It takes years of research to bring new drugs to the marketplace

ON CALL

February 16, 1993|By Dr. Simeon Margolis | Dr. Simeon Margolis,Contributing Writer

Q: Can you explain why it takes so long before a promising new drug is available to patients?

A: Perhaps a description of the process for drug approval will explain why it takes so long and costs the pharmaceutical company so much money before a drug is approved by the Food and Drug Administration (FDA). The following steps are involved (all times are approximations).

* The pharmaceutical company does laboratory and animal studies to show safety and activity of the drug against a disease. Time: 3 1/2 years.

* The company files an Investigational New Drug application with the FDA to begin trials of the drug on people. The Institutional Review Board where the study will be conducted must also review and approve the application.

* Phase I Clinical Trials determine safe doses of the drug, as well as how the body handles the drug, in 20 to 80 normal, healthy volunteers.

Time: 1 year.

* Phase II Clinical Trials are carried out in 100 to 300 volunteers to assess drug effectiveness. Time: 2 years.

* Phase III Clinical Trials monitor how well the drug works and side effects of the drug in 1,000 to 3,000 patients. Time: 3 years.

* If the results of these three phases of clinical trials all demonstrate the safety and effectiveness of the drug, the company files a New Drug Application with the FDA. The FDA reviews the scientific and clinical information from the animal testing and clinical trials and decides whether to approve the drug. Time: 6 months to 3 years.

* FDA approval of the application allows physicians to prescribe the drug for their patients.

Dr. Margolis is professor of medicine and biological chemistry at the Johns Hopkins School of Medicine and associate dean for faculty affairs at the school.

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