Pharmaceutical Recalls: Strategies for Minimizing the Damage

Abstract

With the increasing complexities of the design and manufacturing processes, more stringent inspection procedures, and the product liability and regulatory burdens under which manufacturers operate, the odds are that a pharmaceutical firm will undergo a recall of one of its products.

The ability of a firm to execute an effective recall strategy is crucial in the litigation arena. As a firm enacts a recall plan, its efficiency and effectiveness, its relationship with Food and Drug Administration officials, and the overall perception of the firm's attempt to remove its “harmful” product from public exposure, can have a very powerful positive value in product liability litigation. If done wrong, a recall can impact a company in product liability exposure, sales, manufacturing costs, and public perception.

This article will explore various recall strategies and propose steps by which a firm can minimize its damage. An overview of the involvement of the Food and Drug Administration (FDA) is provided, and appropriate recall strategies are presented.