Postmarketing Surveillance – An Imperfect System
The FDA does not and cannot guarantee that all the medical treatments it approves are safe and effective. Thus, it is left to the postmarketing period to identify inferior products, especially those that have deadly side effects. Finding and removing inferior products falls to FDA's post marketing surveillance (PMS) program, but unfortunately the current system is inadequate. The PMS relies primarily on the lowest level of research methods — case reports, which are sent to the agency where they are analyzed and remedial steps taken if the evaluation shows there is an unanticipated problem. However, it was taking the FDA too long to identify a significant problem and decide what to do about it and in the interval; people were suffering and dying needlessly. There were numerous suggestions on how to improve the system, but FDA's response tends to be judged as unresponsive by its critics. To meet the postmarketing challenge the FDA needs the authority to require (1) independent teams to investigate serious adverse reactions; (2) the use of cohort studies to monitor the performance of newly approved drugs and (3) the employment of clinical trials to investigate unresolved efficacy and safety issues.
KeywordsAdverse reaction drug labeling drug safety market withdrawal postmarketing surveillance
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Chapter 24 — Postmarketing Surveillance
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