The Food & Drug Administration (FDA)

Standards & Regulations

The FDA creates regulations and product standards: -to assure product safety -to provide accurate information

FDA Laws

-1862: Bureau of Chemistry formed -1883: Dr. Harvey Wiley becomes head of Bureau of Chemistry -Food & Drugs Act of 1906 -1927: Food, Drug, & Insecticide Administration created out of Bureau of Chemistry -Federal Food, Drug, & Cosmetic Act of 1938

New Product Review

-Does NOT develop or test products itself -Reviews the results of company testing -What has to be reviewed?

The FDA Center for Drug Evaluation & Research (CDER)

-Evaluates all new drugs for safety and effectiveness -Drug review time reduced to less than one year -Terrorism and the FDA -2001: 66 new drugs approved Gleevac: record 2.5 month approval

FDA Center for Devices and Radiological Health (CDRH)

-Evaluates new medical devices for safety & effectiveness -Ensures consumer products meet radiation safety standards -CDRH has streamlined its review processes and reduced the average time from 26 months to 12 months

What does the FDA cover?

-Food -Medicines, biologics, & medical devices -Consumer & medical products -Animal drugs -Cosmetics -True & informative labels

Surveillance & Inspection

-Inspects manufacturers -Checks import shipments -Test for contamination Reviews problem reports for products after they are marketed (over 400,000 problem reports each year)

Why do we have the FDA?

-Misbranded & adulterated food -Cure-alls, tonics, and "patent" medicines -Chemicals, preservatives, and toxic food coloring -The "Poison Squad" -Upton Sinclair's The Jungle -Elixir of Sulfanilamide

FDA Review Process

-New Drug Application (NDA) -Safe & effective = "approvable" -"Letter of Approval"

Food & Drug Administration

-One of the nation's oldest & most respected consumer protection agencies -FDA regulated products account for 25 cents out of every $1 spent by consumers -The FDA costs each American just over a penny a day

Research

-Provides scientific basis for its regulatory decisions -Identifies risks caused by products -Develops standards -Evaluate new products -Study emerging risks

FDA Enforcement

-Recall & field correction: class I recall, class II recall, class III recall -Medical Device Notification or Safety Alert -Injunction -Seizure -Prosecution

The FDA Review Process

-Some products, such as new drugs & complex medical devices, must be proven safe & effective before they can be marketed -Other products such as x-ray machines and microwaves, must simply meet certain performance standards. -Once a product gains FDA approval, it must continue to meet FDA standards while on the market -The guiding principle is whether the benefit outweighs the risks (no product is 100% risk free)

What does the FDA do?

5 major activities: 1. New product review 2. Keeping watch 3. Standards & regulations 4. Research 5. Enforcement/Correcting Problems

Enforcement/Correcting Problems

Actions to protect the public health: -manufacturer recall -injunction -seizure -withdraw drug approval -require labeling changes -send out warnings