JAMA editors call for major restructuring of postmarketing surveillance system

In an editorial in the December 1 issue, JAMA Editor-in-Chief, Catherine D. DeAngelis, M.D., M.P.H., Executive Deputy Editor, Phil B. Fontanarosa, M.D., and Deputy Editor Drummond Rennie, M.D., write "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 trust in the effectiveness and integrity of the drug approval and monitoring process. However, the current approval process for drugs and biological agents in the United States has come under intense scrutiny, most notably because of concerns about influence from industry." The editorial, to be published in the December 1 issue of JAMA, is being released early online today because of its relevance to current events.

"To improve the necessary measures to monitor the safety of marketed drugs, the drug approval process must be decoupled from the postmarketing safety and surveillance system. It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong (i.e., that the decision to approve the product was subsequently shown to be incorrect.) One option worth strong consideration, as others have suggested, is to establish an independent drug safety board or independent agency for drug safety, specifically to oversee postmarketing surveillance for drugs and devices." … "Above all, the agency must be completely independent of influence from the pharmaceutical industry, biotechnology firms, and medical device manufacturers."

"The postmarketing surveillance system requires a long overdue major restructuring. Until that occurs – as indicated by the articles in this issue of JAMA, as epitomized by recent evidence of serious harms from widely used and heavily promoted medications, as demonstrated by the influence of industry over postmarketing data, and as illustrated by the lengths to which some manufacturers will go to protect their interests – the United States will still be far short of having an effective, vigilant, and trustworthy system of postmarketing surveillance to protect the public."

(JAMA. 2004;292: 2647 – 2650. Available post-embargo at JAMA.com.)

---

---