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Letters

Postapproval Drug Safety

The authors’ survey was limited to "postapproval safety activities." To argue, as the paper’s title does, that these activities account for drug manufacturers’ spending on postapproval drug safety, misrepresents pharmacovigilance today. At best, the $56 million reflects only what is spent on complying with regulatory requirements, not on comprehensive pharmacovigilance programming globally and locally.

Managing adverse-event information is a small part of pharmacovigilance; looking only at it ignores activities integrated into other postmarketing programs: trials, observational studies, registries, practice patterns/outcome surveys, claims databases and other electronic sources that respond to safety issues, regulatory filings, and legal analysis.

Postmarketing studies have been criticized as being driven by strategy, not safety. Biopharma is making a remarkable effort to mount integrated postapproval programs: clinically beneficial, scientifically defensible, transparent, accommodating to—but not compromised by—commercial priorities, and yielding data assets supporting pharmacovigilance. To exclude these activities disregards the true spending and underlying commitments, and it misinforms all stakeholders in drug safety. At best, the $56 million estimate is the reported spending by corporate headquarters on regulatory safety compliance, not on comprehensive postapproval pharmacovigilance programming, internal and external, stand-alone and integrated, global and local. The two cannot be separated.

In today’s volatile drug safety debates, ambiguous financial estimates are at best of limited benefit to the various stakeholders. It is only a matter of time before the $56 million figure in the paper will be taken out of context, misappropriated, and cited with disregard for the partial merit—but also severe limitations—of the Ridley exercise.

Ivo L. Abraham and Karen M. MacDonald

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