The FDA has burnt its hand. Will it now learn a lesson?

The FDA seems rather fond of punishing people – witness the agency’s consistent prosecution of “off-label” speech.  As of late, however, the FDA has misfired in a couple of cases and wrongfully prosecuted innocent companies and individuals.  A conspicuous example of this is the FDA’s recent accusation of Lauren Stevens, the former in-house lawyer at Glaxo-Smith-Kline of lying to the federal government.  This post at the FDA Law Blog shows just how forcefully Judge Roger Titus of the U.S. District Court for the District of Maryland ripped apart the government’s case.

In the wake of the Stevens acquittal, Douglas B. Farquhar of Hyman Phelps posed the big question:  “Will the result in the Lauren Stevens case chill the government’s pursuit of individuals in other circumstances?”

We certainly hope so.  Food and drug companies are quickly becoming some of the most unfairly regulated and prosecuted companies in the country.   The worst part about it is that FDA’s aggressive nature doesn’t just effect these companies in a vacuum; high legal costs and regulatory obstacles translate to ever-higher food and drug prices.  That’s not something we need with the stock market falling and unemployment at 9.2 percent.

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