FDA Issues Draft Guidance on Post Approval Drug Safety Issues

FDA is seeking public comment on this guidance that details a system for handling postmarket drug safety issues, including drug quality and serious adverse events. CDER will use hazard assessment criteria and will then apply certain modulating factors to classify a newly identified safety issue. CDER staff will first apply the criteria used to estimate the hazard to yield a preliminary classification of either priority or standard.

Priority issues may then be classified as emergencies, if they have involved fatalities, have the potential to affect a very large number of patients, and if lives can be saved or if serious harm can be prevented by prompt action. Emergency issues will be immediately elevated to the attention of senior management. All tracked safety issues (TSIs) not classified as priority or emergency following this approach will be considered standard.

The hazard is then judged against three factors:

(1) the relative seriousness of the issue; (2) the estimated size of the population exposed to the risk of the drug; and (3) the suspected frequency of harm to patients exposed to the drug. The combination of factors 2 and 3 provides an estimate of population risk; the combination of factors 1 and 3 provides an estimate of personal risk to the patient.

Here is the guidance in pdf form.