Vaccines

Vaccines
MANUFACTURER INDICATION U.S. DEVELOPMENT STATUS
Biocine AIDS early research phase
(Ciba-Geigy/Chiron)
(Emeryville, CA)
Biotech Research Labs AIDS research phase
(Rockville, MD)
IIIVAC-le AIDS Phase I
Bristol-Myers/Oncogen
(New York, NY)
Genentech AIDS early research phase
(S. San Francisco, CA)
Institut Merieux AIDS early research phase
(Lyon, France)
Cambridge Bioscience
(Worcester, MA)
VaxSyn~ IIIV-1 AIDS clinical trials
MicroGeneSys
(West Haven, CT)
Otisville BioPharm, Inc. AIDS early research phase
(Otisville, NY)
Repligen AIDS animal studies
(Cambridge, MA)
Merck
(Rahway, NJ)
Viral Technologies - AIDS IND submitted
(CEL-SCI, Alpha 1 Biomedicals)
(Washington, DC)
Wistar Institute AIDS early research phase
(Philadelphia, PA)
The content of this chart has been obtained through government and industry sources (including FDA and NiH) based on the latest information.
Chart current as of November 1, 1988. The information may not be comprehensive. For more specific information about a particular product,
contact the individual company directly. For general information, contact the Pharmaceutical Manufacturers Association at [phone]. (If
you are not receiving the AIDS chart regularly and would like to, please send your request in writing to the Conmmnunications Division at
the Pharmnaceutical Manufacturers Association.)
Copyright 0 1988 by the Pharmaceutical Manufacturers Association. Permission to reprint is awarded if proper credit is given.
The Drug Approval Process

The U.S. system of new drug approvals is
perhaps the most rigorous in the world.
I lere is how a drug is tested and approved.
Preclinical Testing. The promising agent
is first subjected to extensive laboratory and
animal testing to determine answers to two key
questions: Is the compound biologically active?
Is it safe? If the answers to both appear to be
affirmative, the drug sponsor is ready to test
in humans. This stage generally lasts from
one to two years.
Investigational New Drug. Before
human tests can start, the drug sponsor must
file an Investigational New Drug (IND)
application with the Food and Drug
Administration (FDA), showing the results of
all animal testing and how the drug is made.
The IND becomes effective if FDA does not
disapprove the application in 30 days.
Human Testing (Clinical). There are three
phases of human testing, each involving
larger numbers of people than the one before.
Phase I. Safety Studies and Pharmacological Profiling: This phase determines
the drug's pharmacological actions, its safe
dosage range, how it is absorbed, distributed,

metabolized and excreted, and the duration
of its action. These tests involve a small
number of normal healthy subjects (not
patients). Phase I clinical testing can usually
be conducted in less than one year.
Phase II. Pilot Efficacy Studies: This phase
consists of controlled studies in approximately
200 to 300 volunteer patients to assess the drug's
effectiveness. Simultaneous animal and human
studies continue to determine the drug's safety.
Phase II clinical testing may require about
two years to complete.
Phase III. Extensive Clinical Trials: Ilere
the testing moves to larger numbers of
volunteer patients, usually 1,000 to 3,000, in
clinics and hospitals. The drug is administered by practicing physicians to those suffering from the condition the drug is
intended to treat. These studies must confirm earlier efficacy studies and identify lowincidence adverse reactions. Phase III clinical
trials last about three years.
New Drug Application (NDA).
Following completion of Phase Ill, the drug
sponsor must file an NDA with the FDA,
containing all the information the sponsor

has gathered. NDAs typically run into thousands of pages. The information submitted
must include the chemical structure of the
drug, scientific rationale and purpose, animal
and laboratory studies, results of all tests in
humans, formulation and production details,
and proposed labeling. On average, the NDA
review and approval process by FDA takes
two to three years.
Approval. Once an NDA is approved, the
company is required to periodically submit
reports to FDA, including adverse reaction
data and production, quality control and
distribution records. For some drugs, FDA
Srequires affirmative post-marketing monitoring, or additional studies to evaluate the
long-term effects.
NOTE: In October 1988, the Food and Drug
Administration (FDA) announced an Interim
Rule to speed the approval of drugs for lifethreatening and other serious diseases by having
FI)A work more closely with pharmaceutical
companies in designing, monitoring and
evaluating clinical trials. Under the plan, if a
drug shows sufficient promise after Phases I
and II, Phase III would be eliminated.

Pharmaceutical
Manufacturers
Association

5571095.0504.029

1100 15th Street, NW * Washington, DC 20005 * Telephone [phone]