FDA History - Notable Events

1862: Charles Wetherill is appointed to serve in the new Bureau of Chemistry.

1883:  Dr. Harvey Wiley becomes the chief chemist of the Bureau of Chemistry.

1. Became the leader of the “Pure Food Crusade”
2. Known as the father of the Pure Food and Drugs Act.
3. Started the “Hygienic Table”, commonly known as “The Poison Squad”. They were able-bodied volunteers that consumed questionable food additives to determine their impact.
4. Lead to the 1906 signing of the “Food and Drugs Act”

1902:  The “Biologics Control Act” is passed.

1. Purity and Safety of serums and vaccines                                   

 

1906:  President Roosevelt signed the “Food and Drugs Act”

1. The starting point for the laws that are followed today.
2. Focused more on food then on drugs
3. Producers had to prove their products were safe
4. Labels had to list the amounts of dangerous ingredients
5. Labels could not be misleading
6. Drugs could not be sold in any condition other than what was plainly stated on the label
7. Did not address false therapeutic claims                                     

1937:  The Elixir of Sulfanilamide incident.

1. A sulfa drug that was used to treat streptococcal infections.
2. Was safely used in the tablet form.
3. Was dissolved in diethylene glycol to produce a liquid form.
4. The liquid form was never tested for toxicity or safety.
5. Killed 107 people in 15 states in 2 months. Most deaths were children.
6. Public outcry led to a new law.

1938: The Federal Food, Drug, and Cosmetic Act is passed

1. Is the act that is still followed today. The existing GMP rules.
2. Extended control to cosmetics and therapeutic devices.
3. Required new drugs to be shown safe before being marketed (i.e., pre-market approval).
4. Required labels to have adequate directions for safe use.
5. Authorized factory inspections and court injuctions.

1939:  First food standards issued.

1941: The Insulin Amendment requires the FDA to test insulin for purity and potency.

1953: The Factory Inspection Amendment requires the FDA to give manufacturers written reports of the conditions that were observed during FDA inspections and results of any sample analysis that the FDA performs.

1955: The Division of Biologics Control is created within the FDA

1. Brought about after 260 cases of polio were contracted from a polio vaccine that was thought to be inactivated but was actually active polio.

1962: Thalidomide Incident

1. A sleeping pill that was seeking approval in the US
2. Was already approved for use in Western Europe
3. Was found to cause deformities and birth defects
4. Resulted in new laws: Kefauver-Harris Amendments

1962: Passage of Kefauver-Harris Amendments

1. Required drug manufacturers to prove to the FDA that their products are both safe and effective prior to marketing
2. Set stricter controls over clinical trials
3. Required informed consent by patients participating in clinical trials
4. Established GMPs for the drug industry
5. Required the FDA to perform a retrospective review of the effectiveness of all drugs marketed since 1938
6. Required clinical studies to be based on previous animal investigations to assure their safety
7. Resulted in the formation of the first advisory committee

1976: Medical Device Amendments passed

1980: Infant Formula Act gives FDA controls to ensure that formula contains the necessary nutritional content and is safe

1982: Tamper-resistant Packing Regulation issued:

1. Result of 7 people dying in the Chicago area after taking Tylenol capsules laced with cyanide.
2. Johnson and Johnson was the first company to react to the new law. They reintroduced Typenol capsules in a new triple-seal tamper resistant packaging.

1983: The Federal Anti-Tampering Act passed which made tampering with packaged consumer products against the law.

1990: Safe Medical Device Act is passed.

1991: Accelerate the Review of Drugs for life-threatening diseases regulations are published.

1997: FDA Modernization Act:

1. The most wide-ranging reforms since 1938
2. Accelerate review of devices
3. Regulate advertising of unapproved drugs and devices
4. Regulate health claims for foods

2002: The Best Pharmaceuticals for Children Act:

1. Improves safety and efficacy of medicines for children
2. Extend studies of the effects of drugs on children

2002: The Current Good Manufacturing Initiative:

1. A risk based focus
2. That quality standards don’t impede innovation

Consistent approach to issues across FDA