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JUNE 4, 2015

The FDA's Sentinel Initiative

The Food and Drug Administration has launched a new system to assess the safety of prescription drugs after they are approved for sale.

What's the issue?
What's the background?

The FDA's Limited Authority To Require Postapproval Studies

The FDA has the authority to require a drug company to conduct a safety study on an approved drug if FAERS finds a signal or if other studies signal that there may be a problem. But the authority has limits defined in law. For example, the agency can't order such a study unless there's a perceived "serious risk." The FDA has, in practice, set a high bar on the definition of serious risk and has ordered up relatively few postapproval safety studies. In addition, the agency has been criticized for allowing pharmaceutical companies to delay or drag out postmarket safety studies for years, as well as for not sharing full data when such studies are completed.

What's in the law?
  • Prompted by a signal from FAERS, clinical trials, meta-analyses, case reports, or other regulatory bodies outside the United States showing a potential link between a prescription drug and an adverse event or safety risk, the FDA and Harvard Pilgrim staff and authorized researchers from collaborating institutions send a query via a secure portal to Sentinel's network of data partners.
  • The data partners then conduct the query within their systems. All use the same analytical program. The partners are required to update their data sets periodically, with the largest data partners doing this quarterly and less frequent updates coming from smaller partners.
  • The findings are returned from each data partner through a secure portal. A team of data experts ensures the data quality before giving the FDA the findings.
  • A Sentinel probe confirmed FAERS reports and anecdotal accounts from doctors and patients that patients who took the anti-hypertensive drug olmesartan for long periods of time developed intestinal problems. As a result, the FDA added a warning to the drug's label.
  • A Sentinel study of the relationship between the new anticoagulant drug dabigatran (used to treat atrial fibrillation, a heartbeat irregularity) and a purported dangerous risk of bleeding found the drug carried the same risk as other anticoagulants drugs. The finding--still somewhat controversial, with disagreement among experts and additional studies producing conflicting results--contributed to an FDA message to doctors that a reported higher risk associated with the highly prescribed new drug had not been verified.
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