In welcome news for the pharmaceutical industry, the U.S. District Court for the Eastern District of New York, in United States ex rel. Polansky v. Pfizer, Inc., 2012 U.S. Dist. LEXIS 163557 (E.D.N.Y. Nov. 15, 2012), issued a decision distinguishing between unlawful “off-label” marketing and lawfully marketing a drug for use outside of recommended guidelines. By way of background, the Food and Drug Administration approves “labels” (which, in some cases, may be lengthy and more akin to pamphlets or brochures) that must accompany prescription medications.  A label states the purposes for which a medication has been determined to be safe and effective, and pharmaceutical companies are prohibited from promoting or marketing the medication for other “off-label” uses.

Since early 2004, Pfizer, Inc. has been defending a qui tam action that its former Director of Outcomes Management Strategies, Dr. Jesse Polansky, filed under … Read More »