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Practice Tip: The FDA's Good Reprint Practices and Product Liability
The Food and Drug Administration (FDA) recently finalized its guidance document entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices” (the “GRP Guidance”), which describes the conditions under which the agency will allow drug and device companies to disseminate certain off-label use information proactively. Because dissemination of off-label information has the potential to affect product liability exposure, it is worth examining the content of the GRP Guidance carefully. To illustrate the point, I note that the GRP Guidance and the recent sermon of my rabbi share similar characteristics. Both focus on the potential of good news, but also offer a note about caution in saying too much.
My rabbi related a joke he heard: A man is pulled over by a state police officer. The officer informs the driver, “Your license number was drawn in a special lottery, and you won $1 million.” The driver responds, “Even though I don't have my license?” and his wife, in the passenger seat, offers, “Officer, don't listen to a word he says, he's drunk.” The man in the back seat chimes in, “How did he know this is not your car?” I will not attempt to convey my rabbi's moral message from this tale but, for some reason, it made me think of the FDA's GRP Guidance. My mind works in mysterious ways. While the guidance offers pharmaceutical and medical device manufacturers guidance about disseminating specific kinds of off-label information according to proscribed conditions, companies must be careful and cautious in recognizing the potential trapdoor of product liability exposure if they say too much.
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