Transcript FDA: History and Organization - Medical and Public Health Law Site

FDA: History and Organization
Edward P. Richards
Harvey A. Peltier Professor of Law
Louisiana State University School of Law
[email protected]
http://biotech.law.lsu.edu
Click Here For Updated Slides
Colonial Efforts






Public Health and Safety
Central Concern
Raked by Diseases
Unsanitary Food
Nuisance
No Good Science
2
An Act against selling
unwholesome Provisions.
Whereas some evilly disposed persons, from motives of avarice
and filthy lucre, have been induced to sell diseased, corrupted,
contagious or unwholesome provisions, to the great nuisance of
public health and peace:
Be it therefore enacted by the Senate and House of
Representatives, in General Court assembled, and by the
authority of the same, That if any person shall sell any such
diseased, corrupted, contagious or unwholesome provisions,
whether for meat or drink, knowing the same without making it
known to the buyer, and being thereof convicted before the
Justices of the General Sessions of the Peace, in the county
where such offence shall be committed, or the Justices of the
Supreme Judicial Court, he shall be punished by fine,
imprisonment, standing in the pillory, and binding to the good
behaviour, or one or more of these punishments, to be inflicted
according to the degree and aggravation of the offence.
Massachusetts, March 8, 1785
3
1800s - Era of the States





Not Laissez-Faire
Police Powers Were Reserved to the
States
Mostly Local, not State-Wide
Strong Protectionist Bias
Not Well-Suited to a National Market
4
1862 - Agriculture Department



Chemical Division
One Chemist
Adulterated Food



Foods and Food Adulterants, a ten-part
study published from 1887 to 1902
Many Potted Meats Contained None of the
Labeled Meat
Many Adulterants were Dangerous
5
1862 - 1940 - USDA




1862-1890 Chemical Division
1890-1901 Division of Chemistry
1901-1927 Food, Drug, and Insecticide
Administration
1927-1930 Food and Drug
Administration
6
1940 - Present - FDA



1940-1953 Federal Security Agency
1953-1979 Department of Health,
Education, and Welfare
1979-2002 Department of Health and
Human Services
7
Organization




Executive Branch Agency
Under the Secretary of HHS
Senate Confirmation
Much More of a Political Appointment
than in the Past
8
Early Laws

The Vaccine Act of 1813




Bad Smallpox Vaccine
First Federal Law Dealing with Consumer
Protection and Drugs
Short-lived
Biologics Act of 1902

Passed after Deaths Due to Bad Diphtheria
Antitoxin
9
10
The Jungle



Story of the Plight of Workers in the
Food Processing Industry
The Public was Horrified by the Food
Processing, not the Workers
Lead to the 1906 Act
11
1906 Act




Basic Structure of the FDA
Followed in Broad Outline Today
Authority over Interstate Shipment of
Adulterated Foods and Drugs
Narrow Use of Commerce Clause Power
12
1938 Act


Had been proposed 5 years earlier
Pediatric Elixir Put Up In Ethylene Glycol



Sweet and Viscous
Deadly
Public Outcry Lead to the Passage of the
1938 Act


Included Cosmetics
Broadened Definitions of Adulteration and
Misbranding
13
1962 Amendments




Shifted from Premarket Notification to
Premarket Approval
Required Drugs to be Effective
Required Reevaluation of All Marketed
Drugs
Still not Done
14
MDA - 1976





Medical Device Amendments
Passed after Pacemaker and other
Medical Device Scandals
Risk Class Regulation
New Devices Must Be Safe and Effective
510(k) Grandfathering


Substantially Equivalent to a 1976 Device
Most Devices Qualify
15
Subsequent Acts




Added User Fees to Pay for Reviews
Reorganized FDA Functions
Took Away Most Power over Food
Supplements
Still a Work in Progress
16
Other Laws


Biologics
Radiation Products




Nuclear Medicine
X-rays
Microwaves and Ultrasound
Some Role in Food Service and Carriage
17
Key Principles



Regulates Products
Must Be Interstate Commerce
Does Not Regulate Practice of Medicine



Docs can give what they want, as long as
they do not ship it
Can be regulated by the States
Growing Free Speech Questions
18