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Postmarketing Surveillance—Lack of Vigilance, Lack of Trust

Postmarketing Surveillance—Lack of Vigilance, Lack of Trust Editorials represent the opinions EDITORIALS of the authors and THE JOURNAL and not those of the American Medical Association. Postmarketing Surveillance— Lack of Vigilance, Lack of Trust wonder that, in 2003, the pharmaceutical industry ear- Phil B. Fontanarosa, MD marked $4.9 million to lobby the FDA. Drummond Rennie, MD While these concerns are noteworthy, they pale in com- Catherine D. DeAngelis, MD, MPH parison to the shortcomings and failures of the current im- perfect system for postmarketing surveillance. This system is intended to detect adverse drug events and reactions once HYSICIANS AND PATIENTS EXPECT THAT WHEN MEDI- new products are in widespread use, and thereby limit ex- cations are prescribed correctly for labeled indica- posure of the public to hazards of new medications. The in- tions and are used as directed, these medications gen- adequacies of the postmarketing surveillance system (ie, Perally will have beneficial effects and will not cause FDA’s MedWatch program with passive collection of spon- significant harm. This confidence in pharmaceutical prod- taneous reports of adverse drug reactions) for ensuring safety ucts reflects trust in the effectiveness and integrity of the are well known and include: reliance on voluntary report- drug approval and monitoring process. ing http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Postmarketing Surveillance—Lack of Vigilance, Lack of Trust

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Publisher
American Medical Association
Copyright
Copyright 2004 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.292.21.2647
pmid
15572723
Publisher site
See Article on Publisher Site

Abstract

Editorials represent the opinions EDITORIALS of the authors and THE JOURNAL and not those of the American Medical Association. Postmarketing Surveillance— Lack of Vigilance, Lack of Trust wonder that, in 2003, the pharmaceutical industry ear- Phil B. Fontanarosa, MD marked $4.9 million to lobby the FDA. Drummond Rennie, MD While these concerns are noteworthy, they pale in com- Catherine D. DeAngelis, MD, MPH parison to the shortcomings and failures of the current im- perfect system for postmarketing surveillance. This system is intended to detect adverse drug events and reactions once HYSICIANS AND PATIENTS EXPECT THAT WHEN MEDI- new products are in widespread use, and thereby limit ex- cations are prescribed correctly for labeled indica- posure of the public to hazards of new medications. The in- tions and are used as directed, these medications gen- adequacies of the postmarketing surveillance system (ie, Perally will have beneficial effects and will not cause FDA’s MedWatch program with passive collection of spon- significant harm. This confidence in pharmaceutical prod- taneous reports of adverse drug reactions) for ensuring safety ucts reflects trust in the effectiveness and integrity of the are well known and include: reliance on voluntary report- drug approval and monitoring process. ing

Journal

JAMAAmerican Medical Association

Published: Dec 1, 2004

References

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