New drug development

New drug development

In the 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 complete.

Only 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.)

Exceptions to the rule

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.

Sponsors 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.

Despite 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.)