Our legal system supports two regulators of the safety of prescription drugs ' the U.S. Food and Drug Administration and courts applying the tort liability regime. The FDA's mission, while narrowly circumscribed in its early years, grew dramatically over the last half of the twentieth century. Today, the FDA administers the most comprehensive drug regulatory system in the world.

In October, Eli Lilly and Co. became the latest drug manufacturer to announce that it will begin limiting quantities of pharmaceutical products shipped to Canadian wholesalers.

Nearly 83,000 Fen-Phen users, including those whose claims have already been approved, may have their payments delayed or denied due to a new scheme instituted by the trustees of the Wyeth Settlement Trust, according to a lawsuit filed Nov. 5 by New York City-based law firm Napoli, Kaiser, Bern & Associates. The suit was filed on behalf of several individuals who are awaiting payment of damages from the trust, formerly known as The American Home Products Settlement Trust.

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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?

Billions of dollars in potential awards, a new map for antitrust litigation, and what many say is a likely spot on the Supreme Court docket; <i>Empagran v. F. Hoffman-LaRoche</i> has it all. What could it mean for U.S. pharmaceutical (and other) companies? "Corporations in this country and all over the world are really scared of this," says Paul Gallagher, a Washington D.C.-based Cohen, Milstein, Hausfeld &amp; Toll partner who serves as lead plaintiffs counsel in the case.

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