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FDA Enlists Big Data to Track Down Pharma Fraud

The views expressed are those of the author and are not necessarily those of Scientific American.

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Predictive analytics—lumped under the faddish banner of Big Data—is the high-profile set of techniques that tame numeric deluges to deduce that a new epidemic is starting to break or that a last-minute steal of an airfare has just popped up. The best uses for Big D may be yet to come, though.

The FDA just issued a solicitation document, a request for quotation, seeking a contractor to comb drug makers’ expenditures, everything from phone calls to educational promotional materials, that would ferret out instances when companies have been peddling drugs for uses that have not received regulatory approval. The  contractor that wins approval would furnish this information in real-time to the FDA’s Office of Criminal Investigations. There’s a latent demand for these services, as the FDA, even without the ability to marshal the desired level of analysis, has discovered some whoppers in recent years: GlaxoSmithKline had to pay $3 billion for pushing drugs off-label: the antidepressant Wellbutrin for weight loss and sexual dysfunction is one example.

This is where Big Data gets interesting.

See Fierce Biotech and Regulatory Focus for more.





Gary Stix About the Author: Gary Stix, a senior editor, commissions, writes, and edits features, news articles and Web blogs for SCIENTIFIC AMERICAN. His area of coverage is neuroscience. He also has frequently been the issue or section editor for special issues or reports on topics ranging from nanotechnology to obesity. He has worked for more than 20 years at SCIENTIFIC AMERICAN, following three years as a science journalist at IEEE Spectrum, the flagship publication for the Institute of Electrical and Electronics Engineers. He has an undergraduate degree in journalism from New York University. With his wife, Miriam Lacob, he wrote a general primer on technology called Who Gives a Gigabyte? Follow on Twitter @@gstix1.

The views expressed are those of the author and are not necessarily those of Scientific American.

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  1. 1. AGaffney 10:06 pm 06/4/2013

    Thank you very much for the link to my article, Gary. I’ll certainly be curious to see how FDA manages to leverage this technology in the future and how industry reacts to the increased scrutiny.

    - Alexander Gaffney (@AlecGaffney)

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