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PACCARB Day 2: Welcome & Presentation on FDA’s Guidance for Industry #213


>>GOOD MORNING, LADIES AND GENTLEMEN.
I WONDER IF WE COULD GET STARTED THIS MORNING. I’M MARTIN BLASER,I’M THE CHAIR OF PACCARB,
I’M GOING TO TURN FLOOR OVER TO DR. BRUCE GELLIN,OUR DESIGNATED FEDERAL OFFICIAL AND
HE’S GOING TO TURN THE CHAIR OVER TO DR. LONNIE KING, THE CO-CHAIR OF THIS COMMITTEE, AND
HE’LL BE LEADING TODAY’S EVENTS. DR. GELLIN>>MY FUNCTION THIS MORNING IS TO GET US ALL
STARTED. AND TAKE A ROLL CALL OF THE MEMBERS.
I’LL GO AROUND AND JUST SAY IF YOU’RE HERE OR IF YOU’RE SUBSTITUTING FOR SOMEONE LET
US KNOW WHO THAT IS. DR. BLASER, HERE.
>>MIKE APLEY.>>HERE.
>>HELEN BOUCHER.>>HERE.
>>ANGIE CALIENDO0>>HERE
>>ALICIA COLE.>>HERE ISH
>>SARA COSGROVE.>>HERE.
>>PETER DAVIES. IS HE ON THE PHONE THIS MORNING?
NOT YET, OKAY. LONNIE KING.
>>HERE.>>KENT KESTER.
>>RAMANAN LAXMINARAYAN.>>HERE.
>>AILEEN MARTY>>HERE.
>>JOHN REX>>HERE.
>>TOM SHRYOCK>>RANDY SINGER.
>>HERE.>>BOB WEINSTEIN.
>>HERE.>>LIAISON RICH CARNEVALE.
>>HERE.>>JAY BUTLER.
>>HERE.>>SHERRY DORNBERGER.
>>ELIZABETH WAGSTROM>>HERE
>>ELIZABETH JUNGMAN>>HERE.
>>EX OFFICIOS BETH BELL WILL BE HERE SHORTLY. DENNIS DICKSON.
>>JANE KNISLEY FOR DENNIS DICKSON.>>THANKS JANE.
>>JOE LARSEN. SHARI LING.
>>HERE.>>PETER LURIE.
>>HERE.>>DAVID SMITH.
PAIGE WATERMAN. BRIAN McCLOSKEY.
>>HERE.>>STEVE KAPPES.
>>CYRIL GRAY STANDING IN FOR STEVE KAPPAS.>>AND DAVID GOLDMAN.
>>NEENA ANANDARAMAN FOR DAVID GOLDMAN.>>DR. KING, BACK TO YOU.
>>OKAY, THANKS VERY MUCH. LADIES AND GENTLEMEN, LET ME ADD MY GOOD MORNING,
AND WELCOME. I HOPE THAT MANY OF YOU WERE WITH US YESTERDAY.
WE HAD AN OUTSTANDING DISCUSSION AND PRESENTATIONS ON INCENTIVES.
IT WAS A REALLY GOOD AND A VERY THOUGHTFUL DAY.
TODAY WE TURN OUR ATTENTION TO A COUPLE OTHER TOPICS BUT ESPECIALLY ENVIRONMENT.
BEFORE WE DO THAT, IN A MINUTE I’M GOING TO CALL ON DR. BILL FLYNN FROM CENTER FOR VETERINARY
MEDICINE AT FDA AND HE’S GOING TO GIVE US AN UPDATE ON THE STATUS OF GUIDANCE 209213
AND CHANGES IN THE VETERINARIAN FEED DIRECTIVE AND KIND OF GIVES US AN UPDATE AS THAT TRANSITION
IS NOW ENTERING INTO THE THIRD YEAR. THEN WE’LL TURN OUR ATTENTION TO THE ENVIRONMENT,
AND WE HAVE THREE GROUPS OF PRESENTATIONS, WE’RE GOING TO BE TALKING ABOUT DRIVERS OF
ANTIMICROBIAL RESISTANCE AND COMPARTMENTS OF ANTIMICROBIAL RESISTANCE AND ANTIBIOTIC
METABOLITES AND THEN SHIFT OUR FOCUS TO SURVEILLANCE AND ACTIVITIES IN GOVERNMENT AGENCIES.
WE’LL SUMMARIZE THOSE THREE DIFFERENT SECTIONS AND THEN ALSO HAVE AN OPPORTUNITY FOR PUBLIC
COMMENT AND THEN SUMMARIZE THE DAY. THAT’S HOW TODAY WILL PLAY OUT, AND LET ME
GIVE MY THANKS IN ADVANCE TO DOCTORS AILEEN MARTY FOR HELPING CHAIR THE SESSION AND RANDY
SINGER WHO PUT ON I THINK A REALLY OUTSTANDING GROUP OF PRESENTERS AND I THANK THE PRESENTERS
IN ADVANCE TOO FOR COMING JOINING US TODAY. WITHOUT FURTHER ADO LET ME TURN MY ATTENTION
TO DR. BILL FLYNN. FLYNN YOU WANT TO GIVE US AN UPDATE ON THE
STATUS OF 213 PLEASE.>>YES.
THANK YOU. GOOD MORNING.
THANKS TO THE COUNCIL FOR THE OPPORTUNITY TO UPDATE ON YOU THE PROGRESS OF FDA’S ACTIVITIES
RELATED TO ANTIBIOTIC USE IN ANIMAL AGRICULTURE. SO I KNOW TIME IS BRIEF SO I HAVE A FEW SLIDES
TO PROVIDE A BRIEF UPDATE AND PROVIDE OPPORTUNITY FOR DISCUSSION.
THERE ARE THREE, MANY OF YOU KNOW BUT I’LL REVIEW SEVERAL KEY DOCUMENTS THAT REALLY ARE
LINKED TOGETHER IN TERMS OF EFFORTS MOVING FORWARD.
THERE’S TWO GUIDANCE DOCUMENTS THAT FDA ISSUED AS WE’LL AS REGULATION.
SO I’M GOING TO BRIEFLY TOUCH ON THOSE IN TERMS OF WHAT THE SIGNIFICANCE ARE AND PROVIDE
UPDATE IN TERMS OF WHERE WE ARE IN TERMS OF OVERALL GOAL OF COMPLETING OR IMPLEMENTING
CHANGES BY THE END OF THIS YEAR. THE FIRST OF THESE THREE DOCUMENTS IS A GUIDANCE
THAT WE ISSUED IN FINAL FORM IN 2012, 209, REALLY AN IMPORTANT STATEMENT OF POLICY BY
FDA IN TERMS OF SETTING OUT KEY RECOMMENDATIONS AS FAR AS THE USE OF ANTIBIOTICS IN PARTICULAR
MEDICALLY ANTIBIOTICS IN FOODPRODUCING ANIMALS, LAYING OUT TWO KEY CHANGES WE FELT SHOULD
BE MADE TO SUPPORT JUDICIOUS USE OF THESE DRUGS IN FOODPRODUCING ANIMALS.
ONE THAT IS TO LIMIT THE USE OF MEDICALLY IMPORTANT DRUGS TO THOSE USES THAT ARE REALLY
FOUND TO BE NECESSARY FOR ENSURING ANIMAL HEALTH AND THAT ESSENTIALLY MEANS LIMIT THEIR
USE TO THERAPEUTIC USE AND ELIMINATE THEIR USES FOR PRODUCTION OR GROWTH PROMOTION USES.
SECONDLY THEN TO BRING ALL THERAPEUTIC USES OF THOSE DRUGS UNDER VETERINARY OVERSIGHT.
THE SECOND DOCUMENT IS GUIDANCE 213 WHICH WE PUBLISHED IN FINAL FORM THE SUBSEQUENT
YEAR IN 2013. THIS ESSENTIALLY IS AN IMPLEMTATION PLAN LAYS
OUT STRATEGY FOR HOW WE WERE GING TO BRING ABOUT MAKING THESE CHANGES TO THOSE PRODUCTS.
IT PROVIDED MORE CLARITY IN TERMS OF WHAT DRUGS ARE AFFECTED BY THIS POLICY.
AGAIN, WE’RE FOCUSED ON MEDICALLY IMPORTANT ANTIBIOTICS, NOT NECESSARILY ALL ANTIBIOTICS
FROM A RISK PERSPECTIVE. IT ALSO IMPORTANTLY ESTABLISHED A THREEYEAR
TIME LINE, SO WITH THIS DOCUMENT BEING PUBLISHED IN 2013 THAT THREEYEAR CLOCK STARTED THEN.
THAT MEANS THAT THE END OF THIS YEAR IS THE TARGET DATE FOR COMPLETION AND ESSENTIALLY
IT BRINGS ABOUT� LAYS OUT A STRATEGY BY WHICH THE CHANGES TO THE PRODUCTS WOULD BE�
WE WOULD SEEK THE COOPERATION OF THE PHARMACEUTICAL COMPANIES THAT MARKET THESE PRODUCTS TO VOLUNTARILY
COME INTO FDA AND MAKE THE NEEDED CHANGES, ULTIMATELY THAT IS TO REMOVE GROWTH PROMOTION
USE FROM APPROVED LABELS OF THESE PRODUCTS AND THEN CHANGE THEIR MARKETING STATUS FROM
OVER THE COUNTER TO PRESCRIPTION OR VFD. AND THE PRIMARY FOCUS OF THIS WHOLE INITIATIVE
IS ON THE USE OF MEDICALLY IMPORTANT ANTIBIOTICS THAT ARE ADMINISTERED TO ANIMALS EITHER THROUGH
FEED OR DRINKING WATER. THE THIRD DOCUMENT THAT’S REALLY CRITICAL
TO THIS WHOLE EFFORT IS A REGULATION THAT WE ISSUED BECAUSE MANY OF THE PRODUCTS THAT
WE’RE TALKING ABOUT HERE ARE FEED USE ANTIBIOTICS, CHANGING THEIR STATUS FROM OVER THE COUNTER
TO REQUIRE VET OVERSIGHT BY LAW MEANS THEY WOULD BE DESIGNATED AS THEN BEING DIRECTIVE,
SIMILAR TO A PRESCRIPTION STATUS IN THAT THE USE OF THESE PRODUCTS ONCE DESIGNATED AS VFD
WOULD REQUIRE AUTHORIZATION OF A LICENSED VETERINARIAN.
AND SO THE VETERINARY FEED DIRECTIVE IS IN PLACE FOR A NUMBER OF YEARS, A REGULATION
IN PLAINS SINCE 2001 THAT NEEDED TO BE UPDATED TO MAKE SURE WE COULD FACILITATE TRANSITION
OF WHAT IS A RELATIVELY LARGE NUMBER OF PRODUCTS FROM THEIR OVER THE COUNTER STATUS TO VFD.
SO THIS RULE RELATES TO THE REQUIREMENTS THAT HAVE TO DO WITH THE DISTRIBUTION AND USE OF
VFD DRUGS, AND THE PURPOSE OF UPDATING TO MAKE SURE REQUIREMENTS ASSOCIATED WITH SALE
WAS AS EFFICIENT AS POSSIBLE GIVEN WE WERE CHANGING AN ENVIRONMENT WHERE THERE WERE A
LIMITED NUMBER DESIGNATED AS VFD, WE NEEDED TO MAKE SURE THE PROCESS WAS EFFICIENT AND
AS STREAMLINED AS POSSIBLE TO FACILITATE THE CHANGE, A CRITICAL ELEMENT OF THE OVERALL
STRATEGY. SO ALSO TO THE SCOPE OF THIS INITIATIVE, IT
IS FOCUSED FROM A RISK PERSPECTIVE ON THOSE ANTIBIOTICS THAT HAVE HUMAN MEDICAL IMPORTANCE
AND ARE ALSO BEING USED IN ANIMALS IN THIS CASE IN FEEDER WATER FOR EITHER GROWTH PROMOTION
AND/OR A NUMBER OF THERAPEUTIC INDICATIONS, THAT REALLY AFFECTS THESE SEVEN CLASSES OF
ANTIBIOTICS, BUT IN FACT A NUMBER OF PRODUCTS WHICH I’LL GET TO IN A MINUTE IS QUITE LARGE
AS FAR AS TIME LINE THE IMPORTANT ISSUE, IMPORTANT FACTOR WITH GUIDANCE 213 WAS ESTABLISHING
THREEYEAR TIME LINE, CLEARLY THAT TIME LINE WAS IMPORTANT FOR A NUMBER OF REASONS INCLUDING
PROVIDING TIME TO LAY OUT A PLAN WITH THE PHARMACEUTICAL INDUSTRY TO BE ABLE TO BRING
ABOUT ALL THESE CHANGES TO THESE PRODUCTS IN A COORDINATED FASHION.
ALSO CLEARLY THERE’S AN IMPORTANT BECAUSE OF THE SIGNIFICANCE OF THESE CHANGES AND THE
IMPACT, POTENTIAL IMPACT, ON PRODUCERS, VETERINARIANS, FEED INDUSTRY, WE NEEDED A BUILTIN TIME TO
DO THE NECESSARY OUTREACH AND EDUCATION TO MAKE SURE FOLKS WERE AWARE OF WHAT WAS COMING
AND TO START ADJUSTING PRACTICES. THE TARGET DATE THAT WE’VE SET THEN IS OUR
EXPECTATION IS BY JANUARY�1, 2017, MEDICALLY IMPORTANT DRUGS USED IN FEED AND WATER WILL
BE ONLY USED FOR THERAPEUTIC PURPOSES AND WILL BE UNDER THE OVERSIGHT OF VETERINARIANS.
SO WHILE THE VOLUNTARY ASPECT OF THIS STRATEGY WAS ASKING THE COMPANIES TO VOLUNTARILY COME
IN AND MAKE THESE CHANGES, ONCE THE CHANGES ARE MADE IT WILL BE ILLEGAL TO USE THESE PRODUCTS
FOR PRODUCTION PURPOSES, GROWTH PROMOTION, ILLEGAL TO USE WITHOUT THE AUTHORIZATION OF
A LICENSED VETERINARIAN. SO JUST TO GIVE YOU A SENSE OF THE NUMBERS,
THERE’S A BIT UNDER 300 APPROVED DRUGS OR DRUG PRODUCTS THAT WERE AFFECTED BY THIS.
AND THAT INCLUDES BOTH PRODUCTS THAT ARE PIONEERS, ORIGINAL PIONEER PRODUCTS, AS WELL AS ASSOCIATED
GENERIC AS WELL AS COMBINATION APPROVALS, SO SOME 290 APPROVALS WERE ACROSS THOSE DIFFERENT
TYPES OF APPLICATIONS. THERE’S A LOT OF INTERCONNECTEDNESS BETWEEN
THEM, AS YOU CAN IMAGINE, WITH A PIONEER VERSUS GENERIC AS WELL AS COMBINATION USES.
SO THERE WAS REALLY A NEED TO MAKE SURE WE TRIED TO COORDINATE THIS AS MUCH AS POSSIBLE.
THE GOOD NEWS IS ALL THE COMPANIES THAT HAVE AFFECTED PRODUCTS MADE A COMMITMENT IN WRITING
TO FDA AT THE BEGINNING OF THIS THREEYEAR PLAN, MAKING A COMMITMENT THAT THEY WOULD
WORK WITH US TO VOLUNTARILY MAKE THE NEEDED CHANGES.
WE HAVE WORKED WITH THE PHARMACEUTICAL INDUSTRY SINCE THE BEGINNING OF THIS TO OUTLINE REALLY
THE MORE DETAILED PROCESS OF HOW TO GO ABOUT GETTING ALL THESE CHANGES MADE WITHIN THE
TIME LINE. WE COMMUNICATED TO THEM IN A VERY DETAILED
PROCESS LETTER TO THEM SORT OF OUTLINING AN SOP FOR HOW WE WERE GOING TO GO ABOUT GETTING
ALL THESE CHANGES MADE TO ALL THESE PRODUCTS IN A COORDINATED FASHION.
SO TO DATE THERE HAVE BEEN SOME CHANGES MADE, AND INCLUDING ABOUT 40 APPLICATIONS THAT HAVE
BEEN WITHDRAWN COMPLETELY. I WOULD NOTE OF THE 290SOME APPROVED PRODUCTS
THAT ARE AFFECTED, NOT ALL OF THOSE PRODUCTS ARE MARKETED.
THERE’S A LARGE PERCENTAGE THAT ARE NOT CURRENTLY MARKETED SO A DECISION NEEDS TO BE MADE ABOUT
WHETHER THOSE PRODUCTS WILL IN FACT BE UPDATED OR CERTAINLY COMPANIES HAVE THE OPTION TO
SIMPLY WITHDRAW THE APPROVAL OF THOSE APPLICATIONS WHICH, AGAIN, HAS BEEN DONE IN AT LEAST 41
CASES SO FAR. HOWEVER, I WOULD POINT OUT BY DESIGN MOST
OF THE CHANGES ARE EXPECTED TO BE OCCURRING IN A COORDINATED FASHION AT THE END OF THE
YEAR. SO, AGAIN, BY THE FACT THAT WE’VE SEEN A FAIRLY
LIMITED NUMBER OF CHANGES SO FAR IS ACTUALLY BY DESIGN BECAUSE OF THE INTERCONNECTEDNESS
BETWEEN ALL THESE PRODUCTS WE’RE TRYING TO DO THIS IN SORT OF A COORDINATED WAY SO THAT
THERE’S CONSISTENCY IN THE MARKETPLACE WHEN WE SWITCH OVER ALL THESE PRODUCTS, PARTICULARLY
AS RELATES TO THE MARKETING STATUS OF THE PRODUCTS.
AGAIN, SO THAT WE HIT OUR TARGET BY JANUARY�1. CLEARLY A KEY ASPECT OF WHAT WE’VE BEEN DOING
DURING THIS PERIOD OF TIME IS REACHING OUT TO ALL AFFECTED STAKEHOLDERS ON THIS ISSUE.
THERE’S A LOT OF INFORMATION THAT NEEDS TO GET OUT TO FOLKS ABOUT THE CHANGES THAT ARE
COMING PARTICULARLY AS IT RELATES TO SWITCHING PRODUCTS FROM AN OVERTHECOUNTER STATUS TO
VETERINARY OVERSIGHT AND THE TECHNICAL DETAILS ASSOCIATED WITH THAT.
WE’VE BEEN DOING WHAT WE CAN TO GET OUT INTO THE COMMUNITY AND TRY TO REACH OUT TO DIFFERENT
SEGMENTS OF THE INDUSTRY, AND HAVE PARTICIPATED AND PRESENTED IN AT LEAST 60 PRESENTATIONS
ON THE OVERALL INITIATIVE. WE POSTED MATERIALS, QUITE A BIT OF MATERIALS
ON THE WEBSITE, INCLUDING A POWERPOINT PRESENTATION SORT OF WALKING THROUGH THE KEY ASPECTS OF
THAT AND THERE’S BEEN SEVERAL THOUSAND HITS ON THAT WHICH IS ENCOURAGING.
WE’VE ALSO DEVELOPED A NUMBER OF BROCHURES AND HAVE RECEIVED DIRECTIVE REQUIREMENTS THAT’S
TARGETED TO DIFFERENT STAKEHOLDERS THAT ARE AFFECTED AND WORKED TO GET THAT INFORMATION
DISTRIBUTED TO FOLKS, A NUMBER OF GUIDANCE DOCUMENTS HAVE BEEN PUBLISHED IN ASSOCIATION
WITH IT AS WELL AS, AGAIN, ADDITIONAL MATERIALS ON OUR WEBSITE TO SUPPORT THE ISSUE.
MOVING FORWARD, THERE’S STILL IN TERMS OF THE UPCOMING SIX MONTHS AND BEYOND I THINK
THERE’S GOING TO BE A CONTINUING NEED TO LEVERAGE WHAT WE CAN AS FAR AS EDUCATION, CERTAINLY
ONE ASPECT OF THIS IS WE’RE WORKING WITH USDA LOOKING TO DEVELOP WITH THEM AN EDUCATION
MODULE SPECIFICALLY RELATED TO THE VFD RULE THAT APIS WILL INCORPORATE INTO ONE OF THESE
ACCREDITATION MODULES FOR VETERINARIANS SEEKING ACCREDITATION, PROVIDING ANOTHER AVENUE FOR
VETERINARIANS TO TAP INTO INFORMATION ON WHAT THE NEW REQUIREMENTS ARE.
WE’RE ALSO DEVELOPING A NUMBER OF TRAINING VIDEOS WE HOPE TO MAKE AVAILABLE BY THE END
OF THE YEAR SO THAT CAN BE USED BY STAKEHOLDERS. AGAIN, WE HAVE A FAIRLY EXTENSIVE LIST OF
MATERIALS UP ON OUR WEBSITE AT THIS POINT. SO JUST ONE LAST SLIDE HERE IN TERMS OF, YOU
KNOW, KIND OF WHAT NEXT. I THINK IT’S AN IMPORTANT POINT TO MAKE IS
THAT CLEARLY THE CHANGES WE’RE MOVING FOR UNDER GUIDANCE 213 WITH VERY IMPORTANT AND
SIGNIFICANT CHANGES TO HOW ANTIBIOTICS HAVE BEEN USED IN ANIMAL AGRICULTURE FOR DECADES
AND THEY ARE DEFINITELY AN IMPORTANT STEP FORWARD.
THESE CHANGES HOWEVER DON’T NECESSARILY RESOLVE ALL ISSUES RELATED TO ANTIBIOTIC USE AND CERTAINLY
THERE’S MORE WORK TO BE DONE. I THINK ONE POINT WAS MENTIONED YESTERDAY
THAT, YOU KNOW, THERE ARE CONCERNS ABOUT, YOU KNOW, WHAT ELSE IS ON THE HORIZON AND
UNCERTAINTY ABOUT MAYBE OTHER RESTRICTIONS OR LIMITATIONS THAT MAY BE ON THE HORIZON
SO I THINK ONE OF OUR GOALS IS BY THE END OF THE YEAR TO GET A BROADER PLAN OUT THERE
TO WHAT WE SEE ARE SOME OF THE OTHER IMPORTANT ISSUES WE NEED TO FOCUS ON IN THE UPCOMING
3 TO 5 YEARS SO THERE’S SOME CLARITY AS TO WHAT IT’S ON THE HORIZON AND WHAT MORE NEEDS
TO BE DONE. AND I THINK I’LL STOP THERE.
THANK YOU VERY MUCH.>>THANK YOU.
WE APPRECIATE THAT. WE’VE BUILT IN SOME TIME FOR QUESTIONS AND
ANSWERS. SO I’LL OPEN IT UP AND, JOHN, DO YOU WANT
TO START?>>THAT WAS A REALLY GOOD PRESENTATION, DELIGHTED
TO SEE HOW MUCH WORK YOU GUYS HAVE BEEN DOING. I WENT BACK TO THE DEFINITION OF MEDICALLY
IMPORTANT ANTIBIOTICS, THAT SEEMS TO BE SOMETHING CALLED GFI 152 PUBLISHED IN 2003.
SO TWO QUESTIONS THEN ABOUT THAT. DOES THAT NEED TO BE UPDATED?
AND ALSO I CAN’T QUICKLY FIGURE OUT WHAT’S NOT A MEDICALLY IMPORTANT ANTIBIOTIC.
CAN YOU GIVE ME A QUICK THUMB NAIL?>>THE LAST POINT, A GOOD EXAMPLE WOULD BE
CLASS OF DRUGS CALLED IONOPHORES, WHICH TECHNICALLY SPEAKING WE COULD CONSIDER THEM TO BE ANTIMICROBIAL,
CLEARLY IT’S A CLASS THAT HAS NO HUMAN MEDICAL USE AND LITTLE TO NO INFORMATION TO SUGGEST
THAT USE OF IONOPHORES HAS IMPLICATIONS FOR PUBLIC HEALTH CONCERN, THAT’S ONE CLASS WE
FELT FROM A RISK PERSPECTIVE DIDN’T POSE THE SAME RISK THAT THESE OTHER DRUGS DO.
THAT WOULD BE ONE CLASS. BACITRACIN IS ANOTHER WITH TOPICAL USES BUT
WE DON’T CONSIDER TO BE MEDICALLY IMPORTANT. THIS DOES TIE BACK AS WE MENTIONED TO A GUIDANCE
THAT FDA ISSUED IN THE EARLY 2000s THAT IS TIED IN TO THE ASSESSMENT PROCESS THAT WE
DO FOR NEW ANTIMICROBIALS COMING IN THE DOOR FOR APPROVAL THAT WE HAVE A RISK ASSESSMENT
PROCESS THAT WE APPLY, AS PART OF THAT RISK ASSESSMENT PROCESS WE CONSIDER THE HUMAN MEDICAL
IMPORTANCE OF THAT ANTIMICROBIAL AND SO THAT RANKING OR RISK IMPORTANCE LIST WAS CREATED
TO SUPPORT THAT ASSESSMENT PROCESS. SO ESSENTIALLY WE’RE POINTING TO THAT EXISTING
RANKING LIST AS THE DRUGS WE CONSIDER MEDICALLY IMPORTANT.
TO YOUR QUESTION DOES IT NEED TO BE UPDATED, I THINK THE ANSWER IS YES.
I THINK WE RECOGNIZE THAT IS NOT A STATIC THING.
IT WAS PUT IN PLACE IN 2003, SO OBVIOUSLY A NUMBER OF YEARS HAVE TRANSPIRED.
IT IS ONE OF THE THINGS THAT’S ON OUR TODO LIST, TO LOOK AT UPDATES TO THAT BUT AT THIS
POINT I THINK CLEARLY THE DRUGS WE HAVE LISTED ARE ONES THAT WE DO WANT TO MOVE FORWARD WITH
AND MAKE THESE CHANGES TO AND CERTAINLY WILL GO THROUGH THE UPDATE PROCESS WHICH WOULD
LIKELY BE PUTTING AN UPDATE OUT ON THAT GUIDANCE TO UPDATE THAT WITH.
>>GREAT. ENTIRELY RECOGNIZE YOU CAN’T BOIL THE OCEAN
AT THE VERY START. GLAD YOU’RE TACKLING ALL THAT.
>>THANK YOU.>>MARTY, GO AHEAD.
>>DR. FLYNN, THANK YOU SO MUCH FOR THE UPDATE. MY QUESTION IS THIS IS GOING TO BE ONE OF
THE BIGGEST CHANGES IN AGRICULTURE IN DECADES. YOU’RE WORKING WITH THE MANUFACTURERS, WORKING
WITH THE VETS. WHAT ABOUT THE FARMERS?
MAYBE YOUR COLLEAGUES IN THE DEPARTMENT OF AGRICULTURE CAN COMMENT ON HOW THEY ARE BEING
EDUCATED, HOW ARE THEY GOING TO PREPARE FOR THIS?
>>YES, CERTAINLY THAT’S A SIGNIFICANT CHALLENGE. I THINK ONE OF THE REASONS WHY WE DID BUILD
IN THE THREEYEAR TIME LINE WAS RECOGNIZING THE SIGNIFICANT OF THESE CHANGES.
IN PARTICULAR, VETERINARY OVERSIGHT CHANGES IS PRETTY SIGNIFICANT JUST BECAUSE OF THIS
IMPACT IT’S GOING TO HAVE ON HOW PRODUCERS HAVE ACCESSED PRODUCTS FOR DEALING WITH THEIR
ANIMAL HEALTH ISSUES AND CERTAINLY TAKING INTO ACCOUNT, YOU KNOW, THE SIZE OF THE COUNTRY,
THE KEY FACTOR IS JUST AN ISSUE TOO OF VETERINARY� ACCESS TO VETERINARY ACCESS IN CERTAIN PARTS
OF THE COUNTRY, A CHALLENGE TO GET INFORMATION OUT DOWN TO THE PRODUCER LEVEL.
AGAIN, AS PART OF YOU KNOW, WE’VE BEEN WORKING TO COLLABORATE WITH DIFFERENT ORGANIZATIONS
TO HOLD PUBLIC LISTENING SESSIONS, ONE EXAMPLE WAS THE FORM FOUNDATION HOSTING SESSIONS ACROSS
THE COUNTRY. I THINK THERE WERE A DOZEN SESSIONS, WE HAD
REPRESENTATION FROM FDA AS WELL AS USDA AT THOSE MEETINGS.
WE HAD LOCAL VETERINARIANS AND PRODUCERS COMING TO THOSE MEETINGS TO GET INFORMATION.
BUT, AGAIN, IT IS A REAL CHALLENGE TO REALLY GET INFORMATION DOWN TO THE LOCAL LEVEL, AND
I THINK THAT’S GOING TO CONTINUE TO BE SOMETHING WE’RE GOING TO HAVE TO WORK AT AS WE CLEARLY
GO FORWARD IN THE NEXT SIX MONTHS BUT CERTAINLY BEYOND THEN AND WE’RE LOOKING TO OTHER ORGANIZATIONS,
YOU KNOW, TO HELP US, YOU KNOW, AGAIN WORKING WITH THE DIFFERENT VETERINARY ASSOCIATIONS,
PRODUCER ORGANIZATIONS, EDUCATIONALASSOCIATED ORGANIZATIONS TO GET INFORMATION OUT AND TO
LOOK FOR OPPORTUNITIES TO EDUCATE FOLKS ON WHAT THOSE CHANGES ARE.
>>NINA, YOU WANT TO COMMENT ON THAT FROM THE USDA STANDPOINT?
>>BRIAN McCLUSKEY FROM APHIS. AS DR. FLYNN JUST MENTIONED, WE HAVE BEEN
PARTICIPATING WITH FARM FOUNDATION SEMINARS, ALSO WITH OUR INDUSTRY GROUPS, AND THAT’S
PROBABLY THE BEST WAY TO GET TO FARMERS IS THROUGH INDUSTRY GROUPS LIKE ASSOCIATION OF
SWINE VETERINARIANS, ASSOCIATION OF BOVINE PRACTITIONERS, ET CETERA, BECAUSE THEY DEAL
WITH FARMERS VERY DIRECTLY SO EDUCATING THE VETERINARIANS FIRST IS I THINK A REAL PLUS.
BUT WE DO HAVE IN APHIS AN EXTENDED FIELD THAT GET ON FARMS EVERY DAY AND WE’RE ACTUALLY
STARTING TO TALK ABOUT HOW THAT EDUCATIONAL PROCESS NOT JUST WITH ACCREDITED VETERINARIANS
BUT DOWN TO THE FARM LEVEL IS REALLY IMPORTANT.>>JUST FOR A MINUTE, DR. WAGSTROM, YOU HAVE
A COMMENT, OR MAYBE DR. APLEY?>>YES, A QUICK OVERVIEW FROM THE PORK SIDE
WE HAVE AN ANTIBIOTICS RESOURCE CENTER AT PORK.ORG WITH FAQs AND RESOURCES.
WE HAVE PAID MEDIA AS WELL AS NEWS LETTER TO 67,000 PRODUCERS ON A THEME THAT SAYS DON’T
WAIT, BE READY. THERE’S A CHECKLIST THAT TALKS ABOUT UNDERSTANDING
THE VFD, STRENGTHENING THE VETERINARY RELATIONSHIP, COMMUNICATING WITH THE FEED MILL, ASSESSING
HERD HEALTH, ENSURING RECORD KEEPING COMPLIANCE, THAT SAYS U.S. CARE AND WE HAVE A COUNTDOWN
CLOCK SHOWING THE PORK TRADE SHOWS, WE HAD PORK EXPO LAST WEEK AND HAD ABOUT 28,000 PEOPLE
THROUGH SEEING A CLOCK COUNTING DOWN IN MINUTES, DAYS, HOURS TO JANUARY�1, SO IT’S BEEN OUR
MAJOR COMMUNICATION STRATEGY FOR THE INDUSTRY.>>DR. APLEY, YOU WANT TO MAKE A COMMENT AS
WELL?>>AS ONE OF THE EXECUTIVE COMMITTEE OF THE
AMERICAN ASSOCIATION OF BOVINE PRACTITIONERS HAVE ENGAGED IN THIS AS WELL AS ACADEMY OF
VETERINARY CONSULTANTS, WORKING CLOSELY WITH NATIONAL CATTLE ASSOCIATION, AT THE PRODUCER
LEVEL AND VETERINARY LEVEL AT OUR AABP MEETING HERE COMING UP IN CHARLOTTE WE’LL HAVE SIX
SPECIFIC VFD SEMINARS, WE’VE INVITED THE FDA, WORKING WITH FEED MANUFACTURERS ASSOCIATION
TO MAKE SURE THOSE LINKS ARE MADE. FOUR OF US WERE IN THE ROOM AT KANSAS STATE
UNIVERSITY, AND BETWEEN US WE MADE 18 PRESENTATIONS TO PRODUCERS THAT MONTH AND WE’RE USING FDA
MATERIALS AND PARTNERING WITH THE EXTENSION. THE PARTNERSHIP BETWEEN PRODUCERS, FDA, USDA
IS EXTENSIVE ON THIS.>>RANDY, ANYTHING ELSE, POULTRY INDUSTRY?
>>SURE. I HAVEN’T BEEN THAT ACTIVE IN WORKING WITH
GROWERS THROUGH THE AAP, AVIAN PATHOLOGISTS AS WELL AS DIFFERENT VETERINARY GROUPS FOR
BROILER PRODUCTION, TURKEY PRODUCTION, WORKING WITH COMPANIES THERE’S BEEN A LOT OF EDUCATION
ON THIS PROGRAM WE’VE BEEN TALKING ABOUT SINCE IT WAS FIRST ANNOUNCED THREE YEARS AGO.
IT’S BEEN VERY COORDINATED WITH FDA AND USDA TO GET THE POULTRY INDUSTRY READY FOR THE
TRANSITION.>>I GOT FIVE PEOPLE IN LINE HERE.
ELIZABETH, YOU’VE BEEN WAITING. WE’LL START WITH YOU.
>>I’LL START BY ECHOING THANKS FOR THE PRESENTATION AND UPDATE.
THIS IS SIGNIFICANT AND MEANINGFUL AND DELIGHTED TO SEE IT HAPPENING.
ALSO THE PLAN TO HAVE AN ACTION PLAN FOR THE END OF THE YEAR IS FANTASTIC.
MY QUESTION IS ABOUT DATA AND SURVEILLANCE. HOW ARE YOU GOING TO KNOW WHETHER OR HOW THIS
IS WORKING? THAT MAY BE A QUESTION FOR YOU, DR. FLYNN,
OR MAYBE FOR USDA.>>IT’S ANOTHER IMPORTANT PRIORITY THAT WE’RE
FOCUSED ON IS AGAIN THAT’S AN AREA WE’RE WORKING CLOSELY WITH USDA ON, AS WE MOVE FORWARD BEYOND
2017 UNDERSTANDING WHAT THE IMPACTS ARE OF THE CHANGES WE’RE MAKING.
WE DID HOLD A PUBLIC MEETING ON THIS ISSUE LAST FALL, IN COLLABORATION WITH USDA AND
CDC, OUTLINED A BROAD VISION OF WHAT WE SEE THAT LOOKING LIKE WHERE IT IS SOMETHING THAT
INVOLVES, WE THINK, A VARIETY OF DATA INCLUDING SOME DATA THAT CURRENTLY EXISTS INCLUDING
OUR SALES DATA THAT WE CURRENTLY COLLECT, NARMS DATA THAT’S ALSO AN IMPORTANT SOURCE
OF DATA ON RESISTANCE TRENDS IN FOODBORNE PATHOGENS.
WE NEED TO LOOK AT INFORMATION ABOUT ANIMAL DEMOGRAPHICS AND DISEASE INCIDENCE IN ANIMALS
TO BETTER UNDERSTAND AGAIN IN THE END, TO ASSESS WHETHER OR NOT THE USE OF ANTIBIOTICS
ARE APPROPRIATE AND ARE IN ALIGNMENT WITH WHAT WE THINK AS GOOD STEWARDSHIP PRINCIPLES.
I THINK THE CHALLENGES WE DON’T HAVE ALL THE DATA THAT WE WOULD LIKE, ADDITIONAL DETAIL
IS NEEDED AS FAR AS HAVING BETTER UNDERSTANDING OF ANTIBIOTIC USE AT THE FARM LEVEL.
I THINK WE’VE HAD SOME CHALLENGES MOVING FORWARD WITH THAT BECAUSE OF FUNDING LIMITATIONS,
PARTICULARLY LACK OF FUNDING FOR FY16 I THINK HAS BEEN A BIT OF A SETBACK FOR US.
ON THAT I THINK WE’RE YOU KNOW, HOPEFULLY WE’LL SEE IN FUTURE YEARS FUNDING TO SUPPORT
SOME EXPANSION IN THAT AREA. AGAIN WE’RE WORKING CLOSELY WITH USDA, IN
TERMS OF OPPORTUNITIES TO LEVERAGE EXISTING INFRASTRUCTURE AT USDA TO COLLECT ADDITIONAL
INFORMATION AS AN EXAMPLE THROUGH THEIR NOMS PROGRAM, TO GATHER INFORMATION ABOUT USE PRACTICES
ON THE FARM. SO THAT I THINK THERE’S A LOT OF WORK THAT
STILL NEEDS TO BE DONE THERE. WE ARE PLANNING TO MOVE FORWARD WITH, AGAIN,
FURTHER ARTICULATING WHAT OUR PLAN IS IN TERMS OF, YOU KNOW, ASSESSING PROGRESS.
CERTAINLY THE FIRST GOAL IS SEARCH TO UNDERSTAND THAT WE’VE GOT FULL IMPLEMENTATION OF GUIDANCE
213, A KEY STEP THAT ALL THOSE CHANGES ARE MADE.
THE NEXT CHALLENGE IS WHAT IMPACT IS THAT ACTUALLY HAVING ON USE PRACTICES ON THE FARM
AND THEN ALSO ON RESISTANCE PATTERNS. AND THEN OF COURSE OTHER CHANGES THAT WE’RE
LOOKING AT DOWN THE ROAD IT’S GOING TO BE IMPORTANT THAT WE HAVE A SYSTEM IN PLACE FOR,
YOU KNOW, ASSESSING USE PRACTICES TO MAKE SURE THAT THE THINGS WE’RE DOING ARE MOVING
THE NEEDLE, SO TO SPEAK, IN TERMS OF MOVING US TO, YOU KNOW, A GOOD STEWARDSHIP PRACTICES
ON THE FARM.>>THANKS.
DON?>>THANK, LONNIE.
A COMMENT AND QUESTION. THE COMMENT IS WE’VE HEARD FROM PORK AND BEEF
AND I’M SURE POULTRY ON EDUCATING CONSTITUENCIES. FROM THE SMALL HOLDERS WITH 20 BACK YARD PIGS,
COST MIGHT OVERSHADOW THE ACCESS TO PRODUCTS SO THAT WOULD BE A COMMENT HOW FAR DOWN INTO
THE FOOD CHAIN, SO TO SPEAK, MIGHT THAT GO. BUT THE QUESTION I REALLY WANT TO POSE TO
YOU IS LOOKING AT THE EUROPEAN EXPERIENCE WITH THE WITHDRAWAL OF ANTIBIOTICS FOR THE
PRODUCTION PURPOSES THERE IS A SURGE OF DISEASE, PARTICULARLY IN SWINE, BUT ALSO OTHER SPECIES
THAT RESULTED IN INCREASED THERAPEUTIC USE. SO THAT COULD BE ONE OUTCOME.
WE KNOW THAT VETERINARIAN OVERSIGHT REQUIRED FOR PREVENTION CONTROL AND TREATMENT, WHAT
WOULD BE THE CONTINGENCY PLANS, HOW ARE WE GOING TO KNOW?
MAYBE IT’S A SURVEILLANCE QUESTION THAT ELIZABETH ASKED FOR ANIMAL DISEASE THAT MIGHT HAVE A
HIGHER PREVALENCE ALL OF A SUDDEN ACROSS ALL SPECIES AT THE SAME TIME.
I JUST WANT TO GET A SENSE FOR THE “WHAT IF” KIND OF SCENARIO THERE.
>>I THINK THAT’S AN IMPORTANT POINT IN TERMS OF I KNOW THERE’S A LOT WE CAN LEARN ABOUT
WHAT OTHER COUNTRIES� EXPERIENCES OTHER COUNTRIES HAVE HAD, THAT’S CERTAINLY BEEN
ONE OF THE ISSUES THAT WE’VE BEEN SENSITIZED TO SINCE WE STARTED THIS INITIATIVE IN THAT
THERE IS THE POTENTIAL FOR THAT KIND OF BLOWBACK EFFECT, SO TO SPEAK, IN TERMS OF SHIFTING
OR A SPIKE IN INCIDENCE OF DISEASE WHICH MAY LEAD TO A SPIKE IN ANTIBIOTIC USE SO I THINK
IT’S IMPORTANT FOR US TO BE AWARE OF THOSE POTENTIALS AND BE LOOKING AT THAT AS WE GO
FORWARD. I THINK THAT AGAIN WAS ALSO ONE OF THE REASONS
WHEN WE SET OUT OUR STRATEGY THREE YEARS AGO WAS THAT WE WERE ALSO ENCOURAGING THE INDUSTRY
TO LOOK AT TRYING TO IDENTIFY WHERE THERE MIGHT BE ANIMAL HEALTH GAPS, IF THESE� ONCE
THESE PRODUCTION USES ARE REMOVED DO THEY SEE POTENTIAL GAPS WHERE DISEASE MAY BE UNADDRESSED
SUFFICIENTLY AND ARE THERE NEW MORE TARGETED THERAPEUTIC INDICATIONS THAT CAN BE ADDED
TO THESE PRODUCTS AT THE TIME THAT THE GROWTH PROMOTION USES ARE WITHDRAWN AS A WAY OF TRYING
TO FILL THAT GAP. NOW, AGAIN, TIME WILL TELL IN TERMS OF HOW
THAT PLAYS OUT BUT I THINK IT’S IMPORTANT THAT WE BE AWARE THAT IT IS A POTENTIAL AND
THERE IS SORT OF THE EXPECTATIONS KIND OF ISSUE TO MANAGE HERE AROUND, YOU KNOW, AND
UNDERSTANDING WE HAVE TO BE AWARE THAT WE’RE SORT OF IN THIS FOR THE LONG HAUL AND WE MAY
NOT BE SEEING, YOU KNOW, IMMEDIATE SHIFTS OR CHANGES RIGHT AWAY AND TO ME THAT’S WHY
IT’S IMPORTANT THAT WE HAVE A DATA COLLECTION SYSTEM IN PLACE THAT’S SUSTAINABLE IN THE
LONG RUN SO WE CAN LOOK AT TRENDS OVER A LONGER PERIOD OF TIME.
THE LIKELIHOOD IS WE’RE NOT GOING TO SEE AN IMMEDIATE EFFECT ON JANUARY�2.
>>ANGIE?>>YES, I’M WONDERING IF THERE’S ADEQUATE
NUMBER OF VETERINARIANS TO MANAGE AND IMPLEMENT THIS WHOLE PLAN AND ARE THERE PLANS TO TRAINING
MORE VETS?>>YEAH, THAT WAS ONE OF THE QUESTIONS THAT
I THINK EMERGED RIGHT AWAY, YOU KNOW, SEVERAL YEARS AGO WAS, YOU KNOW, WHAT THE IMPLICATIONS
WERE FOR SHIFTING PRODUCTS FROM OVER THE COUNTER TO VET OVERSIGHT BECAUSE CLEARLY PARTICULARLY
CERTAIN PARTS OF THE COUNTRY WHERE VETS MAY� THE NEAREST VET MAY BE 150 OR 200�MILES
AWAY THAT COULD BE A PRACTICAL PROBLEM FOR PRODUCERS IF THE ONLY WAY TO GET ACCESS TO
A PRODUCT THEY NEED IS TO GET AUTHORIZATION FROM A LICENSED VETERINARIAN, THAT’S A FOCUS
OF ATTENTION FROM THE BEGINNING AND I KNOW THAT USDA HAS BEEN ACTIVE IN THAT ARENA.
IT’S A BIG CHALLENGE TO OVERCOME. WE’VE BEEN COGNIZANT, FOR EXAMPLE LOOKING
AT UPDATING VFD REGULATION IN TERMS OF SPECIFIC PROCESS ASSOCIATED WITH A VET’S AUTHORIZATION
THAT WE HAD THAT CONCERN IN MIND TO TRY TO SEE IF THERE ARE OPPORTUNITIES TO PROVIDE
SOME LATITUDE TO PROVIDE SOME RELIEF THERE, BUT IT IS A CHALLENGING ISSUE TO OVERCOME
BECAUSE OF, WELL, GEOGRAPHY AND THE ECONOMICS OF VETERINARY PRACTICE, THE USDA MAY HAVE
OTHER THOUGHTS ON THAT ISSUE AS WELL.>>THERE ARE DEFINITELY PROGRAMS WITHIN THE
USDA THAT ARE INCENTIVIZING VETERINARIANS TO WORK IN MORE RURAL AREAS SO PROVIDING SCHOLARSHIP
DOLLARS, PAY BACK FOR LOANS, THAT TYPE OF THING, THROUGH THE USDA TO TRY TO FACILITATE
THAT RURAL PRACTICE, BUT IT IS A PROBLEM NOT JUST FOR THIS ISSUE BUT FOR MANY ISSUES REALLY
TO VETERINARY MEDICINE.>>RAMADAD?
>>I IMAGINE THAT MANY OF THESE MANUFACTURERS ALSO SELL ABROAD, AND I ALSO IMAGINE VFD DOESN’T
APPLY TO SALES ABROAD, FDA APPLIES ONLY TO THE U.S., CORRECT?
>>WELL, THE VFD CONCEPT I THINK IS FAIRLY UNIQUE TO THE U.S
IN OTHER COUNTRIES THERE MAY BE VETERINARY OVERSIGHT OF ANTIBIOTICS WHETHER IN FEED OR
OTHER DOSAGE FORMS, BUT IN LIKELIHOOD THOSE PROBABLY HAVE PRESCRIPTION STATUS.
SO I THINK YOU COULD LOOK ACROSS THE WORLD IN TERMS OF YOU KNOW, I THINK WE’RE OBVIOUSLY
IN A LOT OF PARTS OF THE WORLD MANY OR MOST OF THESE PRODUCTS ARE ALREADY UNDER VETERINARY
OVERSIGHT, BUT THEY MAY BE UNDER A DIFFERENT FRAMEWORK BECAUSE I THINK FEED DIRECTOR FRAMEWORK
IS FAIRLY UNIQUE TO THE U.S.>>WE’VE DISCUSSED TO SOME DEGREE THE NEED
TO LOOK AT DATA BEFORE THIS EVENT. ARE THERE PROPRIETARY DATA HELD BY FARMERS
OR PRODUCTION GROUPS THAT WE NEED TO THINK ABOUT INCENTIVES TO GET ACCESS TO TRACK WHAT
HAPPENS BEFORE AND AFTER JANUARY�1 OF 2017?>>CERTAINLY ONE OF THE ISSUES OR CONCERNS
ABOUT GETTING NEW DATA COLLECTION UP AND RUNNING SOONER RATHER THAN LATER WAS THAT THE BASELINE
CONCERN OF GETTING DATA IN HAND BEFORE THE END OF THIS YEAR, CERTAINLY WITH THE FUNDING
ISSUE WE’VE GOT A BIT OF A SETBACK THERE BUT I THINK� I DON’T THINK ALL IS LOST.
I MEAN, I THINK WE ARE LOOKING AT, AGAIN, WORKING WITH OUR COLLEAGUES AT USDA TO LOOK
AT OPPORTUNITIES WHERE WE CAN DATA MINE, SO TO SPEAK, AND TRY TO FIND DATA THAT EXISTED.
SOME DATA HAS BEEN COLLECTED OVER THE YEARS, UP TO THIS POINT, SO THERE’S AN OPPORTUNITY
TO TAP INTO THAT TO HELP TRY TO BUILD A BASELINE. YOU MENTIONED PROPRIETARY DATA, I THINK THAT’S
ANOTHER POTENTIAL SOURCE, OF COURSE THERE’S REAL LOGISTICAL ISSUES THERE IN TERMS OF HOW,
ARE THERE MECHANISMS TO TAP INTO SUCH DATA IN A WAY THAT CAN STILL PROTECT CONFIDENTIALITY.
FDA DID PUT OUT A FUNDING OPPORTUNITY ANNOUNCEMENT BACK IN MARCH, SEEKING PROPOSALS ON DIFFERENT
APPROACHES FOR COLLECTING DATA, INCLUDING POTENTIALLY TAPPING INTO SUCH DATA AND SO
IT WASN’T LIMITED TO NECESSARILY SURVEY APPROACH BUT ALSO THE POSSIBILITY OF MECHANISMS FOR
TAPPING INTO THAT, YOU KNOW, THAT PROPRIETARY DATA, SO TO SPEAK.
WE’VE RECEIVED A NUMBER OF PROPOSALS. THEY ARE CURRENTLY BEING REVIEWED NOW AND
WE HOPE TO MOVE FORWARD WITH A FEW PROPOSALS WHICH, AGAIN, ONE OF THE SPECIFIC REQUIREMENTS
OF THAT FUNDING OPPORTUNITY ANNOUNCEMENT WAS A SYSTEM THAT WAS CAPABLE OF CAPTURING DATA
FROM 2016 WITH THE GOAL OF BEING ABLE TO CAPTURE� HELP SUPPORT THE BASELINE ISSUE.
>>RICH?>>YEAH, JUST A COMMENT ON THE INTERNATIONAL
ASPECT. BILL IS RIGHT.
MOST OF THESE PRODUCTS IN DEVELOPED COUNTRIES AT LEAST ARE HANDLED THROUGH A PRESCRIPTION
PROCESS. SO THAT’S ALREADY BEING CONTROLLED IN PARTICULARLY
EUROPEAN COUNTRIES. I WOULD MENTION THAT CANADA IS ALSO GOING
THROUGH A SIMILAR PROCESS TO THE 213 THAT FDA’S IMPLEMENTED, AND THEY ANNOUNCED IT ABOUT
THE SAME TIME THAT THE FDA, SO THEY ARE GOING THROUGH THE SAME THING THROUGH THEIR HEALTH
CANADA, AND THEIR MINISTRY OF AGRICULTURE, BUT I THINK THEY ARE ON A ALSO BIT DIFFERENT
TIME FRAME. THEY MAY BE A LITTLE BIT LATER IN IMPLEMENTING
THIS THAN THE U.S SO JUST INFORMATION ABOUT THE INTERNATIONAL
SIDE.>>SO MAYBE JUST A COMMENT BILL, THIS IS NOT
YOUR ISSUE, BUT ONE OF THE CONSEQUENCES ALSO, YOU KNOW, THERE’S 3500 NEW VETERINARIANS GRADUATING
EVERY YEAR IN THE U.S., AND WE HAVEN’T DONE A VERY GOOD JOB IN VETERINARY SCHOOLS STANDARDIZING
EDUCATION, WE HAVE ACCREDITATION PROGRAM WITH THE USDA BUT WE HAVE TO DO A BETTER JOB STANDARDIZING
GETTING NEW PROFESSIONALS MORE ENGAGED IN UNDERSTANDING ANTIMICROBIAL RESISTANCE AND
THEIR OBLIGATIONS UNDER THE VETERINARY FEED DIRECTIVE, SOMETHING ELSE WE’LL NEED TO WORK
ON. ANY OTHER FINAL COMMENTS?
DR. FLYNN, WE APPRECIATE YOU BEING HERE. THANK YOU FOR UPDATING US AND I’M SURE THAT
IN THE FUTURE WE MAY BE CALLING ON YOU AGAIN AS YOUR ACTIONS MATURE AND YOU HAVE FURTHER
UPDATE. THANK YOU VERY MUCH.
>>THANK YOU.

Reynold King

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