Postmarketing Surveillance: Beyond medWatch

Gerald A. Faich, MD
JAMA. 1993;270(18):2180. doi:10.1001/jama.1993.03510180050027.
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To the Editor.  —As one who has actively participated in adverse effects surveillance over the past 10 years,1,2I wish to applaud the new Food and Drug Administration (FDA) MEDWATCH initiative.3 The FDA commissioner and his staff are to be congratulated on recognizing that major efforts must be made to heighten awareness of the importance of reporting by the medical community. The use of a single unified form that does not require practitioners to distinguish between devices, drugs, and biologicals is a great advance.It must be pointed out, however, that surveillance systems generate signals that require further quantification and risk evaluations. Stimulating reporting without providing resources to ensure adequate follow-up and epidemiologic assessments is only a partial solution. The FDA must give further attention to expanding its internal and extramural epidemiologic programs. While the agency has increased preapproval resources and activities, the proportion of manpower and funding


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