NCPA - National Center for Policy Analysis

Prescription Drug Safety

June 9, 2015

The Food and Drug Administration has launched a new system to assess the safety of prescription drugs.

Prescription drugs are a mainstay of medical care. In particular, people who have chronic conditions may take prescription medicines every day for years or decades. Generally, these treatments have been shown to manage or improve patients' health. But all drugs carry some risks. Many risks only become evident after drugs reach the market and begin being used.

Prescription drugs undergo clinical testing for efficacy and safety before the FDA approves them for marketing. But preapproval clinical trials cannot detect every possible adverse reaction or safety issue that a new drug might cause. This is due to the fact that prescription drugs are almost always tested in limited numbers of patients in controlled settings, and the trials often exclude key populations of patients who would get the drug after its approval.

Here is how the system works to proactively assess drug safety:

  • Prompted by a signal from FAERS, clinical trials, meta-analyses, case reports, or other regulatory bodies showing a potential link between a prescription drug and an adverse event or safety risk, the FDA and other staff 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.
  • 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.

Sentinel has tremendous promise. But the FDA has yet to prove that it can use this new tool to its full potential. That may now change as Sentinel transitions from a pilot project to a full-scale program.

Source: Steven Findlay, "The FDA's Sentinel Initiative," Health Affairs, June 4, 2015. 


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