS
SECTION 411-G OF TITLE 23,
UNITED STATES CODE.
RELATED TO DISTRACTED DRIVING
STUDY.
THE
THE GENTLELADY'S NOTICE WILL BE
RECORDED IN THE RECORD.
THANK YOU, MR.
PURSUANT
SPEAKER.
PURSUANT TO CLAUSE 8 OF RULE
20, THE CHAIR WILL POSTPONE
FURTHER PROCEEDINGS TODAY ON
THE MOTION TO SUSPEND THE RULES
ON WHICH A RECORDED VOTE OR THE
YEAS AND NAYS ARE ORDERED OR ON
WHICH THE VOTE INCURS OBJECTION
UNDER CLAUSE 6 OF RULE 20.
ANY RECORDED VOTE ON THE
POSTPONED QUESTION WILL BE
TAKEN LATER.
FOR WHAT PURPOSE DOES THE
GENTLEMAN FROM MICHIGAN SEEK
RECOGNITION?
MR. SPEAKER, I MOVE
TO SUSPEND THE RULES AND PASS
S. 3187 AS AMENDED.
THE
CLERK WILL REPORT THE TITLE OF
THE BILL.
SENATE 3187, AN ACT
TO AMEND THE FOOD, DRUG AND
COSMETIC ACT TO EXTEND THE USER
FEE FRAMS FOR PRESCRIPTION
DRUGS AND MEDICAL DEVICES, TO
ESTABLISH USER FEE PROGRAMS FOR
GENERIC DRUGS AND BIOSIMILARS
AND FOR OTHER PURPOSES.
PURSUANT TO THE RULE, THE
GENTLEMAN FROM MICHIGAN, MR.
UPTON, AND THE GENTLEMAN FROM
CALIFORNIA, MR. WAXMAN, EACH
WILL CONTROL 20 MINUTES.
GENTLEMAN FROM MICHIGAN.
THE CHAIR RECOGNIZES THE
MR. SPEAKER, I'D ASK
UNANIMOUS CONSENT THAT ALL
MEMBERS MAY HAVE FIVE
LEGISLATIVE DAYS TO REVISE AND
EXTEND THEIR REMARKS AND INSERT
EXTRANEOUS MATERIALS IN THE
RECORD.
WITHOUT OBJECTION.
MR. SPEAKER, I YIELD
MYSELF TWO MINUTES.
THE
GENTLEMAN IS RECOGNIZED.
MR. SPEAKER, I WANT
TO THANK MR. WAXMAN, CHAIRMAN
HARKIN, SENATOR ENS EAND
MEMBERS ON BOTH SIDES OF THE
AISLE IN BOTH THE HOUSE AND
SENATE WHO PLAYED A ROLE IN
THIS PROCESS.
S. 3187 IS A REFLECTION OF THE
HARD WORK PUT IN BY BOTH
MEMBERS AND STAFF.
AND OF EVERYONE'S WILLINGNESS
TO PUT PART SANSHIP ASIDE TO
LOOK AT THE ISSUES TOGETHER.
AND BECAUSE OF THAT OUTSTANDING
DEDICATION, WE HAVE A BILL
TODAY THAT WILL MAKE A REAL
DIFFERENCE IN THE LIVES OF SO
MANY PATIENTS AND PROVIDE
MUCH-NEEDED SUPPORT FOR
INNOVATORS ACROSS OUR GREAT
COUNTRY.
AT THE OUTSET OF THIS CONGRESS,
I SET A GOAL OF ENACTING THIS
BILL BY THE END OF JUNE, AND
HERE WE ARE.
WELL BEFORE THE CLOCK HAS
EXPIRED FOR THIS MONTH.
IN ORDER TO PROVIDE CERTAINTY
FOR AMERICAN PATIENTS AND
INNOVATORS.
I NEVER LOST CONFIDENCE THAT WE
COULD DELIVER THE BIPARTISAN
REFORMS THAT WE NEEDED AND I AM
SO PROUD THAT WE WILL
ACCOMPLISH THAT GOAL.
MR. SPEAKER, THIS IS, THIS IS A
JOBS BILL, AND IT'S A MEDICAL
INNOVATION BILL AND AS WE PUT
THIS PACKAGE TOGETHER OUR GOAL
IS TO IMPROVE THE
PREDICTABILITY, CONSISTENCY,
TRANSPARENCY AND EFFICIENCY OF
F.D.A. REGULATION.
THESE REFORMS WILL HELP GET NEW
TREATMENTS TO PATIENTS MORE
QUICKLY.
IT WILL HELP US NOT ONLY KEEP
JOBS IN MICHIGAN AND ALL ACROSS
NEW ONES.
THE COUNTRY BUT ALSO TO CREATE
IN ORDER TO GET IT RIGHT WE
TURN TO PATIENTS, INNOVATORS,
JOB CREATORS WHO PROVIDED
FIRSTHAND EXPERIENCE OF HOW THE
CURRENT SYSTEM IS BROKEN, AND
WE INCLUDED MANY OF THEIR
SUGGESTIONS IN THE BILL.
THIS BILL INCLUDES SIGNIFICANT
ACCOUNTABILITY AND REFORM
MEASURES DESIGNED TO HOLD THE
F.D.A. RESPONSIBLE FOR ITS
PERFORMANCE.
THE MEASURE INCLUDES
INDEPENDENT ASSESSMENTS OF
F.D.A.'S DRUG AND DEVICE REVIEW
PROCESS.
IT ALSO INCLUDES REQUIRING
QUARTERLY REPORTING FROM THE
DEVICE CENTER SO WE DON'T HAVE
TO WAIT A YEAR TO FIND OUT
F.D.A.'S PROGRESS.
THE BILL IS ABOUT PATIENTS, AND
THAT'S WHY SO MANY PATIENT
ADVOCATES HAVE SPOKEN OUT IN
SUPPORT OF THESE REFORMS.
WHETHER IT'S THE STEPS WE TOOK
TO SUPPORT TREATMENTS FOR RARE
DISEASES OR MITIGATE DRUG
SHORTAGES OR SPEED UP THE
APPROVAL OF DEVICES THAT WILL
IMPROVE PATIENT'S QUALITY OF
LIFE, THESE ARE STEPS THAT WILL
DIFFERENCE.
MAKE A REAL AND SIGNIFICANT
THEY WILL KEEP THE U.S. AT THE
FOREFRONT OF MEDICAL INNOVATION
WHERE WE BELONG.
STEP.
THIS BILL IS JUST THE FIRST
THIS BILL PROVIDES THE
RESOURCES AND THE GAME PLAN SO
PERFORMANCE.
THAT F.D.A. CAN IMPROVE ITS
IT'S NOW -- I YIELD MYSELF AN
ADDITIONAL MINUTE.
THE
GENTLEMAN IS RECOGNIZED FOR ONE
MINUTE.
IS NOW UP TO THE
F.D.A. TO EXECUTE THAT GAME
PLAN, AND I GIVE MY COMMITMENT
TODAY THAT OUR COMMITTEE WILL
CONTINUE TO MONITOR AND HOLD
PERFORMANCE.
THE F.D.A. ACCOUNTABLE FOR ITS
SO TOGETHER, THE MEMBERS OF THE
HOUSE AND SENATE HAVE PRODUCED
A BILL THAT IS A WIN FOR
AMERICAN PATIENTS, INNOVATION
AND JOB CREATION.
BEFORE I CONCLUDE, I'D LIKE TO
RECOGNIZE WARREN BURKE, MEGAN
FROM THE LEGISLATIVE COUNSEL
OFFICE, THE ROLE OF LEGISLATIVE
COUNSEL GOES UNNOTICED.
ALSO APPRECIATE OUR STAFF
DIRECTOR, GARY, FOR PUSHING
STARTING WITH OUR STAFF
THIS LEGISLATION OVER THE
FINISH LINE, CLAY ON THE
MAJORITY STAFF, RACHEL,
MINORITY STAFF, AND PARTICULAR,
RYAN, THE CHIEF COUNSEL FOR THE
.
HEALTH SUBCOMMITTEE.
AMERICAN WORKERS WILL KEEP US ON
EDGE OF MEDICAL
INNOVATION AND I RESERVE THE
BALANCE OF MY TIME.
THE
GENTLEMAN RESERVES.
THE GENTLEMAN FROM CALIFORNIA.
MR. SPEAKER, I YIELD
MYSELF THREE MINUTES.
THE
GENTLEMAN IS RECOGNIZED FOR
THREE MINUTES.
TODAY THE HOUSE
CONSIDERS A BILL THAT REPRESENTS
A SIGNIFICANT BIPARTISAN AND
BICAMERAL ACHIEVEMENT.
ON MAY 30 THIS YEAR, THE HOUSE
PASSED ITS USER FEE LEGISLATION
BY A DRAMATIC VOTE OF 387-5.
THAT BILL WAS A STRONG ONE.
BUT THROUGH OUR COLLABORATIVE
PROCESS WITH THE SENATE, WE HAVE
MADE IT EVEN BETTER.
IT HAS BEEN A PLEASURE TO WORK
NOT ONLY WITH MR. UPTON, MR.
DINGELL AMONG MANY INVOLVED
PITTS, MR. PALLONE, AND MR.
HOUSE COLLEAGUES, BUT ALSO WITH
OUR SENATE COLLEAGUES, SENATOR
HARKIN AND INSY.
-- ENZI.
WHEN WE BEGAN THIS PROCESS THERE
WERE DIVERGENT VIEWS ON THE
VARIOUS ISSUES CONTAINED IN THIS
BILL, BUT WE WORK TOGETHER AND
WE FOUND WAYS TO BRIDGE OUR
DIFFERENCES IN A FASHION THAT
PROTECTS PATIENTS AND FOSSERS
INNOVATION.
THIS -- FOSTERS INNOVATION.
THIS LEGISLATION CONTAINS MANY
PROVISIONS CRIT CRITICAL TO THE
FUNDING OF MAJOR PARTS OF THE
F.D.A.
WE RE-AUTHORIZE THE F.D.A. DRUG
AND MEDICAL DEVICE USER FEE
PROGRAM WHICH WILL PROVIDE
RESOURCES TO ENABLE THE
EFFICIENT REVIEW OF APPLICATIONS
AND GIVE PATIENTS RAPID ACCESS
TO NEW THERAPIES.
WE ALSO RE-AUTHORIZING TWO
PEDIATRIC PROGRAMS WHICH FOSTER
THE DEVELOPMENT AND SAFE USE OF
PRESCRIPTION DRUGS IN CHILDREN.
THIS YEAR WE ARE ESTABLISHING
TWO NEW PROGRAMS TO HELP F.D.A.
SPEED UP THEIR REVIEW OF NEW
GENERICS AND BIOSIMILARS.
THESE PROVISIONS HAVE A
BIPARTISAN COMMITMENT TO
ENSURING A VIBRANT GENERIC
MARKETPLACE AND ALL OF US WILL
SEE THE BENEFITS WHEN MORE
LOW-COST GENERICS ARE ON THE
MARKET.
ONE OF THE MOST IMPORTANT
IMPROVEMENTS OF THE HOUSE PASSED
BILL IS IN THE AREA OF
ANTIBIOTICS.
WE ACCEPTED THE SENATE LANGUAGE
THAT DIRECTS INCENTIVES FOR THE
DEVELOPMENT OF ANTIBIOTICS
TOWARD SERIOUS AND LIFE
THREATENING INFECTIONS.
THIS BILL ALSO INCLUDES
PROVISIONS TO MODERNIZE F.D.A.'S
AUTHORITIES WITH RESPECT TO THE
DRUG SUPPLY CHAIN.
TODAY 80% OF ACTIVE INGREDIENTS
AND BULK CHEMICALS USING U.S.
DRUGS COME FROM ABROAD.
AND 40% OF FINISH DRUGS ARE
MANUFACTURED ABROAD.
F.D.A. IS TRYING TO KEEP PACE
WITH THIS INCREEDINGLY
GLOBALIZED DRUG SUPPLY CHAIN
USING AN OUTDATED STATUTE.
THIS LEGISLATION WILL GIVE THE
F.D.A. CRITICAL NEW TOOLS TO
POLICE THIS DRAMATICALLY
DIFFERENT MARKETPLACE.
WE HAVE ALSO WORKED TO ADDRESS
THE AREA OF DRUG SHORTAGES WHICH
IS A COMPLEX AND MULTIFACETED
PROBLEM.
BUT THIS LEGISLATION TAKES
SENSIBLE FIRST STEPS.
I WANT TO THANK MY COLLEAGUES ON
BOTH SIDES OF THE AISLE ON THEIR
STAFFS FOR THE HARD WORK THEY
PUT INTO MAKING THIS A STRONG
BIPARTISAN BILL.
I PARTICULARLY WANT TO THANK MR.
PALLONE AND MR. DINGELL'S STAFF
MEMBERS, TIFFANY AND TIM AS WELL
AS MR. UPTON AND MR. PITTS'
STAFF, RYAN AND CLAY.
LEGISLATIVE COUNSEL, WARREN AND
MEGAN -- ADDITIONAL 30 SECONDS I
YIELD TO MYSELF.
WARREN AND MORGAN HAVE DONE
TREMENDOUS WORK ON THIS BILL.
I'D LIKE TO EXPRESS MY
APPRECIATION FOR THEIR EFFORT.
I WANT TO THANK MY OWN STAFF,
KAREN, RACHEL, ERIC, AND ALAN.
THE AMERICAN PUBLIC WILL BENEFIT
BILL.
FROM THE PROVISIONS OF THIS
THE F.D.A. WILL HAVE THE
RESOURCES TO REMAIN THE GOLD
STANDARD FOR THE FUTURE.
THIS IS IMPORTANT BILL, A GOOD
ONE.
I URGE ITS SUPPORT.
I RESERVE THE BALANCE OF MY
TIME.
THE
GENTLEMAN RESERVES.
THE GENTLEMAN FROM MICHIGAN.
I YIELD ONE MINUTE TO
THE CHAIRMAN EMERITUS TO THE
ENERGY AND COMMERCE COMMITTEE,
BARTON.
THE GENTLEMAN FROM TEXAS, MR.
THE
GENTLEMAN IS RECOGNIZED FOR ONE
MINUTE.
I THANK THE
DISTINGUISHED CHAIRMAN.
I ASK UNANIMOUS CONSENT TO
REVISE AND EXTEND MY REMARKS.
WITHOUT
OBJECTION.
MR. SPEAKER, I RISE
IN STRONG SUPPORT OF THIS BILL.
WHEN THE AMERICAN PUBLIC ASKED
WHY CAN'T CONGRESS JUST WORK
TOGETHER, WE SHOULD HOLD THIS
BILL UP AS EXHIBIT NUMBER A THAT
IT IS POSSIBLE.
AS THE RANKING MEMBER JUST
POINTED OUT, THIS IS A
BIPARTISAN, BICAMERAL
PRECONFERENCE AGREEMENT FOR A
VERY COMPLICATED BILL.
WE RE-AUTHORIZE THE FOOD AND
DRUG ADMINISTRATION USER FEE
PROGRAM FOR FIVE YEARS.
WE ALSO RE-AUTHORIZED THE
MEDICAL DEVICE USER FEE PROGRAM
FOR FIVE YEARS.
AND I BELIEVE FOR THE FIRST TIME
DO ONE FOR GENERIC AND
BIOSIMLARS.
THIS IS A COMPLICATED, COMPLEX
PIECE OF LEGISLATION, BUT IT HAS
AGREEMENT.
BEEN WORKED OUT IN A BIPARTISAN
I HAVE HAD SOME CONCERNS ABOUT
THE EXTENT AND THE COST OF THE
USER FEES.
I WILL CONTINUE TO MONITOR THAT,
MR. SPEAKER.
BUT THIS IS A GOOD PIECE OF
LEGISLATION.
THE CHAIRMAN AND RANKING MEMBER
AND THE COMMITTEE CHAIRMAN AND
RANKING MEMBER AND ALL THE
OTHERS WHO HAVE WORKED ON THIS
SHOULD BE COMMENDED.
THIS IS AN EXCELLENT BILL AND I
HOPE THAT THE CONGRESS WILL
UNANIMOUSLY SUPPORT IT AND THE
SENATE WILL AGREE WHEN WE SEND
IT TO THE OTHER BODY.
THANK YOU.
THE
GENTLEMAN FROM CALIFORNIA.
AT THIS TIME I'D
LIKE TO YIELD THREE MINUTES TO
THE GENTLEMAN FROM NEW JERSEY,
MR. PALLONE, THE RANKING MEMBER
OF THE HEALTH SUBCOMMITTEE THAT
WAS RESPONSIBLE FOR THIS
LEGISLATION IN ITS FIRST
I'D LIKE TO ASK UNANIMOUS
INSTANCE.
CONSENT THAT MR. PALLONE BE
PERMITTED TO MANAGE THE REST OF
THE TIME ON OUR SIDE OF THE
AISLE.
WITHOUT
OBJECTION.
THE GENTLEMAN IS RECOGNIZED FOR
THREE MINUTES.
THANK YOU, MR.
SPEAKER.
AND THANK YOU, CHAIRMAN WAXMAN.
TO SAY I'M VERY PROUD TO
SUPPORT THE BILL BEFORE US WHICH
WOULD RE-AUTHORIZE AND
REVITALIZE A NUMBER OF DIFFERENT
PROGRAMS AT THE F.D.A.
THIS BILL REALLY REPRESENTS A
GREAT COMPROMISE BETWEEN THE
HOUSE AND THE SENATE AND STRIKES
THE RIGHT BALANCE BY INCLUDING
STRONG PROVISIONS THAT WILL BE
GOOD FOR BOTH INNOVATION AND
PATIENT SAFETY.
WHEN WE PASS THE HOUSE VERSION
OF THIS BILL, I SPOKE HIGHLY OF
A GREAT CORDIAL PROCESS AND I'M
HAPPY TO BE ABLE TO ECHO THOSE
SEPTEMBERMENTS HERE TODAY.
THIS PROCESS SHOULD BE A MODEL
FOR CONGRESSIONAL BIPARTISAN
COOPERATION IN THE FUTURE.
NOT ONLY DID WE ALL WORK SO WELL
TOGETHER, STAFFS WERE ABLE TO
RECTIFY THE DIFFERENCES AMONG
THE TWO CHAMBERS' VERSIONS OF
THE BILL IN MATTER OF TWO WEEKS.
THAT'S COMMENDABLE.
IT'S A CLEAR INDICATION THAT
CONGRESS IS CERTAINLY CAPABLE OF
GREATNESS IF WE JUST FOLLOW OR
ALLOW OURSELVES TO SET POLITICS
ASIDE AND SIMPLY LEGISLATE.
I WANT TO THANK CHAIRMAN UPTON
AND RANKING MEMBER WAXMAN FORURE
LEADERSHIP AND ALL THE STAFF --
FOR YOUR LEADERSHIP AND ALL THE
WHO WORKED AROUND THE
CLOCK AND PARTICULARLY TIFFANY,
MY STAFF PERSON, THEY WERE ALL
DEDICATED TO ACHIEVING A
CONSENSUS PRODUCT AND THEY HAVE
DONE JUST THAT.
THE BILL BEFORE US TODAY
PROVIDES THE F.D.A. WITH MORE
THAN $6 BILLION OVER FIVE YEARS
TO PAY FOR THE TIMELY AND
EFFICIENT REVIEWS OF MEDICAL
PRODUCTS.
TOGETHER THESE AGREEMENTS WILL
ENSURE THAT AMERICANS HAVE
ACCESS TO SAFE AND EFFECTIVE NEW
MEDICINES AND MEDICAL DEVICES.
IT WILL REDUCE THE DRUG COSTS
FOR CONSUMERS BY SPEEDING THE
APPROVAL OF LOWER COST GENERIC
DRUGS WITH THE ESTABLISHMENT OF
THE NEW USER FEE PROGRAM FOR
GENERIC DRUGS AND LOWER COST
IT ALSO INCLUDES PROMISING
VERSIONS OF BIOTECH DRUGS AS
WELL.
PROVISIONS THAT ADDRESS THE
SAFETY OF THE SUPPLY CHAIN, HELP
TO FOSTER THE DEVELOPMENT AND
SAFE USE OF DRUGS FOR CHILDREN,
INCREASE EFFORTS TO ADDRESS DRUG
SHORTAGES, CHANGE CONFLICT OF
INTEREST RULES SO THE F.D.A. HAS
ACCESS TO THE BEST EXPERTISE ON
THE ADVISORY PANELS, AND OTHER
PROVISIONS WHICH ARE IMPORTANT
TO THE PUBLIC HEALTH OF OUR
NATION.
THIS BILL IS GOOD FOR THE
F.D.A., GOOD FOR INDUSTRY, GOOD
FOR PATIENTS ALIKE.
CRITICAL BILL OVERWHELMINGLY
I'M CONFIDENT WE WILL PASS THIS
EARLY NEXT WEEK SO WE CAN SEND
TODAY AND THE SENATE WILL ACT
IT TO THE PRESIDENT FOR HIS
SIGNATURE AS SOON AS POSSIBLE.
I URGE ALL MEMBERS TO SUPPORT
THIS BILL AND THANK YOU, MR.
SPEAKER.
I RESERVE THE BALANCE OF MY
TIME.
THE
GENTLEMAN RESERVES.
THE GENTLEMAN FROM MICHIGAN.
I YIELD TWO MINUTES
TO THE DISTINGUISHED CHAIRMAN OF
THE HEALTH SUBCOMMITTEE, MR.
PITTS FROM PENNSYLVANIA.
THE
GENTLEMAN IS RECOGNIZED FOR TWO
MINUTES.
THANK YOU, MR.
SPEAKER.
I STAND TO STRONGLY SUPPORT THIS
LEGISLATION.
THIS BIPARTISAN AGREEMENT
REPRESENTS OVER 18 MONTHS OF
WORK FROM THE ENERGY AND
COMMERCE HEALTH SUBCOMMITTEE AND
I'M ESPECIALLY PROUD AND
APPRECIATIVE OF THE HARD WORK OF
RYAN AND CLAY FOR THEIR DILIGENT
AND TIRELESS EFFORTS IN HELPING
TO MAKE THIS BILL POSSIBLE.
THE F.D.A. SAFETY AND INNOVATION
ACT IS CRITICAL TO SAVING LIVES
AND APPROVING REGULATORY
OPERATIONS AND SUSTAINING A
INDUSTRY.
VITAL AND DYNAMIC AMERICAN
AMERICAN COMPANIES ARE THE
LEADING DEVELOPERS OF NEW
MEDICAL DEVICES AND DRUGS TO
SAVE AND SUSTAIN LIFE.
TO ENSURE THAT PRODUCTS ARE BOTH
SAFE AND EFFECTIVE, WE HAVE
TASKED THE FOOD AND DRUG
ADMINISTRATION WITH REVIEWING
PRODUCTS BEFORE THEY MAKE THEIR
WAY INTO THE MARKET.
AND THIS IS A CRITICAL
RESPONSIBILITY.
THE DEVICE AND DRUG INDUSTRIES
ARE DYNAMIC AND INNOVATIVE.
COMPANIES SPEND HUNDREDS OF
MILLIONS OF DOLLARS AND YEARS OF
RESEARCH AND WORK TO DEVELOP
PRODUCTS.
THE REVIEW STAMING IS A CRITICAL
TIME FOR ANY COMPANY, AND
INCONSISTENT REVIEWS MEAN THAT
THE TRUE COST OF DEVELOPING NEW
PRODUCTS IS HIDDEN, MAKING IT
DIFFICULT TO PROPERLY PREPARE.
WHEN OUR HEALTH SUBCOMMITTEE
BEGAN CONSIDERING THIS
LEGISLATION LAST YEAR, WE HEARD
FROM A NUMBER OF INDIVIDUALS
ABOUT THE INCREASING DIFFICULTY
OF WORKING THROUGH THE REVIEW
PROCESS.
AMERICAN PATIENTS WERE WAITING
ALMOST FOUR YEARS LONGER FOR NEW
APPROVED IN EUROPE AND DESPITE
DEVICES THAT HAD ALREADY BEEN
THE SLOWER U.S. REVIEW PROCESS,
THE SAFETY OUTCOMES FROM
COMPARABLE.
THE F.D.A. SAFETY AND INNOVATION
ACT CONTAINS IMPORTANT REFORMS
TO THE MEDICAL DEVICE USER FEE
ACT AND WILL HOLD F.D.A.
ACCOUNTABLE AND KEEP REVIEWS ON
SCHEDULE.
THERE ARE MANY REFORMS IN THIS
BILL.
FINALLY, WE INCLUDE LANGUAGE TO
HELP PATIENTS AND DOCTORS AND
HOSPITALS DEAL WITH DRUG
SHORTAGES.
MR. SPEAKER, I'M PROUD OF THE
WORK WE HAVE DONE.
I'M PROUD WE HAVE SUCH A
BIPARTISAN EFFORT.
I'D LIKE TO ESPECIALLY THANK
RANKING MEMBER FRANK PALLONE AND
HIS STAFF FOR PATIENTLY WORKING
WITH US.
FOR MR. DINGELL, MR. WAXMAN WE
HAVE ACCOMPLISHED MUCH WITH THIS
LEGISLATION.
IT WILL HELP SAVE LIVES, CREATE
JOBS, TWO GOALS WE CAN ALL AGREE
ON.
THANKS TO OUR CHAIRMAN, MR.
UPTON, I YIELD BACK.
THE
GENTLEMAN'S TIME HAS EXPIRED.
THE GENTLEMAN FROM NEW JERSEY.
THANK YOU, MR.
SPEAKER.
I YIELD NOW THREE MINUTES TO OUR
CHAIRMAN EMERITUS, THE GENTLEMAN
FROM MICHIGAN, MR. DINGELL, WHO
WORKED SO *** THIS BILL,
PARTICULARLY WITH REGARD TO THE
SAFETY PROVISION.
THE
GENTLEMAN IS RECOGNIZED FOR
THREE MINUTES.
MR. SPEAKER, I ASK
UNANIMOUS CONSENT TO REVISE AND
EXTEND MY REMARKS.
WITHOUT
OBJECTION.
MR. SPEAKER, THIS
IS A GOOD BILL.
I URGE MY COLLEAGUES TO SUPPORT
IT.
I RISE IN STRONG SUPPORT OF IT
AND I URGE MY COLLEAGUES TO DO
THE SAME.
THIS LEGISLATION ENJOYS BROAD
BIPARTISAN SUPPORT ON BOTH SIDES
OF THE CAPITOL, AND FROM
INDUSTRY AND PATIENT GROUPS.
WE SHOULD ALSO BE PROUD OF THE
WORK WE HAVE DONE TO GET IT HERE
TODAY.
I WOULD OBSERVE THAT IT HAS BEEN
DONE BECAUSE THE MEMBERS WORKED
TOGETHER IN THE MOST -- FINEST
TRADITIONS OF THIS BODY.
AND I'M ALSO PROUD OF THE WORK
THAT MY COLLEAGUES ON THE
COMMITTEE AND STAFF HAS GONE ON
THIS MATTER.
I WAS PLEASED TO WORK WITH THEM
TO INCLUDE STRONG DRUG SUPPLY
CHAIN PROVISIONS, SOMETHING
THAT'S BEEN A LONG PRIORITY OF
MINE.
I'M ALSO PLEASED THAT FOR THE
FIRST TIME IMPORTERS WILL BE
REQUIRED TO REGISTER SO WE KNOW
WHETHER IT'S SAFE OR NOT.
IT WILL ALSO BE ABLE TO CLEAR
INSPECTIONS IN DOMESTIC AND
FOREIGN DRUG FACILITIES.
SOMETHING THAT IS A MAJOR
PROBLEM BECAUSE FOREIGN
FACILITIES AND FOREIGN
MANUFACTURERS NOW IMPORT MUCH
INTO THIS COUNTRY AND MUCH OF
WHICH IS UNSAFE AND IMPROPERLY
INSPECTED.
F.D.A. WILL BE ABLE TO MAINTAIN
A PRACTICE IN WHICH THERE WAS
DRUGS THAT WERE UNSAFE OR
INTENTIONALLY OR OTHERWISE
ADULTERATED.
THEE WILL BE ABLE TO POSE
INCREASED PENALTIES ON THOSE WHO
ADULTERATE THESE DRUGS AND
PHARMACEUTICALS.
THESE PROVISIONS WHICH MIRROR MY
SAFETY BILL WILL EQUIP F.D.A.
WITH THE AUTHORITY IT NEEDS TO
BETTER OVERSEE OUR INCREASINGLY
GLOBALIZED DRUG SUPPLY CHAIN AND
GIVE AMERICAN FAMILIES COMFORT
THAT THE PHARMACEUTICALS THAT
THEY ARE TAKING ARE SAFE.
TO DETER AND TO RESPOND
TO ANY FUTURE INCIDENTS WHICH
KILLED SOME 80 AMERICANS AND
HURT THOUSANDS MORE.
WHILE I AM DISAPPOINTED WE ARE
UNABLE TO COME FORWARD WITH A
CONSENSUS ON NATIONAL TRACK AND
TRACE STANDARD, IT'S MY HOPE
THAT WE WILL CONTINUE TO WORK ON
THIS IN COMING DAYS.
I WANT TO COMMEND MY COLLEAGUES,
MR. MATHISON AND MR. BILBRAY,
FOR THE FINE WORK THEY HAVE DONE
ON THIS MATTER.
I HAVE ALSO BEEN WORKING ON THIS
ISSUE FOR MANY YEARS AND WE HAVE
COME CLOSER THAN EVER BEFORE IN
FINDING A CONSENSUS.
GIVING ADDITIONAL TIME, I THINK
WE COULD HAVE RESOLVED THIS
ISSUE BUT BECAUSE OF TIME
PRESSURES WE WERE NOT.
I ALSO WANT TO THANK MY FRIENDS,
MR. UPTON, MR. HARKER, RANKING
MEMBERS AND STAFF FOR THEIR HARD
WORK WHICH THEY DID TO SEND THIS
CRITICAL BILL TO THE PRESIDENT
BEFORE JULY 4.
I ALSO WANT TO THANK KIMBERLY OF
MY STAFF FOR HER DILIGENCE ON
THE SUPPLY CHAIN PROVISIONS AND
OTHER MATTERS.
COLLEAGUES TO SUPPORT
THIS BILL.
IT WILL BE SOMETHING WHICH WE
WILL BE PROUD.
IT WILL CONFIRM MUCH SAFETY ON
THE AMERICAN PEOPLE IN AREAS OF
VERY SUBSTANTIAL DANGER.
AND IT WILL SEE TO IT THAT
THROUGH A MODEST DEGREE AT LEAST
THE INDUSTRY SUPPORTED
PROVISIONS, INCLUDING THOSE
WHICH INVOLVED THE COLLECTION OF
FEES, WILL BEGIN TO WORK FOR THE
BEP FIT OF THE AMERICAN PEOPLE.
I THANK YOU.
I YIELD BACK THE BALANCE OF MY
TIME.
THE
.
GENTLEMAN'S TIME HAS EXPIRED.
THE
GENTLEMAN'S TIME HAS EXPIRED.
THE GENTLEMAN FROM MICHIGAN.
THANK YOU, MR.
SPEAKER.
I'D YIELD TWO MINUTES TO THE
DISTINGUISHED VICE CHAIR OF THE
BURGESS, TWO MINUTES.
HEALTH SUBCOMMITTEE, DR.
THE
GENTLEMAN IS RECOGNIZED FOR TWO
MINUTES.
I THANK THE
CHAIRMAN FOR YIELDING, MR.
SPEAKER, FOR THE RECOGNITION.
TODAY WE ARE CONSIDERING THE
FOOD AND DRUG ADMINISTRATION
SAFETY INNOVATION ACT, AND I
IT.
URGE MY COLLEAGUES TO SUPPORT
THIS BILL RE-AUTHORIZES THE
FOOD AND DRUG ADMINISTRATION'S
USER FEE PROGRAMS.
CONTINUE TO PARTNER IN
THE BILL WILL ALLOW INDUSTRY TO
PROVIDING OUR PHYSICIANS THE --
PROVIDE THEM THE TOOLS THEY
NEED TO PREVENT AND ALLEVIATE
HUMAN SUFFERING.
THE LEGISLATION RETAINS
SIGNIFICANT REFORMS THAT WERE
MADE IN OUR HOUSE BILL AND
ENHANCES OTHER PROVISIONS SUCH
AS THOSE ON DRUG SHORTAGES.
FOOD AND DRUG ADMINISTRATION
THE BILL WILL ENSURE THAT THE
HAS THE SCIENTIFIC AND MEDICAL
EXPERTISE THAT THEY NEED WHEN
REVIEWING PRODUCTS UTILIZING
EMERGING SCIENCE OR FOR THOSE
DISEASES.
POPULATION WITH VERY RARE
THIS BILL WILL SPUR INNOVATION
FOR ANTIBIOTICS, WILL HELP
THOSE WITH RARE DISEASES AND BE
PARTICULARLY HELPFUL FOR THE
COMMUNITY OF PHYSICIANS THAT
TAKES CARE OF OUR PEDIATRIC
CANCER PATIENTS.
THE FOOD AND DRUG
ADMINISTRATION IS NOW REQUIRED
TO NOTIFY CONGRESS BEFORE
ISSUING GUIDANCE REGARDING THE
DEVELOPED TESTS.
REGULATION OF LABORATORY
I STILL BELIEVE WE SHOULD
PROVIDE OVERSIGHT OF TESTS
ANY
DUPLICATIVE LEGISLATION.
IT WILL ADDRESS NUMEROUS OTHER
ISSUES TO ENHANCE THE WORK OF
THE F.D.A. WHILE CORRECTING
MISSTEPS OF THE AGENCY IN TERMS
OF GOOD GUIDANCE PRACTICES AND
THE MANUFACTURING OF DEVICES.
THE VOTE WAS RESPECTFUL AND
CHAIRMAN UPTON, THANK YOU, AND
I WANT TO THANK RYAN AND CLAY
ON THE STAFF OF THE MAJORITY
WHO SACRIFICED MUCH TO GET THIS
PRODUCT TO THE FLOOR TODAY.
THIS VOTE IS REALLY ABOUT
PATIENTS WHO WILL BE SERVED BY
THE PASSAGE OF THIS BILL AND I
URGE ITS EXPEDITIOUS PASSAGE.
I YIELD BACK.
THE
GENTLEMAN'S TIME HAS EXPIRED.
THE GENTLEMAN FROM NEW JERSEY.
MR. SPEAKER, I
YIELD TWO MINUTES TO THE
GENTLEWOMAN FROM COLORADO, MS.
DEGETTE, WHO WORKED VERY HARD
ON THE DRUG SHORTAGE PROVISIONS
IN THE LEGISLATION.
THE
GENTLELADY IS RECOGNIZED FOR
TWO MINUTES.
THANK YOU VERY
MUCH, MR. SPEAKER.
I'M DELIGHTED TO SUPPORT THIS
BIPARTISAN LEGISLATION WHICH
ADDRESSES CRITICAL PROBLEMS
AFFECTING THE SAFETY OF DRUGS
AND MEDICAL DEVICES IN THIS
COUNTRY.
THERE ARE SEVERAL HIGHLIGHTS
I'D LIKE TO TALK ABOUT, LIKE
DR. GINGREY'S INSEPTEMBERIVES
FOR ANTIBIOTIC DEVELOPMENT --
INCENTIVES FOR ANTIBIOTIC
DEVELOPMENT OR THE SUPPLY CHAIN
FOR YEARS.
THAT MR. DINGELL HAS WORKED ON
THERE IS AN ISSUE I HAVE BEEN
WORKING ON WITH A BIPARTISAN
BASIS THROUGHOUT THIS CONGRESS
THAT I WANT TO DISCUSS BRIEFLY.
DRUG SHORTAGES HAVE RAN OVER
FAMILIES.
HOSPITALS, DOCTORS AND OUR
FIGURES RECENTLY RELEASED BY
THE UNIVERSITY OF UTAH SHOWS
THERE WERE 56 MORE NULL
REPORTED DRUG SHORTAGES IN THE
U.S. LAST YEAR THAN IN 2010
WHEN THERE WERE 211.
SO, AGAIN, LET ME SAY AGAIN,
211 DRUGS IN SHORTAGE.
HOW CAN THIS BE HAPPENING AND
WHAT CAN WE DO ABOUT IT?
REPRESENTATIVE TOM ROONEY AND
I, FROM FLORIDA, INTRODUCED THE
LIFE PRESERVING MEDICATIONS
ACT.
IT CREATES AN EARLY WARNING
SYSTEM BETWEEN THE F.D.A., DRUG
COMPANIES AND PROVIDERS SO A
COMMUNITY CAN RESPOND TO A DRUG
SHORTAGE QUICKLY AND
EFFICIENTLY.
IT WON'T SOLVE THE ROOT
PROBLEMS OF THE DRUG SHORTAGE
CRISIS BUT IT WILL HELP
PROVIDERS AND DOCTORS AND
HOSPITALS IDENTIFY THOSE CRISES
AND HELP WITH THE PATIENTS.
THIS FEBRUARY, FOR EXAMPLE,
UNDER A VOLUNTARY PROGRAM, THE
F.D.A. STEPPED IN TO ALLOW FOR
TEMPORARY EMERGENCY IMPORTATION
OF THE CANCER DRUG, DOXIL,
WHICH WAS IN SHORTAGE, AND AT
THE SAME TIME THE F.D.A.
PRIORITIZED THE REVIEW OF THE
NEW MANUFACTURER OF THE SAME
DRUG WHEN THE CANCER DRUG WENT
INTO SHORTAGE.
AND SO WHAT OUR BILL WILL DO IS
MAKE THIS PROGRAM MANDATORY.
WHAT WE THINK IT WILL DO IS IT
WILL HELP PATIENTS ACROSS THE
NEED.
SPECTRUM GET THE DRUGS THEY
WILL HELP THE HOSPITALS AND
THE PROVIDERS IDENTIFY
POTENTIAL SHORTAGES, AND IT
WILL HELP THE MANUFACTURERS
BETTER MAKE SURE THAT THEY GET
THE DRUGS TO THE PATIENTS THAT
I'M THRILLED THAT THIS IS
NEED THEM.
CONTAINED, AND I WANT TO THANK
THE CHAIRMAN.
THE
GENTLEWOMAN'S TIME HAS EXPIRED.
THE GENTLEMAN FROM MICHIGAN.
MR. SPEAKER, I'D
YIELD ONE MINUTE TO THE
DISTINGUISHED GENTLEMAN FROM
FLORIDA, MR. STEARNS, ONE
MINUTE.
THE
GENTLEMAN IS RECOGNIZED FOR ONE
MINUTE.
MR. SPEAKER, I ASK
UNANIMOUS CONSENT THAT THE
ATTACHED LETTERS I HAVE PART OF
MY SPEECH BE MADE PART OF THE
RECORD.
WITHOUT OBJECTION.
MY COLLEAGUES,
THIS RE-AUTHORIZATION OF F.D.A.
USER FEES WILL PROVIDE
STABILITY FOR F.D.A.'S NEW
PRODUCT REVIEW AS COMPANIES
SUBMIT NEW AND INNOVATIVE
DRUGS, MEDICAL DEVICES AND
BIOLOGICS.
AND I'M GLAD THAT H.R. 4132,
FAST, WAS INCLUDED IN THE
F.D.A. REFORM ACT.
FAST MODERNIZES F.D.A.'S
APPROVAL PATHWAY TO
INCLUDE TECHNOLOGIES, NEW DRUGS
FROM PEOPLE SUFFERING FROM RARE
DISEASES.
THERE ARE 30 MILLION AMERICANS
FROM SUFFERING ONE OF OVER
7,000 RARE DISEASES THAT ONLY
250 CURRENTLY HAVE ANY
TREATMENT.
FAST WILL SAVE LIVES, SO I'M
PLEASED ALSO THE BILL INCLUDES
THE EXPERT ACT, H.R. 4156.
THIS WILL HELP F.D.A. CONSULT
WITH MEDICAL EXPERTS WHEN
EVALUATING DRUGS DESIGNED FOR
FIBROSIS.
RARE DISEASES SUCH AS SITHIC
I'M GLAD -- CYSTIC FIBROSIS.
I OBVIOUSLY SUPPORT PASSAGE OF
THIS BILL AND WOULD LIKE TO
ENTER MY FULL STATEMENT IN THE
RECORD.
THE
GENTLEMAN'S TIME HAS EXPIRED.
THE GENTLEMAN FROM NEW JERSEY.
THANK YOU, MR.
SPEAKER.
I YIELD A MINUTE AND A HALF TO
THE GENTLEWOMAN FROM
CALIFORNIA, MRS. CAPPS.
THE
GENTLELADY IS RECOGNIZED FOR
ONE MINUTE AND A HALF.
I THANK MY
COLLEAGUE FOR YIELDING AND, MR.
SPEAKER, I RISE TODAY IN STRONG
SUPPORT OF THE F.D.A. SAFETY
AND INNOVATION ACT.
THIS BIPARTISAN EFFORT WILL
IMPROVE THE HEALTH AND SAFETY
OF THE AMERICAN PEOPLE AND AT
THE SAME TIME SUPPORT GOOD JOBS
AND INNOVATION IN THE HEALTH
CARE INDUSTRY.
I'M ESPECIALLY PLEASED THAT
THIS BILL INCLUDES TWO
PROVISIONS WHICH I AUTHORED.
THE FIRST IS MODELED ON MY
SAFETY DEVICE ACT AND IT WILL
IMPROVE POSTMARKET SURVEILLANCE
OF MEDICAL DEVICES AND
IMPLEMENTATION OF THE UNIQUE
DEVICE IDENTIFIER PROGRAM.
THIS ESSENTIAL PROGRAM WILL
ALLOW US TO IDENTIFY POTENTIAL
DEVICE PROGRAMS EARLY THEREBY
PROTECTING PATIENTS AND
IDENTIFYING ISSUES WHEN THEY
ARE EASIER AND LESS COSTLY TO
ADDRESS.
THE SECOND PROVISION I AUTHORED
COMES FROM MY BIPARTISAN HEART
FOR WOMEN ACT WHICH THE HOUSE
HAS PASSED TWO TIMES.
IT REQUIRES THE F.D.A. TO
REPORT ON THE AVAILABILITY OF
NEW DRUG AND DEVICE SAFETY AND
EFFICACY DATA BY SEX, AGE AND
RACIAL AND ETHNIC SUBGROUPS.
DRUGS AND DEVICES CAN HAVE
DISSIMILAR EFFECTS AMONG
VARIOUS POPULATIONS AND THIS
PROVISION WILL REDUCE
SUBSTANTIAL DISPARITIES IN
HEALTH CARE, ESPECIALLY FOR
WOMEN AND MINORITIES.
SO I THANK THE CHAIRMAN AND
RANKING MEMBERS FOR THEIR
LEADERSHIP ON THE F.D.A. SAFETY
AND INNOVATIONS ACT AND FOR
PROVISIONS.
THEIR SUPPORT OF THESE TWO
I URGE MY COLLEAGUES TO SUPPORT
THIS BIPARTISAN BILL, AND I
TIME.
YIELD BACK THE BALANCE OF MY
THE
BALANCE OF HER TIME.
GENTLELADY YIELDS BACK THE
THE GENTLEMAN FROM MICHIGAN.
MR. SPEAKER, I'D
YIELD ONE MINUTE TO THE
DISTINGUISHED GENTLEWOMAN FROM
NORTH CAROLINA, THE VICE CHAIR
OF THE ENERGY AND COMMERCE
COMMITTEE, MRS. MYRICK, ONE
MINUTE.
THE
GENTLELADY IS RECOGNIZED FOR
ONE MINUTE.
THANK YOU, MR.
CHAIRMAN.
THE BILL BEFORE US CONTAINS
CRITICAL IMPROVEMENTS TO THE
CURRENT LAW.
AMONG THEM IS THE CREATION OF A
PRIORITY REVIEW VOUCHER PROGRAM
FOR COMPANIES THAT DEVELOP
DISEASES.
TREATMENTS FOR RARE PEDIATRIC
THE LONG-TERM SUCCESS OF
FAILURE OF CRUCIAL DRUGS AND
DEVICE APPROVALS DOESN'T JUST
DEPEND ON APPROVING NEW FUNDS
AND GUIDELINES FOR F.D.A.
IT ALSO DEPENDS ON INSTILLING A
CULTURE AT F.D.A. THAT SEEKS
OUT PRACTICAL SOLUTIONS TO THE
DISEASES THAT OUR CONSTITUENTS
FACE.
F.D.A. MUST RECOGNIZE THAT
PATIENTS, ESPECIALLY THOSE WITH
FATAL ILLNESSES, DESERVE TO
AVAILABLE.
HAVE POTENTIAL TREATMENTS MADE
WHENEVER POSSIBLE, F.D.A.
SHOULD USE ALL THE TOOLS IT HAS
AVAILABLE TO APPROPRIATELY WARN
DOCTORS AND PATIENTS OF RISKS
ASSOCIATED WITH THE TREATMENT
WITHOUT REMOVING PATIENT
ACCESS.
PATIENTS FACING A FATAL
DIAGNOSIS, WHETHER IT'S
METASTATIC CANCER, A.L.S. OR
OTHERWISE, SHOULD BE GIVEN THE
BENEFIT OF THE DOUBT UNLESS THE
TREATMENT IS VERY RISKY.
THIS SHOULD BE A GUIDING
PRINCIPLE OF THE F.D.A. AND NOT
SIMPLY A CONSIDERATION.
SO I URGE SUPPORT OF THE BILL.
THE
GENTLELADY'S TIME HAS EXPIRED.
THE GENTLEMAN FROM NEW JERSEY.
MR. SPEAKER, I
YIELD ONE MINUTE TO THE
GENTLEMAN FROM NEW YORK, MR.
ENGEL.
THE
GENTLEMAN IS RECOGNIZED FOR ONE
MINUTE.
I THANK MY FRIEND
FOR YIELDING TO ME AND I RISE
IN SUPPORT OF S. 4187, THE FOOD
AND DRUG ADMINISTRATION SAFETY
AND INNOVATION ACT OF 2012.
THIS IS A RARE DAY IN CONGRESS
WHERE WE ARE WORKING IN A
BIPARTISAN MANNER TO GET GOOD
THINGS DONE.
THIS BIPARTISAN AND BICAM RELL
AGREEMENT IS A PRIME EXAMPLE OF
THE GOOD LEGISLATIVE WORK THAT
CAN BE DONE BY THIS BODY WHEN
COMPROMISES ARE ACCEPTED.
IN PARTICULAR, I'D LIKE TO
THANK THE CHAIRMAN OF THE
FULL-ENERGY AND COMMERCE AND
HEALTH SUBCOMMITTEE.
I'D LIKE TO THANK THEM FOR
INCLUDING THE RE-AUTHORIZATION
OF THE CRITICAL PATH
PUBLIC-PRIVATE PARTNERSHIPS IN
THIS LEGISLATION, SOMETHING
WHICH I PUSHED FOR A LONG TIME.
SO NEED IMPROVEMENTS IN
REGULATORY SCIENCE CAN
CONTINUE.
I BELIEVE THIS BILL WILL HELP
THE NEEDS OF THE F.D.A.
INDUSTRY AND MOST IMPORTANTLY
PATIENTS AND I LOOK FORWARD TO
ITS PASSAGE.
I YIELD BACK THE BALANCE OF MY
TIME.
THE
GENTLEMAN YIELDS BACK.
THE GENTLEMAN FROM MICHIGAN.
THANK YOU, MR.
SPEAKER.
I'D YIELD ONE MINUTE TO THE
DISTINGUISHED GENTLEMAN FROM
MINUTE.
PENNSYLVANIA, DR. MURPHY, ONE
THE
GENTLEMAN IS RECOGNIZED FOR ONE
MINUTE.
THANK YOU, MR.
SPEAKER.
MR. CHAIRMAN, WHAT GOOD ARE
AFFORD THEM?
LIFE-SAVING DRUGS IF YOU CAN'T
THAT'S WHY REAL REFORM OF THE
NEAGS' HEALTH CARE SYSTEM
BEGINS PROMOTING QUALITY AND
AFFORDABILITY.
I'M EXCITED THIS LEGISLATION IS
MOVING FORWARD BECAUSE THE
F.D.A. WILL FINALLY HAVE A
SYSTEM FOR BRINGING MORE
LIFE-SAVING GENERIC DRUGS TO
MARK.
TODAY'S BILL AUTHORIZES THE
FIRST GENERIC USER FEE PROGRAM
TO EXPEDITE APPROVAL OF GENERIC
WHICH IS A FACTION OF THE COST
OF BRAND NAME DRUGS.
THEY CAN SAVE A PATIENT $1,000
A YEAR ON MEDICATION ALONE BUT
IT MAY WELL YIELD BILLIONS IN
SAVINGS ACROSS OUR NATION WHEN
AFFORDABLE GENERIC DRUGS ARE
USED TO TREAT ACUTE AND CHRONIC
ILLNESS.
RIGHT NOW CONSUMERS ARE
SPENDING MILLIONS IF NOT
BILLIONS MORE IN OUT-OF-POCKET
COSTS BECAUSE THE F.D.A.
DOESN'T HAVE THE RESOURCES TO
TACKLE 2,800 GENERIC
APPLICATIONS AWAITING REVIEW.
THERE WILL BE FEWER STROKES,
HEART ATTACKS AND CASES OF
CARDIOVASCULAR DISEASES WHEN
THIS BILL MOVES FORWARD INTO
LAW AND WILL BE ASSURE THE
MEDICINES OUR FAMILIES TAKE
WILL BE OF THE HIGHEST QUALITY.
WE WILL LOOK BACK THE CHINA
DRUG WHICH KILLED 2,000 PEOPLE.
I'D LIKE TO THANK CHAIRMAN
DEAL, WAXMAN AND UPTON FOR THIS
BALANCE OF MY TIME.
BILL AND I YIELD BACK THE
THE
GENTLEMAN'S TIME HAS EXPIRED.
THE GENTLEMAN FROM NEW JERSEY.
PALLONE PALLONE MR. SPEAKER,
CAN I INQUIRE ABOUT HOW MUCH
TIME REMAINS ON EACH SIDE?
YOU
HAVE 6 1/2 MINUTES AND THE
GENTLEMAN FROM MICHIGAN HAS
NINE MINUTES.
THANK YOU.
I YIELD NOW A MINUTE AND A HALF
TO THE GENTLEMAN FROM NORTH
CAROLINA, MR. BUTTERFIELD.
THE
GENTLEMAN IS RECOGNIZED FOR 90
SECONDS.
LET ME THANK
YOU, MR. PALLONE, FOR YIELDING
THE TIME AND THANK YOU SO VERY
MUCH FOR YOUR LEADERSHIP ON THE
HEALTH SUBCOMMITTEE.
OUR COMMITTEE.
YOU DO EXTRAORDINARY WORK ON
MR. SPEAKER, I RISE TODAY IN
SUPPORT OF S. 3187, THE AMENDED
VERSION OF THE FOOD AND DRUG
ADMINISTRATION SAFETY AND
INNOVATION ACT.
I STRONGLY SUPPORT THIS BILL
AND PARTICULARLY PLEASED THAT
THE INTENT OF H.R. 3059, THE
CREATING HOPE ACT, SPONSORED BY
MY GOOD FRIEND FROM TEXAS, MR.
MCCAUL, AND MYSELF WAS INCLUDED
IN THE FINAL BILL.
I'M THRILLED TO HIGHLIGHT
SECTION 908, THE RARE PEDIATRIC
DISEASE PRIORITY REVIEW VOUCHER
INCENTIVE PROGRAM.
THE PROGRAM WILL INCENTIVIZE
PHARMACEUTICAL COMPANIES TO
DEVELOP NEW DRUGS FOR CHILDREN
WITH RARE PEDIATRIC DISEASES
SUCH AS CHILDHOOD CANCERS AND
SICKLE CELL DISEASE, BY
EXPANDING THE COST-NEUTRAL
PRIORITY REVIEW VOUCHER
PROGRAM, EXPANDING THE VOUCHER
PROGRAM WILL ALLOW
PHARMACEUTICAL COMPANIES TO
EXPEDITE F.D.A. REVIEW OF MORE
PROFITABLE DRUGS IN RETURN FOR
DEVELOPING TREATMENTS FOR RARE
PEDIATRIC DISEASES.
I THINK THAT IS A GOOD
TRADEOFF.
I WOULD LIKE TO THANK MR.
MCCAUL AND MR. WAXMAN AND MRS.
MYRICK AND ALL OF YOU WHO
WORKED ON THIS BILL WITH US.
I WANT TO THANK OUR SENATE
COLLEAGUES, MR. CASEY AND MR.
BROWN, FOR WORKING DILIGENTLY
SEE TO ITS INCLUSION.
WITH ME AND OUR COLLEAGUES TO
FINALLY, I WANT TO RECOGNIZE
NANCY GOODMAN, WITH KIDS VERSUS
CANCER, WHO CONTINUES TO BE A
ISSUE.
TIRELESS ADVOCATE FOR THIS
THANK YOU, MR. PALLONE, THANK
YOU, MR. SPEAKER.
I YIELD BACK THE BALANCE OF MY
TIME.
THE
GENTLEMAN FROM MICHIGAN.
MR. SPEAKER, I'D
YIELD ONE MINUTE TO THE
DISTINGUISHED GENTLEMAN FROM
CALIFORNIA, A MEMBER OF THE
COMMITTEE, MR. BILBRAY, ONE
MINUTE.
THE
GENTLEMAN FROM CALIFORNIA IS
RECOGNIZED FOR ONE MINUTE.
MR. SPEAKER, I
STAND IN SUPPORT OF THE BILL
AND I WANT TO THANK CHAIRMAN
UPTON AND LEADERSHIP ON BOTH
SIDES OF THE AISLE FOR GETTING
TOGETHER AND DOING WHAT'S RIGHT
AT THIS TIME WE TALK ABOUT
FOR THE AMERICAN PEOPLE.
ECONOMIC STRIFE WE HAVE TO
REMEMBER THAT THE F.D.A.
CONDITION A FRIEND OR ENEMY IF
NOT ONLY OF OUR HEALTH BUT ALSO
OUR JOBS AND OUR ECONOMIC
OPPORTUNITIES.
IN CALIFORNIA ALONE, MR.
CHAIRMAN -- MR. SPEAKER, WE
HAVE OVER 267 PEOPLE WORKING IN
THE PHARMACEUTICAL INDUSTRY.
WE HAVE OVER 42,000 JUST
WORKING IN SAN DIEGO COUNTY.
THIS BILL WILL NOT ONLY HELP TO
PROTECT JOBS BUT THIS BILL IS A
BIPARTISAN BILL TO SAVE LIVES.
HOW MUCH BETTER CAN WE SEND TO
THE AMERICAN PEOPLE THAT
WASHINGTON IS LISTENING TO THE
FACT IN THEY WANT BIPARTISAN
SUPPORT AND BIPARTISAN EFFORTS
AND BIPARTISAN SUCCESSES ON
THINGS THAT MATTER.
THIS BILL IS SOMETHING THAT
MATTERS.
WE'RE TALKING ABOUT PRESERVING
THE ECONOMIC OPPORTUNITIES OF
OUR FELLOW CITIZENS.
AND WE'RE TALKING ABOUT SAVING
THE LIVES OF OUR FAMILY MEMBERS
AND OUR NEIGHBORS.
I'D LIKE TO YIELD BACK MY TIME
AT THIS TIME.
THE
GENTLEMAN'S TIME HAS EXPIRED.
THE GENTLEMAN FROM NEW JERSEY.
THANK YOU, MR.
SPEAKER.
GENTLEMAN FROM MASSACHUSETTS,
I YIELD TWO MINUTES TO THE
MR. MARKEY.
THE
GENTLEMAN FROM MASSACHUSETTS IS
RECOGNIZED FOR TWO MINUTES.
THANK YOU.
THANK CHAIRMAN UPTON
AND PITTS AND RANKING MEMBERS
WAXMAN AND PALLONE AND THEIR
STAFFS FOR THEIR WORK IN
BRINGING THE F.D.A. SAFETY AND
INNOVATION ACT TO THE FLOOR
TODAY.
PASSING THIS BILL WILL ALLOW THE
F.D.A. TO CONTINUE ITS CRITICAL
EFFECTIVE DRUGS AND MEDICAL
MISSION OF BRINGING SAFE AND
DEVICES TO THE PATIENTS WHO NEED
THEM.
REVIEWING DRUG AND DEVICE
APPLICATIONS HAS BECOME
INCREASINGLY CHALLENGING.
MEDICAL BREAKTHROUGHS OF TODAY
OFTEN TARGET RARE DISEASES OF
GENETIC SUBSETS -- OR GENETIC
SUBSETS OF THOSE DISEASES.
F.D.A. REVIEWERS MUST LOOK AT
SPECIALIZED TREATMENTS.
I'M PLEASED THAT THIS BILL
INCLUDES LANGUAGE I HELPED
ALTOGETHERER TO IMPROVE
COLLABORATION BETWEEN F.D.A. AND
EXTERNAL EXPERTS IN RARE
DISEASES LIKE CYSTICIFY BROW
SICK AND -- CYSTIC FIBROSIS AND
SICKLE CELL DISEASE.
THIS ALSO ENSURES THAT MILLIONS
OF AMERICANS WHO ARE BLIND OR
ENVIRONMENTALLY -- VISUALLY
IMPAIRED HAVE SAFE AND
INDEPENDENT ACCESS TO THE
INFORMATION ON PRESCRIPTION DRUG
LABELS.
NO ONE SHOULD HAVE TO SACRIFICE
THEIR PRIVACY OR INDEPENDENCE TO
ACCESS THE VITAL INFORMATION ON
THESE BOTTLES AND I'M GLAD WE'RE
HERE TODAY.
TAKING STEPS TO ADDRESS THAT
AND FINALLY THIS BILL HELPS
INCREASE THE AVAILABILITY OF
PEDIATRIC MEDICAL DEVICES AND
ENSURES THAT MEDICATIONS ARE
TESTED AND LABELED APPROPRIATELY
FOR CHILDREN.
I WAS PROUD TO WORK ON THESE
PROVISIONS WITH MY COLLEAGUES,
CONGRESSWOMAN ESHOO AND
CONGRESSMAN ROGERS.
I WOULD HAVE LIKED TO HAVE SEEN
ADDITIONAL MEASURES INCLUDED IN
THIS BILL TO ENSURE THE SAFETY
OF MEDICAL DEVICES BASED ON
DEFECTIVE MODELS THAT HAVE
ALREADY BEEN APPROVED BY THE
F.D.A.
THAT UNFORTUNATELY CONTINUE TO
BE SOLD AND JEOPARDIZED,
PATIENTS' HEALTH AYE ALL ACROSS
THIS COUNTRY.
I'M -- ALL ACROSS THIS COUNTRY.
I'M GOING TO CONTINUE TO WORK ON
THIS ISSUE.
I BELIEVE IT'S A PROBLEM WE MUST
SOLVE.
ONCE THE F.D.A. APPROVES THE
DEVICE AND THEN IT TURNS OUT
THAT THERE'S A DEFECT, THERE
SHOULD BE NO EXCUSE FOR ALLOWING
NEW COMPANIES TO BUILD THE
DEVICE -- THEIR DEVICES BASED
UPON THE OLD APPROVED DEFECTIVE
APPROVED.
MODEL THAT THE F.D.A. HAD
TENS OF THOUSANDS OF AMERICANS
ARE PUT IN JEOPARDY AND I WOULD
LIKE TO WORK TO SOLVE THAT
PROBLEM.
BUT NONETHELESS THIS IS AN
EXCELLENT PIECE OF SLEDGELATION
AND I HOPE THAT -- LEGISLATION
AND I HOPE THAT THE HOUSE GIVES
ITS APPROVAL.
THE
GENTLEMAN'S TIME HAS EXPIRED.
RECOGNIZED.
THE GENTLEMAN FROM MICHIGAN IS
THANK YOU, MR.
SPEAKER.
I WOULD ASK UNANIMOUS CONSENT
THAT MR. DENT'S FULL STATEMENT
IN SUPPORT OF THIS LEGISLATION
BE INCLUDED IN THIS RECORD AT
THIS POINT.
WITHOUT
OBJECTION, SO ORDERED.
AND I WOULD YIELD TWO
MINUTES TO THE DISTINGUISHED
GENTLEMAN FROM GEORGIA, DR.
COMMITTEE.
GINGREY, A MEMBER OF THE
THE
GENTLEMAN FROM GEORGIA IS
RECOGNIZED FOR TWO MINUTES.
MR. SPEAKER, I
THANK THE GENTLEMAN FOR
YIELDING.
THE F.D.A. SAFETY AND INNOVATION
ACT OF 2012 MAY NOT BE A GREAT
BILL BUT IT IS A DARN GOOD BILL.
AND AS A PHYSICIAN AND A MEMBER
OF THE ENERGY AND COMMERCE
COMMITTEE I STRONGLY SUPPORT IT.
AS MY COLLEAGUES HAVE SAID ON
BOTH SIDES, THIS IS A BICAMERAL,
BIPARTISAN PIECE OF LEGISLATION
AND, YES, WE CAN GET OUR WORK
DONE.
I WANT TO PARTICULARLY THANK
CHAIRMAN UPTON, RANKING MEMBER
WAXMAN, HEALTH SUBCOMMITTEE
CHAIRMAN PITTS, RANKING
SUBCOMMITTEE MEMBER MR. PALLONE,
AND ALL OF THE MEMBERS THAT HAVE
WORKED SO *** THIS REALLY
VAST, HUGE BILL THAT COVERS A
LOT OF THINGS, NOT THE LEAST OF
WHICH OF COURSE IS TO PROVIDE
65% OF THE FUNDING FOR THE
F.D.A.
SO THAT THEY CAN INDEED HIRE THE
BEST AND BRIGHTEST SCIENTISTS
SO, THEY CAN GET THEIR WORK DONE
IN A TIMELY MANNER.
GET NEW DRUGS TO THE MARKET,
MEDICAL DEVICES AND BOTTOM LINE,
KEEP THE HEALTH CARE SYSTEM IN
THIS COUNTRY THE BEST IN THE
WORLD FOR OUR CONSTITUENTS AND
OUR PATIENTS.
MR. SPEAKER, I WANTED TO MENTION
PARTICULAR ASPECT OF THE
BILL THAT I WAS VERY MUCH
INVOLVED IN AND THAT'S THIS
ISSUE OF ANTIBIOTICS SHORTAGE.
THE BILL AS IT STOOD ALONE WAS
CALLED THE GAIN ACT AND I HAD A
TREMENDOUS AMOUNT OF HELP ON
BOTH SIDES OF THE AISLE.
ON THE DEMOCRATIC SIDE
CONGRESSWOMAN ESHOO, DEGETTE,
CONGRESSMAN GENE GREEN, ON MY
SIDE OF THE AISLE, MIKE ROGERS
OF MICHIGAN, MR. SHIMKUS, MR.
WHICH THE FIELD.
AND WHAT WE DO WITH THAT -- MR.
WIT FIELD, AND WHAT WE DO -- MR.
WIT FIELD.
AND WHAT WE -- MR. WIT FIELD.
-- MR. WHITFIELD.
THIS CAN BRING THESE INNOVATION
FIFTH AND SIXTH GENERATION
ANTIBIOTICS TO THE MARKET AND
STILL HAVE AN OPPORTUNITY TO
RECOUP THE INVESTMENT AND THE
EXPENSE OF DOING SO.
SO I WANT TO JUST SAY TO MY
COLLEAGUES ON BOTH SIDES OF THE
AISLE, IT'S A PROUD DAY I THINK
FOR ALL OF US, FOR CHAIRMAN
EMERITUS DINGELL, FORMER
CHAIRMAN ON OUR SIDE OF THE
AISLE, MR. BARTON, AND EVERYBODY
I THANK ALL OF YOU.
INVOLVED IN THIS BILL.
LET'S ALL SUPPORT UNANIMOUSLY
THIS BILL.
AND I YIELD BACK THE BALANCE OF
MY TIME.
THE
GENTLEMAN'S TIME HAS EXPIRED.
THE GENTLEMAN FROM NEW JERSEY.
MR. SPEAKER, I HAVE
NO ADDITIONAL SPEAKERS SO I'LL
RESERVE.
THE
GENTLEMAN RESERVES THE BALANCE
OF HIS TIME.
THE GENTLEMAN FROM MICHIGAN.
MR. SPEAKER, I WOULD
GENTLEMAN FROM NEW JERSEY, MR.
YIELD ONE MINUTE TO THE
COMMITTEE.
LANCE, A MEMBER OF THE
THE
GENTLEMAN FROM NEW JERSEY IS
RECOGNIZED FOR ONE MINUTE.
THANK YOU, MR.
CHAIRMAN.
MR. SPEAKER, THIS LEGISLATION
WILL ENSURE THAT PATIENTS GET
IMPROVED ACCESS TO INNOVATIVE,
LIFE-SAVING THERAPIES AND
MEDICAL DEVICES WHILE PROTECTING
AN CREATING U.S. JOBS -- AND
CREATING U.S. JOBS.
THE BILL IS CRITICALLY IMPORTANT
TO NEW JERSEY WHERE WE HAVE A
HIGH CONCENTRATION OF MEDICAL
DEVICE, PHARMACEUTICAL AND LIFE
SIGNS -- SCIENCE EMPLOYEES.
I'M PLEASED THAT THIS CONTAINS
PROVISIONS IMPORTANT TO
STREAMLINE AND MODERNIZE F.D.A.
WHILE PROMOTING
PATIENT SAFETY.
TODAY'S MEASURE IS FISCALLY
RESPONSIBLE, REDUCING THE
DEFICIT BY $311 BILLION OVER THE
C.B.O.
NEXT 10 YEARS ACCORDING TO THE
I THANK CHAIRMAN UPTON, CHAIRMAN
PITTS, RANKING MEMBER WAXMAN,
RANKING MEMBER PALLONE AND
MEMBERS OF THE ENERGY AND
COMMERCE COMMITTEE FOR WORKING
TOGETHER IN A BIPARTISAN
CAPACITY ON A FINAL BILL THAT
PROTECTS PATIENTS AND BRINGS
MUCH-NEEDED CERTAINTY TO THE
MEDICAL AND BIOPHARMACEUTICAL
INDUSTRIES.
THIS IS THE WAY CONGRESS SHOULD
WORK.
I YIELD BACK THE BALANCE OF MY
TIME.
THE
GENTLEMAN FROM MICHIGAN.
MR. SPEAKER, I WOULD
YIELD ONE MINUTE TO THE
GENTLEMAN FROM CONNECTICUT, MR.
GUTHRIE -- KENTUCKY, MR.
GUTHRIE.
THE
GENTLEMAN IS RECOGNIZED FOR ONE
MINUTE.
THANK YOU, MR.
SPEAKER.
I APPRECIATE THE GENTLEMAN FOR
YIELDING.
I RISE TODAY IN SUPPORT OF THE
LEGISLATION TO RE-AUTHORIZE THE
PRESCRIPTION DRUG AND MEDICAL
DEVICE USER FEE ACTS AND
AUTHORIZE NEW USER FEE PROGRAMS
FOR GENERIC DRUGS AND BIOSIMS.
THE LEGISLATION ALSO INCLUDES
IMPORTANT REFORMS TO GRANT
PATIENTS IMPROVED ACCESS TO NEW
THERAPIES AND PROMOTES
INNOVATION AND JOB CREATION.
JOBS AND THE ECONOMY ARE TOP
ISSUES FOR MOST AMERICANS AND
THIS BILL FOCUSES ON THAT.
AS A MANUFACTURER I'VE HEARD
MANY STORIES FROM MANY DEVICE
MANUFACTURERS ACROSS THE COUNTRY
ABOUT PROBLEMS THEY FACED WITH
THE F.D.A. AND HOW THOSE
STRUGGLES WERE MAKING IT HARDER
FOR THEM TO MANUFACTURE IN
AMERICA.
THIS BILL INCLUDES IMPORTANT
CHANGES, INCLUDING ONE THAT I
CHAMPIONED TO REFORM THE
F.D.A.'S GUIDANCE PROCESS THAT
WILL INJECT CERTAINTY INTO THE
JOBS.
PROCESS AND CREATE MORE AMERICAN
THIS BILL IS AN EXAMPLE OF
WORKING IN A BIPARTISAN WAY TO
ACHIEVE A QUALITY PRODUCT THAT
CREATES JOBS.
I THANK THE CHAIRMAN AND THE
RANKING MEMBER FOR THEIR WORK
AND, MR. SPEAKER, I URGE MY
COLLEAGUES TO SUPPORT THIS BILL
AND I YIELD BACK THE BALANCE OF
MY TIME.
THE
GENTLEMAN'S TIME HAS EXPIRED.
HAS THREE MINUTES LEFT.
THE GENTLEMAN FROM NEW JERSEY
AND THE GENTLEMAN FROM MICHIGAN
HAS FOUR MINUTES LEFT.
THE GENTLEMAN FROM NEW JERSEY.
MR. SPEAKER, I
YIELD 30 SECONDS TO THE
GENTLEMAN FROM VIRGINIA, MR.
MORAN.
THE
GENTLEMAN FROM VIRGINIA IS
RECOGNIZED FOR 30 SECONDS.
THANK YOU, MR.
CHAIRMAN.
HAVE CONCERNS ABOUT ONE ELEMENT
I DON'T OPPOSE THE BILL BUT I DO
OF THIS BILL AND THAT IS WHAT
AFFECTS WHISTLE BLOWERS.
THE LAW THAT WOULD APPLY IS THAT
OF THE MILITARY.
THE DEFENSE DEPARTMENT.
WHICH FRANKLY IS WEAKER THAN
APPLIES TO PROTECTING WHISTLE
BLOWERS WHO ARE IN THE CIVIL
BLOWERS.
SERVICE, CIVILIAN WHISTLE
AND I DO THINK PROTECTION OF
WHISTLE BLOWERS NEEDS TO BE A
PRIORITY AND IN THIS CASE I
WOULD HOPE THAT WE COULD WORK IN
SUBSEQUENT LEGISLATION TO
PROTECT THE RIGHTS OF WHISTLE
BLOWERS WHO ARE SEE LENTION --
DO OUR JOB AS WELL AS THOSE
ESSENTIAL TO OUR BEING ABLE TO
PEOPLE IN THE EXECUTIVE BRANCH.
SO I JUST WANTED TO MAKE NOTE OF
THANK YOU.
THAT POINT.
THE
GENTLEMAN FROM MICHIGAN.
MR. SPEAKER, I'D
YIELD ONE MINUTE TO THE
GENTLEMAN FROM NEW MEXICO, ONE
MINUTE -- NEW HAMPSHIRE, ONE
MINUTE, A MEMBER OF THE
COMMITTEE, MR. BASS.
THE
GENTLEMAN FROM NEW HAMPSHIRE IS
RECOGNIZED FOR ONE MINUTE.
MR. SPEAKER, I RISE IN
STRONG SUPPORT OF THE FOOD AND
DRUG ADMINISTRATION SAFETY AND I
INNOVATION ACT AND I THANK THE
DISTINGUISHED CHAIRMAN OF THE
COMMITTEE FOR RECOGNIZING ME FOR
ONE MINUTE.
THE USER FEE PROCESS IS A VITAL
ELEMENT IN MAINTAINING
OPERATIONS AT THE F.D.A. TO
BRING VALUABLE DRUGS AND DEVICES
THROUGH THE APPROVAL PATHWAY AND
TO MARKET.
I'M OPTIMISTIC THAT WITH
ENHANCED FINANCIAL INCENTIVES
AND RESOURCES AVAILABLE TO THE
F.D.A. INCLUDED IN THE USER FEE
AGREEMENTS, WE WILL SEE SHORTER
APPROVAL TIMES AND MORE PRODUCTS
AVAILABLE TO PATIENTS.
THROUGHOUT THIS PROCESS THERE'S
BEEN A COMMITMENT TO ADDRESSING
THE UNIQUE ISSUES ASSOCIATED
WITH THE RARE DISEASE COMMUNITY
AND BRINGING IT TO THE FOREFRONT
OF THIS DEBATE AND I'M PROUD TO
HAVE HAD MY BILL, THE
HUMANITARIAN DEVICE REFORM ACT,
INCLUDED AS A PROVISION IN THIS
DEVICE REGULATORY SECTION.
THIS LANGUAGE WILL MAKE IT
EASIER FOR MEDICAL DEVICE
MANUFACTURERS TO CREATE DEVICES
SPECIFICALLY FOR THE TREATMENT
OF INDIVIDUALS, BOTH CHILDREN
AND ADULTS, WHO ARE AFFLICTED
WITH VERY RARE DISEASES.
WITH THIS INCREASED FOCUS ON
PROVIDING INCENTIVES TO
MANUFACTURERS TO INVEST IN THE
DEVELOPMENT OF THESE DEVICES AND
DRUGS, IT CAN BE AN ATTAINABLE
GOAL FOR AN INDIVIDUAL AND
FAMILY AFFLICTED BY RARE
DISEASES NOT ONLY TO IMPROVE THE
QUALITY OF LIFE BUT POSSIBLY
EVEN FIND A CURE.
I RISE IN SUPPORT OF THIS BILL
AND YIELD BACK.
THE
GENTLEMAN FROM MICHIGAN.
MR. SPEAKER, I WOULD
YIELD ONE MINUTE TO THE
GENTLEMAN FROM MINNESOTA IN