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Taking Away Your Pills

Taking Away Your Pills

Examining the Varied Blueprint for Pharmaceutical Recall and Withdrawl

16 June 2007

Product recalls are an accepted phenomenon of American commerce. Companies routinely issue public alerts to make consumers aware of defects in manufactured goods that become known through marketing surveillance. They remedy the problem by either replacing the faulty part, or if a fix is not possible, withdrawing the product entirely from the marketplace. The expectation is that the manufacturer is proactively looking out for the safety of its consumers. This process can be more complicated in the pharmaceutical industry because of the time and expense of developing and testing drugs , the difficulty in isolating a direct link to the problem from the drug in question, and – in high profile cases – lapses in ethical judgment regarding the safety of patients, clouded by the magnitude of lost potential revenue. In addition, with branded prescription pharmaceuticals, there is pressure by stakeholders to maximize the revenue of a given drug during its window of exclusivity granted by the Food and Drug Administration (FDA) before the compound is opened up to generic competition . These variables can result in a significant range of inconsistency regarding the urgency of action taken by companies in addressing products recalled or withdrawn for very similar reasons.
This paper will investigate the varied actions surrounding pharmaceutical product recall by looking at three different cases – Tylenol, Baycol and Vioxx. It will discuss the factors that weighed into the decision-making and steps taken by the manufacturers, elucidate how information was collected and disseminated, measure the swiftness of each response and examine the consequences that arose from each deliberation, both to the company and to the public. The threat or safety determination for these drugs will be considered – with the information available to them at the time – as will...