ing of adverse events provides a signal or hypothesis that may be further evaluated by epidemiological methods and forms the basis for further epidemiological studies when appropriate (FDA, 2005b). Manufacturers must report to the FDA the following serious and previously unknown adverse events within 15 days of their occurrence and conduct a follow-up investigation (FDA, 2005c):

  • Events associated with drug use in a professional practice

  • Events resulting from accidental or intentional overdose

  • Events occurring from drug abuse

  • Events occurring from drug withdrawal

  • Any failure of expected pharmacological action

The analysis of serious adverse events identifies issues that should result in changes to drug labels or that require physician notification of adverse events. This information, as Anne Trontell, deputy director of the FDA’s Office of Drug Safety, noted, allows the FDA, in collaboration with the manufacturer, to ensure that there is effective product labeling to alert health-care practitioners and patients to possible safety risks and areas of risk prevention.

Daniel Troy, a partner at Sidley Austin LLP and former chief counsel at the FDA, added that after a drug is approved by the FDA, manufacturers must submit quarterly reports for the first three years and annual reports after this three-year period. The FDA can extend the quarterly reporting period upon written notice. The content of reports includes a narrative summary, analysis of information in the 15-day alert reports, and a listing of actions taken since the last report, such as labeling changes or any studies that were initiated. The FDA can withdraw the approval of a drug if the correct reporting has not occurred.

The FDA does not conclude from a submitted report that a drug is the direct cause of an adverse event, but rather that the event is associated with use of the drug. The FDA does not impose on physicians any legal requirements for reporting adverse events because it lacks authority to regulate the practice of medicine, a responsibility of individual state governments. Currently, 20 states have mandatory reporting systems, but according to Mr. Troy his experience has been that there are known cases of adverse reactions that are not reported. In states without mandatory reporting systems, report submission is completely voluntary and therefore dependent on the participation of health-care professionals. Possible reasons for underreporting include the time it takes to complete a report, fear that reporting events will have a negative effect on the practice of medicine, and liability concerns. Mr. Troy recommended that the AERS be streamlined to encourage reporting, for example, a single-page form



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement