Food Safety Regulation


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In the Fall of 2009 I coincidentally worked on a policy project that suggested removing the regulation of foods from the FDA.

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  • Jetter, A. (2008, April) Strong Medicine: What ’s Ailing the FDA [on-line article]? Reader’s Digest : pp. 1-3. Retrieved from:
  • 1. Hamburg, M. (2009, October). Keeping America ’s Families Safe: Reforming the Food Safety System. Speech Before the Committee on Health, Education, Labor, and Pensions. Retrieved from: Science and Our Food Supply-Middle School Guide, Module 5 (2007). U.S. Food and Drug Administration [website]. Retrieved from: 2. Schmit, J. (2008, February). FDA Receives Modest Boost in Budget Plan [on-line article]. USA Today . Retrieved from: 3. Jetter, A., p.2. 4. Goldstein, J. (2008, March). FDA Decisions on Drug Approval Could Start Slipping [on-line article]. Wall Street Journal [Health Blog on-line edition]. Retrieved from: 5. Summary of the FDA ’s FY 2010 Budget. (2009, May). Food and Drug Administration [website]. Retrieved from: 6. Wang, S. FDA Delays Take Toll on Neuroscience Drug Development [on-line article]. Wall Street Journal [on-line Health Blog]. Retrieved from: 7. Ibid. Also Reference Summary of FDA ’s FY 2010 Budget
  • Food Safety Regulation

    1. 1. THE FOOD AND DRUG ADMINISTRATIONFood Safety RecommendationsBy: Elliott Bosslet, Anthony Hopper, JessicaJacobs, and Sarah Okorie
    2. 2. PURPOSEShort Term Goal Long Term Goal Increase the Budget  Break up the FDA
    3. 3. HISTORYThe FDA is the oldest comprehensive consumerprotection agency in the U. S. federal government. 1820 – U.S. Pharmacopeia established 1902 – Biologics Control Act 1906 – Food and Drug Acts 1938 – Food, Drug, and Cosmetic Act 1968 – Animal Drugs Amendment 1976 – Medical Device Amendments 1990 – Safe Medical Device Act 1997 – Current FDA Modernization Act 2009 – Family Smoking Prevention and Tobacco Control Act
    4. 4. THE BUSIEST AGENCY IN GOVERNMENT What the FDA does notWhat the FDA Regulates Regulate Biologics  Advertising Cosmetics  Alcohol Drugs  Consumer Products Foods  Drugs of Abuse Medical Device  Health Insurance Radiation-Emitting  Meat and Poultry Electronic Products  Pesticides Veterinary Products  Restaurants& Grocery Stores  Water
    6. 6. CURRENT CHALLENGES: BUDGET Its budget for 2009:  (approx) $2.7 billion Employees: 11,000 (high turnover) It Oversees $1.5 trillion in produce, drugs, other items
    7. 7. CURRENT CHALLENGES:BUDGETQuestion: Can the FDA adequately do its job given its current budget?Answer: No “The FDA is expected to regulate $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, radiation-emitting machines, animal feeds and drugs, cell phones, dietary supplements, biotechnology, and gene therapy…Yet the agency’s annual funding, $2 billion, is about what Fairfax County, Virginia, pays for its public schools.” (1) --Alexis Jetter, Reader’s Digest$2.7 billion is not enough to achieve agency’s twin goals of safety and access
    8. 8. CURRENT CHALLENGES: BUDGET Lack of Money = Slower Problems with Safety Access to Drugs Food-borne illnesses kill thousands of Americans each  The FDA is falling behind in year and sicken millions more processing paperwork for new people (as many as 76 million drug trials (4 individuals) (1)  The agency Also falling behind on “The agency inspected 1.28% of setting meetings with companies the 9.4 million shipments that to discuss trial results pre-Phase came to the USA in fiscal 2007. III (6) That will drop to 1.26% in fiscal  It might become more 2009.” (2) problematic as agency steps up 15,107 deaths due to adverse effort to insure drug safety by drug reactions in 2006 (3) requiring more paperwork, longer trial times, etc. (7) The FDA acknowledges these issues in its 2010 budget request (5)
    9. 9. RECOMMENDATIONSIncrease FDA Budget Where Should the Money Go? June 2009: The U.S.  Reconfigure & Government improve the FDA’s IT Accountability Office system sad the FDA is under-  Allocate more money budgeted to oversee foods & Numerous experts, supplements including th ex-  Increase salaries to director of FDA, argue key personnel to be for an increase more competitive with 2010 Budget private industry Consider adding user  Hire additional fees to food, cosmetic, employees & supplement makers
    10. 10. CURRENT CHALLENGES: FOOD REGULATION“Food items are actually regulated by up to sixteen different agencies,and the jurisdictional rules governing who regulates what items canborder on the absurd: closed-face sandwiches are FDA fare, forexample, but take off the top slice of bread and you have a USDA-regulated open-face sandwich product. Many foods covered by eitheragency are made by the same producers in the same plants, leading toa lot of overlap (and presumably a lot of waste).” -- Gareth Sparks
    11. 11. BRIEF FOOD ISSUES: ¼ people will have a food-borne illness each year 1.2% of food imports are inspected each year This year, the agency will spend just 73 cents on food safety for every dollar spent on drugs, according to the Institute of Medicine.
    12. 12. USER FEE APPROPRIATIONS Proposed FutureCurrent Appropriations Breakdown* 2008 User Fees, FDA
    13. 13. RECOMMENDATION: SPLIT THE FDAUS Dept of Human Department ofServices Agriculture Biologics  Veterinary Products Cosmetics  Foods Drugs Medical Device Radiation-Emitting Electronic Products
    14. 14. EVERYONE WINSPharmacology Agriculture Industry:  Industry:  Too complex, so there  Don’thave to report to isn’t enough focus on multiple agencies the safety of drugs  Government:  This may speed the  More focused process of drug oversight on foods approval Government:  Helps with oversight
    15. 15. CONSISTENT WITH OTHER COUNTRIES Of the WHO’s outcomes for health systems, the US ranks #37 In an analysis of higher- ranking countries we found that they are split between agriculture and medical divisions
    16. 16. CONSISTENT WITH CURRENT ADMINISTRATION Bridging the gap with the “Food Safety Working Group”  March 2009 Purpose:  Prevention  Surveillance/Enfo rce  Improve Responses to Food- borne Illness
    17. 17. CURRENT SOLUTION: BRIDGE THEGAP  New Positions:  FDA– Deputy Commissioner for Foods  USDA– Chief Medical Officer  Reports to FSIS- Food, Safety, and Inspection Service  Implication: Move food to USDA