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A SENATOR: MR. PRESIDENT?
THE PRESIDING OFFICER: THE
SENATOR FROM OKLAHOMA.
MR. COBURN: I ASK THAT THE
PENDING AMENDMENT BE SET ASIDE
AND THAT AMENDMENT 213 1 BE
CALLED UP.
THE PRESIDING OFFICER: WITHOUT
OBJECTION, THE CLERK WILL
REPORT.
THE CLERK: THE SENATOR FROM
OKLAHOMA, MR. COBURN, FOR
HIMSELF AND MR. BURR, PROPOSES
AMENDMENT NUMBERED 2131.
MR. COBURN: I ASK UNANIMOUS
CONSENT THE AMENDMENT BE
CONSIDERED AS READ.
THE PRESIDING OFFICER: WITHOUT
OBJECTION.
MR. COBURN: LET ME SAY HOW PROUD
I AM OF THE RANKING MEMBER AND
ALL THE MEMBERS OF THE HELP
COMMITTEE ON THIS VERY DIFFICULT
AND COMPLICATED ISSUE THAT THEY
ARE BRINGING BEFORE US.
F.D.A. HAVING BEEN IN BUSINESS
AND UNDER THE CONTROL OF THE
F.D.A. AS A MEDICAL DEVICE
MANUFACTURER, THIS IS A VERY
COMPLICATEED AREA OF LAW THAT IF
IT'S DONE RIGHT WILL HAVE
TREMENDOUS POSITIVE EFFECTS ON
THIS COMPANY, AND I THINK YOU
HAVE PUT OUT A VERY GOOD BILL,
AND I CONGRATULATE YOU AND ALL
THE MEMBERS ON DOING THAT.
I HAVE TWO AMENDMENTS I'M GOING
TO SPEAK A VERY PERIOD OF TIME
ON BOTH OF THEM, AND THEN I WILL
WORK WITH THE RANKING MEMBER AND
CHAIRMAN TO SEE IF WE CAN'T GET
THEM SO WE DON'T HAVE TO VOTE ON
THEM.
JUST A LITTLE HISTORY WITH
PADUFA AND MADUFA.
THE REASON THEY WERE SET UP IN
THE FIRST PLACE WAS TO HELP FUND
THE F.D.A. AND THE REAP THE
MANUFACTURERS DID THAT WAS TO
GET MORE TIMELINESS IN RESPONSE
TO THEIR APPLICATIONS.
THAT WAS THE WHOLE BASIS FOR IT.
WHAT WE HAVE BEFORE US TODAY IS
SOME IMPROVEMENT IN TERMS OF THE
F.D.A.'S RESPONSE BUT REALLY NOT
EVERYTHING THAT WE SHOULD HAVE
GOTTEN.
I ALONG WITH SENATOR BURR ASKED
FOR A G.A.O. STUDY TO THE F.D.A.
IN TERMS OF MEETING STATED
PERFORMANCE GOALS, AND WE FOUND
OUT A WHOLE LOT ABOUT THAT, AND
THAT'S MY NEXT AMENDMENT, BUT I
SAY THAT TO PREFACE WHY I HAVE
THIS AMENDMENT.
IN THIS BILL IS A WONDERFUL
REQUIREMENT THAT CAUSES THE
F.D.A. TO CONTRACT WITH AN
INDEPENDENT MANAGEMENT COMPANY
TO ASSESS THE MANAGEMENT OF THE
MISSIONS AND RESOURCES OF THE
DEVICE REGULATION COMPONENT OF
F.D.A.
WHAT IS MISSING IS THAT SAME
INDEPENDENT REVIEW IN TERMS OF
DRUGS.
IT'S ONE OF THOSE THINGS WHERE
WE WOULD INVEST IN SOMETHING
THAT IS GOING TO PAY US
ADDITIONAL BIG DIVIDENDS.
I KNOW IT'S GOING TO PAY US BIG
DIVIDENDS IN THE DEVICE AREA.
IT'S ALSO GOING TO PAY US BIG
DIVIDENDS IN THE DRUG AREA.
I DON'T KNOW THE WORKINGS OF THE
COMMITTEE, WHY THEY DECIDED NOT
TO PUT THIS IN AS FAR AS THE
DRUG REVIEW PROCESS, BUT HAVING
A SECOND LOOK AT A VERY
COMPLICATED REGULATORY AND
APPROVAL STRUCTURE COULD BE VERY
BENEFICIAL IN TERMS OF IMPROVING
BOTH THE QUALITY OF THE OUTCOME
AS WELL AS THE TIMELINESS.
SO THIS AMENDMENT SIMPLY SAYS
THAT WHAT WE'RE GOING TO DO FOR
THE DEVICE IN THE BILL ALREADY,
WE'RE ALSO GOING TO DO FOR THE
DRUG SIDE OF THE F.D.A.
IT'S ABOUT GATHERING KNOWLEDGE,
BOTH FOR THE F.D.A. AND FOR US,
AS WE HELP THIS AGENCY PERFORM
VERY NEEDED THINGS.
I READ A LOT ABOUT NEW SCIENCE
ON NEW DRUGS AS A PHYSICIAN.
I WANT TO TELL YOU, THE THINGS
THAT ARE COMING INTO THIS
COUNTRY ARE GOING TO BE
PHENOMENAL IN TERMS OF NEW
TREATMENTS AND NEW DRUGS AND NEW
CAPABILITIES.
WE NEED IN TERMS OF OUR
COMPETITIVENESS WORLDWIDE BUT
ALSO IN TERMS OF HOW WE ADDRESS
THESE DISEASES TO HAVE THE MOST
EFFICIENT REGULATORY AGENCY WE
CAN.
SO ALL I'M ASKING IS THAT WE
TREAT ALL OF F.D.A. THE SAME IN
TERMS OF TAKING A LOOK, HOW WELL
ARE THEY DOING, WHAT COULD THEY
DO BETTER, HOW COULD THEY DO IT
BETTER?
THAT REPORT COMES TO US AND THE
F.D.A.
WE HAVEN'T BEEN THROUGH EVERY
AREA OF THE F.D.A. AS MEMBERS OF
THE SENATE, AND TO HAVE AN
INDEPENDENT ASSESSMENT OF THE
DRUG SIDE AS WELL AS THE DEVICE
SIDE WILL PAY HUGE BENEFITS TO
THE F.D.A., BUT MOSTLY IT WILL
PAY HUGE BENEFITS TO THE PEOPLE
OF THIS COUNTRY IN TERMS OF
TIMELINESS OF DRUG PRESENTATION.
SO WITH THAT, I WON'T SPEAK ANY
MORE TO THAT.
IT'S A COMMONSENSE GOOD
GOVERNMENT AMENDMENT.
PART OF IT IS ALREADY IN THE
BILL.
PART OF IT IS NOT IN THE BILL.
IT'S SOMETHING THAT WILL PAY US
BIG DIVIDENDS BOTH IN TERMS OF
HEALTH CARE, BOTH IN TERMS OF
IMPROVING THE OPERATION OF THE
F.D.A., BUT ALSO IN TERMS OF
IMPROVING OUR COMPETITIVENESS
WORLDWIDE.
I WOULD ASK THAT THAT AMENDMENT
BE SET ASIDE AND CALL UP 2132.■■
THE PRESIDING OFFICER: WITHOUT
OBJECTION.
THE CLERK WILL REPORT.
THE CLERK: THE SENATOR FROM
OKLAHOMA, MR. COBURN, FOR
HIMSELF AND MR. BURR PROPOSES AN
AMENDMENT NUMBERED 2132.
AT THE END --
MR. COBURN: I ASK UNANIMOUS
CONSENT THE AMENDMENT BE
CONSIDERED AS READ.
THE PRESIDING OFFICER: WITHOUT
OBJECTION.
MR. COBURN: THIS IS AN AMENDMENT
THAT COMES OUT OF A STUDY OF
G.A.O.'S FINDINGS, AND G.A.O.
DID A WONDERFUL JOB LOOKING AT
THE F.D.A.
WHAT WE FOUND OUT, PART OF IT
WILL BE COVERED IF, IN FACT, WE
DO THIS OTHER STUDY ON THE
MANAGEMENT, BUT WHAT G.A.O. IS
TELLING US IS THERE IS AN
IRREGULAR PATTERN OF PERFORMANCE
REVIEW AT THE F.D.A.
ABOUT 40% OF THE PEOPLE WHO ARE
INVOLVED IN THE DRUG AND DEVICE
APPROVAL PROCESS, PART OF THEIR
EVALUATION IN TERMS OF THEIR
PERFORMANCE REVIEW HAS TO DO
WITH THE TIMELINESS OF THEIR
WORK PRODUCT.
AND IT'S ONLY A SMALL COMPONENT
BUT IT'S YET STILL A COMPONENT
OF IT, AND WHAT THIS AMENDMENT
DOES IS JUST SAID F.D.A., MAKE
THIS A PART OF YOUR COMPONENT ON
THE PEOPLE THAT ARE ACTUALLY
REVIEWED IN THE REVIEW PROCESS.
NOT TO TRY TO PUSH THEM TO DO IT
BETTER BUT TO HAVE A MANAGEMENT
TOOL WITH WHICH TO EVALUATE
INDIVIDUAL EMPLOYEES DOING THIS.
THE FACT THAT THEY ARE ALREADY
DOING THIS ON SOME AND WHAT
G.A.O. REALLY SAID IS JUST A
LACK OF MANAGEMENT EFFECTIVENESS
THAT THEY HAVEN'T INSTALLED IT
EVERYWHERE ELSE, ALL THIS
AMENDMENT SAYS IS THIS SHOULD BE
A COMPONENT, AS THEY EVALUATE
THEIR EMPLOYEES THAT ARE
ASSOCIATED, AS ONE COMPONENT OF
THEIR PERFORMANCE REVIEW, HOW
DID YOU DO ON TIMELINESS?
WAS YOUR WORK PRODUCT TIMELY?
THE IDEA BEHIND THIS IS NOT TO
PUSH DRUGS OUT THAT SHOULDN'T BE
APPROVED.
IT'S NOT TO PUSH OUT DEVICES
THAT SHOULDN'T BE APPROVED, BUT
REMEMBER THE PURPOSE FOR PDUFA
IN THE FIRST PLACE AND MDUFA.
THE PURPOSE WAS TO FIND F.D.A.
WITH MORE MONEY SO THEY WOULD BE
MORE TIMELY.
THE OPPOSITION THAT I HEAR TO
THIS AMENDMENT IS THAT WE'RE
AFRAID IF THIS IS A COMPONENT OF
REVIEW THAT THEY MIGHT REVIEW A
PRODUCT AND LET IT GO WHEN THEY
SHOULDN'T DOESN'T MAKE SENSE
SINCE ALREADY 40% OF THE
EMPLOYEES THAT ARE DOING THIS
ARE BEING EVALUATED ON THIS
PERFORMANCE STANDARD ANYWAY.
SO I WOULD RAISE THE QUESTION IF
WE'RE IN OPPOSITION TO THIS
AMENDMENT, WHY IN THE WORLD
HAVEN'T WE ELIMINATED THIS AS A
PART OF ALL THE REVIEW PROCESS
ALREADY IF, IN FACT, IT'S A
CONCERN.
AND THERE ISN'T A CONCERN WITH
IT.
IT'S A GOOD MANAGEMENT TOOL.
IT'S USED IN ALL OTHER SORTS OF
GOVERNMENT AGENCIES.
I WOULD COMMEND AND ASK
UNANIMOUS CONSENT TO PUT THE
G.A.O. REPORT IN THE RECORD THAT
BACKS UP EXACTLY WHAT I'M
SAYING, AND THEIR
RECOMMENDATION.
THESE AREN'T TOM COBURN'S
RECOMMENDATION.
THESE ARE THE G.A.O.
RECOMMENDATIONS FOR F.D.A., AND
THEY ADDRESS THE CONCERNS OF
INAPPROPRIATE PRESSURE FOR EARLY
APPROVAL OR INAPPROPRIATE
APPROVAL FOR DRUGS OR DEVICES.
SO, AGAIN, IT'S GOOD GOVERNMENT,
IT'S COMMON SENSE, IT'S HOW YOU
WOULD MANAGE A PRIVATE
ORGANIZATION.
YOU WOULD PUT EVERY COMPONENT
THAT THE EMPLOYEE IS INVOLVED
WITH AS A COMPONENT OF PART OF
THEIR REVIEW PROCESS.
AND MY HOPE IS THAT WE DON'T
HAVE TO VOTE ON THIS, WHEN YOU
ACTUALLY THOROUGHLY STUDY THE
G.A.O. REPORT, YOU WILL EMBRACE
WHAT THEY ARE SAYING AS COMMON
SENSE WITH SOUND JUDGMENT THAT
WILL ACTUALLY IMPROVE THE F.D.A.
WITH THAT, I WOULD YIELD THE
FLOOR.
MR. HARKIN: WOULD THE SENATOR
YIELD FOR A QUESTION?
A SENATOR: I WOULD BE HAPPY TO.
MR. HARKIN: I THINK THE SENATOR
IS MAKING A LOT OF SENSE.
THE ONLY QUESTION I WOULD ASK --
I DON'T KNOW A LOT ABOUT THIS.
I HAVEN'T READ THE G.A.O.
REPORT, I WOULD BE THE FIRST TO
ADMIT.
IF, IN FACT, EVERY EMPLOYEE SAYS
I KNOW THEY ARE GOING TO GET ME
ON THIS TIMELINESS, SO IT'S THE
BALANCE OF SAFETY, SAFETY AND --
AND -- AND QUICKNESS, SAFETY AND
EXPEDIENCY.
IN OTHER WORDS, WE TRY TO GET A
BALANCE.
WE WANT DEVICES AND DRUGS
APPROVED AS QUICKLY AS POSSIBLE
BUT WE DON'T WANT TO JEOPARDIZE
SAFETY.
THOSE ARE THE TWO THINGS.
WE ALWAYS TRY TO BALANCE IT
HERE.
SAFETY BEING THE FOREMOST.
WE WANT THINGS TO BE SAFE.
I JUST -- I GUESS I ASK THE
QUESTION WOULD ENSHRINING THIS
IN LAW RATHER THAN THE
ADMINISTRATION, WOULD THIS
SOMEHOW PUT MORE UNDO PRESSURE
ON REVIEWERS AND THINGS TO DO
SOMETHING QUICKLY AND JEOPARDIZE
THE SAFETY ASPECT?
MR. COBURN: WELL, MY ANSWER TO
THE CHAIRMAN THROUGH THE CHAIR
IS THE F.D.A. DOES NOTHING
QUICKLY NOW, AND HE KNOWS THAT
BECAUSE HE HAS BEEN SITTING IN
OVERSIGHT OVER HIM FOR YEARS.
THAT'S NUMBER ONE.
NUMBER TWO, THE ANSWER TO THAT
IS THEY HAVE NO EXPLANATION IF
YOU WILL READ THE G.A.O. REPORT
ON WHY THEY DO IT ON SOME
EMPLOYEES AND NOT OTHERS.
SO THE FACT IS IF THIS IS A BAD
THING, WHY ARE THEY DOING IT ON
40% OF THE EMPLOYEES NOW?
IT'S NOT.
THE NUMBER ONE AND NUMBER TWO
THINGS THAT THE F.D.A. IS
CHARGED WITH IS SAFETY AND
EFFICACY, SAFETY AND EFFICACY.
SAFETY COMES FIRST.
THEY GET GRADED ON HOW WELL THEY
DO ON THAT.
SO YOU HAVE THIS COUNTERBALANCE,
BUT WHAT WE HAVE IS A LACK OF
RESPONSIVENESS EVEN THOUGH
BILLIONS OF DOLLARS ARE GOING TO
THE F.D.A. FROM THE DEVICE
COMPANIES AND THE DRUG
COMPANIES.
PART OF THE DEAL WAS IS TO MAKE
THEM MORE TIMELY.
THAT MEANS IN NO WAY DO YOU
IGNORE SAFETY AND IN NO WAY DO
YOU IGNORE EFFICACY.
THE FACT IS THEY DO DESERVE
ANSWERS, AND WHAT HAS HAPPENED
IS A LOT OF TIMES THEY ARE NOT.
I FULLY SUPPORT THE BUREAUCRACY
OF THE F.D.A. IN TERMS OF DOING
THEIR JOB.
I THINK THEY DO AN AWFULLY GOOD
JOB.
THEY ARE JUST AWFULLY SLOW AT
IT.
WHEN YOU ASK WHY, THERE IS NOT A
GOOD ANSWER.
AND SO THE POINT IS IF THERE IS
A LARGE NUMBER OF EMPLOYEES THAT
ARE ALREADY REVIEWED, A SMALL
COMPONENT, IT DOESN'T HAVE TO BE
A MAJOR ONE, BUT IT OUGHT TO
HAVE TO BE SOMETHING YOU THINK
ABOUT.
YOU KNOW, DO I PUSH THIS ONE OFF
MY DESK BECAUSE I'M BORED WITH
IT?
DOES THE TIME FRAME MEAN
ANYTHING?
WE'RE NOT GOING AFTER
ELIMINATING SAFETY AND EFFICACY.
WE'RE GOING AFTER SMART
MANAGEMENT.
AND THOSE TWO THINGS, SAFETY AND
EFFICACY REIGN SUPREME AT THE
F.D.A.
THAT'S WHY WE SPEND SO MUCH IN
THIS COUNTRY.
THAT'S WHY MOST OF THE DRUGS ARE
APPROVED OUTSIDE OF THIS COUNTRY
WAY AHEAD OF WHEN THEY GET
APPROVED HERE, BECAUSE OUR DRUGS
AND DEVICES ARE SAFE AND WE'RE
SLOW TO APPROVE AND RIGHTLY SO
BUT WE SHOULDN'T BE LIKE FROZEN
ICE SLOWLY SLIPPING DOWN A HILL,
AND ALL THIS SAYS IS LET'S MAKE
ONE COMPONENT OF MANY IN TERMS
OF THE REVIEW, DO IT.
AGAIN, I WOULD TELL THE
CHAIRMAN, THIS IS NOT MY
RECOMMENDATION.
THIS IS THE G.A.O.'S
RECOMMENDATION.
SO I WOULD APPRECIATE THE
CONSIDERATION BY THE CHAIRMAN
AND REGULAR MEMBER FOR THESE
AMENDMENTS.
I THINK THEY ARE COMMON SENSE.
WE CAN LOOK AT THEM AGAIN.
IF YOU THINK THERE IS A PROBLEM,
WE CAN PUT A CAVEAT.
LET'S LOOK AT THEM IN A YEAR AND
SAY HAVE THERE BEEN PROBLEMS
BECAUSE WE HAVE DONE THIS.
BUT IT IS GOOD MANAGEMENT, IT
DOES MAKE SENSE.
THEY ARE ALREADY DOING IT ON 40%
OF THEIR EMPLOYEES WHO ARE
INVOLVED IN THE APPROVAL OF BOTH