Postmarketing Surveillance Systems Come Under Scrutiny

JANUARY 01, 2005

In an editorial in the December 1, 2004 issue of the Journal of the American Medical Association, the journal's editors shared their views on the US approval for drug and biological agents. "Physicians and patients expect that when medications are prescribed correctly for labeled indications and are used as directed, these medications generally will have beneficial effects and will not cause significant harm. This confidence in pharmaceutical products reflects the trust in the effectiveness and integrity of the drug approval and monitoring process. However, the current approval process for drug and biological agents in the United States has come under intense scrutiny, most notably because of concerns about influence from the industry," wrote Catherine D. DeAngelis, MD, MPH, editor-in-chief, Phil B. Fontanarosa, MD, executive deputy editor, and Drummond Rennie, MD, deputy editor.

The editors further stated that improving measures to monitor the safety of marketed drugs has to do with the approval process being "decoupled from the postmarketing safety and surveillance system." The authors agreed with one recommendation brought to the table by experts in the field: "to establish an independent drug safety board or independent agency for drug safety, specifically to oversee postmarketing surveillance for drugs and devices."

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