THE FUTURE OF THE USFDA

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THE FUTURE OF THE USFDA

• CARL A. ROCKBURNE
• ROCKBURNE GROUP

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RESTRUCTURING

• IDENTIFIED AS A TOP PRIORITY TO REBUILD THE FOOD
  AND DRUG ADMINISTRATION
• PRESIDENT OBOMA MENTIONED IN AN INTERVIEW ON
  FEBRUARY 02/09 promised a comprehensive review
  of the Food and Drug Administration amid a
  salmonella outbreak linked to a Georgia peanut
  processor.

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MISSION STATEMENT

• THE FDA IS RESPONSIBLE FOR PROTECTING THE PUBLIC
  HEALTH BY ASSURING THE SAFETY, EFFICACY, AND
  SECURITY OF HUMAN AND VETERINARY DRUGS,BIOLOGICAL
  PRODUCTS, MEDICAL DEVICES,OUR NATIONS FOOD
  SUPPLY, COSMETICS, AND PRDUCTS THAT EMIT
  RADIATION
• IN ADDITION THE AGENCY IS RESPONSIBLE FOR
  ADVANCING THE PUBLIC HEALTH BY ACCELERATING
  INNOVATIONS THAT MAKE MEDICINES AND FOODS MORE
  EFFECTIVE, SAFER, AND MORE AFFORDABLE.

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PUBLIC DEPENDENCY

• THE AMERICAN PUBLIC DEPENDS ON THE AGENCY TO GET
  ACCURATE, SCIENCE-BASED INFORMATION NEEDED TO USE
  MEDICINES AND FOODS TO IMPROVE THEIR HEALTH.

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KEY AREAS

• KEY AREAS WITHIN THE FDA INCLUDE FOOD, DRUGS,
  MARKET DEVICES, ANIMAL VETERINARY, COSMETICS,
  RADIATION EMITTING PRODUCTS, AND COMBINATION
  PRODUCTS.
• THEIR TASK IS TO ASSURE SAFETY IN THE RELATED
  AREAS AND PROTECT PUBLIC HEALTH.

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THE BUDGET

• FOR FY 2009 BUDGET FDA REQUESTS 2.4 BILLION
• REPRESENTING A NET PROGRAM LEVEL INCREASE OF 130
  MILLION OVER FY 2008.
• USER FEES REPRESENT 628 MILLION
• AN INCREASE OF 14 PERCENT OVER FY 2008.
• THE FY 2009 REQUEST COVERS THE PERIOD OF OCT. 1,
  2008 THROUGH SEPT. 30, 2009.

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BUDGET FY 2010

• IN THE RECENTLY ANNOUNCED BUDGET FOR FY 2010 THE
  FUNDING HIGHLIGHTS INDICATED THE ADMINISTRATION
  WOULD INVEST OVER 1 BILLION FOR FOOD AND DRUG
  ADMINISTRATION
• FOOD SAFETY EFFORTS TO INCREASE AND IMPROVE THE
  FOLLOWING

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BUDGET FY 2010 CONTD

• IN ADDITION
• TO INCREASE AND IMPROVE INSPECTIONS
• -BY BEEFING UP FOREIGN / DOMESTIC INSPECTIONS
• IMPROVE DOMESTIC SURVEILLANCE
• EXPAND LABORATORY CAPACITY
• IMPROVE DOMESTIC RESPONSE TO PREVENT AND CONTROL
  FOODBORNE ILLNESS.
• GMA CALLING ON CONGRESS TO RAISE FOOD BUDGET
  PORTION FDA TO 900 MILLION

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COMPLEX ORGANIZATION

• GAP BETWEEN GROWING FDA DEMANDS , EVOLVING
  SCIENCE, AND AVAILABLE RESOURCES MUST BE CLOSED
• LONG TERM COMMITMENTS ARE REQUIRED BY CONGRESS
• UNDERFUNDING MUST BE MET

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THE LEADER

• THE NEED FOR A STRONG LEADER POSSESSING STRONG
  MANAGEMENT SKILLS IS PARAMOUNT
• DR. FRANK M. TORTI, MD., M.P.H., F.A.C.P. WAS
  NAMED ACTING COMMISSIONER OF FOOD AND DRUGS ON
  JANUARY 20, 2009
• HOWEVER WE ARE AWAITING THE REVIEW ANNOUNCED BY
  THE PRESIDENT 02/02/09

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CHANGES

• CRITICS ARE QUICK TO POINT OUT THAT DURING THE
  PAST 10 YEARS THE FDA WAS WITHOUT A CONFIRMED
  COMMISSIONER HALF THE TIME.
• THE FDA REQUIRES A LEADER CAPABLE OF MANAGING A
  LARGE COMPLEX ORGANIZATION
• FDA IS A LARGE DIVERSE SCIENCE BASED AGENCY OF
  10,000 PROFESSIONALS

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INTERAGENCY COORDINATION

• FDA INTERRELATES WITH GOVT DEPT./AGENCYS
• CDC
• HOMELAND SECURITY
• DEPT. OF AGRICULTURE / STATES
• VA
• INTERNATIONAL ORGANIZATIONS, EMA,
  CFIA,JAPAN,AUSTRALIA ETC
• FOOD IS A GLOBAL INDUSTRY/ GLOBAL SUPPLY CHAIN
  (150 COUNTRIES/ 189,000 PLANTS)
• NECESSARY TO ELIMINATE CONFUSING RESPONSIBILITIES

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SUMMARY

• ESTABLISH A FOOD INSPECTION AGENCY THE U.S. IS
  THE ONLY COUNTRY THAT COMBINES DRUGS AND FOOD IN
  ONE AGENCY
• ESTABLISH PARTNERS TO ASSIST AGENCY TO MORE
  EFFECTIVELY AND EEFICIENTLY MEET THEIR
  GOALSSAFETY

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SUMMARY CONTD

• PARTNERS CAN BE TAKEN FROM THE PRIVATE / PUBLIC
  SECTORS
• - COMMON TRAINING MODULE ESSENTIAL
• PERFECT / MONITOR REPORTING TECHNIQUES
• WORK WITH COMMERCE TO ESTABLISH FOREIGN OFFICES (
  IF NECESSARY)

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FOLLOW UP

• CARL A. ROCKBURNE
• CROCKBURNE_at_BELLSOUTH.NET