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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.

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: http://www.rd.com/your-america-inspiring-people-and-stories/problems-in-the-fda/article55513.html.
  • 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: http://www.fda.gov/NewsEvents/Testimony/ucm187566.htm. Science and Our Food Supply-Middle School Guide, Module 5 (2007). U.S. Food and Drug Administration [website]. Retrieved from: http://www.fda.gov/Food/ResourcesForYou/StudentsTeachers/ScienceandTheFoodSupply/ucm183598.htm. 2. Schmit, J. (2008, February). FDA Receives Modest Boost in Budget Plan [on-line article]. USA Today . Retrieved from: http://www.usatoday.com/money/industries/food/2008-02-04-fda-budget-food-safety_N.htm. 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: http://blogs.wsj.com/health/2008/03/05/fda-decisions-on-drug-approval-could-start-slipping/. 5. Summary of the FDA ’s FY 2010 Budget. (2009, May). Food and Drug Administration [website]. Retrieved from: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/BudgetReports/ucm153154.htm. 6. Wang, S. FDA Delays Take Toll on Neuroscience Drug Development [on-line article]. Wall Street Journal [on-line Health Blog]. Retrieved from: http://blogs.wsj.com/health/2008/11/10/fda-delays-take-toll-on-neuroscience-drug-development/ 7. Ibid. Also Reference Summary of FDA ’s FY 2010 Budget
  • Transcript

    • 1. THE FOOD AND DRUG ADMINISTRATIONFood Safety RecommendationsBy: Elliott Bosslet, Anthony Hopper, JessicaJacobs, and Sarah Okorie
    • 2. PURPOSEShort Term Goal Long Term Goal Increase the Budget  Break up the FDA
    • 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. 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
    • 5. CURRENT CHALLENGES: BUDGETSAFETY ACCESS
    • 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. 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. 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. 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. 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. 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. USER FEE APPROPRIATIONS Proposed FutureCurrent Appropriations Breakdown* 2008 User Fees, FDA
    • 13. RECOMMENDATION: SPLIT THE FDAUS Dept of Human Department ofServices Agriculture Biologics  Veterinary Products Cosmetics  Foods Drugs Medical Device Radiation-Emitting Electronic Products
    • 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. 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. 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. 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

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