New Medicines In Development For Women
(continued)
What is the Status of Drug Development for These Medicines?
More great news- of these 348 medicines in development for 62 different conditions,
40 new drug applications (NDA) had already been submitted to the Food
and Drug Administration (FDA) for review and marketing approval at the time
the New Medicines in Development for Women report was prepared. One of
those drugs, Tamiflu ® (for the prevention and treatment of symptoms of the
flu), has already received FDA approval, just in time for flu season. The bad
news is that it may still take several months for those 39 NDA's to be reviewed;
it may take several years for the remaining 308 drugs to reach the point where
their manufacturers can even submit an NDA. FDA approval is required for any
prescription or non-prescription ("over the counter" or OTC) medicine to be
marketed for a particular indication in the United States. (Note that this does
not apply for vitamins, supplements, or herbal products.) By law, the FDA is
mandated to review an NDA within 6 months of submission. New chemical entities-
the first in class drugs- are generally given priority review status, as are
medicines for diseases considered to be a public health threat (e.g. HIV/AIDS
or influenza).
The average NDA review time for new molecular entities approved in 1998, however,
was nearly 12 months.
It is important to note that the PhRMA Drugs in Development for Women
report only summarizes research of new drugs in development for women
for new indications. Once the FDA approves an NDA and the medicine is
available for physicians to prescribe, companies must still continue to submit
periodic reports to the FDA, including any reports of adverse reactions and
other quality control records. In addition, for some products, the FDA requires
additional "post marketing surveillance trials" ("Phase IV") to evaluate long-term
effects. In many cases, companies continue research on approved products to
determine further uses, to expand the approved indication, or to develop new
dosage forms.
It is also important to note that this report focuses on drugs that are in
clinical trials-i.e. studies in humans-only. That means that these medicines
have already been extensively studied in animals ("preclinical testing") and
have received FDA consent to proceed with human trials. The first phase of clinical
testing ("Phase I") involves normal, healthy volunteers to test safety, dosage,
absorption, metabolism, excretion, and length of action. The next stage of clinical
testing ("Phase II") usually involves 100-500 closely monitored patients with
the relevant condition to evaluate effectiveness. Phase III clinical trials
usually involve 1,000-5,0000 closely monitored patients to confirm efficacy
and to identify potential adverse effects. Of the new medicines in development
for women report, 84 medicines are currently in Phase III trials. After completion
of these studies, a company compiles and analyzes all of the data and composes
an NDA. This document contains all of the relevant scientific information available
to date about the product and is typically over 100,000 pages!
The drug development process is a costly and time-consuming one. It takes from
12--15 years for an experimental drug to go from discovery in the lab to usage
in American patients. Of 5,000 compounds that enter preclinical testing, only
5 will even make it into human testing. Only one of these 5 will be approved
to be marketed. This process costs approximately $500 million to get one new
medicine from the lab to the drugstore.
How Far Have We Come?
In 1991, PhRMA performed its first survey to assess how well the research-based
pharmaceutical industry was meeting the medical research needs of women. This
survey revealed that 263 medicines were then in various phases of development
for use in women by 79 different companies; the 1999 survey listed 348 medicines
in development for use in women by 143 companies. While this is a slight decrease
from the 373 medicines in development for women in the 1997 survey, it shows
a consistent commitment on the part of the pharmaceutical industry to research
and development treatments that target diseases and conditions that affect only
women, disproportionately affect women or are among the top ten causes of death
for women.
Click here for more information on medicine. Click here for more information
on clinical trials.
Created: 1/6/2000 - Donnica Moore, M.D.
...For some patients, it may make the difference between being able to tolerate a medication and getting the desired effect, or not being able to take the medicine. For some of those patients, these little changes can ultimately mean the difference between life and death. 
