Original Arthur: Addie D. Anderson
CRB Consulting Engineers, Inc.
• Important milestones establishing our
current system of regulations
• Step-by-step overview of the drug
• Fast-track drug development
• More Information
• U.S. became the world’s dumping ground
for counterfeit, contaminated, diluted, and
decomposed drug materials.
• U.S. Customs Laboratories were
established to administer the Import Drugs
Act of 1848.
– Mission: Enforce purity and potency standards
State of Food and Drug Supply
• Agricultural to industrial economy
• Principle means of refrigeration – ICE
• Unpasteurized milk
• Cows weren’t tested for TB
• Pioneers of bacteriology just starting string
of victories over infectious diseases
• “Kick-a-poo Indian Sagwa”
• “Warner’s Safe Cure for Diabetes”
• Opium, morphine, heroin, and cocaine – no
restrictions or labeling
Medicine Men vs Circus
Pure Food and Drug Act of 1906
• Prohibited interstate commerce of
misbranded and adulterated foods and
• Allowed for seizure and criminal
• Did not address:
– Food or drug standards
– False advertising
– Inspection of food and drug facilities.
• Enforced by Division of Chemistry
1937 – Elixir of Sulfanilamide
• Liquid form of Sulfanilamide
produced using diethylene glycol as
• Diethylene glycol = Antifreeze
• Administered to mostly children to
treat streptococcal infections.
• Existing laws did not require any kind
of pharmacological studies
demonstrating that a drug is safe.
• 107 people died.
1938- Food, Drug and Cosmetic
• Extended control to cosmetics and
• Required new drugs to be demonstrated as
safe before marketing.
• Eliminated requirement to prove intent to
defraud in drug misbranding cases
• Provided standards and safe tolerances.
• Authorized factory inspections.
1961- Thalidomide Crisis
• Hailed as a wonder drug for
• Relieved many morni