New drug development
past, drugs were found by trial and error. Now they’re de-veloped primarily by
systematic scientific research. The Food and Drug Administration (FDA)
carefully monitors new drug develop-ment, which can take many years to
after reviewing extensive animal studies and data on the safety and
effectiveness of the proposed drug will the FDA ap-prove an application for an
investigational new drug (IND). (See Phases of new drug development.)
Although most INDs undergo all four phases of
clinical evaluation mandated by the FDA, some can receive expedited approval.
For example, because of the public health threat posed by acquired
immunodeficiency syndrome (AIDS), the FDA and drug compa-nies have agreed to
shorten the IND approval process for drugs to treat the disease. This allows
doctors to give qualified AIDS pa-tients “treatment INDs,” which aren’t yet
approved by the FDA.
of drugs that reach phase II or III clinical trials can apply for FDA approval
of treatment IND status. When the IND is approved, the sponsor supplies the
drug to doctors whose pa-tients meet appropriate criteria.
the extensive testing and development that all drugs go through, serious
adverse reactions may occasionally occur, even though they weren’t discovered
during clinical trials. It’s also possible that drug interactions aren’t
discovered until after clinical trials have concluded and the drug has been
approved. The FDA has procedures in place for reporting adverse events and
other problems to help track the safety of drugs. (See Reporting to the FDA.)