THE FOOD AND DRUG ADMINISTRATION

Food Safety Recommendations

By: Elliott Bosslet, Anthony Hopper, Jessica Jacobs, and Sarah Okorie

PURPOSE

Increase the Budget Break up the FDA

Short Term Goal Long Term Goal

HISTORY

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

The FDA is the oldest comprehensive consumer protection agency in the U. S. federal government.

Biologics Cosmetics Drugs Foods Medical Device Radiation-Emitting

Electronic Products Veterinary Products

Advertising Alcohol Consumer Products Drugs of Abuse Health Insurance Meat and Poultry Pesticides Restaurants& Grocery

Stores Water

What the FDA Regulates What the FDA does not Regulate

THE BUSIEST AGENCY IN GOVERNMENT

CURRENT CHALLENGES: BUDGET

SAFETY ACCESS

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

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

CURRENT CHALLENGES: BUDGET

Food-borne illnesses kill thousands of Americans each year and sicken millions more people (as many as 76 million individuals) (1)

“The agency inspected 1.28% of the 9.4 million shipments that came to the USA in fiscal 2007. That will drop to 1.26% in fiscal 2009.” (2)

15,107 deaths due to adverse drug reactions in 2006 (3)

The FDA acknowledges these issues in its 2010 budget request (5)

The FDA is falling behind in processing paperwork for new drug trials (4

The agency Also falling behind on setting meetings with companies to discuss trial results pre-Phase III (6)

It might become more problematic as agency steps up effort to insure drug safety by requiring more paperwork, longer trial times, etc. (7)

Problems with Safety Lack of Money = Slower Access to Drugs

RECOMMENDATIONS

June 2009: The U.S. Government Accountability Office sad the FDA is under-budgeted

Numerous experts, including th ex-director of FDA, argue for an increase

2010 Budget Consider adding user

fees to food, cosmetic, & supplement makers

Reconfigure & improve the FDA’s IT system

Allocate more money to oversee foods & supplements

Increase salaries to key personnel to be more competitive with private industry

Hire additional employees

Increase FDA Budget Where Should the Money Go?

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

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.

USER FEE APPROPRIATIONS

Current Appropriations Proposed Future Breakdown

* 2008 User Fees, FDA

RECOMMENDATION: SPLIT THE FDA

Biologics Cosmetics Drugs Medical Device Radiation-Emitting

Electronic Products

Veterinary Products Foods

US Dept of Human Services Department of Agriculture

EVERYONE WINS

Industry: Too complex, so

there isn’t enough focus on the safety of drugs

This may speed the process of drug approval

Government: Helps with oversight

Industry: Don’t have to report

to multiple agencies Government:

More focused oversight on foods

Pharmacology Agriculture

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

CONSISTENT WITH CURRENT ADMINISTRATION

Bridging the gap with the “Food Safety Working Group” March 2009

Purpose: PreventionSurveillance/Enforce

Improve Responses to Food- borne Illness

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