Morgan Lewis on Life Sciences
July/August 2006

In this Issue:

• New Developments and Product Liability Implications of FDA Prescription Drug Labeling Rule:
  The January 2006 Food and Drug Administration (FDA) final rule on prescription drug labeling, with its significant product liability implications, opens the door to judicial interpretations of FDA’s pronouncements. A recent district court case sheds some light on how this area of law is beginning to evolve. This article briefly revisits the provisions of the January rule, discusses reactions to the rule in recent litigation, analyzes the recent district court decision, and provides practical suggestions for drug manufacturers in the context of defending product liability actions related to product labeling and the FDA approval process.
• EU Pharmaceutical Review:
  2005 heralded a number of significant changes for the European pharmaceutical industry, thanks in large part to three new pieces of EU legislation that completely overhauled the existing pharmaceutical regulatory framework. As a result, 2006 promises to be an interesting, albeit challenging, year for many pharmaceutical companies as they come to terms with the changes and their impact on the industry.
• Events, Speeches, and Articles

For the full story, please view the PDF.