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You Have Access to Those Drugs That Work After a Trial Is
Complete?
Often, the company developing
a new drug may try to see that you can continue to get it,
even before the FDA has approved it for sale. You may be able
to do this under what is termed a compassionate plea basis.
This means that because the new drug has been so helpful,
the manufacturer can give it to a physician, who may then
prescribe it for you.
While companies often make
such a new drug available, there may also be good reasons
why a company cannot. Perhaps only a very small amount of
a drug was prepared for the research project, and no more
is available for use afterwards. Then again, a manufacturer
may want to further test the drug under certain conditions,
or to examine the results of a research study more fully before
releasing it for compassionate plea use. A company would be
especially careful if a new medication required that the doctor
who prescribed it have some special knowledge or skill to
monitor its safe use.
You and any family members
interested in your well-being should discuss with the director
of the research your questions about compassionate plea use.
Each case is different, so the agreement has to be between
the drug manufacturer and your own doctor.
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