FDA Sentinel: Catching Biopharmaceutical Sponsors by Surprise

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Applied Clinical Trials

This article will discuss FDA's post-marketing surveillance programs, and how biopharmaceutical sponsors can work with the FDA to identify unreported Adverse Events.

The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program, Andrew C. von Eschenbach stated, “The full magnitude of some potential risks does not always emerge during the mandatory clinical trials conducted before approval.” 1 This article will discuss FDA’s post-marketing surveillance programs, and how biopharmaceutical sponsors can work with the FDA to identify unreported Adverse Events (AEs).

Most Post-Marketing AEs are Not Reported

Unfortunately most post-marketing adverse effects are not reported, according to a report from the Department of Health and Human Services (DHHS). 2  This report indicated that 86% of adverse events were not reported from medical institutions; of these unreported adverse events, 61% resulted from a lack of staff perceiving and reporting the event, whereas 25% resulted from the staff knowing of an AE occurrence, but, did not report it. 2

In order to promote a culture of safety, a recent IOM report suggested that the FDA embrace safety reporting methods and infrastructures that involve numerous outside partners, and that the culture of safety will need to penetrate industry, academia and other healthcare organizations to evangelize the identification and reporting of safety outcomes. 3

The Sentinel Initiative and What it Means for Sponsors

In 2008, the FDA launched the Sentinel Initiative, which is an electronic system that integrates into hospital Electronic Medical Records Systems (EMRs) in order to monitor post-marketing safety events.4  The system essentially takes an active approach towards detecting safety outcomes; for example, the FDA can run a query for a specific adverse event, and detect it as soon as it is recorded in a patient’s EMR.5  It is not known how many hospital systems Sentinel is integrated with, however, a recent blog from the FDA indicated that Sentinel evaluated the safety of two vaccines and uncovered that these vaccines slightly increased the risk of a rare bowel problem compared to previous observational trials.  A sponsor voluntarily withdrew one of its vaccines from the market due to this risk. 5

Sentinel poses a challenge for drug Sponsors because the FDA can now catch sponsors by surprise and may impose unexpected black box warnings, and recommendations for withdrawals.  For sponsors, such findings can adversely impact drug sales, and revenue forecasts not only for newly released medical products, but, also for medical products that have been approved and on the market for a longer period of time.


Getting Along With Sentinel: How Sponsors can Collaborate with the FDA

Drug sponsors currently leverage traditional methods in order to capture AE reporting.  I recall when I worked at the sponsor level, that many sponsors imposed extensive training on AE reporting, which required an obligation to report an AE if an employee heard it in a conversation on the plane, or reading about it on someone’s Facebook post.  While these systems are merely in place to protect the sponsor from litigation and penalties from the FDA, the approach of existing reporting infrastructures remains passive.  In order to take an active approach, and embrace a culture of safety, sponsors should employ AE reporting systems similar to Sentinel, systems that employ an active approach.  If sponsors take an active approach by leveraging aggregated EMR systems to seek out and report AEs, they are less likely to be caught by surprise by the FDA.

An Active Approach Towards AE Reporting: Expect the Unexpected

Leveraging aggregated EMR allows Sponsors to not only acknowledge the reality of their medical product’s safety outcomes on patients, but also prepare for potential setbacks, enhance communications with the investment community, proactively report AEs to the FDA, and most importantly, protect patient safety.



  1. The Future of FDA's Drug Safety Program
  2. Hospital Incident Reporting Systems Do Not Capture Most Patient Harm
  3. Challenges for the FDA: The Future of Drug Safety, Workshop Summary.
  4. FDA's Sentinel Initiative
  5. The Sentinel Initiative: Access to Electronic Healthcare Data for More Than 25 Million Lives.