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FDA Drug Event Data Now More Easily Available

Prescription drug errors hurt and kill people in the United States every year. Between pharmacists providing the wrong pills, doctors prescribing the wrong medications, and drug companies marketing unsafe drugs, the problem is staggering. The Food and Drug Administration (FDA) is the federal agency that has been charged with keeping track of complaints about medications. The FDA also announces voluntary recalls of medications when those recalls are initiated. However, up until now, the FDA has not provided the public with easy access to that information.

That is about to change. The FDA announced earlier this month that it is launching a “new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.” This information will all be available at a new website titled openFDA. This new step toward transparency has been in the works for some time, but is being released just shortly after the Centers for Disease Control made their new treatment tracker website available, which is based on records of Medicare payments to doctors.

Helping Improve Medical Care

This could be very helpful to medical malpractice plaintiffs in a couple of ways. First of all, it will now be much easier to find information about complaints about drugs in order to figure out how many people have been affected and how long a drug manufacturer has been aware of a problem. But the second benefit of this information is technological. The FDA states that it is going to make this information easily accessible to technological developers in a user friends way. This means that while the FDA is providing the very basic information and a search platform to find it, other software developers will be able to build on the FDA platform to make more specific programs that can be tailored to an individual client’s needs.

The site is currently only useful for prescription drugs, but eventually its scope will be expanded to some of the FDA’s other areas of regulation. Currently there are plans to add information about medical devices and foods that the FDA regulates. There are additional plans to include information about changes to medication’s safety warnings. The CDC has expressed interest in the project, so it is possible that some day information from both agencies could be combined, creating a large, easily accessible online warehouse for medical information. Of course, since the records are public, personal identifying information is redacted.

The information currently available is staggering. Businessweek reports that the new software will allow the public to browse 3.6 million reports about drug side effects. These reports come from 2004 to 2013, and were originally processed in a wide variety of formats: online, by fax, or even by paper forms mailed to the agency. Due to the open source nature of this project, developers are already creating websites that make the information easier to search.

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