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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.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.