þ FDA0428.99 TRANSCRIPT

\>\>\> I\'M MARK BARNETT, COMMUNICATIONS DIRECTOR

WITH FDA's CENTER FOR DEVICES AND RADIOLOGICAL HEALTH.

AND I\'LL BE SERVING AS YOUR MODERATOR TODAY FOR THIS

LIVE INTERACTIVE TELECONFERENCE FOR FDA STAKEHOLDERS.

TODAY\'S BROADCAST, WHICH IS A FOLLOW-UP TO THE STAKEHOLDER

MEETINGS WE HAD LAST SUMMER, IS PART OF A LARGER ONGOING EFFORT

TO IMPROVE COMMUNICATION BETWEEN THE AGENCY AND THE PEOPLE

AND GROUPS IT MOST DIRECTLY AFFECTS \--

CONSUMERS, PATIENTS, PRACTITIONERS AND MANUFACTURERS.

AS YOU KNOW, THIS BROADCAST IS BEING HELD IN CONJUNCTION

WITH REGIONAL STAKEHOLDER MEETINGS HOSTED BY THE FDA THAT

ARE TAKING PLACE IN EIGHT LOCATIONS ACROSS THE

COUNTRY TODAY.

DEPENDING ON THE TIME ZONE IN THOSE LOCATIONS, THE REGIONAL

MEETINGS MAY TAKE PLACE DIRECTLY BEFORE OR

DIRECTLY AFTER THE BROADCAST.

FDA's GOAL IN ALL THESE OUTREACH EFFORTS IS A

REGULATORY PROCESS THAT\'S MORE TRANSPARENT TO YOU

AND MORE ACCOUNTABLE TO THE PUBLIC.

WE\'RE TRYING TO ACCOMPLISH THAT BY FOSTERING A REAL INTERCHANGE

WITH STAKEHOLDERS, IN WHICH THE AGENCY MAKES ITS PRIORITIES

AND ITS EXPECTATIONS CLEAR TO THOSE WHO WILL BE AFFECTED

BY THEM, AND, IN TURN, RECEIVES MEANINGFUL FEEDBACK ABOUT WHETHER

ITS PROGRAMS ARE ON THE RIGHT TRACK.

A LIVE INTERACTIVE TELECONFERENCE LIKE THIS ONE CAN

BE AN EFFECTIVE WAY TO DO THAT, BECAUSE IT ALLOWS

THE FDA FOLKS TO EXPLAIN WHAT THEY\'RE DOING

AND WHAT THEY PLAN TO DO.

AND THEN IT ALLOWS STAKEHOLDERS ALL ACROSS THE COUNTRY TO ASK

QUESTIONS AND OFFER COMMENTS.

IN OTHER WORDS, IT ALLOWS REAL INTERACTION TO TAKE PLACE

AND IN REAL TIME.

ONE OF OUR SPECIFIC GOALS FOR TODAY IS TO HELP

STAKEHOLDERS BETTER UNDERSTAND OUR STRATEGIC PLANNING

AND OUR BUDGET, PARTICULARLY, AS THEY RELATE TO THE FDA

MODERNIZATION ACT, OR FDAMA.

LET ME BRIEFLY EXPLAIN THE FORMAT WE\'RE

GOING TO USE THIS AFTERNOON.

TO SET THE STAGE FOR THE DISCUSSION, WE\'LL FIRST HEAR

FROM DR. JANE HENNEY, THE COMMISSIONER OF FOOD

AND DRUGS.

WE\'LL HEAR ABOUT HER PLANS AND PRIORITIES, AND

ABOUT HER VIEWS AS TO WHERE THE AGENCY SHOULD BE GOING

IN THE NEW MILLENNIUM.

THEN WE\'LL HEAR FROM DR. LINDA SUYDAM, FDA SENIOR ASSOCIATE

COMMISSIONER, ABOUT THE PROGRESS THE AGENCY\'S MADE IN ITS EFFORT

TO IMPLEMENT THE FDA MODERNIZATION ACT.

AT THAT POINT, WE\'LL TAKE A 15-MINUTE BREAK, AND THEN

WE\'LL BEGIN THE INTERACTIVE PORTION OF THE BROADCAST.

AND DURING THAT SEGMENT, WE\'LL BE RESPONDING TO

QUESTIONS AND COMMENTS THAT YOU PHONE OR FAX IN TO US.

NOW, SINCE YOU MAY BE THINKING ABOUT QUESTIONS OR COMMENTS

DURING THE EARLY PART OF THE BROADCAST, LET ME BRIEFLY

EXPLAIN THAT THEY SHOULD BE FOCUSED ON THE FIVE QUESTIONS

POSED TO FDA STAKEHOLDERS IN THE MARCH 22nd FEDERAL

REGISTER NOTICE.

A COPY OF THOSE FIVE QUESTIONS IS AVAILABLE AT THE REGIONAL

MEETINGS.

BUT FOR THOSE WATCHING THE BROADCAST FROM OTHER

LOCATIONS, HERE ARE THOSE QUESTIONS.

NUMBER ONE \--

WHAT ACTIONS DO YOU PROPOSE THE FDA TAKE

TO EXPAND ITS CAPABILITY TO INCORPORATE STATE-OF-THE-ART

SCIENCE INTO ITS RISK-BASED DECISION MAKING?

OF COURSE, IMPROVING FDA\'s

SCIENCE BASE IS ONE

OF DR. HENNEY\'S TOP PRIORITIES.

AND WE\'RE GOING TO BE DISCUSSING THIS

ISSUE WITH HER IN JUST A FEW MINUTES.

THE SECOND QUESTION IS \--

WHAT ACTIONS DO YOU PROPOSE TO FACILITATE

THE EXCHANGE AND INTEGRATION OF SCIENTIFIC

INFORMATION TO BETTER ENABLE FDA TO MEET ITS

PUBLIC HEALTH RESPONSIBILITIES THROUGHOUT A

PRODUCT\'S LIFE CYCLE?

THIS QUESTION GOES BACK

TO PREVIOUS STAKEHOLDER COMMENTS

THAT THE FDA SHOULD CONSIDER

SCIENTIFIC EXCHANGE TO IMPROVE

ACCOUNTABILITY AND TRANSPARENCY.

THE THIRD QUESTION IS \--

WHAT ACTIONS DO YOU PROPOSE

OR EDUCATING THE PUBLIC ABOUT THE CONCEPT

OF BALANCING RISKS AGAINST BENEFITS IN PUBLIC

HEALTH DECISION MAKING?

AND THAT ONE GOES BACK

TO AN ANALYSIS OF PREVIOUS

STAKEHOLDER RECOMMENDATIONS THAT

CONSUMERS NEED BETTER

INFORMATION ABOUT THE RISKS

AND BENEFITS OF THE PRODUCTS

THEY USE AND ABOUT HOW

RISK/BENEFIT DECISIONS ARE MADE

BY THE FDA.

THE FOURTH QUESTION IS \--

WHAT ACTIONS DO YOU PROPOSE TO ENABLE FDA

TO FOCUS RESOURCES ON AREAS OF GREATEST RISK

TO PUBLIC HEALTH?

AND THIS ONE RELATES TO THE NEED

FOR FDA TO MAKE MAXIMUM USE

OF A LIMITED BUDGET TO GET

ITS CONSUMER PROTECTION JOB DONE.

AND THE FIFTH AND FINAL QUESTION IS \--

WHAT ADDITIONAL ACTIONS TO YOU PROPOSE FOR ENHANCING

FEEDBACK OR EVALUATION OF FDA's MODERNIZATION EFFORTS?

THIS ONE GOES BACK TO PREVIOUS STAKEHOLDER COMMENTS THAT FDA

SHOULD SET UP A SYSTEM TO GET FEEDBACK

FROM STAKEHOLDERS ABOUT ITS PROGRESS

IN MODERNIZING THE AGENCY.

NOW, WE\'LL SHOW THESE FIVE QUESTIONS

ON YOUR SCREEN AGAIN DURING THE BREAK.

DURING THE INTERACTIVE SESSION, WE\'D ALSO LIKE TO HEAR

FROM YOU ABOUT A COUPLE OF BROADER ISSUES.

FIRST OF ALL \--

HOW ARE WE DOING IN IMPLEMENTING FDAMA?

AND SECONDLY \--

HOW CAN WE FURTHER ENHANCE OUR EFFORTS TO MODERNIZE

THE AGENCY, AND HOW CAN YOU AS A STAKEHOLDER

HELP IN THAT EFFORT?

WE\'LL ALSO GOING TO BE RESPONDING TO QUESTIONS AND

COMMENTS FROM OUR STUDIO AUDIENCE.

THE STUDIO AUDIENCE IS MADE UP OF REPRESENTATIVES

OF BROAD-BASED STAKEHOLDER ORGANIZATIONS FROM PATIENT

AND CONSUMER GROUPS, THE CLINICAL AND ACADEMIC

COMMUNITIES, AND THE REGULATED

INDUSTRIES.

BY THE WAY, THOSE FAX LINES ARE

OPEN RIGHT NOW, AND THEY\'RE GOING TO STAY

OPEN ALL THROUGH THE BROADCAST.

SO YOU CAN GO AHEAD AND START FAXING QUESTIONS TO US ANYTIME.

WE\'LL ANSWER THEM DURING THE INTERACTIVE SESSION

LATER ON IN THE BROADCAST.

OR YOU CAN CALL A QUESTION IN AND LEAVE

IT WITH US TO BE ANSWERED LATER ON.

THE NUMBERS FOR FAXES AND PHONE CALLS SHOULD BE APPEARING

ON YOUR SCREEN, AND THEY\'RE GOING TO REAPPEAR FROM

TIME TO TIME ALL THE WAY THROUGH THE BROADCAST.

IF YOU WANT TO CALL YOUR QUESTION IN AND SPEAK

DIRECTLY WITH THE PANEL \--

THAT COMES LATER, AND I\'LL TELL YOU WHEN YOU

CAN START MAKING THOSE LIVE CALLS.

WHICHEVER METHOD YOU USE TO GET YOUR QUESTIONS TO US, IF YOU\'RE

AT ONE OF THE EIGHT REGIONAL MEETINGS, YOU\'LL BE USING

A STANDARD FORM TO WRITE THEM DOWN ON, AND THAT HOLDS TRUE EVEN

IF ITS A PHONED-IN QUESTION.

THAT WAY, IF A QUESTION DOESN\'T GET ANSWERED ON THE AIR, WE HAVE

A RECORD OF IT AND WE CAN ANSWER IT LATER ON.

AND NOW LET ME INTRODUCE THE TWO PEOPLE SITTING WITH ME HERE

IN THE STUDIO.

DR. JANE HENNEY IS COMMISSIONER OF THE FOOD AND DRUG

ADMINISTRATION.

SHE BEGAN AS COMMISSIONER IN NOVEMBER.

AND PRIOR TO THAT, SHE WAS VICE PRESIDENT FOR HEALTH

SCIENCES AT THE UNIVERSITY OF NEW MEXICO.

THAT WAS FROM 1994 TO 1998.

DR. HENNEY IS NO STRANGER TO THE FDA.

SHE SERVED AS FDA's DEPUTY

COMMISSIONER FOR OPERATIONS FROM 1992 TO 1994.

AND SHE\'S ALSO NO STRANGER

TO GOVERNMENT SERVICE, HAVING

SERVED AS DEPUTY DIRECTOR

OF THE NATIONAL CANCER INSTITUTE

AT NIH IN THE EARLY 1980s.

DR. HENNEY IS AN ONCOLOGIST,

AND SHE WAS VICE PRESIDENT

FOR HEALTH AFFAIRS

AT THE UNIVERSITY OF KANSAS

MEDICAL SCHOOL FROM

1985 TO 1992.

DR. LINDA SUYDAM IS FDA's SENIOR

ASSOCIATE COMMISSIONER.

ONE OF HER TASKS IS TO DEVELOP

AND PUT INTO PRACTICE NEW

REGULATORY STRATEGIES FOR FDA.

AND ONE OF HER PRINCIPAL

RESPONSIBILITIES RIGHT NOW IS

TO DEVELOP THE FDA PLAN THAT\'S

REQUIRED UNDER SECTION 406-B

OF THE FDA MODERNIZATION ACT.

PRIOR TO HER PRESENT POSITION,

DR. SUYDAM WAS ASSOCIATE VICE

PRESIDENT FOR PLANNING

AND DEVELOPMENT AT THE HEALTH

SCIENCES CENTER AT

THE UNIVERSITY OF NEW MEXICO.

LIKE DR. HENNEY, DR. SUYDAM HAS

A LONG HISTORY OF GOVERNMENT

SERVICE.

PRIOR TO 1995, SHE SPENT

17 YEARS IN THE FDA.

AND BEFORE LEAVING THE AGENCY TO GO

TO NEW MEXICO, SHE WAS FDA's

INTERIM DEPUTY COMMISSIONER

FOR OPERATIONS.

DR. HENNEY, WELCOME TO YOUR

FIRST TELECONFERENCE.

DID YOU NOTICE THE FLOWERS?

WE HAVE DONE \-- I WANT \-- THE

PEOPLE WATCHING WHO ARE REGULAR

VIEWERS WILL KNOW THIS.

WE HAVE DONE 50 OF THESE, OVER 50.

THIS IS THE FIRST TIME WE HAVE

HAD A FLORAL ARRANGEMENT.

SO THIS IS FOR YOUR DEBUT.

\[ LAUGHTER \]

WE WERE GOING TO HAVE THE

CAMERAMAN SCATTER THEM ON THE SET.

\>\> OH.

\>\> LIKE AT BULL FIGHTS AFTER, BUT THAT

WAS KIND OF DRAMATIC.

I WANT TO START OUT BY TALKING

TO YOU ABOUT SCIENCE AND THE FDA.

ONE OF YOUR TOP PRIORITY, AND

YOU\'VE SAID IT OVER AND OVER \-- MAYBE IT\'S

YOUR NUMBER ONE PRIORITY \-- IS STRENGTHENING THE SCIENCE BASE

OF THIS AGENCY.

AND I WANT TO KNOW WHY THAT\'S SO IMPORTANT TO

YOU, PARTICULARLY IN VIEW OF THE

FACT THAT THIS IS, AFTER ALL,

PRIMARILY A REGULATORY AGENCY.

IT\'S NOT NIH.

THIS IS THIS IS NOT A RESEARCH

ORGANIZATION.

AND YET, SCIENCE, IN YOUR MIND, IS VERY HIGH.

WHY IS THAT?

\>\> WELL, MARK, I THINK IT\'S NOT

JUST MY PRIORITY.

I THINK TO KEEP THE AGENCY

REALLY AT THE TOP OF WHAT IT

SHOULD BE, WHICH IS A

SCIENCE-BASED REGULATORY AGENCY,

WE ALL REALLY NEED TO FOCUS ON

HOW WE CAN BEST DO THAT.

BECAUSE IT SEEMS TO ME, EVERY

DECISION THAT GETS MADE BY THE

AGENCY AND THE STAFF WITHIN THE

AGENCY MUST BE GROUNDED IN

SCIENCE.

AND WHETHER YOU\'RE

TALKING ABOUT OUR REVIEWERS WHO

ARE REVIEWING APPLICATIONS AND

DEVICES OR DRUGS OR BIOLOGICS,

THEY NEED TO BE FIRMLY GROUNDED

IN SCIENCE AS THEY MAKE

JUDGMENTS ABOUT APPLICATIONS

THAT ARE COMING IN FROM SOME OF THIS

NATION\'S BEST SCIENTISTS.

SO THEY REALLY NEED TO BE AT THE TOP OF

THE GAME SCIENTIFICALLY, STRONG IN TERMS OF THEIR

CURRENCY AND CREDENTIALS IN THE SCIENTIFIC WORLD.

BUT IT GOES FAR BEYOND OUR REVIEWERS.

I THINK OUR INSPECTORS IN THE

FIELD, CLEARLY, AS THEY COME INTO

THE AGENCY HAVE A REQUIREMENT

THAT THEY HAVE A CERTAIN NUMBER

OF SCIENCE BACKGROUND HOURS IN

THEIR COLLEGE EXPERIENCE AND

TRAINING.

BUT WE NEED TO MAKE SURE THAT THEY ARE ALSO CURRENT

AS THEY GO OUT AND INSPECT INDUSTRY AND HAVE TO MAKE

DECISIONS ABOUT COMPLIANCE OR ENFORCEMENT DECISIONS.

AND IT IS TRUE ALSO IN OUR POLICY ARENA.

OUR POLICIES NEED TO BE GROUNDED IN SCIENCE.

SO IT IS FOR ME VERY IMPORTANT THAT ALL ASPECTS OF

THIS AGENCY BE ALL THAT THEY REALLY CAN AND SHOULD BE IN

TERMS OF SCIENTIFIC EXPERTISE, BECAUSE IT IS ONLY THAT THAT

WILL MAKE OUR DECISIONS MEANINGFUL.

I THINK IF OUR DECISIONS ARE

GROUNDED IN GOOD SCIENCE, THEN

OTHER THINGS CAN TRY TO SWAY US, BUT WE\'LL

HAVE A FIRM FOOTING ON WHICH WE CAN STAND.

AND SO THAT IS WHY I\'M VERY HEAVILY INVESTED

IN THIS ISSUE.

\>\> YOU TALKED ABOUT REVIEWERS.

THE PRODUCTS THEY REVIEW ARE MORE AND MORE COMPLEX.

THE TECHNOLOGY THAT UNDERLIES THEM IS MORE AND MORE COMPLEX.

ARE YOU CONCERNED THAT AS TIME GOES BY, THERE MAY BE A GAP

DEVELOPING BETWEEN THE KNOWLEDGE

BASE OF THE SPONSOR AND THE

KNOWLEDGE BASE OF THE PEOPLE

THAT REVIEW THE PRODUCT?

\>\> WELL, I THINK THAT I HAVE

USED THE WORDS \"MAINTAIN AND

ENHANCE THE SCIENCE STRENGTH OF

THE AGENCY.\"

I THINK THAT WE HAVE TO PAY

ATTENTION NOT ONLY AT THE TIME

WE RECRUIT STRONG SCIENTISTS TO

THE AGENCIES, BUT WE NEED TO

MAKE EVERY EFFORT TO MAKE SURE

THAT OUR CURRENCY, IF YOU WILL, OR OUR CREDIBILITY IN SCIENCE IS

STILL STRONG.

WE CAN DO THAT IN A NUMBER OF WAYS, EITHER

THROUGH THE STAFF COLLEGES THAT WE HOLD WITHIN THE

REVIEWING CENTERS IN TERMS OF

THEIR TRAINING AND ONGOING

ASPECTS, CLEARLY, LEVERAGING

WITH THE INSTITUTIONS THAT HAVE

A TREMENDOUS AMOUNT OF INTELLECTUAL CAPITAL, THE OTHER

FEDERAL RESEARCH AGENCIES, NIH, NSF THAT YOU MENTIONED,

CERTAINLY WITH ACADEMIA AND OUR

PARTNERSHIPS THERE THAT WE HAVE

IN TERMS OF BRINGING IN EXPERTS

FOR OUR ADVISORY COMMITTEES, BUT

ALSO EXCHANGES BETWEEN AND AMONG

THE FACULTY AND THE \-- OF THOSE

INSTITUTIONS AND OUR OWN STAFF, AND CERTAINLY

THE INTERACTIONS THAT WE CAN HAVE WITH REGULATED

INDUSTRY.

I KNOW WITHIN THE CENTER FOR

DEVICES, THE EXPERIENCE AND

STRENGTH OF HOLDING VENDOR DAYS

HAS BEEN A VERY STRONG ONE FOR

THE AGENCY.

SO I\'M REALLY

LOOKING AT A BROAD RANGE OF

OPPORTUNITIES THAT WE CAN HAVE

IN TERMS OF MAKING SURE WE KEEP

OUR SCIENTISTS STRONG.

\>\> YOU\'RE PARTICULARLY INTERESTED IN THE

MOFFETT CENTER IN CHICAGO, TOO, AS AN

EXAMPLE OF WHAT CAN BE DONE.

YOU WANT TO TALK ABOUT THAT A LITTLE?

\>\> WELL, THE MOFFETT CENTER IS

VERY UNIQUE, AND I HOPE THAT IT

WON\'T BE SO UNIQUE IN DAYS AHEAD.

\>\> NOT ONE OF A KIND.

\>\> NOT ONE OF A KIND, BECAUSE IT

DOES REALLY REPRESENT A VERY

STRONG PARTNERSHIP IN \-- I GUESS

IT\'S A THREE-WAY PARTNERSHIP.

BUT IT IS AMONG THE AGENCY

ACADEMIA, THE TECHNOLOGY

INSTITUTE AT ILLINOIS AND

REGULATED INDUSTRY.

WE\'RE NOT DEVELOPING ANY

PRODUCTS THERE, AND THAT\'S NOT

REALLY WHAT WE\'RE LOOKING AT.

BUT WE ARE CONFIRMING PROCESSES

THERE THAT INDUSTRY HAS \-- LOOKS AT

DIFFERENT ASPECTS OF MAKING FOOD SAFE.

IT STARTED SOME YEARS AGO.

I THINK IT HAS BEEN A HIGHLY

SUCCESSFUL VENTURE, AND WE\'RE

USING IT AS A PROTOTYPE FOR WHAT

WE COULD BE DOING IN OTHER AREAS

AS WELL.

\>\> ARE YOU LOOKING FOR IDEAS

FROM STAKEHOLDERS ON THIS AS TO HOW WE CAN \--

\>\> OH, ABSOLUTELY.

AS I\'VE BEEN GOING OUT TO

OUR DIFFERENT DISTRICT OFFICES, I\'VE TRIED TO

TAKE THE OPPORTUNITY TO MEET

WITH STATE OFFICIALS, BOTH

PUBLIC HEALTH AND OUR PARTNERS

FROM THE DEPARTMENTS OF

AGRICULTURE, MEET WITH MEMBERS

OF THE REGULATED INDUSTRY, MEET

WITH PATIENT AND CONSUMER

GROUPS.

I\'M TRYING TO TAP THE IDEAS OF

ALL OF THOSE GROUPS IN TERMS OF

MAKING THE AGENCY AS STRONG AS

IT SHOULD BE.

\>\> FOR SEVERAL YEARS THIS AGENCY

WAS CRITICIZED HEAVILY FOR

PERCEIVED SLOWNESS IN GETTING

NEW PRODUCTS TO MARKET.

\>\> I THOUGHT WE WERE BEING

DELIBERATIVE, MARK.

\[ LAUGHTER \]

\>\> DELIBERATIVE, RIGHT, RIGHT.

IT\'S ALL IN HOW YOU LOOK AT IT, RIGHT?

\>\> YEAH.

\>\> ANYWAY, THAT HAS STILLED NOW BECAUSE

THE AGENCY HAS, IN FACT, TURNED THINGS

AROUND, AND REVIEW TIMES ARE DOWN.

YOU DON\'T HEAR A LOT OF THAT CRITICISM NOW.

WHAT YOU HEAR NOW IS SOMETHING ELSE.

AND IT\'S EXEMPLIFIED, I\'VE GOT A \"WALL STREET JOURNAL\"

FROM LAST WEEK.

THE HEADLINE SAYS \--

\"FDA FINDS TRIES TO FIND RIGHT BALANCE ON

DRUG APPROVALS.\"

AND THEN IT SAYS IN THE SECOND PARAGRAPH \--

\"THE AGENCY IS CAUGHT IN PINCERS

BETWEEN TWO PRESSURES.\"

THAT MUST BE VERY PAINFUL.

\"DEMANDS TO MOVE FASTER AND

FASTER IN APPROVING DRUGS AND

RISING INSISTENCE TO SHOW MORE

CAUTION.\"

ARE YOU, INDEED, CONCERNED THAT

THE EXTRA SPEED THAT WE\'VE PUT

ON HAS OR COULD RESULT IN

COMPROMISING PUBLIC HEALTH?

\>\> WELL, LET ME RESPOND TO YOUR

QUESTION IN A NUMBER OF WAYS.

I WOULD BE VERY CONCERNED IF I

DIDN\'T THINK THE STANDARD, THE

STRONG STANDARD THAT WE HAVE FOR

APPROVAL, SAFETY AND

EFFECTIVENESS WAS NOT BEING MET.

AND AS LONG AS THAT\'S BEING MET,

THE TIMELINESS IN WHICH WE DO IT, I THINK, CAN

ONLY BENEFIT PATIENTS AND CONSUMERS THAT ARE

GOING TO USE OUR PRODUCTS.

SO IF THE STANDARD IS STILL HIGH

AND WE ARE MEETING THAT STANDARD

AS WE MAKE APPROVALS, THE TIME

IS OF CRITICAL IMPORTANCE TO

MANY OF THE POPULATIONS THAT

NEED THESE PRODUCTS.

SO I\'M NOT AS CONCERNED ABOUT SPEED.

IN FACT, I THINK YOU ALLUDE TO

DAYS GONE BY WHEN THE AGENCY WAS

HEAVILY CRITICIZED FOR SLOWNESS IN REVIEW, FOR

NOT ONLY BEING DELIBERATIVE, BUT HAVING THE PROCESS TAKE TOO LONG.

I THINK THAT THE EXPERIMENT THAT

THE AGENCY ENGAGED IN WITH THE

INDUSTRY AND CONGRESS IN TERMS

OF THE DESIGN OF THE USER FEE

PROGRAM IN THE AREAS PARTICULARLY OF PRESCRIPTION

DRUGS AND BIOLOGICS WHERE AN

ADEQUATELY RESOURCED AGENCY AND, IN THIS CASE, THE RESOURCES CAME

FROM USER FEES, ALLOWING US TO

HIRE THE KIND \-- THE KIND AND

THE NUMBERS OF PEOPLE THAT WE

NEEDED AT THE AGENCY TO APPLY

THEIR SKILLS TO THE REVIEW

PROCESS AND BE HELD TO TIMELY

AND ACCOUNTABLE REVIEWS HAS BEEN

A VERY SUCCESSFUL EXPERIMENT.

AND I THINK THAT WE CAN LOOK

BACK ON THAT WITH GREAT PRIDE, THAT THAT

EXPERIMENT HAS WORKED, THAT THE SAFE AND EFFECTIVE

PRODUCT IS STILL BEING DELIVERED

TO THE MARKET NOW IN A TIMELY WAY.

AND YOU ALLUDE TO MY PAST EXPERIENCE

AS A MEDICAL ONCOLOGIST.

TIME IS OF THE ESSENCE FOR MANY

OF THE PATIENT POPULATIONS WE SERVE.

AND SO WE MUST KEEP IT AS AN ISSUE, BUT WE MUST ALSO KEEP

AS AN ISSUE BEFORE US THE FACT THAT WE ARE CHARGED WITH DOING A

FAIR \-- A VERY CAREFUL SAFETY AND EFFICACY REVIEW.

AND THAT\'S ALWAYS FINDING THE BALANCE OF RISK AND BENEFIT.

\>\> EVEN WITH THE BEST PREMARKET

REVIEW SYSTEM WE COULD HAVE,

THERE IS NO WAY THAT WE CAN

GUARANTEE SAFETY, NO WAY THAT WE CAN

GUARANTEE, IN FACT, THAT RARE

ADVERSE EFFECTS UNFORESEEN WILL

NOT OCCUR ONCE A PRODUCT IS ON THE MARKET.

SO THE QUESTION GETS TO BE, DO

WE HAVE A SYSTEM IN PLACE

NATIONWIDE STRONG ENOUGH AND

QUICK ENOUGH TO DETECT THESE

ADVERSE EFFECTS IN A TIMELY

WAY SO WE CAN TAKE CORRECTIVE ACTION?

\>\> WELL, MARK, I WOULD SAY THAT

AS ONE OF THE REASONS WHY

YESTERDAY WHEN I APPEARED BEFORE

THE APPROPRIATIONS COMMITTEE \--

\>\> THIS IS, INDEED, LIVE TELEVISION.

\>\> THIS IS, INDEED, LIVE TELEVISION \-- THAT I WAS ASKING FOR

MONEY TO ENHANCE WHAT WE DO IN THE

POST-MARKETING ARENA IN

TERMS OF INJURY REPORTING.

WE DO HAVE SOME INJURY REPORTING

SYSTEMS AT THE AGENCY.

ARE THEY AS COMPREHENSIVE AS THEY SHOULD BE?

ARE THEY AS INTEGRATED AS THEY SHOULD BE?

THE ANSWER IS NO.

AND THAT\'S WHY WE NEED MORE INVESTMENT IN THAT AREA.

WE WILL ALWAYS HAVE WITH ANY

PRODUCT THAT WE APPROVE FOR

MARKET, AS IT GOES INTO A WIDER

MARKETPLACE AND HAS MORE USE,

EITHER BY THE POPULATIONS IT WAS

TESTED IN OR BY OTHER

POPULATIONS, THE ADVERSE

REACTION BEYOND THAT USUAL AND EXPECTED

SIDE EFFECT.

WE NEED A WAY IN WHICH WE CAN

CAREFULLY MONITOR THOSE ADVERSE

REACTIONS, SO THAT IF THERE IS A

PROBLEM THAT WE NEED TO TELL

THE GREATER PHYSICIAN COMMUNITY,

PATIENT COMMUNITY OR GENERAL

CONSUMER COMMUNITY ABOUT, WE CAN

DO THAT IN TERMS OF ALERTS.

IF WE NEED TO GO BACK AND

REASSESS WHERE WE ARE IN TERMS

OF THE LABELING SO THAT IT\'S

COMMUNICATED CLEARLY OR, IN THE WORST OF CIRCUMSTANCE, WE HAVE TO

TAKE A PRODUCT OFF THE MARKET, WE NEED

TO BE RESPONDING TO REAL

TIME AND STRONG DATA.

\>\> THE LOGISTICS ARE DAUNTING.

IT\'S 300,000 ADVERSE EVENT REPORTS PER YEAR NOW.

AND IF PEOPLE ARE ENCOURAGED TO REPORT MORE, THERE WILL BE MORE.

AND SO PART IS A DATA MANAGEMENT THING, AND PART OF IT

IS A SYSTEMS APPROACH, ISN\'T IT?

\>\> IT\'S BOTH.

BUT I THINK WHAT WE ARE LOOKING FOR HERE IS

ADVERSE EVENT REPORTING.

NOT SIMPLY ANY EXPECTED SIDE

EFFECT THAT IS ALREADY KNOWN

ABOUT THE PRODUCT.

WE\'RE ALSO TRYING TO USE NEW SYSTEMS.

AND I THINK IN THE DEVICE ARENA, WE ARE LOOKING AT

SENTINEL SYSTEMS.

AND WE HOPE TO EXPAND THE NUMBER OF SITES THAT

WE HAVE IN THE DEVICE SENTINEL SYSTEM TO REALLY GIVE US THOSE

STRONG SIGNALS WE CAN ACT UPON.

\>\> IN THE FDA, THERE IS A NATURAL TENSION

BETWEEN, ON THE ONE HAND, PATIENTS WANTING TO MAKE

THEIR OWN HEALTH CARE DECISIONS, TO USE PRODUCTS AND HAVE PRODUCTS

USED ON THEM OF THEIR CHOICE.

AND ON THE OTHER HAND, THE FDA's MANDATE TO

PROTECT THEM AGAINST DEVICES OR PRODUCTS OF ANY KIND

THAT DON\'T WORK OR THAT AREN\'T SAFE.

HOW DO YOU DEAL WITH THAT IN

YOUR OWN MIND?

NOW, YOU TALKED ABOUT YOUR BEING AN

ONCOLOGIST.

I\'M SURE THAT WAS A FACTOR WHEN PEOPLE

HAVE LIFE-THREATENING ILLNESSES FOR

WHICH THERE IS NOT AN APPROVED

TREATMENT THAT REALLY WORKS VERY WELL.

HOW DO YOU HANDLE THAT AND HOW

DOES THE AGENCY HANDLE THAT KIND

OF PRESSURE?

\>\> WELL, THAT IS A REAL

CHALLENGE.

I THINK THAT THE AGENCY

CERTAINLY IS CHARGED WITH THE

MANDATE TO LOOK AT SAFETY AND

EFFICACY FOR ANY PRODUCT IN A

PARTICULAR POPULATION.

WE NEED TO MAKE SURE, AS I SAID

BEFORE, THAT WE ARE DOING THAT

IN A TIMELY WAY, SO THAT THE

BENEFITS CAN BE ENJOYED BY ALL

OF THOSE THAT COULD IN TERMS OF

MOVING THINGS TO MARKET.

AND I THINK FOR THOSE

POPULATIONS, THE CANCER PATIENTS

THAT WE HAVE MENTIONED, BUT

THERE ARE MANY OTHERS THAT

DON\'T EVEN HAVE THAT KIND OF

TIME LUXURY, WE\'VE TRIED TO OPEN

UP SEVERAL DIFFERENT AVENUES OF

ACCESS TO PRODUCTS EARLY.

\>\> WHICH WE DIDN\'T HAVE A WHILE BACK.

\>\> THAT\'S CORRECT.

THE SORT OF THE COMPASSIONATE USE,

THE HUMANITARIAN DEVICE PROVISIONS, THE PARALLEL TRACK

PROVISIONS THAT I THINK GREATLY EXPANDED THE AVAILABILITY OF

PRODUCTS, PARTICULARLY IN THE AIDS PATIENTS.

ALL OF THESE, I THINK, ARE TRYING TO STRIKE THAT

RIGHT BALANCE IN TERMS OF SAFETY

BUT ACCESS AND MEETING REAL NEEDS.

\>\> IF I\'M A CONSUMER READING A

NEWSPAPER AND WATCHING TELEVISION, I ALMOST HAVE TO

CONCLUDE THAT THE NATION\'S FOOD SUPPLY IS

NOT AS SAFE NOW AS IT WAS.

I MEAN, I DON\'T REMEMBER READING ABOUT

OUTBREAKS LIKE I\'M READING ABOUT

NOW 15 OR 20 YEARS AGO.

SO THE QUESTION GETS TO BE, IS THE

AMERICAN FOOD SUPPLY ACTUALLY

LESS SAFE THAN IT WAS, OR IS THAT AN ILLUSION?

AND IF IT IS, WHY IS THAT SO?

AND WHAT FDA PREPARED TO DO ABOUT IT?

\>\> OH, MARK, I THINK THE AMERICAN FOOD

SUPPLY BY AND LARGE IS VERY SAFE.

BUT WE ARE AT A PERIOD OF TIME

WHEN MANY THINGS HAVE CHANGED

WITH RESPECT TO OUR FOOD SUPPLY

AND FOOD IN GENERAL.

LET ME CITE A FEW EXAMPLES.

I GREW UP IN A VERY SMALL TOWN

IN INDIANA, PROBABLY THE ONLY

THING YOU DIDN\'T MENTION IN MY BIO.

BUT I DO REMEMBER \-- AND IT WASN\'T

THAT MANY YEARS AGO \-- THAT MOST OF

US GOT FOODS FROM EITHER LOCAL

GROWERS OR LOCAL SOURCES.

OUR MOMS USUALLY PREPARED OUR MEALS.

DAD FLIPPED PANCAKES ON SUNDAY, BUT

OUR MEALS WERE PREPARED IN OUR HOME.

WHEN WE ATE OUT AT A RESTAURANT,

I MEAN, IT WAS A REAL TREAT.

AND ABOUT THE ONLY OTHER TIME

WHEN SOMEBODY ELSE PREPARED OUR

FOOD WAS WHEN WE WENT TO

SOMEBODY ELSE\'S HOME THAT WE

KNEW OR WE WENT TO A CHURCH

SUPPER OR SOMETHING LIKE THAT.

SO THE FOOD PREPARERS WERE WELL KNOWN TO US.

WHEN WE HAD STRAWBERRIES, IT WAS

FOR TWO WEEKS IN JUNE.

I MEAN, IT WAS THE STRAWBERRY SEASON.

NOW WE GET STRAWBERRIES ALL YEAR LONG.

\>\> FROM OTHER COUNTRIES.

\>\> THROUGH MANY COUNTRIES, ALL YEAR LONG.

SO, I MEAN, JUST THINK ABOUT IT.

NOW ACTUALLY ALMOST 90% OF OUR

FOOD SUPPLY IS IN SOME WAY

REGULATED BY THE FDA.

LOTS MORE FRESH FRUITS,

VEGETABLES, BUT ALSO MUCH MORE SEAFOOD.

SO THE COMPOSITION OF OUR FOOD THAT WE EAT IS

DIFFERENT.

WE EAT OUT AS AMERICANS OR HAVE

FOOD PREPARED BY OTHERS MORE THAN 50% OF THE TIME.

WHEN YOU CONSIDER TAKE-OUT FOOD

OR FOOD THAT\'S PREPARED BY

SOMEONE ELSE OR GOING OUT TO EAT IN A RESTAURANT.

\>\> SO THIS IS CONDUCIVE TO MASS

OUTBREAKS AS OPPOSED TO BEING

SICK ALONE IN YOUR HOME?

\>\> WELL, YES.

\[ LAUGHTER \]

HOME ALONE, YES.

\>\> YEAH.

\>\> AND WE HAVE ALL KINDS OF THINGS

NOW AVAILABLE TO US BECAUSE OF

FOOD THAT CAN COME INTO US FROM

ALL OVER THE WORLD.

IT\'S TRANSPORTED ALL OVER THIS

COUNTRY AND COMES IN FROM ALL

OVER THE WORLD.

SO THAT CREATES A DIFFERENT SET

OF CHALLENGES, I GUESS, THAN WE

HAD IN THE PAST.

AND WE DO HAVE AN INCREASED

NUMBER OF BACTERIA AND OTHER

MICROBES THAT SEEM TO CAUSE

PROBLEMS FOR US.

WHAT IT HAS CREATED FOR US IS A

CHALLENGE AS AN AGENCY.

BUT IT HAS ALSO CREATED, I THINK, A NEW

ENGAGEMENT BY BOTH ALL OF THE

AGENCIES AT FEDERAL

GOVERNMENT LEVEL THAT ARE

CHARGED WITH THIS WHOLE ISSUE OF

SAFETY OF THE FOOD SUPPLY, BE IT

THE DEPARTMENT OF AGRICULTURE,

BE IT THE CDC OR BE IT THE FDA, TO

ALSO PARTNER WITH THOSE PEOPLE WHO WORK WITH THIS ISSUE

DAY IN AND DAY OUT IN THE STATES, IN THE DEPARTMENTS OF

AGRICULTURE, DEPARTMENTS OF HEALTH IN OUR STATES.

SO WE ARE HAVING TO CREATE A NEW WAY OF

MONITORING THE SAFETY ISSUES

RELATED TO THE FOOD SUPPLY IN OUR COUNTRY.

\>\> WHAT ABOUT COORDINATING THE

EFFORTS OF THESE VARIOUS AGENCIES YOU\'RE TALKING ABOUT SUCH

THAT THEY\'RE NOT STEPPING ON EACH OTHER\'S TOES AND THAT

THERE ARE NO GAPS?

IS THAT AN IMPORTANT ISSUE?

\>\> WELL, I CAN SAY FROM MY OWN

EXPERIENCE WHAT OCCURS NOW IN

TERMS OF COORDINATION, COOPERATION AND COMMUNICATION

BETWEEN AND AMONG THE FEDERAL AGENCIES WHO HAVE ADOPTED ONE

FOOD POLICY UNDER A PRESIDENTIAL INITIATIVE AND STRONGER

PARTNERSHIPS WITH THE STATE OFFICIALS THAT DEAL WITH FOOD

ISSUES, IS AT AN ALL-TIME HIGH.

AND IT MAKES FOR THOSE OUTBREAKS THAT DO

HAPPEN EASIER TO TRACK, EASIER TO FOLLOW.

DO WE HAVE A WAYS TO GO IN TERMS

OF GETTING IT BETTER?

PROBABLY, YES.

BUT THIS IS ANOTHER SYSTEM THAT I THINK CAN

ALWAYS BE CONTINUOUSLY IMPROVED.

\>\> WE\'RE TALKING A LOT TODAY

ABOUT RESOURCES.

AND ONE WAY TO DO MORE WITH LESS

RESOURCES IS TO OUTSOURCE, TO

USE SUBCONTRACTORS.

AND WE CALL IT THIRD PARTIES, THAT IS, GETTING PEOPLE OUTSIDE THE

GOVERNMENT TO DO SOME OF THE WORK IN TERMS OF PREMARKET

REVIEW AND IN TERMS OF INSPECTION.

DO YOU VIEW THAT AS A KIND OF

WAVE OF THE FUTURE?

AND IF SO, DO YOU WORRY ABOUT THE IDEA THAT

THIS MAY COMPROMISE THE QUALITY, THE

THOROUGHNESS, THE INTEGRITY OF THE FDA PROGRAM?

\>\> I DON\'T THINK THAT WITH ANY

OF THESE KIND OF INITIATIVES, MARK, THERE IS AN INTENT TO

LOWER THE STANDARD THAT IS EXPECTED BY THE AMERICAN PUBLIC

OF THIS REGULATORY AGENCY.

AND I THINK EVEN IF YOU GO BACK

TO THE MODERNIZATION ACT, WHEN

SOME OF THESE ISSUES WERE REALLY

RAISED, LIKE THIRD-PARTY REVIEW,

IT WAS ALWAYS WITH THE RECOGNITION THAT THE STANDARD

STILL BE THE SAME AND STILL BE HIGH.

COULD THE WORK BE DONE BY OTHERS

LOOKING AT PRODUCTS, PARTICULARLY IN THE DEVICE AREA

THAT PERHAPS DIDN\'T POSE AS GREAT A RISK, COULD THEY BE

REVIEWED BY OTHERS?

AND WERE WE ALSO CHARGED WITH MAKING SURE

THAT WE OVERSAW THAT EXPERIMENT TO MAKE

SURE THAT IT WAS WORKING?

THE ANSWER TO THAT IS YES.

IN TERMS OF THE INSPECTIONAL

AREA, WE HAVE, I THINK, HAD

SOME VERY STRONG SUCCESS IN THAT REGARD,

AND THE MAMMOGRAPHY PROGRAM COMES TO MIND.

SO I THINK WE HAVE TO USE THESE KIND OF

OPPORTUNITIES FOR PARTNERING

WISELY AFTER WE SELECT THEM, AND

WE ALWAYS NEED TO MAKE SURE THAT

THE STANDARD BY WHICH WE ARE

USING IS NEVER LOWERED.

\>\> EVERYBODY INVOLVED WITH

MEDICAL PRODUCTS, WHETHER IT\'S

THE PATIENT, WHETHER IT\'S THE

PRACTITIONER, WHETHER IT\'S THE

MANUFACTURER OR THE AGENCY, IS

CONCERNED THAT PEOPLE WHO ARE

USING THESE PRODUCTS UNDERSTAND BENEFITS AND RISKS.

AND IT GOES TO IN A GENERAL WAY TO PATIENTS

UNDERSTANDING THE FEDERAL GOVERNMENT CAN\'T ENSURE ABSOLUTE

SAFETY AND, THEREFORE, YOU DO HAVE TO CONSIDER BENEFITS AND

RISKS IN MAKING DECISIONS.

IN A MORE SPECIFIC WAY, UNDERSTANDING THE BENEFIT AND

THE RISK OF THIS PARTICULAR PRODUCT BEING USED ON YOU AND DECIDING

ACCORDINGLY.

EVERYONE AGREES ON THAT, AND

EVERYONE HAS A ROLE TO PLAY.

WHAT\'S FDA's ROLE, AND HOW DOES

IT TIE IN WITH OTHER STAKEHOLDERS?

\>\> WELL, THE ISSUE OF SAFETY DOESN\'T MEAN \"NO RISK.\"

IT MEANS THAT A RISK AND BENEFIT

HAS BEEN ANALYZED, BALANCED AND

TAKEN INTO ACCOUNT.

SO OFTENTIMES WE TALK ABOUT

SAFETY AND EFFICACY.

AND I THINK IT HAS BECOME SHORTHANDED

TO \"SAFE, NO RISK,\" AND UNFORTUNATELY THAT\'S NOT THE CASE.

ALMOST ANY PRODUCT YOU THINK

ABOUT, AT SOME LEVEL, HAS A RISK.

WHAT WE AT THE AGENCY ARE CHARGED TO DOING, AS WE REVIEW NEW

PRODUCTS FOR THE MARKETPLACE, IS LOOKING AT THIS BALANCE, THIS

ANALYSIS OF RISK/BENEFIT FOR A PARTICULAR POPULATION OF

PATIENTS IN WHICH THE PRODUCT HAS BEEN TESTED.

AND FOR THAT POPULATION, IS THE RISK BENEFIT

EQUATION RIGHT TO PERMIT THIS PRODUCT ON THE MARKET?

ONCE A PRODUCT GETS ON THE MARKET, OUR ISSUE IS LESS OF

CONTROL TO THE MARKETPLACE AND IT BECOMES MUCH MORE AN ISSUE OF

INFLUENCING THE REST OF THE SYSTEM.

AND, WHEN YOU THINK ABOUT WHAT A

PHYSICIAN DOES OR A HEALTH

PROVIDER DOES WITH AN INDIVIDUAL

PATIENT EVERY DAY IN A PHYSICIAN/PATIENT ENCOUNTER,

THEY\'RE WEIGHING RISKS AND BENEFITS FOR THE INDIVIDUAL PATIENTS.

DOES THIS PRODUCT FOR MY PATIENT \-- IS THERE A

STRONG BALANCE OF RISK AND BENEFIT?

AND WHEN YOU THINK ABOUT CONSUMERS WHO ARE USING

OVER-THE-COUNTER PRODUCTS, THEY\'RE BALANCING \-- THEY\'RE

CHARGED WITH BALANCING THEIR OWN RISK AND BENEFITS.

HOPEFULLY, WE AID THEM BY WHAT\'S ON THE LABEL SO THAT WHEN THEY

WALK INTO THE DRUGSTORE LATE AT NIGHT OR THE GROCERY STORE AND

THEY\'RE LOOKING FOR SOMETHING THAT MIGHT HELP THEM, THEY CAN

LOOK AT, WHAT ARE THE USES FOR THIS PRODUCT?

WILL IT HELP ME?

AND WHAT ARE THE THINGS I MIGHT

HAVE TO LOOK OUT FOR?

SO IN WAYS THEY BECOME THEIR OWN RISK/BENEFIT MANAGER.

ALL THE WAY THROUGH THAT SYSTEM,

WHEN THINGS HAPPEN OUTSIDE OF

THOSE PARAMETERS.

WE NEED STRONG FEEDBACK LOOPS SO THAT WE CAN

CONTINUOUSLY IMPROVE THE QUALITY OF RISK/BENEFIT

MANAGEMENT, THAT EACH ONE IN THAT CONTINUUM CAN

MAKE EITHER FOR THEMSELVES OR FOR A NEW PRODUCT TO THE MARKETPLACE.

\>\> SEEMS OUT OF ALL THE THINGS YOU\'RE

TALKING ABOUT, THIS IS ONE THAT WAS REALLY CONDUCIVE TO A PARTNERSHIP

WITH

OTHER PEOPLE, OTHER STAKEHOLDERS, BETWEEN THE FDA AND OTHERS.

\>\> OH, IT HAS TO BE.

I MEAN, THIS IS SOMETHING THAT

WE, AS AN AGENCY, CONTROL ONE

PIECE AND INFLUENCE ANOTHER, AND

A PLACE WHERE OUR STAKEHOLDERS

CONTROL ANOTHER PORTION OF THE

SEQUENCE AND INFLUENCE US.

SO THAT BALANCING HAS TO BE RIGHT,

THAT ENGAGEMENT, THE INTEGRATION,

THE INTERACTION HAS TO BE STRONG

OR THE WHOLE SYSTEM DOESN\'T

BENEFIT IN THE WAY THAT IT SHOULD.

\>\> LET ME ASK YOU A MANAGEMENT

QUESTION.

YOU\'VE HAD TOP LEADERSHIP

POSITIONS IN GOVERNMENT AND ALSO

IN THE PRIVATE SECTOR.

IN GOING THROUGH THAT AND IN

TERMS OF GETTING AN ORGANIZATION

TO GET THE JOB DONE, IS THERE A

COMMON THREAD THAT RUNS THROUGH

ALL THAT YOU\'VE BEEN ABLE TO

KIND OF PICK UP AND APPLY IN

YOUR ROLE AS COMMISSIONER?

\>\> I WOULD THINK THAT BOTH

IN GOVERNMENT SERVICE AND IN

ACADEMIA, I HAVE BEEN CHARGED

WITH HAVING VERY COMPLEX

ORGANIZATIONS FUNCTION WELL ON

BEHALF OF OTHERS.

AND I THINK IF THERE HAS BEEN \-- IF I HAVE

BEEN SUCCESSFUL, AND IF THERE\'S BEEN ANY SECRET TO THAT,

IT\'S TO TRY TO MAINTAIN ORGANIZATIONAL FOCUS.

I HAVE USUALLY DONE THAT BY ESTABLISHING VERY CLEAR

PRIORITIES FOR AN ORGANIZATION, MAKING SURE THAT THE INTERNAL

PEOPLE WITHIN THE ORGANIZATION KNEW WHAT THOSE PRIORITIES ARE,

AS WELL AS ALL OF THE CONSTITUENCY GROUPS THAT WERE

EITHER SERVED OR SERVED BY OR PARTNERED WITH THE ORGANIZATION.

AT THE FDA, I HAVE ESTABLISHED FIVE.

ONE IS THIS WHOLE ISSUE OF FULL IMPLEMENTATION OF THE FDA

MODERNIZATION ACT.

SECOND, AND IT\'S RUNNING VERY

CLOSE TO THE NUMBER ONE, IS THIS

WHOLE ISSUE OF THE SCIENCE BASE

OF THE AGENCY AND MAKING SURE

THAT IT\'S MAINTAINED AND ENHANCED.

THE THIRD AND FOURTH CRUCIAL

ISSUES OF SAFETY AND IMPORTANCE,

IT SEEMS TO ME TO THE AMERICAN

PUBLIC, THE SAFETY OF OUR BLOOD

SUPPLY, THE SAFETY OF OUR FOOD

SUPPLY, AND THE FIFTH, THE

TOBACCO ISSUE, AND MAKING SURE

THAT WE\'RE DOING OUR PART, ALL

OF OUR PART, IN KEEPING YOUTH

FROM STARTING SMOKING AND

RESTRICTING THEIR ACCESS TO TOBACCO.

THOSE ARE THE THINGS THAT I HAVE

ESTABLISHED AS PRIORITY AREAS FOR THE AGENCY.

WILL WE BE CALLED UPON TO DO

THINGS OUTSIDE THOSE PRIORITY

AREAS THAT ARE OF CRITICAL

IMPORTANCE?

SURE.

I MEAN, WE\'RE BOMBARDED ALL THE

TIME WITH IMPORTANT ISSUES.

BUT I THINK THAT WHAT WE SHOULD DO

IF WE TAKE ONE OF THOSE KIND OF

ISSUES ON IS TO DO IT BY DELIBERATION, NOT BY DRIFT, NOT

JUST BY \-- DO IT BY INTENT, NOT JUST GOOD INTENTION.

AND IN THAT WAY, WE CAN MAINTAIN OUR ORGANIZATIONAL

FOCUS AND USE OUR LIMITED RESOURCES MORE WISELY.

IT\'S GOING TO BE VERY HARD TO DO AT AN AGENCY LIKE THE FDA,

BECAUSE I\'VE BEEN HERE BEFORE, I KNOW THE KIND OF PEOPLE THAT WORK
HERE.

THEY PRIDE THEMSELVES ON BEING

CAN-DO, CAN DO ANYTHING.

BUT IT\'S VERY CLEAR TO ME THAT WE

CAN\'T DO EVERYTHING WITH THE

LIMITATIONS WE HAVE ON OUR RESOURCES.

AND THAT\'S WHY I\'M REALLY

LOOKING TO BUILDING THE BRIDGES

THAT WE NEED TO OUR PARTNERS IN

THE STATES, IN REGULATED INDUSTRY, WITH CONSUMERS, WITH

PATIENTS, AND SO THAT WE CAN BUILD A STRONGER SYSTEM FOR ALL

OF OUR BENEFIT.

\>\> DR. HENNEY, THANKS FOR THAT INSIGHT.

LINDA, LET\'S START TALKING NOW SPECIFICALLY ABOUT FDAMA.

\>\> OKAY.

\>\> EVERY PIECE OF LEGISLATION HAS KIND OF AN OVERARCHING THEME,

AN INTENT OF CONGRESS.

IN A GENERAL WAY, WHAT WAS CONGRESS\'S INTENT HERE, WHAT DO THEY

WANT FDA TO DO DIFFERENTLY, WHAT WAS THE PROBLEM AS THEY

PERCEIVED DO YOU THINK?

\>\> WELL, I THINK THE REAL KEY THEME TO

FDAMA FOCUSES ON THAT WORD \"MODERNIZATION.\"

I THINK CONGRESS WANTED US TO

BE \-- TO REALIZE WE NEED TO CONTINUALLY BE

CREATIVE AND INNOVATIVE IN HOW WE APPROACH THE WORK THAT WE DO.

BUT MORE SPECIFICALLY, THE LAW GAVE US REALLY THREE DIRECTIONS.

THE FIRST IS THAT WE NEED TO

MAKE SURE THAT WE\'RE ENGAGING

OUR STAKEHOLDERS, THAT WE KNOW WHAT PEOPLE WANT

FROM THE AGENCY, THAT WE UNDERSTAND THEIR EXPECTATIONS

AND CAN COMMUNICATE WHY WE\'RE DOING SOMETHING.

THE SECOND THING IS THAT I THINK IT CODIFIED A LOT OF THE

RE-ENGINEERING THAT THE AGENCY HAD BEEN DOING FOR REALLY THE

LAST FIVE YEARS.

A LOT OF EFFORT HAD GONE ON IN THE AGENCY TO

MAKE SURE THAT WE WERE STREAMLINED, RE-ENGINEERED,

REALIGNED, AND ALL OF THAT WORK WAS CODIFIED BY THIS LAW.

AND THEN THE THIRD THING WAS

THAT THE FDA HAD TO REALIZE THAT

WE WERE OPERATING WITHIN A GLOBAL ECONOMY.

AND THAT WE HAVE AN OPPORTUNITY FOR THE HIGH STANDARDS FOR

QUALITY AND SAFETY THAT THE AGENCY HAS.

WE HAD A STAND \-- WE A HAD AN OPPORTUNITY TO

INFLUENCE THAT WORLDWIDE.

\>\> YOU TALKED ABOUT THE FACT

THAT THE CONGRESS WANTED US, OR

GAVE US, THE OPPORTUNITY REQUIRED

THAT WE CODIFY THE CHANGES THAT WE HAD BEGUN TO

MAKE WITH RE-ENGINEERING AND SO ON.

WERE THEY ALSO THINKING ABOUT

PREVENTING US FROM BACKSLIDING?

IN OTHER WORDS, YOU CAN SAY, \"IF

IT\'S IN THE LAW, YOU CAN\'T GO

BACK TO OUR OLD WAYS AGAIN\"?

IS THAT \-- WAS THAT PART OF IT?

\>\> WELL, YOU KNOW, THAT\'S HARD FOR ME TO SAY, MARK.

I\'M NOT SURE I CAN GUESS WHAT WAS IN THE

MINDS OF THE PEOPLE AS THEY WERE

PASSING THAT LAW.

BUT I DO THINK THAT IT RATIFIED THE HARD WORK

THAT THE AGENCY HAD ALREADY PUT INTO THINKING CREATIVELY ABOUT

HOW WE DO OUR JOBS.

AND SO I THINK, FROM A PROCESS STANDPOINT, IT IS

PUTTING INTO LAW THE THINGS THAT WE FELT NEEDED TO BE DONE.

\>\> YOU ALSO MENTIONED THE IDEA THAT THIS GIVES THE FDA THE

OPPORTUNITY TO, IN A SENSE, EXPORT ITS HIGH STANDARDS AROUND THE WORLD.

ANOTHER POSSIBILITY WOULD BE, TOO, THAT THE CONGRESS

HAD IN MIND PERHAPS THAT THEY WANTED TO BE SURE THAT FDA

REGULATIONS DID NOT NEEDLESSLY IMPEDE AMERICAN MANUFACTURERS

FROM COMPETING WORLDWIDE.

IS THAT VALID, DO YOU THINK?

\>\> WELL, I\'M SURE THAT\'S AN IMPORTANT

CONSIDERATION.

I THINK THAT WE DO HAVE AN

IMPACT ON A LARGE INDUSTRY.

AND, IN FACT, IT\'S IMPORTANT FOR THAT

INDUSTRY TO BE GLOBALLY COMPETITIVE.

BUT I THINK THE REALLY KEY ISSUE

IS THAT KEY CAN EXPORT FDA's

HIGH STANDARDS THROUGHOUT THE WORLD.

\>\> THIS IS A VERY SPECIFIC PIECE

OF LEGISLATION.

ONE OF THE THINGS IT REQUIRES IS

THAT WE DEVELOP A PLAN AND THEN

MEASURE PERFORMANCE AGAINST THAT PLAN.

WHAT PROGRESS HAVE WE MADE SO FAR IN THAT AREA?

\>\> WELL \--

\>\> AND THERE IT IS.

\[ LAUGHTER \]

\>\> THERE\'S THE PLAN.

IN NOVEMBER OF \'97 \-- OF \'98, WE PUT OUT THE FDA PLAN

FOR STATUTORY COMPLIANCE.

AND THIS PLAN DOES A VARIETY OF THINGS.

IT WAS DONE, FIRST OF ALL, AFTER

CONSULTATION WITH OUR STAKEHOLDERS.

WE HELD A SERIES OF MEETINGS

LAST SUMMER, AND WE MET WITH

PEOPLE IN ALL OF OUR PRODUCT AREAS.

AND WE HAD MORE THAN A COUPLE HUNDRED PEOPLE TALKING TO

US ABOUT WHAT THEY EXPECTED FROM FDA.

WE TOOK THAT, WE PUT THAT \-- TOOK THAT INTO

CONSIDERATION AND DEVELOPED A

PLAN THAT TALKS VERY CLEARLY

ABOUT THE MISSION STATEMENT, THE

NEW MISSION STATEMENT OF THE

AGENCY TO PROMOTE AND PROTECT

THE PUBLIC HEALTH, THAT DESCRIBES THE CHALLENGES

THAT FDA FACES, THAT THE KIND OF

ENVIRONMENT WE\'RE LIVING IN RIGHT NOW.

IT LAYS OUT THE GAP THAT WE

CURRENTLY HAVE BETWEEN WHAT IS

EXPECTED OF US, BOTH IN OUR

STATUTORY REQUIREMENTS AND WHAT

THE PUBLIC EXPECTS IN GENERAL,

AND THE RESOURCES WE HAVE TO

MEET THAT GAP.

AND THEN FINALLY, IT DEVELOPS

SOME STRATEGIC DIRECTIONS FOR

WHAT \-- FOR HOW THE AGENCY CAN

MANAGE OUR WORKLOAD AS WE MOVE

INTO THE NEXT CENTURY.

\>\> SO IT\'S KIND OF A BLUEPRINT AS

TO WHAT TO DO IN THE FUTURE?

\>\> YEAH, I REALLY THINK IT IS.

IT GIVES US A FRAMEWORK FOR HOW WE CAN OPERATE

WITHIN \-- AND MEET THE LIMITS OF THE LAW.

\>\> THAT\'S \-- DESPITE THE FACT THAT IT\'S VERY

BEAUTIFUL, IT IS A WORK IN PROGRESS.

I MEAN \--

\[ LAUGHTER \]

\>\> YEAH.

\>\> YOU KNOW, IT\'S SOMETHING YOU

WILL BE CHANGING, I ASSUME, BASED UPON \--

\>\> YES, AND THAT\'S WHY WE\'RE HAVING

THESE MEETINGS TODAY.

I THINK WE\'VE CONTINUED TO RECEIVE INPUT FROM OUR STAKEHOLDERS.

AND WE ARE EXPECTED TO PRESENT AN ANNUAL

PLAN \-- AN ANNUAL REPORT \-- TO CONGRESS EVERY YEAR ON HOW WE\'RE

MEETING THE PERFORMANCE MEASURES WE\'VE ESTABLISHED UNDER THIS PLAN.

\>\> THE AGENCY HAS MADE A LOT OF

PROGRESS SO FAR IN IMPLEMENTING FDAMA.

AND YOU CAN\'T GO THROUGH \-- I WOULDN\'T WANT YOU TO \-- BUT, IN A

GENERAL WAY, WHAT\'S HAPPENED?

\>\> WELL, YOU\'RE RIGHT.

WE\'VE MADE \-- WE\'VE DONE A TREMENDOUS NUMBER OF THINGS.

AND THERE\'S BEEN AN AMAZING AMOUNT OF EFFORT PUT

INTO EVERY ASPECT OF THIS LAW DUE TO, IN A LARGE PART, ALL THE

HARD WORK THAT THE FDA EMPLOYEES HAVE PUT INTO MEETING THE

REQUIREMENTS OF THIS LAW.

WE MET ALMOST EVERY STATUTORY DEADLINE.

WE\'VE PUT OUT 16 FINAL REGULATIONS \-- 18 FINAL REGULATIONS, 6 PROPOSED

REGULATIONS, 38 GUIDANCE DOCUMENTS.

THE NUMBERS JUST GO ON AND ON.

BUT WE ALSO HAVE SOME VERY

SPECIFIC THINGS THAT I\'D JUST

LIKE TO HIGHLIGHT.

BECAUSE, AS YOU SAID, IF I MENTIONED EVERYTHING, WE\'D

BE HERE ALL AFTERNOON.

\>\> WE\'LL DO WORD ASSOCIATION LIKE ON THE

PSYCHIATRIST\'S COUCH.

I\'LL SAY SOMETHING AND YOU SAY

THE FIRST \--

\>\> OKAY.

\[ LAUGHTER\]

\>\> THE FIRST THING THAT COMES TO YOUR MIND.

BIOLOGICS.

\>\> YEAH.

IN THE BIOLOGICS PROGRAM, AS

A RESULT OF THE CONCERNS WE

HEARD FROM A LOT OF PEOPLE, THE

LAW SAYS THAT WE MUST HAVE A

UNIFIED BIOLOGICS APPLICATION.

AND SO WE\'VE TAKEN 17 DIFFERENT

FORMS TO MODERNIZE THE BIOLOGICS

PROGRAM.

\>\> FAST TRACK.

\>\> THE \-- IN THE DRUGS AREA, WE

HAVE TAKEN WHAT WE HAD DEVELOPED

AS AN INITIAL PROGRAM BEFORE

FDAMA AND MOVED INTO A FAST-TRACK PROGRAM THAT WILL GET

DRUGS TO THE MARKET FASTER THAN

THEY HAVE IN THE PAST.

\>\> THIRD PARTY.

\>\> IN THE DEVICE AREA, WE\'VE

IMPLEMENTED A NEW INITIATIVE AS

DR. HENNEY ALLUDED TO EARLIER

THAT WE HOPE WILL BE A PILOT THAT WE

CAN EXPAND WHERE LESS RISKY DEVICES WILL BE REVIEWED BY

THIRD PARTIES ON THE OUTSIDE.

\>\> STANDARDS?

\>\> IN \-- ALSO IN DEVICES, WE\'VE

TAKEN THE 510-K PROGRAM, THE DEVICE INDUSTRY CAN

NOW REFERENCE 300 STANDARDS THAT ARE ALREADY EXISTING

AS OPPOSED TO COMING IN WITH A WHOLE NEW RANGE OF DATA TO

SUPPORT THEIR PRODUCT APPLICATION.

\>\> FOOD IRRADIATION.

\>\> IN THE FOODS AREA, AS

WE ALSO \-- AS DR. HENNEY ALSO MENTIONED, WE

HAVE CONCERNS, GREATER CONCERNS ABOUT FOODBORNE PATHOGENS.

AND THE FOOD IRRADIATION REGULATION WAS

FINALIZED SO THAT WE CAN LIMIT SOME OF THOSE PATHOGENS.

\>\> DISSEMINATING INFORMATION ON UNAPPROVED USES.

\>\> THAT\'S ANOTHER THING THAT \--

\>\> THAT\'S A THORNY ONE.

\>\> YEAH, IT\'S BEEN A LITTLE CONTROVERSIAL.

BUT I THINK IT SAYS THAT WE CAN, IN FACT, HAVE

A SYSTEM WHEREBY INFORMATION CAN BE PROVIDED TO

PATIENTS ABOUT OFF-LABEL USES.

\>\> FDAMA REQUIRES, IN ADDITION TO

HAVING THE REPORT, THAT YOU INTERACT WITH STAKEHOLDERS, THAT

YOU HAVE MEETINGS.

OBVIOUSLY, THE FIRST STEP WAS THE MEETING LAST SUMMER.

THIS TELECONFERENCE IS ANOTHER STEP.

\>\> MM-HMM.

\>\> BETWEEN THOSE TWO EVENTS, WHAT\'S

HAPPENED IN TERMS OF WORKING WITH STAKEHOLDERS AND GETTING THE

BALL MOVING?

\>\> MARK, THERE\'S A WHOLE SERIES OF THINGS.

AND I THINK I\'D LIKE TO JUST HIGHLIGHT A FEW OF THEM.

WE HAVE, IN FACT, IMPROVED HOW INFORMATION IS BEING PROVIDED TO

CONSUMERS.

ONE OF THE THINGS WE HEARD AT

LAST YEAR\'S MEETINGS WAS THAT

CONSUMERS WANT INFORMATION

THAT\'S BALANCED, THAT THEY CAN

TRUST FROM THE FDA.

AND AS A RESULT, WE HAVE HAD THIS YEAR

TWO LABELING DOCUMENTS THAT HAVE BEEN FINALIZED.

ONE IS OVER-THE-COUNTER LABELING

INFORMATION WHICH IS NOW IN A STANDARDIZED FORMAT.

AND THE OTHER IS A LABELING REQUIREMENT

THAT IS A STANDARDIZED EASY-TO-READ FOR

THE DIETARY SUPPLEMENTS AS WELL.

WE\'VE ALSO HAVE PROVIDED MORE ACCESS OPPORTUNITIES FOR

STAKEHOLDERS TO THE FDA.

WE HAVE ELECTRONIC SUBMISSIONS NOW OF NDAs.

WE HAVE ELECTRONIC \-- WE HAVE MORE WEBSITES.

WE HAVE ONLINE ACCESS TO \-- FOR AGENCY RECORDS.

WE HAVE HAD A ROUNDTABLE IN CEDAR WITH HEALTH PROFESSIONALS.

WE\'VE HAD NATIONAL CONSUMER FORUMS AROUND THE COUNTRY.

OUR WOMEN\'S HEALTH ORGANIZATION HAS INCREASED AWARENESS OF FDA

BY IMPLEMENTING A VERY COMPREHENSIVE WEBSITE FOR WOMEN.

WE HAVE MORE PATIENT REPRESENTATIVES ON OUR AGENCY

ADVISORY COMMITTEES.

WE\'VE ALSO DEVELOPED MORE PARTNERSHIPS WITH SOME OUTSIDE GROUPS.

FOR EXAMPLE, WE\'RE WORKING WITH THE STATE HEALTH DEPARTMENTS TO

DEAL WITH INTERSTATE OUTBREAKS OF FOODBORNE ILLNESSES.

WE\'VE HAVE COLLABORATED WITH USDA TO HAVE A BETTER \-- TO BETTER

INTEGRATE

OUR SAFETY INSPECTIONS IN THE \-- WITHIN THE JURISDICTION OF BOTH

AGENCIES.

AND WE HAVE WORKED COOPERATIVELY WITH OTHER PUBLIC

HEALTH SERVICE AGENCIES TO PROVIDE INFORMATION TO HIV/AIDS

TREATMENT ISSUES, PATIENTS, SO THAT THEY HAVE SOME GREATER

INFORMATION.

WE\'VE ALSO ESTABLISHED SYSTEMS THAT\'LL HELP US CATCH HEALTH

RISKS MORE QUICKLY.

FOR EXAMPLE, PULSENET IS AN INTERAGENCY COMPUTERIZED DNA

FINGERPRINTING PROGRAM WHERE WE CAN NOW REDUCE THE INCIDENCE OF

FOODBORNE DISEASE.

AND THIS WILL MORE RAPIDLY IDENTIFY THE

SOURCES OF CONTAMINATION OF FOOD.

AND THE SEAFOOD HACPP AREA, WE\'VE WORKED EXTENSIVELY

TO TRAIN STATE INSPECTORS SO THAT WE CAN HAVE A BETTER COVERAGE OF OUR

SEAFOOD INDUSTRY.

WE\'VE ALSO INCREASED OUR EFFICIENCY BY HAVING MRAs

WITH THE EUROPEAN UNION.

AND WE HAVE A DEVICE ACTION PLAN IN THE BIOLOGICS

AREA THAT WILL HARMONIZE OUR REGULATION OF DEVICES.

AND FINALLY, WE\'RE DEVELOPING THE CAPABILITY TO

ADDRESS NEEDS FOR SPECIAL CONSUMERS AND PATIENTS.

WE\'VE HAD TREATMENT ADVOCACY CONFERENCES.

AND FOR THE FIRST TIME, WE\'VE DEVELOPED A BROCHURE

THAT WILL ENCOURAGE PARTICIPATION OF MINORITIES IN

CLINICAL TRIALS.

SO I THINK WE HAVE AN IMPRESSIVE LIST.

\>\> I THINK IT SOUNDS IMPRESSIVE, TOO.

LET\'S TALK ABOUT MONEY NOW FOR A WHILE.

\>\> OH, ONE OF MY FAVORITE TOPICS.

\>\> YOUR FAVORITE TOPIC, I KNOW.

IF YOU\'RE AN OUTSIDER AND YOU\'RE THINKING

ABOUT THE FDA, IT\'S CONFUSING.

ON THE ONE HAND, I HAVE A QUOTE HERE\'S

FROM AN ARTICLE IN A MAGAZINE CALLED \"GOVERNMENT EXECUTIVE.\"

AND IT SAYS, AND I\'M QUOTING, \"THE FDA HAS A

PROBLEM THAT EVERY AGENCY WOULD LIKE TO SHARE.

ITS BUDGET IS RISING BY MORE THAN 6% PER YEAR SINCE 1992,

WHICH SOUNDS GOOD.

THEN ON THE OTHER HAND, THEIR

AGENCY PRONOUNCED SOMETHING ABOUT THE FACT THAT, AT LEAST IN

CERTAIN AREAS, THERE IS NOT ENOUGH MONEY

TO GET THE JOB DONE.\"

SO WHERE, IN FACT, DOES THE TRUTH LIE?

IS THERE OR IS THERE NOT ENOUGH MONEY

ON HAND TO DO FDA's JOB?

\>\> WELL, I THINK BOTH OF THOSE THINGS ARE TRUE, MARK.

THE AGENCY\'S BUDGET, AS YOU LOOK

AT IT FROM 1992, IT DOES LOOK

LIKE IT\'S GOING UP.

BUT WHAT IS HAPPENING IS THOSE \-- THAT

INCREASES \-- THOSE INCREASES HAVE BEEN TARGETED FOR VERY

SPECIFIC PROGRAMS.

AND SO THE BASE PROGRAMS OF THE FDA HAVE ACTUALLY BEEN

DECREASING.

SO WHAT WE HAVE IS NEW PROGRAMS THAT WE\'VE BEEN

GIVEN THE RESPONSIBILITY FOR, AND WE HAVE OUR CORE

RESPONSIBILITIES, WHICH HAVE HAD

THEIR BASE ERODED OVER A PERIOD

OF FIVE YEARS.

\>\> ARE THERE PLACES IN THAT BASE

PROGRAM WHERE THERE REALLY ISN\'T

ENOUGH MONEY TO DO THE BASELINE

JOB THAT\'S REQUIRED?

\>\> WELL, I THINK WE\'RE GETTING

TO A POINT WHERE WE HAVE VERY

LIMITED RESOURCES IN MANY OF OUR

PROGRAMS.

I THINK WE\'VE BEEN HELPED IN

SOME AREAS BY HAVING THE USER

FEE PROGRAM FOR PRESCRIPTION

DRUGS.

BUT IN OTHER AREAS, IN

ORDER TO MAINTAIN THAT BASE FOR

PRESCRIPTION DRUG USER FEES, WE

HAVEN\'T BEEN ABLE TO HAVE SOME

OF THE BASICS.

SO, YOU KNOW, WE

HAVE PLACES WHERE OUR SCIENTIFIC

PERSONNEL HAVEN\'T BEEN ABLE TO

GO TO A PROFESSIONAL MEETING FOR

THREE OR FOUR YEARS.

AND WHEN YOU\'RE REALLY TRYING TO IMPROVE

AND ENHANCE THE SCIENCE BASE, THAT\'S

NOT THE KIND OF THING THAT YOU

WANT TO HAVE HAPPEN.

\>\> IS THE SOLUTION TO LEARN HOW

TO DO MORE WITH LESS?

\>\> WELL, YOU KNOW, MORE WITH LESS TO

ME IS A MYTH.

I DON\'T THINK YOU CAN DO MORE WITH LESS.

YOU CAN DO THINGS DIFFERENTLY.

AND I THINK THIS AGENCY HAS BEEN

INCREDIBLY INNOVATIVE IN HOW

IT\'S LOOKED AT ITS PROCESSES, AND

HOW IT\'S MADE PROGRESS OVER TIME

AND HOW IT HAS BEEN DOING OUR

JOB IN A MORE EFFICIENT AND

EFFECTIVE WAY.

WE\'VE RECEIVED MORE THAN 50

HAMMER AWARDS THAT ARE BEING

GIVEN OUT TO THE GOVERNMENT FOR

RE-ENGINEERING THE WORKLOAD THAT

WE HAVE.

\>\> ARE WE ALSO TALKING ABOUT A

CULTURAL SHIFT HERE, I MEAN, THE IDEA OF

LOOKING AT HIGH-RISK, HIGH-IMPACT PRODUCTS AS

OPPOSED TO ROUTINE THINGS FOR

COST INSPECTIONS, MORE AND LESS

ROUTINE?

IS THAT PART OF A SHIFT IN THE

FDA CULTURE?

\>\> I THINK THAT\'S PART OF IT.

I THINK THAT ONE OF THE

STRATEGIC DIRECTIONS IS TO LOOK

AT OUR WORKLOAD IN TERMS OF

RISK-BASED PRIORITIES.

AND CLEARLY THE FDAMA GAVE US THAT

RESPONSIBILITY WHEN IT STARTED

GIVING US SOME OF THE

AUTHORITIES THAT WE HAVE, LIKE,

YOU KNOW, BEING ABLE TO USE

STANDARDS INSTEAD OF \-- INSTEAD

OF DEVELOPING YOUR OWN

INFORMATION ABOUT 510-Ks AND

BEING ABLE TO USE THIRD PARTIES.

SO, YES, PART OF THAT IS LOOKING AT RISK

AND THINKING ABOUT CHANGING.

\>\> AN OBVIOUS PLACE TO LOOK FOR RESOURCES IS

USER FEES.

THEY\'VE BEEN SUCCESSFUL WITH PRESCRIPTION DRUGS,

WHAT ABOUT THE POSSIBILITY OF

EXPANDING THAT?

\>\> WELL, THE 2000 BUDGET, WHICH

IS THE ONE THAT WE WERE TALKING

ABOUT, DR. HENNEY WAS TESTIFYING

ABOUT YESTERDAY, DOES INCLUDE AN

OPPORTUNITY FOR USER FEES INTO

OTHER AREAS.

BUT LET ME SAY A FEW THINGS ABOUT

HOW \-- WHY THE PRESCRIPTION DRUG

USER FEE HAS BEEN SO SUCCESSFUL.

IT\'S BEEN SUCCESSFUL BECAUSE,

NUMBER ONE, WE\'VE HAD INDUSTRY

SUPPORT.

NUMBER TWO, WE\'VE DEVELOPED

PERFORMANCE MEASURES AND

PERFORMANCE GOALS.

AND WE\'VE SAID

THESE ARE THE THINGS THAT WE\'RE GOING

TO DO.

AND THE THIRD THING IS THAT

WE\'VE HAD CONGRESSIONAL SUPPORT

AND COOPERATION IN DEVELOPING THAT

PIECE OF LEGISLATION.

SO ALL OF THOSE THINGS ARE

ESSENTIAL TO MAKE \-- AND IT

PROVIDED A BASE OF MONEY, MONEY

ON TOP OF A BASE THAT WE ALREADY

HAD.

ALL OF THOSE THINGS ARE

ESSENTIAL TO MAKE ANY USER FEE

PROGRAM WORK.

SO WE\'RE HOPEFUL THAT IN THE

AREA OF FOOD CONTACT SUBSTANCES

AND FOOD ADDITIVES IN FOODS,

THAT WE WILL HAVE AN OPPORTUNITY

TO DEVELOP A USER FEE PROGRAM

FOR SOME OF THEIR NEEDS.

AND, ALSO, IN THE AREA OF

MEDICAL DEVICES, WE\'VE BEEN VERY

CAREFUL TO LISTEN TO THE

INDUSTRIES INVOLVED AND

UNDERSTAND THEIR CONCERNS.

AND EVEN THOUGH WE KNOW THAT THEY\'RE

NOT WIDELY ENTHUSIASTIC ABOUT

THE POSSIBILITY, WE THINK IT IS

A WAY TO GIVE THE AGENCY SOME OF

THE VERY NECESSARY RESOURCES WE

NEED TO REVIEW THOSE PRODUCTS.

\>\> THERE IS TALK THAT FDA WILL

BE RECEIVING \-- GETTING A

SIZABLE INCREASE IN BUDGET FOR

FISCAL YEAR 2000.

IF THAT HAPPENS, HOW FAR WILL

THAT GO TO SOLVING THE PROBLEM?

\>\> WELL, WE\'RE HOPEFUL.

THE PRESIDENTIAL BUDGET THAT

WENT FORWARD REALLY DID GIVE THE

AGENCY ONE OF THE LARGEST

INCREASES IN ITS HISTORY.

AND AS A PERCENTAGE OF BUDGET

WAS CLOSE TO 18% INCREASE.

AND WE\'RE HOPEFUL THAT CONGRESS WILL PUT

FORWARD THAT BUDGET WHEN THEY DO

THEIR MARKUP AND SEND IT

FORWARD.

IT STILL DOESN\'T MEET ALL OF OUR

NEEDS.

THIS IS AN AGENCY THAT HAS AN

INCREDIBLE BREADTH AND DEPTH OF RESPONSIBILITY.

AND WE HAVE A LOT OF UNMET NEEDS AT THIS

POINT IN TIME.

AND I THINK IT\'S THE BEGINNING \--

IT\'S THE DOWN PAYMENT, IS A NICE WAY TO SAY IT, ON

ALLOWING US TO HAVE THE KIND OF

SCIENTIFIC REGULATORY AGENCY THAT I THINK THE

AMERICAN PEOPLE EXPECT.

\>\> LINDA, ONE LAST QUESTION BEFORE WE GET

READY FOR A BREAK, AND THAT IS THE USEFULNESS,

OR HOW WE\'RE GOING TO USE TODAY\'S MEETING.

WE\'VE TOLD PEOPLE, OF COURSE, THAT THIS IS IMPORTANT, WE\'RE

GOING TO USE IT.

HOW, IN FACT, CAN WE USE WHAT WE LEARN TODAY FROM

STAKEHOLDERS IN FDA's PROGRAMS?

\>\> I THINK THAT\'S VERY IMPORTANT, MARK.

THERE ARE SO MANY WAYS WE\'RE GOING

TO BE USING \--

WE\'VE ALREADY USED THE INFORMATION THAT WE RECEIVED

LAST YEAR, AND THIS YEAR WE\'RE FACTORING THIS

INFORMATION INTO OUR CURRENT BUDGET PROCESS.

IF YOU WERE \-- REMEMBER, THE TIMING LAST YEAR WASN\'T

RIGHT TO DO OUR BUDGET FOR THIS YEAR, BUT

NOW WE ARE RIGHT AT THE TIME WHEN WE CAN,

IN FACT, INFLUENCE WHAT WILL BE IN OUR

YEAR 2001 BUDGET.

SO THAT\'S BUDGET, PLANNING AND THEN FINALLY WE

NEED TO DO OUR ANNUAL REPORT TO CONGRESS, BUT EVEN MORE IMPORTANTLY, IT

ALLOWS US TO LOOK AT OUR PROCESSES AND SEE

IF WE\'RE USING THE RIGHT ONES.

\>\> THANK YOU BOTH FOR A GOOD DISCUSSION.

DON\'T GO AWAY.

WE\'RE GONNA BE BACK IN A LITTLE BIT.

WE\'RE READY NOW TO TAKE A 15-MINUTE BREAK.

DURING THE BREAK, WE\'LL BE SHOWING ON YOUR

SCREEN THE FIVE STAKEHOLDER QUESTIONS \-- THE ONES WE

TALKED ABOUT \-- THAT WE\'D LIKE YOUR FEEDBACK ON.

AND ALSO, WE\'LL BE GIVING YOU SOME IMPORTANT ADDRESSES AND

OTHER INFORMATION.

WHEN WE COME BACK, WE\'LL BEGIN THE

INTERACTIVE PORTION OF THE BROADCAST, IN

WHICH WE\'LL BE TAKING QUESTIONS AND COMMENTS FROM YOU,

AS WELL AS FROM OUR STUDIO AUDIENCE.

SO YOU MIGHT WANT TO USE THE BREAK TO

FAX SOME QUESTIONS TO US, OR COMMENTS, OR TO PHONE THEM

IN AND LEAVE THEM HERE TO BE ANSWERED, ALONG WITH THE FAXES.

WE\'LL SEE YOU BACK HERE IN 15 MINUTES.

\\P

þ 2

\>\>\> OKAY, WE\'RE BACK LIVE, AND WE\'RE READY TO

BEGIN OUR INTERACTIVE SESSION.

WE HAVE SEVERAL SENIOR FDA PEOPLE

IN THE STUDIO THIS AFTERNOON, AND THEY MAY BE

JOINING DRS. HENNEY AND SUYDAM IN RESPONDING TO

QUESTIONS AND COMMENTS.

SO LET ME INTRODUCE THOSE PEOPLE BEFORE WE BEGIN.

DENNIS BAKER IS FDA's ASSOCIATE COMMISSIONER FOR REGULATORY

AFFAIRS.

JANICE OLIVER IS DEPUTY DIRECTOR OF FDA's CENTER

FOR FOOD SAFETY AND APPLIED NUTRITION.

LINDA KAHAN IS DEPUTY DIRECTOR FOR REGULATIONS

AND POLICY IN FDA's CENTER FOR DEVICES AND RADIOLOGICAL HEALTH.

DR. MURRAY LUMPKIN IS DEPUTY DIRECTOR FOR

REVIEW MANAGEMENT IN FDA's CENTER FOR DRUG EVALUATION AND RESEARCH.

DR. DAVID FEIGAL IS DEPUTY DIRECTOR FOR MEDICINE IN FDA's

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH.

DR. BERT MITCHELL IS ACTING DEPUTY DIRECTOR IN

FDA's CENTER FOR VETERINARY MEDICINE.

AND DR. BERN SCHWETZ IS DIRECTOR OF FDA\'s NATIONAL CENTER

FOR TOXICOLOGICAL RESEARCH.

BEFORE WE START TAKING QUESTIONS AND COMMENTS,

LET ME EXPLAIN OUR GOALS FOR THIS SESSION.

AS I SAID EARLIER, WE WANT YOUR INPUT AND IDEAS

ON THE FIVE QUESTIONS THAT APPEARED IN THE FEDERAL REGISTER NOTICE,

PLUS YOUR FEEDBACK ON HOW WE\'RE DOING WITH FDAMA AND WHAT ELSE

WE MIGHT DO TO MODERNIZE THE AGENCY.

THAT\'S THE KIND OF FEEDBACK WE NEED FROM YOU

AS WE PLAN FOR THE FUTURE, AND THOSE ARE THE KINDS

OF QUESTIONS AND COMMENTS THAT ARE MOST

APPROPRIATE AND MOST USEFUL IN THIS BROADCAST.

CONVERSELY, WHAT\'S INAPPROPRIATE FOR THIS BROADCAST

ARE QUESTIONS OR COMMENTS ABOUT INDIVIDUAL PRODUCTS OR

COMPANIES, OR ISSUES RELATED TO THOSE PRODUCTS OR COMPANIES.

WE\'RE ALWAYS HAPPY TO ANSWER THOSE QUESTIONS USING REGULAR

CHANNELS OF COMMUNICATION, BUT WE CAN\'T RESPOND TO THEM

DURING THIS BROADCAST.

I SHOULD MENTION BEFORE WE BEGIN THAT, GIVEN OUR TIME LIMIT,

WE MAY NOT BE ABLE TO GET TO EVERY QUESTION OR COMMENT.

THAT\'S A FACT OF LIFE WITH ANY CALL-IN SHOW.

BUT THOSE UNANSWERED QUESTIONS AREN\'T GOING

TO SIMPLY EVAPORATE IN THE WIND.

IF YOU HAVE SOMETHING IMPORTANT TO SAY, WE WANT

TO HEAR IT.

WE\'LL HAVE A RECORD OF ALL THE QUESTIONS AND

COMMENTS THAT WERE PHONED OR FAXED IN,

INCLUDING THE ONES THAT DIDN\'T GET ON THE AIR.

AND IN ADDITION, IF YOU\'RE AT ONE OF THE EIGHT LIVE

MEETINGS WE\'RE HOSTING ACROSS THE COUNTRY

AND YOU HAVE A QUESTION THAT WE DON\'T HAVE TIME FOR ON THE AIR, WRITE

IT ON ONE OF THE STANDARD FORMS WE\'RE DISTRIBUTING

AND GIVE IT TO YOUR FDA HOST.

WE\'RE GONNA COMPILE ALL THE LEFTOVER QUESTIONS, AND

WE\'LL TRY TO RESPOND TO THEM IN A KIND OF THEMATIC WAY ON

OUR WEBSITE IN THE WEEKS TO COME.

THAT INTERNET ADDRESS, BY THE WAY, SHOULD BE APPEARING

ON YOUR SCREEN.

\\B

OKAY, LET ME BEGIN WITH A COMMENT, OR QUESTION

FROM THE STUDIO AUDIENCE.

THE AMERICAN SOCIETY FOR HEALTH SYSTEMS PHARMACISTS HAD TWO

ISSUES THEY WANTED TO RAISE ABOUT INFORMATION TO

PRACTITIONERS AND PATIENTS.

DO WE HAVE SOMEBODY HERE FROM THAT ORGANIZATION?

DO YOU WANT TO IDENTIFY YOURSELF FIRST?

\>\> YES, THANK YOU.

MY NAME IS BILL ZELMER WITH THE AMERICAN SOCIETY OF HEALTH SYSTEM

PHARMACISTS.

FIRST OF ALL, COMMISSIONER HENNEY, THANK YOU

VERY MUCH FOR HOSTING THIS SESSION TODAY.

IT\'S VERY INFORMATIVE.

I\'D LIKE TO ASK YOU TO COMMENT A BIT FURTHER, PLEASE,

ON THE ROLE OF THE AGENCY IN SAFETY MANAGEMENT AT

THE PATIENT CARE LEVEL AFTER A PRODUCT HAS BEEN APPROVED FOR MARKETING.

WE CERTAINLY AGREE THAT HEALTH PROFESSIONALS HAVE

THEIR PRIMARY RESPONSIBILITY FOR HELPING

PATIENTS BALANCE RISK AND BENEFIT

INFORMATION, BUT IT DOES SEEM TO US THAT OCCASIONALLY

THERE ARE INSTANCES WHERE IT\'S VERY IMPORTANT FOR

THE AGENCY TO HAVE A ROLE AT THE PATIENT CARE LEVEL.

JUST TO GIVE YOU A COUPLE OF EXAMPLES, THERE ARE

INSTANCES WHERE PRODUCTS, AFTER THEY\'RE APPROVED, IT\'S

DISCOVERED THAT PERHAPS THE NAME OF THE PRODUCT, THE

PACKAGING OF THE PRODUCT, THE DESIGN OF THE

LABELING IS CONTRIBUTING TO MEDICATION ERRORS, PERHAPS

AT THE PRESCRIBING, THE DISPENSING OR THE MEDICATION

ADMINISTRATION LEVEL.

AND WE WOULD HOPE THAT THE AGENCY WOULD BE QUITE ACTIVE IN WORKING WITH

THE MANUFACTURER AND WITH HEALTH PROFESSIONALS IN

RESOLVING THOSE PROBLEMS.

ANOTHER EXAMPLE THAT\'S OF GREAT CONCERN TO OUR MEMBERS

DEALS WITH DIRECT-TO-CONSUMER ADVERTISING AND THE FACT

THAT OCCASIONALLY THIS CAN INDUCE OVERWHELMING PATIENT DEMAND FOR A

PRODUCT THAT MAY NOT BE IN

A PARTICULAR PATIENT\'S BEST INTERESTS.

AND WE WOULD APPRECIATE YOUR PERSPECTIVES ON

CURRENT THINKING WITHIN THE AGENCY ON THESE ISSUES.

\>\> LET ME RESPOND TO THE TWO ISSUES AND, PERHAPS,

DR. LUMPKIN WOULD WANT TO ADD TO MY COMMENTS.

I THINK, WITH RESPECT TO THE FIRST ISSUE THAT YOU RAISE IN

TERMS OF THE NEED FOR CONTINUED ACTIVITY BY THE

AGENCY, EVEN AFTER A PRODUCT IS MARKETED, IS WELL TAKEN.

AND I THINK THAT I WOULD STRESS THAT WE

NEED A STRONG FEEDBACK LOOP FROM NOT ONLY

THE HEALTH PROFESSIONALS, BUT CONSUMERS AND PATIENTS

AT LARGE, ABOUT ISSUES THAT COME UP THAT ARE CONFUSING

TO THEM, LIKE THE SIMILAR NAMES OF PRODUCTS AND/OR ADVERSE

REACTIONS, AND I WOULD HOPE THAT WE HAVE

ESTABLISHED STRONG WAYS IN WHICH WE CAN RECEIVE

AND THEN ACT ON THAT INFORMATION.

IN THAT WE MIGHT HAVE TO ENHANCE THAT, I WOULD WELCOME YOUR

SUGGESTIONS, BUT WE HAVE IN THE PAST AND CURRENTLY AND HOPEFULLY

IN THE FUTURE, TRIED TO STRESS THIS STRONG FEEDBACK THAT\'S

REALLY NEEDED BY THE AGENCY TO REALLY MAKE SURE

THAT WE ARE CONTINUOUSLY IMPROVING WHAT THE CONSUMER, THE

PATIENT, ACTUALLY TAKES AS IT USES ONE OF THESE PRODUCTS.

I THINK A RECENT EXAMPLE WAS THE ISSUE BROUGHT

TO OUR ATTENTION WHERE A SIMILAR NAME WAS VERY

CONFUSING AND WE HAD TO TAKE THE PRETTY

DRASTIC STEP OF ASKING A COMPANY TO GO BACK AND

RENAME A PRODUCT, SOMETHING THAT WE THINK THAT WE

DO A GOOD JOB OF AS WE REVIEW PRODUCTS THROUGH

THE SYSTEM, BUT THERE ARE FROM TIME TO TIME CASES

WHERE WE HAVE TO MAKE THOSE KIND OF CHANGES.

TO THE ISSUE OF DIRECT-TO-THE-CONSUMER ADVERTISING, I THINK,

LIKE MANY OF THE ISSUES THAT MARK MENTIONED

BEFORE, THERE ARE TWO SIDES OF THAT.

WE CERTAINLY WANT CONSUMERS, PATIENTS, TO BE

WELL-INFORMED IN THIS COUNTRY.

WE WANT TO MAKE SURE THAT THEY HAVE ADEQUATE

INFORMATION AVAILABLE TO THEM, AND I THINK

THAT THERE HAS BEEN AN UPTICK, IF YOU WILL, IN THE

AMOUNT OF DIRECT CONSUMER ADVERTISING.

WHETHER PEOPLE CAN SORT ALL OF THAT INFORMATION

OUT IS, I THINK, ONE ISSUE.

WHETHER THAT CREATES SITUATIONS IN WHICH PATIENTS

OR CONSUMERS WILL GO TO THEIR HEALTH PROFESSIONAL AND

ASK ABOUT A PRODUCT, BUT AT LEAST INITIATE

THE DIALOGUE WITH THE HEALTH PROFESSIONAL SO THAT THEY CAN

SAY THIS IS EITHER RIGHT OR NOT FOR YOU, OR LOOK AT AN ARRAY OF

OTHER APPROACHES TO THE SPECIFIC QUESTIONS A PATIENT HAS.

YOU KNOW, THOSE ARE SOME OF THE PLUSES AND MINUSES

IN ALL THIS.

FOR THE AGENCY, OUR BIGGEST POINT OF CONCERN IS

THAT ANY INFORMATION THAT IS PRESENTED IS BALANCED AND THAT IT\'S

NOT MISLEADING.

BUT I DO THINK THAT WE ALL ARE GOING TO HAVE

TO WORK TOGETHER AS WE MAKE SURE THAT WE STRIKE

THAT GOAL OF BALANCE \--

NOT MISLEADING, BUT NOT INFORMATION OVERLOAD, AND PRESENT IT IN SUCH A

WAY THAT IT REALLY IS HELPFUL

AT THE END OF THE DAY TO A CONSUMER OR A PATIENT.

AND I DON\'T KNOW IF DR. LUMPKIN WOULD WANT TO ADD \--

\>\> BEFORE WE GO ON, LET ME GIVE YOU A BOX SCORE AS TO WHERE WE STAND,
IN

TERMS OF TIME AND WORKLOAD HERE.

WE HAVE A FAIRLY LARGE STACK OF FAXES THAT HAVE COME IN ALREADY.

\>\> I CATCH THE DRIFT, MARK.

\[ LAUGHTER \]

\>\> HOWEVER, WE DON\'T HAVE PHONE CALLS, AND I WANT TO REMIND OUR

STUDIO AUDIENCE, GO AHEAD, MAKE THE CALLS NOW AND SPEAK

LIVE TO OUR PANELISTS.

WE REALLY ENCOURAGE YOU TO DO THAT.

SO WE\'RE WAITING TO HEAR FROM YOU.

AND WE WILL GIVE PRIORITY TO LIVE PHONE CALLS.

NOW, DR. LUMPKIN, DID YOU WANT TO ADD BRIEFLY?

\>\> VERY BRIEFLY, MARK, RIGHT?

\[ LAUGHTER \]

THE ONLY THING I WOULD ADD IS THE FACT THAT WHEN YOU TALK ABOUT

MEDICATION ERRORS, WE WOULD BE THE FIRST TO SAY THAT

WHEN YOU LOOK AT THE WHOLE ISSUE OF MEDICATION ERRORS, THEY CAN

HAPPEN ANYWHERE WITHIN THE HEALTH DELIVERY SYSTEM.

AND I THINK WE RECOGNIZE THIS, THIS IS A SYSTEMS ISSUE,

AND THERE ARE CERTAIN AREAS WITHIN THAT SYSTEM

THAT YOU POINTED OUT THAT ARE AREAS WHERE, INDEED, WE CAN HAVE

A ROLE.

AND WE HAVE CREATED WITHIN OUR POST-MARKETING GROUP

A STAFF WHOSE SOLE RESPONSIBILITY, WHOSE DAY JOB RESPONSIBILITY,

IS TO DEAL WITH THE ISSUE OF MEDICATION ERRORS AND TO TRY

TO SORT OUT THOSE THAT WE CAN HAVE AN IMPACT ON.

AND THE PERSON WHO HEADS THAT IS ALSO OUR PERSON WHO

IS ON SEVERAL DIFFERENT STAKEHOLDER ORGANIZATIONS WHO ARE INTERESTED

IN MEDICATION ERRORS, AND HE IS OUR REPRESENTATIVE TO THAT.

SO I THINK IT\'S ONE OF THOSE AREAS WHERE WE REALLY CAN WORK

TOGETHER AND WE\'VE GOT A WAY TO DO IT.

\>\> THANK YOU.

\>\> LET\'S GO TO A FAX.

THIS ONE\'S FROM CHICAGO, IT SAYS \"WHAT INITIATIVES HAS FDA

TAKEN TO ENCOURAGE THE PARTICIPATION OF MINORITY GROUPS IN

CLINICAL DRUG TRIALS?\"

DO YOU WANT TO START ON THAT, OR \-- ?

\>\> MARK, LET ME START WITH THAT.

I THINK THE ISSUE OF INCLUSION IN CLINICAL TRIALS IS A

VERY IMPORTANT ONE.

I THINK THAT IN THE EARLY \'90s,

WE WERE FOCUSED AS AN ORGANIZATION, POSSIBLY

EVEN AS A SOCIETY, ON THE ISSUE OF GENDER INCLUSION, AND WE

TOOK SEVERAL ACTIVE STEPS AT THE AGENCIES TO MAKE SURE

THAT THERE WAS STRONG GENDER INCLUSION IN CLINICAL TRIALS.

NOT JUST THINKING ABOUT THE SPECIFIC ISSUES THAT MAY AFFECT

WOMEN DIFFERENTLY AND MEN FOCUSED ON REPRODUCTIVE SYSTEM

IN CHILDBEARING YEARS, BUT ISSUES THAT WERE MUCH BROADER

THAN THAT.

AND I THINK THAT WE HAVE COME A LONG WAY IN TERMS

OF MAKING SURE THAT WOMEN COULD BE INCLUDED IN CLINICAL TRIALS,

THAT THEY COULD MAKE THEIR OWN CHOICES ABOUT INCLUSION.

AND I THINK THAT WE ARE, IN THAT SUBSET ISSUE OF MINORITY POPULATIONS,

STILL HAVING A WAYS TO GO.

CERTAINLY, WE WANT MINORITIES TO BE INCLUDED IN

CLINICAL TRIALS.

WE REALIZE THAT SOME OF THE \--

BOTH THE CULTURE AND THE HISTORY OF INCLUSION IN CLINICAL

RESEARCH FOR MINORITIES IS A VERY DIFFICULT ISSUE.

THEIR INCLUSION IN THE PAST IN SOME VERY TRAGIC

EXPERIENCES IN THIS COUNTRY HAS LED THEM TO BE

MORE RELUCTANT TO PARTICIPATE IN CLINICAL RESEARCH AND IN

CLINICAL TRIALS.

BUT INSOFAR AS WE CAN SUPPORT AND CREATE AN ENVIRONMENT

WHERE THEY ARE INCLUDED SO THAT WE CAN MAKE SURE THAT

AS NEW PRODUCTS ARE TESTED, THAT THEY ARE WELL UNDERSTOOD BEFORE

THEY ARE JUST SIMPLY USED IN A POST-MARKET SETTING.

SO I WOULD SAY THAT THE AGENCY\'S THRUST IS TO MAKE SURE

THAT WE HAVE STRONG DEMOGRAPHIC REPRESENTATION WITHIN THE

CONTEXT OF CLINICAL TRIALS, RECOGNIZING THAT WE HAVE TO BE

SENSITIVE TO SOME VERY IMPORTANT ISSUES THAT

MINORITY GROUPS HAVE FACED AS THEY HAVE BEEN INCLUDED

PERHAPS \-- WELL, NOT JUST PERHAPS \-- WITHOUT INFORMED CONSENT AND IN

INAPPROPRIATE WAYS IN THE PAST.

I THINK WE DO HAVE SPECIFIC GUIDANCE AND REGULATION

TO THAT POINT THAT IS ACTIVE WITHIN THE AGENCY, AND IF ANYBODY IS

INTERESTED IN THAT PARTICULAR GUIDANCE, OF COURSE,

WE CAN GET THAT OUT TO THEM.

\>\> OKAY.

ANOTHER FAX.

THIS ONE SAYS, \"SECTION 406-B OF FDAMA REQUIRES THE AGENCY TO

ESTABLISH MECHANISMS BY JULY 1st, 1999 FOR ELIMINATING

BACKLOGS AND FOR MEETING STATUTORY TIME FRAMES FOR SUBMISSIONS.

WHAT\'S THE STATUS OF FDA's IMPLEMENTATION

OF THIS SECTION?\"

\>\> MARK, I THINK THAT\'S A VERY IMPORTANT QUESTION,

AND I THINK THE 406-B PLAN WAS THE FIRST STEP TO LOOKING AT

HOW WE ARE GOING TO MEET THE BACKLOGS AND WHAT OPPORTUNITIES

WE HAVE TO, IN FACT, TO INCREASE OUR PERFORMANCE.

SO WHAT WE HAVE DONE IN 1999 BUDGETS, WE\'VE ESTABLISHED THE

PERFORMANCE GOALS FOR ALL OF OUR STATUTORY WORKLOAD, AND WE

WILL BE LOOKING AT THOSE PERFORMANCE GOALS IN RELATIONSHIP

TO THE 2000 BUDGET, AND WE WILL BE ISSUING A REPORT THAT SAYS

WHAT OUR PLAN WILL BE IN JULY OF \'99.

\>\> LET\'S GO TO A COMMENT OR QUESTION

FROM THE STUDIO AUDIENCE.

THE AMERICAN PHARMACEUTICAL ASSOCIATION HAD

SEVERAL QUESTIONS, BUT I WANT TO CONCENTRATE ON ONE

THAT HAD TO DO \-- BECAUSE IT REFERS TO SOMETHING THAT

DR. HENNEY SAID ABOUT COMMUNICATING WITH PATIENTS.

STEPS THE FDA MIGHT TAKE TO WORK WITH HEALTH

PROFESSIONALS IN THAT DIRECTION.

IS THERE SOMEBODY HERE?

IDENTIFY YOURSELF, PLEASE.

\>\> THANK YOU, I\'M LUCINDA MAINE, WITH NPHA,

THE NATIONAL PROFESSIONAL SOCIETY OF PHARMACISTS.

AND OUR QUESTION, REALLY, IT APPEARS THAT THERE IS

DIVERGENT OPINION AMONG STAKEHOLDERS WITH RESPECT TO

THE AGENCY\'S DIRECT ROLE IN PROVIDING CONSUMERS INFORMATION.

YES, I\'D BE INTERESTED IN HAVING YOU REFLECT ON WHY YOU THINK

THE DIVERGENCE OF OPINION EXISTS, AND WHAT STEPS

THE AGENCY IS ANTICIPATING IN RESOLVING SOME OF THESE OUTSTANDING

ISSUES?

\>\> COULD YOU BE MORE SPECIFIC IN OUTLINING

THE DIVERGENCE THAT YOU SEE?

\>\> I THINK THAT THERE IS A DIFFERENCE FROM

THE PERSPECTIVE OF THE ROLES.

I THINK THE CONSUMER IS HUNGRY FOR INFORMATION, CREDIBLE

INFORMATION FROM A VARIETY OF SOURCES, AND I BELIEVE THAT THEY

SEE THE AGENCY AS ONE OF THOSE SOURCES.

ON THE OTHER HAND, HEALTH PROFESSIONALS HAVE

THE ROLE IN THE PROVISION OF INFORMATION, PARTICULARLY ABOUT

THERAPEUTICS TO THEIR PATIENTS, AND I THINK

THAT\'S AT LEAST ONE EXAMPLE OF WHERE THE TENSIONS MAY EXIST.

\>\> WELL, LET ME RESPOND IN THIS WAY.

I THINK THAT CONSUMERS WANT NOT JUST INFORMATION,

BUT THEY WANT INVOLVEMENT.

AND I THINK INSOFAR AS WE CAN PROVIDE CREDIBLE INFORMATION TO

CONSUMERS AND THAT THEY CAN HAVE STRONG INTERACTION

WITH THEIR HEALTH PROFESSIONAL, BE THAT A PHYSICIAN, A NURSE

PRACTITIONER, A PHARMACIST IN TERMS OF HELPING

THEM SORT OUT THAT INFORMATION, HOWEVER CREDIBLE IT MIGHT BE,

AND ITS APPLICABILITY TO THEM, I THINK THAT THAT IS WHERE

YOU HAVE TO STRIKE THAT BALANCE.

THERE IS SO MUCH INFORMATION OUT THERE, WHETHER IT

IS CREDIBLE OR NOT, I THINK IS ONE ISSUE, AND

THEN HAVING THAT SORT-OUT OF CREDIBLE INFORMATION IN

TERMS OF AN INTERACTION WITH SOMEONE AND AN INVOLVEMENT

WITH SOMEONE, I THINK ONLY ENHANCES THE ULTIMATE

DECISIONMAKING BY THE CONSUMER IN TERMS OF

WHETHER THEY ARE GOING TO

USE THE INFORMATION OR NOT.

\>\> LET\'S GO TO ANOTHER FAX.

THIS ONE SAYS \"PLEASE COMMENT ON THE CREATION OF A

CVM, ANIMAL HEALTH PRODUCT INFORMATION WEBSITE DATABASE SIMILAR TO THE

CDER CONSUMER DRUG AND INFORMATION SITE FOR HUMAN DRUGS, AND WHAT ELSE

CAN BE DONE TO IMPROVE CONSUMER VETERINARIAN MANUFACTURER

RELATIONSHIPS WITH REGARD TO INFORMING CONSUMERS

ABOUT POSSIBLE ADVERSE SIDE EFFECTS OF MEDICATION.\"

\>\> I THINK THAT WE REALLY SHOULD ASK AN EXPERT

FROM CVM TO TALK TO THE AUDIENCE ABOUT THE POSSIBILITIES OF A DATABASE.

I THINK THAT WE HAVE A STRONG WORKING RELATIONSHIP BETWEEN THE

COLLEAGUES IN THE CENTER FOR DRUGS AND THE CENTER FOR

VETERINARY MEDICINE.

SO TAT KEEPING THAT DIALOGUE AND INFORMATION FLOW WITHIN

THE AGENCY IS SOMETHING THAT WE WORK HARD AT EVERY DAY.

BUT MAKING AVAILABLE INFORMATION ON A DATABASE,

LET ME ASK DR. MITCHELL TO PERHAPS ADDRESS THAT.

\>\> WELL, WE ARE WORKING TOWARD CREATING A WEBSITE, AND AS THE

COMMISSIONER HAS SAID, WE\'RE WORKING VERY

CLOSELY WITH THE CENTER OF DRUGS FOR AN INFORMATION DATABASE

THAT WILL PROVIDE MUCH MORE INFORMATION ON

REACTIONS TO ANIMAL DRUGS.

WE ARE DOING THAT TO THE BEST OF OUR RESOURCES, AND

WE\'RE QUITE INTERESTED IN PROCEEDING WITH THAT JUST AS FAST AS WE CAN.

\>\> PERHAPS OUR ONLY LIMITATION IS THAT WE

DON\'T HAVE MORE 15-YEAR-OLDS OR 13-YEAR-OLDS OR 8-YEAR-OLDS TO

HELP US ON ALL THIS WEBSITE DEVELOPMENT.

WE\'RE ALL FAIRLY ARCHAIC USER HOSTILE TYPES

THAT HAVE TO COME AROUND TO THIS NOTION OF DOING THINGS BY WEB.

\>\> WELL, HERE\'S ANOTHER FAX.

THIS ONE HAS TO DO WITH \--

IT SAYS, \"THE MEDICAL DEVICE INDUSTRY APPLAUDS

THE INSPECTION EVALUATION THAT THE MEDICAL DEVICE INITIATIVE

GRASSROOTS TASK FORCE IS DOING IN CONJUNCTION WITH

THE UNIVERSITY OF CALIFORNIA AT IRVINE ON COMMUNICATION DURING

THE FDA INSPECTION PROCESS.

IS THE FDA INTERESTED IN WORKING WITH INDUSTRY AND ACADEMIA

TO GET FEEDBACK ON OTHER PROGRAMS, SUCH AS A PRODUCT

REVIEW PROCESS OR OTHER POST-MARKET SURVEILLANCE INITIATIVES?\"

ANYONE WANT TO GRAB THAT?

\>\> WELL, LET ME TAKE A STAB AT IT.

\>\> SURE.

\>\> I KNOW THAT CALIFORNIA WAS REALLY INVOLVED

WITH A GRASSROOTS EFFORT, BUT I THINK IT STARTED IN

DENVER, IF I\'M NOT MISTAKEN, AND CALIFORNIA CAME ALONG.

BUT THAT NOTWITHSTANDING, I ONLY KNOW THAT BECAUSE ONE OF MY

FIRST DISTRICT OFFICE VISITS WAS TO GO OUT

TO THE DENVER DISTRICT OFFICE AND ACTUALLY

MEET WITH A DEVICE GRASSROOTS GROUP FROM

REGULATED INDUSTRY IN THAT AREA.

AND THEY POINT WITH PRIDE TO THIS AS AN

INITIATIVE WHERE WE DID NOT HAVE A HEALTHY RELATIONSHIP WITH THE

INDUSTRY, PARTICULARLY OVER THIS ISSUE OF INSPECTION,

GETTING REPORTS IN A TIMELY FASHION, UNDERSTANDING,

I THINK, BETWEEN AND AMONG ALL PARTIES ABOUT WHAT

THE PROCESS WAS, WHAT ITS INTENT WAS AND HOW WE MIGHT

MAKE IT MORE CONSTRUCTIVE.

I THINK THAT THEY REALLY LED THE WAY IN TERMS

OF DEVELOPING A RELATIONSHIP OF RESPECT BOTH BY

THE REGULATED INDUSTRY AND BY THE AGENCY

FOR REALLY UPGRADING THIS PARTICULAR PROCESS.

THAT HAS FLOWED THROUGH NOW TO A NATIONWIDE INITIATIVE,

WHETHER WE CAN SPREAD IT TO OTHER AREAS, I THINK, IS

SOMETHING THAT WE VERY MUCH WANT TO DO.

\>\> OKAY.

ANYONE WANT TO ADD TO THAT?

\>\> I JUST WANTED TO SAY THAT I THINK THE SHORT

ANSWER TO THAT QUESTION IS, YES, WE\'RE VERY INTERESTED IN

PURSUING THESE KIND OF PARTNERSHIPS AND COLLABORATIONS

ACROSS THE BOARD, NOT JUST WITH INSPECTIONS BUT WITH

POST-MARKET SURVEILLANCE.

WE HAVE LOTS OF INITIATIVES TO TRY TO DO THAT

AND LEVERAGE OUR RESOURCES SO THAT WE CAN GET MORE ACCOMPLISHED.

\>\> LET\'S GO TO A STUDIO AUDIENCE QUESTION NOW.

THE HEALTH INDUSTRY MANUFACTURER ASSOCIATION HAD A

QUESTION ABOUT THE EFFECTIVE STRENGTH AND SCIENCE ON

THE FDAMA PROVISION ABOUT LEAST BURDENSOME.

DO WE HAVE SOMEBODY HERE FROM \--

YES, CAN YOU IDENTIFY YOURSELF?

\>\> YES, I\'M JANET TRUNSEAU WITH THE HEALTH

INDUSTRY MANUFACTURERS ASSOCIATION AND FDA REVIEW

TIMES HAVE SHOWN SIGNIFICANT IMPROVEMENT OVER THE LAST SEVERAL YEARS.

YET, A MAJOR CONCERN FOR THE MEDICAL DEVICE INDUSTRY IS

THAT PRODUCT DEVELOPMENT TIMES HAVE NOT IMPROVED.

SECTION 205 OF THE MODERNIZATION ACT REQUIRES THE AGENCY TO

CONSIDER THE LEAST BURDENSOME MEANS OF SHOWING DEVICE EFFECTIVENESS.

WE AT HEMA BELIEVE THAT FULL IMPLEMENTATION OF THE LEAST BURDENSOME

PROVISION, WITHOUT LOWERING THE STANDARD FOR

EFFECTIVENESS, WOULD ULTIMATELY HAVE A POSITIVE IMPACT ON

THE PRODUCT DEVELOPMENT TIME.

SO THE QUESTION IS, WHAT EFFECT WOULD THE INCREASED AND ENHANCED

SCIENCE BASE AT THE AGENCY HAVE ON THE IMPLEMENTATION OF THE

LEAST BURDENSOME PROVISION?

\>\> LET ME TRY IT FOR STARTERS, MARK, AND THEN TURN

IT OVER TO THE REAL EXPERT.

I THINK THAT THE CLINICAL RIGOR WITH WHICH DEVICES

ARE EVALUATED IS A VERY IMPORTANT ISSUE, AND I

THINK THAT THE STANDARD BY WHICH DEVICES ARE EVALUATED

WILL NOT CHANGE, HAS NOT AND WILL NOT CHANGE.

I THINK THAT WE HAVE UNDERTAKEN A NUMBER OF

LOOKS AT THIS WHOLE ISSUE OF WHAT IS THE APPROPRIATE

STUDY TO MATCH THE NEED AT THE TIME.

I THINK PERSONALLY, IF THE TERMS \"MOST REASONABLE\"

RATHER THAN \"LEAST BURDENSOME\" WOULD HAVE BEEN

SELECTED, I WOULD HAVE BEEN A MUCH HAPPIER CAMPER, \'CAUSE I

THINK THAT IT STRIKES AT THE HEART OF WHAT WE\'RE

TRYING \--

WE\'RE BOTH TRYING TO GAIN, AND THAT IS TO APPLY THE MOST

REASONABLE STUDY DESIGNED THAT WILL GET A

DEVICE THROUGH THE PROCESS KNOWING THAT ULTIMATELY THE STANDARD

HAS TO BE MET.

BUT I THINK THAT THE STAFF IN THE CENTER HAVE

WORKED VERY HARD AND VERY HARD WITH MANY GROUPS

OVER THIS ISSUE OF HOW DO YOU ACTUALLY GO ABOUT THIS, AND ARE

READY TO ISSUE OR SOON WILL ISSUE GUIDANCE IN THAT REGARD.

\>\> I JUST WANTED TO ADD THAT I ACTUALLY THINK THAT DR. HENNEY\'S

VISION ABOUT SCIENCE ENHANCEMENT FOR THE AGENCY REALLY

COMPLEMENTS AND GOES ALONG VERY WELL WITH WHAT WE\'RE CALLING

LEAST BURDENSOME PATHS TO MARKET.

BECAUSE I THINK THAT REVIEWERS AND SCIENTISTS THAT ARE

AT THE TOP OF THEIR FORM, AS DR. HENNEY HAS

SAID, AND WHO ARE WELL-EDUCATED AND HAVE A CHANCE TO DO

CONTINUED EDUCATION AND ARE COMFORTABLE WITH

THE LATEST IN SCIENCE AND TECHNOLOGICAL AND

MEDICAL DEVELOPMENTS ARE THE MOST ABLE TO CALIBRATE

WHAT THEY ASK FOR, WITH THE RISK PRESENTED BY THE PRODUCT IN

FRONT OF THEM.

LESS LIKELY TO SECOND-GUESS AND MOST LIKELY TO

KNOW WHAT THE RIGHT FIT IS BETWEEN WHAT NEEDS TO COME IN

AND WHAT NEEDS TO BE REVIEWED.

\>\> WELL, LET\'S GO TO A FAX.

IT SAYS \"DRUG INTERACTIONS AND ADVERSE EFFECTS OF DRUGS CONTINUE TO BE
A

MAJOR PROBLEM.

WHAT\'S THE FDA's ROLE NOW, AND ARE THERE NEW INITIATIVES

ON THIS IN THE FUTURE?\"

\>\> WELL, SINCE I\'M ALWAYS IN CHARGE OF THE LENGTHY ANSWERS,

THE ANSWER ON THIS ONE WILL BE DR. LUMPKIN.

\[ LAUGHTER \]

\>\> I THINK THE PERSON WHO FAXED IN BRINGS UP SOME

OBVIOUSLY SOME VERY, VERY PERTINENT ISSUES HERE.

I THINK THE ISSUE OF DRUG/DRUG INTERACTIONS IS PARTICULARLY

IMPORTANT AND GROWING WITH THE NUMEROUS DRUGS THAT

ARE NOW AVAILABLE, AND THE FACT THAT WE HAVE SUCH A

WONDERFUL PIPELINE OF NEW DRUGS COMING DOWN THE PIKE.

WHEN WE\'VE GOT A POPULATION THAT\'S AGING, WHEN WE\'VE

GOT A POPULATION THAT HAS POLYPHARMACY, OBVIOUSLY THE INTERACTIONS

ARE COMING FORWARD.

I THINK OUR BIGGEST CHALLENGE IS TWOFOLD \--

ONE, FIGURING OUT THE PROPER WAY TO STUDY THE

DRUG/DRUG INTERACTIONS, AND SECONDLY, TO FIGURE OUT THE

WAY TO COMMUNICATE IT.

AND I THINK THE SECOND ONE IS THE BIGGER CHALLENGE BECAUSE

IT\'S SOMETHING WE\'RE CONTINUING TO LEARN ABOUT, AND I

THINK WE\'RE HAVING TO THINK AS IT WERE OUTSIDE THE BOX

ON WAYS TO COMMUNICATE THIS.

AND THE QUESTION IS, IS LABELING REALLY THE MOST EFFICIENT

WAY TO DO IT?

OR TO GO TO WHAT DR. HENNEY WAS TALKING ABOUT

AND THINKING ABOUT IN TERMS OF WEBSITES AND WAYS OF GETTING

INFORMATION UP QUICKLY, SO THAT PEOPLE KNOW WHERE TO GO TO

FIND THE LATEST INFORMATION ON DRUG/DRUG INTERACTIONS

MIGHT BE THE MORE APPROPRIATE WAY TO COMMUNICATE IT.

\>\> LET\'S GO TO THE STUDIO NOW.

THE COALITION FOR REGULATORY REFORM HAD A QUESTION ABOUT

STAKEHOLDER INPUT ON REGULATORY GUIDANCES.

IS THERE SOMEONE HERE FROM THAT ORGANIZATION?

\>\> YES, I\'M KAY GREGORY, AND I\'M FROM THE AMERICAN ASSOCIATION

OF BLOOD BANKS.

THE OTHER MEMBERS OF THE COALITION FOR REGULATORY REFORM ARE

THE AMERICAN BLOOD CENTERS, THE AMERICAN BLOOD RESOURCES

ASSOCIATION AND THE AMERICAN RED CROSS.

AND I\'M HERE REPRESENTING ALL OF THEM.

AND WE BELIEVE THAT IT WOULD BE BENEFICIAL FOR THE AGENCY

TO SEEK INPUT FROM INDUSTRY EARLY ON IN THE DEVELOPMENT,

PARTICULARLY OF GUIDANCES AND REGULATIONS.

WE APPRECIATE THE FACT THAT WE CAN COMMENT AFTER YOU\'VE

PUBLISHED THEM, BUT WE THINK WE COULD ADD MAYBE EVEN TO THE

SCIENCE AND THE RISK MANAGEMENT DECISIONS IF WE COULD BE INVOLVED

A LITTLE BIT EARLIER IN THE PROCESS.

AND WE\'VE HAD LIMITED SUCCESS IN DOING THAT, BUT WE WONDER

WHETHER YOU\'RE OPEN TO THIS KIND OF EARLY INTERACTION DURING

DEVELOPMENTAL PHASES AND IF SO, HOW CAN CMRR BEST WORK

PARTICULARLY WITH CBER?

\>\> LET ME START IT OUT AND ASK DR. FEIGAL TO FOLLOW.

I THINK IF I HAVE HEARD ANYTHING THAT LEADS TO SUCCESS IN

TERMS OF DEALING WITH A REGULATORY AGENCY, AND MOST PERSONALLY,

THE FDA, IT\'S THREE LITTLE WORDS \-- \"EARLY AND OFTEN.\"

TALKING, INTERACTING, SEEING THAT COMMUNICATION IS CLEAR AND

WHETHER THAT\'S A COMPANY COMING IN WITH AN IDEA WAY BEFORE

THEY HAVE EVERY IDEA WORKED OUT IN TERMS OF THEIR STUDY, THAT

EARLY AND OFTEN COMMUNICATION IS VERY IMPORTANT TO SUCCESS.

WITH RESPECT TO POLICY OR REGULATION DEVELOPMENT, WE HAVE

NUMEROUS FORUMS, I THINK, WHERE WE DO OUR PRELIMINARY

THINKING, PERHAPS, AND THEY AREN\'T TITLED THAT WAY.

AND PERHAPS WE COULD DO SOME OF OUR OWN THINKING ABOUT

HOW WE COULD IMPROVE THAT.

I THINK THE REALITIES ARE, AS YOU POINT OUT, ONCE WE GO

INTO THE MODE OF REGULATORY WRITING, ONCE THAT PROCESS

IS ENGAGED, THAT\'S NOT THE TIME FOR LOTS OF BACK AND

FORTH, BUT IN THE FRONT END OF DOING SOME OF OUR BRAINSTORMING

AND THEN THE MORE FORMAL PROCESS, ONCE A PROPOSED REG COMES

OUT, THE BACK AND FORTH COMMUNICATION THAT YOU\'RE USED TO

SHOULD GO ON.

BUT PERHAPS WE NEED TO MAKE THIS FRONT-END PROCESS MORE TRANSPARENT,

MORE IDENTIFIABLE FOR YOU, SO THAT YOU\'LL KNOW WHEN WE\'RE TRYING

TO PICK YOUR BRAINS OR NOT.

\[ LAUGHTER \]

BUT MAYBE DAVID COULD RESPOND A LITTLE BIT MORE TO THAT.

\>\> WELL, I\'D LIKE TO THANK YOU FOR THE QUESTION.

IT\'S A VERY GOOD ONE.

IT\'S MADE COMPLICATED BY THE FACT THERE\'S MANY DIFFERENT WAYS

THAT REGULATIONS COME INTO BEING.

AND THEY\'RE USUALLY BASED ON EVOLUTION OF THE SCIENCE OR IDENTIFICATION

OF A NEW THREAT TO THE BLOOD SUPPLY.

AND THE WAY WE SEEK INITIAL INPUT IS OFTEN TO PRESENT PRELIMINARY

FINDINGS AND ASK FOR COMMENTS AT PUBLIC ADVISORY COMMITTEES

OR AT WORKSHOPS OR BRING UP THE ISSUE LIAISON MEETINGS THAT

WE HAVE WITH INDUSTRY GROUPS.

THERE HAVE BEEN TIMES, IN FACT, WHEN INDUSTRY GROUPS HAVE

BROUGHT, FOR US, PROPOSALS OF NEW GUIDANCES, NEW VOLUNTARY

STEPS THAT THEY WOULD LIKE TO TAKE TO CHANGE, AND WE\'VE PRESENTED

THINGS THAT WE HAVEN\'T BEEN THE FIRST AUTHOR OF TO OUR ADVISORY

COMMITTEE TO GET SUGGESTIONS ON THOSE.

SO WE DO VERY MUCH WELCOME THE \-- WELCOME THE INPUT.

I THINK IT\'S ALSO VERY IMPORTANT, GIVEN THE WAY THAT THE ADMINISTRATIVE

PROCEDURES ACT TELLS US HOW TO WRITE REGULATIONS, THAT WHEN WE HAVE

THE COMMENT PERIODS, EITHER ON ADVANCE NOTICE OF PROPOSED RULEMAKING

OR PROPOSED RULES, THAT WE GET THE COMMENTS BECAUSE IT\'S \-- WE

OFTEN WILL RECOGNIZE WHEN WE\'RE WRITING A NEW REGULATION THAT

THERE ARE OPTIONS, OR THAT A SUGGESTION\'S BEEN MADE THAT HAS PROBLEMS.

AND WE\'RE PUBLISHING IT SPECIFICALLY TO GET THE COMMENTS, GET

THE FEEDBACK, AND IT HELPS US DECIDE IN THOSE CLOSE CASES WHICH

DIRECTION TO GO.

SO WE VERY MUCH VALUE THE INPUT, AND WE APPRECIATE THE FACT

THAT SUCH A BROAD GROUP OF ORGANIZATIONS HAS FORMED TOGETHER TO

MAKE OUR TASK A LITTLE BIT EASIER.

\>\> THANK YOU.

I\'M ABOUT TO GO TO ANOTHER FAX.

BUT I WANT TO REMIND OUR AUDIENCE AGAIN, PLEASE CALL US.

WE\'RE LONESOME HERE, WAITING TO HEAR FROM YOU.

\[ LAUGHTER \]

THE FIRST CALLER WILL GET A PBS TOTE BAG AND A \--

\[ LAUGHTER \]

CD OF THE THREE TENORS.

\[ LAUGHTER \]

OKAY.

\>\> THEY\'RE ALL CALLING INTO THEIR RADIO TALK SHOW THAT

RUN AROUND NOONTIME.

\>\> THAT\'S RIGHT.

THIS FAX SAYS, \"WHILE FUNDS WERE AVAILABLE, CVM PROVIDED

INTERN \-- EXTERNSHIPS TO ITS STAFF.

THESE WERE GREATLY APPRECIATED BY BOTH CVM AND BY THE INDUSTRY.

I ENCOURAGE THE FDA TO BUILD UPON THIS MODEST BEGINNING WITH

ONE OR TWO-WEEK DURATION EXTERNSHIPS.

THAT IS A COMMENT, NOT A QUESTION.

DOES SOMEONE WANT TO RESPOND TO THAT \-- FROM CVM?

\>\> WELL, I WOULD COMMENT THAT WE ARE INTERESTED IN THAT PROGRAM.

IN FACT, WE HAVE SUCH GOING ON TO A LIMITED EXTENT AT THIS TIME.

AND IF THERE\'S A WAY OF US CONNECTING SPECIFICALLY WITH THAT \-- THE

SOURCE OF THAT COMMENT, WE\'D BE GLAD TO DEAL WITH IT.

\>\> MM-HMM.

\>\> OKAY.

HERE\'S ANOTHER FAX THAT SAYS, \"WHAT IDEAS DOES THE AGENCY HAVE

FOR THE DISSEMINATION OF UNBIASED, UNDERSTANDABLE INFORMATION ON

THE RISK AND BENEFITS OF PRESCRIPTION DRUGS TO CONSUMERS?\"

THAT\'S A THEME WE HEARD BEFORE, BUT THIS IS A SPECIFIC QUESTION.

\>\> MATT, DO YOU WANT TO \--

\>\> WELL, I THINK THERE ARE TWO DIFFERENT ELEMENTS TO THAT.

ONE IS CLEARLY THE GIVING OF INFORMATION TO CONSUMERS FOR PRODUCTS

WHICH THEY ARE SELECTING THEMSELVES, AND I WOULD SAY THAT THE NEW

OTC LABELING IS PROBABLY THE MOST VISIBLE INITIATIVE THAT WE HAVE

TO TRY TO MAKE THAT INFORMATION CLEARER AND MORE EASILY OBTAINABLE

AND MORE EASILY UNDERSTOOD.

THE SECOND ONE IS THE ISSUE OF TRYING TO GET CONSUMER-FRIENDLY

INFORMATION AND UNBIASED INFORMATION ON PRESCRIPTION DRUG PRODUCTS.

AND I THINK DR. HENNEY TALKED A LITTLE BIT ABOUT THAT.

AS EVERYONE KNOWS, WE HAVE \-- WE\'RE IN THE MIDDLE OF AN INITIATIVE

TO SEE WHAT ELEMENTS CAN OCCUR AS FAR AS PRIVATE SECTOR IS

CONCERNED ON THAT, AND WE WILL BE EVALUATING THE PRIVATE SECTOR

EFFORTS HERE OVER THE NEXT SEVERAL YEARS.

WE\'VE ALSO JUST PUBLISHED A FINAL RULE ON CERTAIN KINDS OF

MED GUIDES THAT WE WOULD BE REQUIRING IN SOME VERY SPECIFIC SITUATIONS,

SO I THINK WE\'RE LOOKING AT AS THREE DIFFERENT THINGS AT THIS POINT

IN TIME THAT I\'VE JUST MENTIONED.

AND THOSE WOULD BE THE THREE SPECIFIC THINGS I WOULD PUT OUT

ON THE TABLE.

\>\> MARK, IF YOU DON\'T MIND IF I COULD TIE A COUPLE OF QUESTIONS

OR RESPONSES TOGETHER, IT\'S \-- YOU RAISE THE ISSUE OF THE OTC LABEL.

ACTUALLY, A GOOD THRUST FOR THAT INITIATIVE REALLY CAME FROM THE

STAKEHOLDER GROUP OF THE NDMA, NOW CHPA, THE CONSUMER HEALTH PRODUCTS

ASSOCIATION, RAISING CONCERNS ABOUT THE UNIFORMITY OF THE LABEL, MAKING

SURE THAT CONSUMERS COULD UNDERSTAND WHAT WAS ON THE LABEL, LOOKING

FOR CLEARER LANGUAGE THAT COULD BE USED.

I THINK THAT THE AGENCY HAS ACTED UPON THAT IN AN APPROPRIATE WAY.

BUT IT SHOWS THE KIND OF, I THINK, INTERACTION THAT WE SEE AS BOTH

HEALTHY BUT ULTIMATELY BENEFICIAL FOR CONSUMERS.

AND SO I THINK THAT TYING THE LAST TWO QUESTIONS TOGETHER IS A

WAY THAT WE ACTED VERY MUCH ON SOMETHING THAT WAS BROUGHT FORWARD BY

THE STAKEHOLDER GROUP.

\>\> HERE\'S ANOTHER FAX THAT SAYS, \"WE REALLY APPRECIATE THE NEW

WARNING LETTER PROGRAM.

DO YOU PLAN TO PUT THE POST-INSPECTION LETTERS ON THE WEB?\"

\>\> IS THAT DEVICES?

\[ LAUGHTER \]

\>\> WELL, THIS ONE IS FROM C.R. BARD, IN FACT.

\>\> MM-HMM.

LET ME CLARIFY.

FOR PEOPLE WHO MAY NOT KNOW WHAT WE\'RE TALKING ABOUT, WE HAVE A

WARNING LETTER PILOT IN WHICH DEVICE INSPECTORS WHO FINISH AN INSPECTION

ARE \-- AND HAVE CHARGES THAT MAY RESULT IN A WARNING LETTER GIVE THE

FIRM AN OPPORTUNITY TO RESPOND, AND IF CORRECTIONS ARE MADE WITHIN

15 DAYS \-- OR SOMETHING LIKE THAT, I\'LL CHECK WITH LILLIAN OVER

THERE \-- THEN WE WON\'T BE ISSUING THE WARNING LETTER.

AS FAR AS PUTTING THOSE RESPONSES, I DON\'T KNOW WHETHER THE CALLER

IS ASKING ABOUT THE AGENCY\'S RESPONSE OR THE FIRM\'S RESPONSE.

BUT I DON\'T THINK OUR PLAN IS TO PUT ANY OF THAT INFORMATION ON

THE WEB.

THE PURPOSE OF THIS IS REALLY TO MAKE THE INSPECTION AS MUCH OF

A LEARNING EXPERIENCE AND AN EFFECTIVE CHANGE FOR THE FIRM, RATHER

THAN TO PUBLICIZE ANY KIND OF WEAKNESSES.

\>\> THANKS.

LET\'S GO TO THE STUDIO AUDIENCE.

THE CONSUMER HEALTH CARE PRODUCTS ASSOCIATION HAD A QUESTION ON

THE MECHANISM FOR ENSURING PRODUCTIVE MEETINGS BETWEEN THE FDA

AND STAKEHOLDERS.

\>\> YES, I\'M BILL ZOELLER WITH THE CONSUMER HEALTH CARE PRODUCTS

ASSOCIATION, AND I DON\'T KNOW WHETHER THIS IS ALSO OPEN TO OUR

OTHER QUESTIONS THAT WE ASKED AS WELL.

THAT PARTICULAR POINT RELATED TO AN INTERACTION THAT WE HAD

WITH CDER, PARTICULARLY MAC LUMPKIN, AND AGAIN, THANKS FOR THOSE VERY

PRODUCTIVE INTERACTIONS WHEN WE WORKED OUT THE MEETINGS MAP 4512.1.

OUR POINT THERE, AS ONE OF OUR \-- PART OF OUR WRITTEN COMMENTS,

RELATED TO THINKING ABOUT HOW DIFFERENT AGENCIES HAVE INTERACTED

WITH STAKEHOLDERS AND USING THOSE GOOD PRACTICES AND APPLYING

THEM OVER INTO ANOTHER CENTER SUCH AS CISSAM.

AND WE WOULD THINK THAT PERHAPS HAVING A SIMILAR TYPE OF MEETINGS

MAP WITH EXTERNAL CONSTITUENCIES MIGHT BE WORTHWHILE.

I\'M WONDERING WHETHER YOU ENTERTAINED OUR OTHER QUESTIONS AS WELL.

\>\> WELL, WE TRY TO PICK THE ONES THAT WERE, IN FACT, ADDRESSING THE

FIVE ISSUES, AND SO THAT\'S WHY WE PICKED THAT ONE BECAUSE IT WAS,

IN FACT, PERTINENT.

DOES SOMEONE WANT TO RESPOND TO THAT NOW?

YES?

\>\> YES, I\'D LIKE TO RESPOND.

I\'VE TALKED TO MAC ABOUT THE PROCEDURES THEY HAVE IN DRUGS.

AND THEY HAVE A SPECIFIC PROCEDURE SET UP FOR INTERACTIVE MEETINGS.

AND WE\'RE GOING TO GET TOGETHER SO I CAN FIND OUT A LITTLE BIT MORE

ABOUT HOW DRUGS OPERATE IN THE INTERACTIVE MEETINGS TO SEE IF IT

MIGHT BE A PROCEDURE WE MIGHT BE ABLE TO USE BETTER IN THE CENTER,

BECAUSE WE\'RE ALWAYS LOOKING FOR BETTER WAYS TO INTERACT WITH

THE INDUSTRY.

AND THAT MIGHT BE A HELPFUL WAY.

\>\> THAT SOUNDS GREAT.

\>\> THANK YOU.

\>\> THIS IS A FAX ABOUT THE POSSIBILITY OF GETTING POST-MARKET

SURVEILLANCE INFORMATION FROM THE PUBLIC.

IT SAYS, \"DOES THE FDA HAVE ANY SPECIFIC PLANS TO ENHANCE

POST-MARKETING SURVEILLANCE?

IN PARTICULAR, I\'M INTERESTED IN EFFORTS TO ENHANCE TIMELY AND

WIDESPREAD REPORTING FROM THE PUBLIC AT LARGE.\"

APPARENTLY SIMILAR TO THE MED WATCH FOR PROFESSIONALS.

ANY THOUGHTS ON THAT?

\>\> MATT, COULD YOU RESPOND?

\>\> WELL, I THINK AS FAR AS MED WATCH, OUR MESSAGE OUT THERE IS NOT

ONLY TO HEALTH CARE PRACTITIONERS, BUT CLEARLY TO CONSUMERS.

AND WE GET A FAIR NUMBER OF OUR REPORTS FROM CONSUMERS.

AND I THINK PARTICULARLY WHEN YOU\'RE LOOKING AT PRODUCTS SUCH

AS OVER-THE-COUNTER PRODUCTS, CONSUMERS ARE GOING TO BE OUR

MAJOR SOURCE OF INFORMATION.

CLEARLY, CONSUMERS, I THINK, BRING A PARTICULAR PERSPECTIVE ON

HOW THEY PERCEIVE WHAT HAS HAPPENED TO THEM WITH THE DRUG.

AND OBVIOUSLY THE BEST OF ALL WORLDS IS WHEN WE HAVE A GIVEN

SUSPECTED ADVERSE EVENT THAT WE HAVE BOTH THE CONSUMER PERSPECTIVE AND

THE HEALTH CARE PROFESSIONAL PERSPECTIVE IF THERE WAS A HEALTH CARE

PROFESSIONAL INVOLVED IN THAT CASE, BECAUSE WE GET DIFFERENT KINDS

OF INFORMATION THAT HELP US UNDERSTAND IT BETTER.

I WOULD HOPE THAT CONSUMERS OUT THERE AND THE PERSON WHO SENT THIS

PARTICULAR FAX WOULD BE AWARE OF, AND MAYBE THAT IS ONE OF THE MESSAGES

TO US \-- WE NEED TO MAKE IT MORE AWARE THAT, THAT INDEED, UNDER MED
WATCH

WE ARE INTERESTED IN GETTING CONSUMER REPORTS, AND THEY SHOULD USE

THOSE FACILITIES JUST AS OTHER REPORTERS DO.

\>\> HERE\'S ANOTHER ONE RELATED TO CONSUMERS.

IT SAYS, \"WHAT RESOURCES ARE AVAILABLE FOR THE FDA TO WORK

WITH LOCAL HIGH SCHOOLS ON EDUCATIONAL PARTNERSHIPS?\"

\>\> WELL, WE DO HAVE RELATIONSHIPS WITH SEVERAL LOCAL HIGH SCHOOLS.

AT LEAST WE USED TO AND JANET HAS HER HANDS UP, SO SHE CAN \--

\>\> WE\'VE HAD RELATIONSHIPS WITH LOCAL HIGH SCHOOLS IN THE D.C. AREA
AND

SOME OF THE DISTRICTS DO IN A NUMBER OF AREAS IN SCIENCE AND CHEMISTRY

AND VARIOUS AREAS LIKE THAT.

BUT IN THE FOOD SAFETY INITIATIVE, THE FIGHT-BACK PROGRAM, WHICH IS

A PUBLIC/PRIVATE PARTNERSHIP WITH INDUSTRY, WITH THE STATES, WITH USDA,

FDA CONSUMERS HAS ONE ELEMENT IN IT THAT WE\'RE TRYING TO GET MORE

INFORMATION ON FOOD SAFETY TO THE HIGH SCHOOLS, AND WE HAVE SOME
RESEARCH

THAT\'S BEEN DONE OVER THE PAST YEAR, AND PROGRAMS ARE GOING OUT FROM

FIGHT-BACK THROUGH THE HIGH SCHOOLS AND SCHOOLS THIS COMING YEAR.

\>\> I SHOULD MENTION THAT WAS FROM A HIGH SCHOOL, IN FACT.

\[ LAUGHTER \]

\>\> GREAT.

\>\> THERE ARE A COUPLE OF OTHER THINGS WE DO.

AND HAVING JUST SIGNED A NUMBER OF CERTIFICATES TO HIGH SCHOOL STUDENTS

WHO PARTICIPATE IN SCIENCE FAIRS.

I AM WELL AWARE THAT WE BOTH HAVE, FROM TIME TO TIME, HIGH SCHOOL

STUDENTS WORKING IN OUR LABS, NOT ONLY HERE IN HEADQUARTERS IN
WASHINGTON,

BUT FROM TIME TO TIME IN SOME OF OUR DISTRICT OFFICES AS WELL.

\>\> HERE\'S A FAX THAT SAYS, \"FDA IS LOOKING AT STRONGER INTEGRATION
OF

FOOD SAFETY PROGRAMS FROM THE FEDERAL, STATE AND LOCAL JURISDICTIONS IN

ORDER TO LEVERAGE ALL AVAILABLE RESOURCES TO MAXIMIZE EFFECTIVENESS.

WHERE ARE WE WITH RESPECT TO BRINGING ALL STAKEHOLDERS, FOR EXAMPLE

INDUSTRY CONSUMER AND ACADEMIA, INTO THE DISCUSSION?\"

\>\> JANICE, DO YOU WANT TO TAKE A SHOT AT THIS?

WE CLEARLY WILL BE DOING THIS IN A \-- AN EVEN MORE VISIBLE WAY THIS

YEAR AS THE FEDERAL AGENCIES ARE CHARGED WITH DEVELOPING THEIR

STRATEGIC PLANNING PROCESS, AND IT CLEARLY WILL INVOLVE A LOT OF

INTERACTIONS WITH ALL OF THE STAKEHOLDERS.

BUT, JANICE, PERHAPS YOU COULD RESPOND.

\>\> SURE.

ONE OF THE FIRST THINGS WE DID IS, IN LOOKING AT OUR INTERACTIONS WITH
THE

STATE AND LOOKING AT HOW CAN WE BETTER PROVIDE FOOD SAFETY THROUGHOUT

THE COUNTRY, WHEN STATES AND LOCAL AGENCIES AND ALL THE FEDERAL AGENCIES

ALL HAVE A PIECE OF THE PIE AND CONSIDERABLE RESOURCES INTO IT IS TO GET

TOGETHER WITH REPRESENTATIVES OF THE STATE AND LOCAL AGENCIES TO TRY

AND SEE WHAT PROGRAMS THEY HAVE, WHAT THE NEEDS WERE, AND TO DEVELOP

PARTICULAR WORKING GROUPS IN THAT AREA.

WE STARTED WITH THE STATES AND LOCALS TO SEE THEIR INTEREST BECAUSE THEY

WERE THE ONES WE WANTED TO WORK WITH AND TO SEE WHAT THE NEEDS WERE.

WE\'VE DONE SOME OUTREACH.

WE HAVE NOT DONE ENOUGH OUTREACH YET TO CONSUMER GROUPS AND TO INDUSTRY,

AND THAT IS OUR NEXT STEP BEFORE WE PROCEED ON.

OUR \-- THE MOST OF WHAT WE\'VE DONE \-- OUR HIGHLIGHT HAS BEEN IN THE

OUTBREAK RESPONSE AREA.

AND THAT STARTED INITIALLY WITH THE FOOD SAFETY INITIATIVE AND WE

DID START AT THAT LAST YEAR.

AND SO THIS YEAR, WE WERE LOOKING AT, ARE THERE OTHER AREAS AS

WE MOVE DOWN THE ROAD?

BUT INDEED, AS DR. HENNEY SAID, WE\'LL BE DOING A LOT MORE INTERACTION

IN STAKEHOLDER INPUT, AND THERE WILL BE PUBLIC MEETINGS AND ASSOCIATION

WITH THE AFDO, ASSOCIATION OF FOOD AND DRUG OFFICIALS.

THEY\'RE HOLDING A WORKSHOP TO DISCUSS THIS IN JUNE.

\>\> HERE\'S A FAX ABOUT ADVERSE EVENT REPORTING.

IT SAYS, \"HOW DOES FDA MONITOR POST-MARKET SURVEILLANCE IN RELATION

TO DRUGS TREATING LIFE-THREATENING ILLNESSES, SUCH AS HIV/AIDS?\"

AND HERE\'S THE KEY PART OF THE QUESTION \--

\"HOW DOES THE ADVERSE REPORTING SYSTEM GET RELAYED TO CONSUMERS?\"

\>\> I\'M GOING TO ASK DR. LUMPKIN TO ANSWER THAT.

\>\> IT\'S A VERY GOOD QUESTION.

I MEAN, AS FAR AS THE GENERAL PROCESS ITSELF IS CONCERNED, IT\'S PART

OF THE OVERALL SPONTANEOUS REPORTING SYSTEM THAT WE HAVE.

THAT\'S BASICALLY, AS PEOPLE WHO HAVE LOOKED AT THIS OVERALL PROCESS

UNDERSTAND, THAT\'S KIND OF THE CATCH-ALL TO TALK ABOUT SOME OF

THE SERIOUS UNEXPECTED KINDS OF ADVERSE EVENTS THAT ARE RARE IN

THE POST-MARKETING AREA.

WE ALSO HAVE SEVERAL OTHER METHODOLOGIES, THOUGH, THAT WE USE TO LOOK

FROM AN EPIDEMIOLOGICAL PERSPECTIVE AT OTHER ISSUES THAT MIGHT ARISE

IN CERTAIN PATIENT POPULATIONS.

WE HAVE A CONTRACT, FOR EXAMPLE, WITH A DATABASE THAT LOOKS AT ADVERSE

EVENTS IN PATIENTS WHO ARE HIV POSITIVE, BECAUSE WE KNOW THAT\'S A VERY

SPECIAL GROUP OF INDIVIDUALS WHO HAVE VERY SPECIAL DRUG-RELATED ISSUES

IN THEIR HEALTH CARE.

SO WE\'VE GOT SEVERAL DIFFERENT MECHANISMS TO LOOK AT SPECIAL
POPULATIONS.

THE QUESTION ABOUT HOW IS THAT THEN COMMUNICATED BACK, I THINK, IS
REALLY

WHERE PEOPLE ARE LOOKING AT THIS POINT IN TIME.

IT\'S ONE THING TO GET THE INFORMATION, TO ASSEMBLE IT AND TO DIGEST IT.

THE REAL CRUX IS IT DOES NO GOOD FOR IT TO STAY IN ROCKVILLE.

IT\'S GOT TO GET BACK OUT TO THE POPULATION.

WE HAVE SEVERAL DIFFERENT MECHANISMS THAT WE\'VE STARTED TO USE.

ONE IS USING OUR WEBSITE, WHICH I THINK WE FOUND IN PARTICULAR
SITUATIONS

HAS BEEN VERY EFFECTIVE FOR GETTING INFORMATION OUT AT A CERTAIN PERIOD

OF TIME.

ONE OF THE ONES IN THE HIV POPULATION THAT WE USED WAS THE LIPODYSTROPHY

ISSUE WITH SOME OF THE PROTEASE INHIBITORS.

SO THERE ARE WAYS THAT WE HAVE.

WE ALSO HAVE DIRECT RELATIONSHIPS WITH DIFFERENT PROFESSIONAL
ORGANIZATIONS

AND DIFFERENT PATIENT GROUPS THROUGH THE MED WATCH PARTNERS PROGRAM,
WHO,

WHEN WE HAVE ISSUES THAT ARE RELATED TO THEIR POPULATION OR TO THEIR

PRACTICE, WE THEN GET BACK WITH THEM AND FEEDBACK TO THEM.

AND WE\'VE FOUND THEY\'VE BEEN WONDERFUL FOR THEM GETTING OUT TO

THEIR CONSTITUENCIES THE INFORMATION THAT WE THINK IS IMPORTANT

AND THAT WE FOUND OUT.

\>\> THANK YOU.

I WANT TO CALL ON THE NATIONAL COUNCIL ON PATIENT INFORMATION AND

EDUCATION FOR NOT A QUESTION BUT A COMMENT.

IS SOMEONE HERE?

YES?

\>\> YES, MY NAME IS RAY BOWLMAN WITH THE NATIONAL COUNCIL ON

PATIENT INFORMATION AND EDUCATION.

LAST FALL, THE NATIONAL COUNCIL ON PATIENT INFORMATION ENCOURAGED FDA

TO SUPPORT THE DEVELOPMENT OF A NATIONAL COLLABORATIVE AND SUSTAINED

CONSUMER MEDICINE SAFETY AND EDUCATION PROGRAMS.

THE GOALS OF A CONSUMER MEDICINE SAFETY AND EDUCATION PROGRAM COULD BE,

FOR EXAMPLE, TO EDUCATE CONSUMERS AND PROVIDERS ABOUT CHANGES AND

IMPROVEMENTS IN MEDICINE INFORMATION AND BETTER EQUIPPED CONSUMERS AND

CAREGIVERS TO RECOGNIZE AND REPORT MEDICINE-RELATED ERRORS, FOR EXAMPLE.

THERE IS A QUESTION, IF I COULD.

\[ LAUGHTER \]

WHY NOT BROADEN THE SCOPE OF FDA's PUBLIC EDUCATION CAMPAIGN TO HELP

CONSUMERS UNDERSTAND THE NEW OTC LABELS \-- MEDICATION LABELS \--

INCORPORATING MORE COMPREHENSIVE MEDICINE INFORMATION AND EDUCATION

OBJECTIVES TO HELP CONSUMERS ALSO UNDERSTAND, FOR EXAMPLE, THE FDA's

APPROVED MEDICATION GUIDES THAT WILL BEGIN APPEARING IN \-- FOR SELECT

PRODUCTS THIS SUMMER, ACTIONS CONSUMERS SHOULD BE TAKING REGARDING THE

IMPACT OF Y2K ON THEIR MEDICINE SUPPLY, FOR EXAMPLE, AND THEIR OWN ROLE

AND RESPONSIBILITIES AND ENSURING SAFE AND APPROPRIATE MEDICINE USE?

\>\> THANK YOU.

\>\> MM-HMM.

\>\> LET ME TAKE AT LEAST TWO ASPECTS OF THE QUESTION.

AND IF OTHERS WANT TO MAKE COMMENTS, AS WELL, THAT WILL BE GREAT.

THE ASPECT OF EDUCATIONAL EFFORTS TO CONSUMERS, PARTICULARLY ABOUT THE

OTC LABEL, BUILT INTO THAT INITIATIVE IS A MORE GENERAL EDUCATIONAL

CAMPAIGN.

WILL IT BE AS ROBUST AS WE ALL WOULD LIKE?

IT\'S GOING TO BE, PERHAPS, LIMITED ONLY BECAUSE OF RESOURCES, BUT WE

ARE LOOKING FORWARD TO PARTNERING WITH OTHER GROUPS WHO CAN ALSO CARRY

THIS MESSAGE, SO I WOULD HOPE THAT WE WOULD KEEP INTERACTING WITH YOU

AND THE OTHER ASSOCIATIONS IN TERMS OF HOW WE MIGHT DO THIS BEST IN

TERMS OF EDUCATING THE CONSUMER ABOUT WHAT IS ON THE LABEL.

THE ISSUE THAT YOU RAISE ABOUT Y2K, I THINK, IS A VERY IMPORTANT ONE.

AND THE ISSUES RANGE, I THINK, FOR THE AGENCY ANYWHERE FROM, ARE WE

READY TO MEET THE CHALLENGE?

AND I WOULD HAPPILY REPORT TO YOU THAT ALL OF OUR CRITICAL SYSTEMS

HAVE BEEN JUDGED TO BE COMPLIANT WITH THE CHALLENGE OF Y2K.

WE ARE \-- WE HAVE BEEN IN DIRECT INTERACTION WITH THE DEVICE INDUSTRY

IN TERMS OF PUTTING UP A WEBSITE, NOT ONLY OF THOSE THAT FEEL LIKE THEIR

SYSTEMS MIGHT NOT BE COMPLIANT OR COMPLIANT YET, AS WELL AS THOSE NOW

THAT ARE COMPLIANT.

AND WE HAVE RECENTLY BEEN SERVING THE PHARMACEUTICAL, BIOLOGICAL,

BIOTECH INDUSTRIES TO GET ASSURANCE ABOUT THE INDIVIDUAL COMPANIES\'

STATES OF COMPLIANCE, TO LOOK AT THAT END OF THE PIPELINE.

THE OTHER INITIATIVE THAT IS GOING ON THAT WE ARE A PART OF AND

THAT IS TO WORK WITH ALL OF, REALLY, THOSE THAT HAVE TO BE IN
PARTNERSHIP,

ALL THE WAY DOWN THIS CONTINUUM FROM THE TIME OF MANUFACTURE TO THE

TIME WHEN A PILL REACHES YOUR MEDICINE CHEST, AND ALL THOSE THAT

INFLUENCE WHAT THE SUPPLY WILL BE LIKE.

AND WE\'VE HAD SEVERAL MEETINGS WITH PEOPLE WHO RUN THE DRUGSTORES,

PEOPLE WHO WRITE THE PRESCRIPTIONS, INTERACTING WITH CONSUMERS AND

SEEING WHAT THE GENERAL SENSE OF THE PUBLIC IS ABOUT THIS ISSUE.

WE BELIEVE THAT WE WILL BE IN A REASONABLE STATE WITH RESPECT TO

SUPPLY COMING OUT OF THE MANUFACTURERS.

WE ARE FOCUSING OUR OWN AGENCY ATTENDANCE ATTENTION, PARTICULARLY IN

THOSE AREAS WHERE WE HAVE ONLY ONE MANUFACTURER OR THE CRITICAL

NEED OF A DRUG.

BUT AS WE GET MORE INFORMATION, WE WILL CERTAINLY GET IT OUT TO THE

GENERAL PUBLIC, SO WE DON\'T HAVE THIS \-- A STATE OF PANIC.

WE DON\'T NEED THAT.

THE COUNTRY DOESN\'T DESERVE IT.

STOCKPILING, WE WOULD STRONGLY DISCOURAGE.

\>\> THANK YOU.

AND THANKS TO EVERYBODY IN THE STUDIO FOR A GOOD DISCUSSION.

WE\'RE JUST ABOUT OUT OF TIME.

AND IN FACT, IT\'S TIME TO WRAP UP THIS BROADCAST.

WE DON\'T WANT TO IMPINGE ON THE LIVE MEETINGS GOING ON AROUND

THE COUNTRY.

I WANT TO THANK DRS. HENNEY AND SUYDAM, AND THE FDA PANEL, AS WELL

AS EVERYBODY WHO TOOK THE TIME TO COME TO ONE OF OUR REGIONAL

MEETINGS OR TO THE STUDIO.

AND I PARTICULARLY WANT TO THANK THOSE OF YOU WHO, I WAS GOING TO

SAY PHONED OR FAXED IN, BUT I\'LL SAY FOR THOSE OF YOU WHO FAXED

QUESTIONS.

AS DR. HENNEY SAID EARLIER, WE TAKE THIS KIND OF FEEDBACK SERIOUSLY.

WE\'VE TAKEN CARE TO RECORD WHAT YOU\'VE SAID TODAY, AND AGENCY MANAGERS

ARE GOING TO TAKE YOUR VIEWS INTO ACCOUNT AS THEY MAKE PROGRAM PLANS

FOR THE FUTURE.

AS I SAID EARLIER, WE\'RE GOING TO BE RESPONDING TO MANY OF THE
QUESTIONS

WE DIDN\'T HAVE TIME FOR \-- THAT IS, THE FAXES THAT WE DIDN\'T GET TO
\-- ON

THE WEBSITE.

ALSO, TODAY\'S BROADCAST IS GOING TO HAVE AN AFTERLIFE.

IT\'S GOING TO BE AVAILABLE AS A WEBCAST ON OUR FDA WEBSITE THROUGH

THE NEXT 30 DAYS.

AND ALSO VIDEOTAPE COPIES ARE GOING TO BE AVAILABLE FOR PURCHASE

THROUGH THE NATIONAL TECHNICAL INFORMATION SERVICE, OR NTIS.

AND THAT INFORMATION SHOULD BE APPEARING ON YOUR SCREEN RIGHT NOW.

WE HOPE THIS BROADCAST WAS HELPFUL TO YOU IN UNDERSTANDING FDA's

PLANS AND PRIORITIES.

I KNOW IT\'S GOING TO BE HELPFUL TO US IN UNDERSTANDING YOUR VIEWPOINTS

AND YOUR SUGGESTIONS.

IF WE\'RE GOING TO BE SUCCESSFUL IN IMPLEMENTING FDAMA, WE\'RE GOING

TO HAVE TO CONTINUE TO WORK CLOSELY WITH STAKEHOLDERS.

AND TODAY\'S TELECONFERENCE AND THESE MEETINGS ACROSS THE COUNTRY IS

GOING TO BE AN IMPORTANT STEP IN THAT DIRECTION.

THEY CERTAINLY ARE NOT GOING TO BE THE LAST STEP, BECAUSE THIS HAS

TO BE A CONTINUING PROCESS.

AND IN FACT, AS PART OF THAT ONGOING PROCESS, WE\'RE GOING TO

CONTINUALLY RE-EVALUATE THE FDA PROGRAMS BASED ON STAKEHOLDER INPUT.

AS PART OF WORKING WITH STAKEHOLDERS, WE MAY DO MORE OF THESE

TELECONFERENCES IN THE FUTURE.

AND THAT DEPENDS LARGELY ON YOUR REACTION TO TODAY\'S BROADCAST, WHICH

WE CONSIDER AS A KIND OF TRIAL RUN, SO WE\'RE REALLY INTERESTED IN

YOUR FEEDBACK.

TO GET YOUR FEEDBACK TO US \-- AND WE WANT YOU TO TELL US WHAT YOU
LIKED,

WHAT YOU DIDN\'T LIKE AND SO ON \-- IF YOU\'RE AT ONE OF THE EIGHT
REGIONAL

MEETINGS AROUND THE COUNTRY, PLEASE FILL OUT THE BRIEF EVALUATION FORM

THAT WAS DISTRIBUTED BY YOUR MEETING COORDINATOR.

AND IF YOU\'RE WATCHING THE BROADCAST AT ANOTHER SITE, YOU CAN E-MAIL

YOUR COMMENTS TO US AT THE ADDRESS WE\'VE BEEN SHOWING ON YOUR SCREEN

ALL THROUGH THE PROGRAM.

AGAIN, THANK YOU FOR TAKING THE TIME TO PARTICIPATE TODAY.

UNTIL WE MEET AGAIN, THIS IS MARK BARNETT.