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Is it ever appropriate for a drug manufacturer to disseminate information about an off-label use of a drug? If so, when is it inappropriate? Is the dissemination of such information commercial speech protected by the First Amendment that cannot be proscribed by the FDA? Can manufacturers be held accountable for this speech by the FDA or in a products liability action?
In the wake of the preemption analysis of Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), and the First Amendment analysis of Washington Legal Foundation v. Henney, 202 F.3d 331 (2000), the dissemination of information about off-label uses of prescription drugs and medical devices is enigmatic legal territory. In the eyes of many commentators, these cases address entirely different issues. The two fight for the same territory, however, and both confuse the already foggy legal backdrop against which drug manufacturers' communications with doctors take place.
The Off-Label World
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
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