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  • Writer's pictureKirk Hartley

A New Drug Company Example of Be Careful What You Wish For

The good news for drug companies is that a federal judge in New York agrees there is a 1st Amendment right to provide information to consumers about off label uses of FDA approved drugs. The not so good news is that various defense oriented lawyers think those actions will take away FDA preemption arguments that drug companies depend on in many cases. For example, consider this quote from an August 10, 2015 article at LAW360:

In theory, this ruling frees companies to promote their drugs more broadly for uses not approved by the FDA, so long as what they say is truthful and not misleading,” Jennifer Bragg of Skadden Arps Slate Meagher & Flom LLP said.

“But any arguments that companies might have previously had that their statements were consistent with FDA’s approval will not be available, to the extent that cases pertain to alleged injuries from off-label uses of their products,” she said.

Be careful what you wish for ….

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