Pharmaceutical Recalls: Strategies for Minimizing the Damage
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Drug Information Journal, Vol. 33, pp. 541-556. 1999 Printed in the USA. All rights reserved.
PHARMACEUTICAL RECALLS: STRATEGIES FOR MINIMIZING THE DAMAGE BRUCER. PARKER,EsQ., AND J. GREGORY LAHR,ESQ. Goodell. DeVries, Leech & Gray, LLP, Baltimore, Maryland
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 k 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. Key Words: Recall; Pharmaceutical; Food and Drug Administration; Product liability
INTRODUCTION ON OCTOBER 4, 1982, Johnson and Johnson announced a nationwide withdrawal of 31 million bottles of Tylenol after seven people died from taking cyanide-laced ExtraStrength Tylenol capsules. Johnson and Johnson’s swift action enabled it to avoid an FDA-requested recall and minimized the possibility of severe financial losses and significant litigation (1,2). This article will review the extent of the FDA’s power to issue recalls of pharmaceuti-
Presented at the DIA 34th Annual Meeting “Thinking Globally: Product Development, Registration, and Marketing in the New Millenium,” June 6-10. 1998, Boston, Massachusetts. Reprint address: Bruce R. Parker, Esq., Goodell, DeVries, Leech & Gray, LLP, One South Street, 20th Floor, Baltimore, MD, 21202.
cal products and the internal procedures by which the FDA effectuates recalls. Also, the effect that recalls have on product liability exposure is discussed. Finally, recommendations for conducting voluntary recalls are offered that will help minimize the potentially devastating effect recalls can have on product liability litigation pertaining to the recalled product. An attempt has been made to present information relevant to both regulatory affairs professionals and lawyers.
AUTHORITY TO ENFORCE THE FOOD, DRUG AND COSMETIC ACT AND CONDUCT RECALLS Brief Overview of the Food, Drug and Cosmetic Act The FDA began actively regulating the manufacturing and marketing of numerous prod-
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ucts in 1938 with the enactment of the Food, Drug and Cosmetic Act (FDCA) (3). This act is authorized by the constitutional power of Congress to regulate interstate commerce, and strives to keep inter
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