EMA Clarifies Adverse Events for Off-Label Drug Use

Drugmakers are expected to collect individual cases of suspected adverse reactions linked to off-label use but not individual reports when there has been no associated adverse event, the EMA said in April.

Ambiguity in off-label use reporting has led to “very divergent and confusing” practices in the pharmaceutical industry, according to the agency’s draft paper. It notes that pharmacovigilance inspectors and drugmakers have misinterpreted the policies governing reporting to mean that they should collect and report all individual cases of off-label use; even those without adverse events.

If companies decide to collect off-label use information not associated with an adverse event, they are not required to submit those in their safety databases.

When off-label use leads to adverse events, drugmakers must report individual cases as individual case safety reports, provide benefit-risk analysis in periodic safety update reports and implement risk minimization measures via risk management plans.

Read the draft paper here: www.fdanews.com/04-29-16-EMAOffLabelReporting.pdf. ― José Vasquez


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