Incident Dissent

  • by: |
  • 11/18/2013

According to a new letter to the British Medical Journal, “Doctors may not report adverse events or speak up when they witness poor care because of fear of punitive action or lack of confidence that reporting will change anything.”

Whose responsibility is it to build confidence in both the pharmacovigilance process as well as the urgent importance of the proposition?  I believe it’s the job of the regulatory body that oversees the both the procedures and the actions that derive from post-marketing reports. That means (in the US), the FDA.

Would it be nice if the FDA could get additional dollars to ramp up pharmacovigilance beyond MedWatch and Sentinel? Sure, but let’s get real – that ain’t gonna happen. What the FDA does have at its disposal is the bully pulpit. It’s time for Janet, Peggy, and Gerald to get up on their soapboxes and start preaching the urgency and importance of pharmacovigilance.

Such renewed efforts are called for since the focus is now increasingly on patient outcomes. If we can’t measure it, it doesn’t count – or counts for less. Perhaps it’s time for the FDA to create an advisory committee of pharmacovigilance issues – and hold meetings to focus on process improvement, greater stakeholder involvement (not just with physicians, but with pharmacists, hospitals and patients), and better ways to share post-marketing data in a transparent and timely fashion – and not just adverse events and label updates but also Substandard Pharmaceutical Events (SPEs), when patient’s don’t respond as they should when their therapy has been impacted by therapeutic switching or interchangeability/bioequivalence issues.

Can you say, “biosimilars?” It's an adverse event horizon.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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