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FDA Action Handbook

9-12-88

APPENDIX:

Federal AIDS Bureaucracies and

AIDS Drug Development Flowchart

 

THE BUREAUCRACY

 (HHS)
U.S. Department of Health
and Human Services
| ------------- |

 (PHS)
U.S. Public Health Service
-| ------- | ------- | ------ |

 ((HCFA)
Health Care Financing
Administration

 (NIH)
National Institutes
of Health

| --------- | ----

(FDA)
Food & Drug Administration
(Young)

(CDC)
Centers for
Disease Control
|
|

(ADAMHA)
Alcohol, Drug
Abuse & Mental
Health Admin.
|

(NCI)
National Cancer
Institute
|
|

(NIAID)
National Institute of Allergy & Infectious
Diseases (Fauci)
|
 

 (CID)
Centers for
Infectious Diseases
(Curran)
|

 (NIMH)
National Institute
of Mental Health

(DTCB)
Division of Tumor Cell
Biology (Gallo)

AIDS Treatment Branch
(Hoth)
| ------- |
 

AIDS Activities
Office

 

(ACTCC)
AIDS Clinical Trials
Coordinating Center

 (ACTG)
AIDS Clinical
Trials Group
 


 

.
National Institute of Allergy and Infectious Diseases
Steps in AIDS Drug Devolopment and Testing

 

Clinical Trials Require:
-- Protocol development and administration
-- Training of personnel
-- Standardization of procedures
-- Bulk synthesis of drug
-- Recruitment and screening of patients

 

   Goal >>>

 Drug Licensed
    Manufacturer Submits New Drug Appilcation (NDA) to Food and Drug Administration 
  Phase III Clinical Trials
Double-blind comprison against standard
or experimental treatment or placebo in
large numbers of patients to determine:
-- Efficacy
--Most desirable dosage for majority of patients
-- Cumulative and chronic toxicity
        Phase II Clinical Ti\rials
Usually double-blind, placebo-controlled
in larger numbers of patients to determine:
-- Dose schedules
-- Additional safety / toxicity
-- Indications of efficacy

 

>> Additional
animal studies
may be required

      Phase I Clinical Trials
in small number of patients to determine:
-- Safety/ toxicity
-- Maximum dose tolerance
-- Bioavailability
    Investigational New Drug (IND)
Status granted by Food and Drug Administration to SPONSOR.
NIAID holds IND for all studies conducted
by AIDS Treatment Evaluation Units and is
repository of all information on clinical use of the drug
 

 Begin >>>

Preclinical Research
-- Tissue culture screening of synthetic compounds
and natural products
-- Short-term animal testing: toxicology and pharmacology
   

 

Foundation of Basic Research in Virology and Immunology

 

 

Back to beginning of FDA Action Handbook > > >

Introduction: WHY THE FDA?

I. WHAT IS THE FDA?
The Federal Health Bureaucracy

___Who's Involved with AIDS
___The NIH and AIDS
___AIDS & the FDA
___FDA: Who Does What
A Brief History of the FDA

___Elixir of Sulfanilamide
___The "Golden Age" of Pharmaceuticals
___Thalidomide
___The Kefauver Amendment
The FDA and Drug Companies:
___Incest and Competition
___The Orphan Drug Act

II. HOW THE FDA CONTROLS ACCESS TO AIDS DRUGS
The Standard Drug Approval Process:
___Clinical Trials: Phase I, II and III
___Protocols, IRB's and Informed Consent
Extraordinary Release:
___Treatment IND
___Compassionate Use IND
___Money
___Post-Marketing Surveillance and De-Regulation:
___Combined Phases II-III and a new Phase IV?
The Underground Market

III. DRUG HORROR STORIES: HOW THE FDA BETRAYED IT'S TRUST & INTENSIFIED THE AIDS CRISIS
Pentamidine Wars
Trimetrexate: Treatment IND Hoax
Imreg-1: Treatment IND Omission
DHPG: Bad Oversight Delays Sight-Saving Drug
IVIG: A Pernicious Placebo
Exclusion of Women, People of Color, Poor People,
___People in Rural Areas, IV Drug Users, Hemophiliacs,
___Prisoners & Children from Drug Trials
FDA & Discrimination in Drug Trials
The Rights of Drug Trials Subjects:
___Drug Trials are Health Care Too
ATR: AIDS Treatment Registries, Local & National

IV. APPENDIX
Federal Drug Law Timeline

Federal AIDS Bureaucracies
AIDS Drug Development Flowchart

 

 



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