Transcript Biotechnology us regulatory

Regulatory Issues in Biotechnology
U.S. Food and Drug Law History
ISAT 455, Spring 2004
College of Integrated Science and
Technology
James Madison University
U.S. Food and Drug Law History
1862



President Lincoln appoints a chemist,
Charles M. Wetherill to serve in the new
Department of Agriculture
Beginning of the Bureau of Chemistry
Bureau of Chemistry is the first
predecessor to the Food and Drug
Administration now in the Department of
Health and Human Services
U.S. Food and Drug Law History
1902




The Biologics Control Act is passed
Insures safety and purity of serums,
vaccines, and similar products used to
prevent or treat diseases in humans
Regulation of production is carried out by
the Public Health and Marine Hospital
Service (PH-MHS)
What factors precipitated this Act?
U.S. Food and Drug Law History
1902



In 1901, thirteen children in St. Louis died
after receiving diptheria antitoxin
contaminated with tetanus spores
No standards for production, dosage, or
safe practices to prevent contamination
No licenses were required
U.S. Food and Drug Law History
1906






The Pure Food and Drugs Act is passed
The Meat Inspection Act is passed (same
day)
First general regulation by Federal
Government
Major concerns are health and safety
Established Federal authority to regulate
foods and drugs (by what authority?)
What factors precipitated these Acts?
U.S. Food and Drug Law History
1906



Federal authority was based upon interstate
commerce, prohibiting misbranded and
adulterated foods, drinks, and drugs
The Acts were precipitated by the book
The Jungle by Upton Sinclair
Revealed unsanitary conditions in meatpacking plants, poisonous food additives
and dangerous patent medicines
U.S. Food and Drug Law History
1938






Federal food, Drug, and Cosmetic
Act is passed
Introduced safety standards
Authorized factory inspections
Authorized criminal penalties
Authorized public disclosures
What factors precipitated this Act?
U.S. Food and Drug Law History
1938



In 1937, an elixir of sulfanilamide
containing a poisonous solvent kills 107
people, mostly children.
This resulted in the Federal Food, Drug,
and Cosmetic Act of 1938.
What did this Act not do?
U.S. Food and Drug Law History
1962






Kefauver-Harris Drug Amendments
passed
Tightened safety requirements
Established efficacy requirements
Established drug company registration
Established compliance with cGMPs
What factors precipitated this Act?
U.S. Food and Drug Law History
1962



In 1962, Thalidomide, a new sleeping
pill, is found to have caused birth
defects in thousands of babies born in
western Europe
The FDA did not allow the drug in the
U.S. market at that time
Thalidomide has recently been
reintroduced to the market
U.S. Food and Drug Law History
1983



The Federal Anti-Tampering Act is
passed
Makes it a crime to tamper with
packaged consumer goods
Precipitated by deaths from cyanide
placed in Tylenol capsules
U.S. Food and Drug Law History
1984




Drug Price Competition and Patent Term
Restoration Act is passed
Allows generic versions of brand-name
drugs without repeating research to
prove safety and efficacy
Allows brand-name companies to apply
for time lost in FDAs approval process
First economic legislation
U.S. Food and Drug Law History
1992




Prescription Drug User Fee Act
(PDUFA) is passed
Requires drug and biologics manufacturers
to pay fees for applications, annual
establishment fees, and annual product
fees
Funds used to hire more reviewers and
speed up approval process
What factors precipitated this ACT?
U.S. Food and Drug Law History
1997





The FDA Modernization Act (FDAMA) is
passed
Must develop plan within one year
Must establish mechanisms for
implementation within two years
Must eliminate backlogs within three
years
What is the current status?
Organizational History of the
FDA






1862 Chemical division , Department of
Agriculture USDA
1901 Bureau of Chemistry, USDA
1927 Food and Drug Insecticide Administration,
USDA
1930 Food and Drug Administration, USDA
1940 FDA, Federal Security Agency
1953 FDA, Department of Health, Education,
and Welfare
Organizational History of the
FDA




1968 FDA, Public Health Service
1970 Pesticide issues transferred to new
EPA
1972 Regulation of Biologics transferred
from PHS to FDA
1988 Food and Drug Administration Act
establishes FDA as an agency of
the Department of Health and
Human Services
Modern FDA Overview
Responsibilities





Food is safe and wholesome
Cosmetics are safe
Medicines and medical devices are safe and
effective
Radiation-emitting products are safe
Feed and drugs for animals are labeled
truthfully