OpenFDA? Well, maybe ajar

  • by: |
  • 06/03/2014

The FDA has publicly released a huge amount of data on drug side effects that it hopes will lead to new applications and research.

Under its open FDA project, the agency has released more than 3 million reports on adverse drug events and medication errors recorded between 2004 and 2013. These kinds of reports were only available before through lengthy Freedom of Information Act requests. 

Before releasing the information, the agency removed patient identification and other sensitive information. It has also been formatted to let researchers, mobile applications and Web developers easily analyze the data and present it in a way that can help improve how people take drugs.

Eventually the agency plans to release more reports on recalls and labeling, as well as other information it thinks can be useful to developers and researchers.

The move to make medical data more transparent isn’t limited to the FDA. Several drug makers working with the National Institutes of Health have begun releasing clinical trial data in a limited fashion to help find new uses for old drugs. 

Obvious by its absence is any mention of greater clinical trial transparency. But that's a whole other can of worms. (For more on this issue, see "Cry Havoc, and let slip the Dogs of Data Transparency.")

A good next step would be for the FDA to be the coordinating body for all relevant e-tized information from both public and private sources. But that’ll take resources. It would be money well spent.

Speaking of transparency – how about an OpenFDA program for the agency’s risk/benefit decision-making process?


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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