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OpenFDA and the Future of Drug Safety Information

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The FDA has collected millions of records on adverse drug events since 1998, amounting to the world’s largest catalog of how drugs interact with the human body. The FDA publishes bulk files on a quarterly basis; however, it takes a great deal of expertise and software to understand the data. Also, the information is extremely inaccessible for anyone outside the FDA (e.g., viewing a report on a specific drug requires a Freedom of Information Act request), making it almost impossible for everyday citizens and physicians to make informed decisions about prescription drugs.

In January 2014, the FDA began the openFDA project to release datasets covering adverse drug events, recalls, and drug documentation. Beta access to the database is expected by this summer, followed by a full launch in the fall. 

Startups have tried to use the FDA’s bulk files to provide information for consumers and clients in the health care industry. For example, AdverseEvents creates reports based on the FDA’s bulk files for insurers and hospitals. DrugCite allows users to search for side effects by medications online. Founders from both organizations have expressed frustrations with the current FDA data, citing challenges such as duplicate records, misspelled drug names, and piecemeal files. Once openFDA is launched, more entrepreneurs and software developers will likely create websites and applications to satisfy the public demand for drug safety information.



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