Postmarketing Surveillance Systems Come Under Scrutiny

In an editorial in the December 1,2004 issue of the Journal of the AmericanMedical Association, the journal'seditors shared their views on the USapproval for drug and biologicalagents. "Physicians and patients expectthat when medications are prescribedcorrectly for labeled indications andare used as directed, these medicationsgenerally will have beneficial effectsand will not cause significant harm.This confidence in pharmaceuticalproducts reflects the trust in the effectivenessand integrity of the drugapproval and monitoring process.However, the current approval processfor drug and biological agents in theUnited States has come under intensescrutiny, most notably because of concernsabout influence from the industry,"wrote Catherine D. DeAngelis,MD, MPH, editor-in-chief, Phil B.Fontanarosa, MD, executive deputyeditor, and Drummond Rennie, MD,deputy editor.

The editors further stated thatimproving measures to monitor thesafety of marketed drugs has to dowith the approval process being"decoupled from the postmarketingsafety and surveillance system." Theauthors agreed with one recommendationbrought to the table by experts inthe field: "to establish an independentdrug safety board or independentagency for drug safety, specifically tooversee postmarketing surveillance fordrugs and devices."