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

1. THE FOOD AND DRUG
ADMINISTRATION
Food Safety Recommendations
By: Elliott Bosslet, Anthony Hopper, Jessica
Jacobs, and Sarah Okorie

2. PURPOSE
Short Term Goal Long Term Goal
 Increase the Budget  Break up the FDA

3. HISTORY
The FDA is the oldest comprehensive consumer
protection 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 not
What 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: BUDGET
SAFETY 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:
BUDGET
Question: 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. RECOMMENDATIONS
Increase 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 can
border on the absurd: closed-face sandwiches are FDA fare, for
example, but take off the top slice of bread and you have a USDA-
regulated open-face sandwich product. Many foods covered by either
agency are made by the same producers in the same plants, leading to
a 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.

13. USER FEE APPROPRIATIONS
Proposed Future
Current Appropriations
Breakdown
* 2008 User Fees, FDA

14. RECOMMENDATION: SPLIT THE FDA
US Dept of Human Department of
Services Agriculture
 Biologics  Veterinary Products
 Cosmetics  Foods
 Drugs
 Medical Device
 Radiation-Emitting
Electronic Products

15. EVERYONE WINS
Pharmacology 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

16. 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

17. 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

18. CURRENT SOLUTION: BRIDGE THE
GAP
 New Positions:
 FDA– Deputy
Commissioner for
Foods
 USDA– Chief
Medical Officer
 Reports to FSIS- Food,
Safety, and Inspection
Service
 Implication: Move food
to USDA