Recalls, Withdrawals and Corrections: Defining Market Actions
Market actions, taken by pharmaceutical manufacturers, are essential for ensuring product safety, maintaining regulatory compliance for the manufacturers involved and protecting public health along with business relationships. These actions, undertaken by drug makers under various circumstances and focused on addressing a range of product-related issues, fall into three categories: recalls, corrections and withdrawals.
Each are unique in origin, execution and intent but all are necessary to protect supply chain integrity and, in turn, consumer and trading partner confidence. Therefore, understanding the key aspects of all three types of market actions is critical for ensuring that the public health, and business, benefits resulting from their successful execution are realized.
Recall
A recall is a comprehensive removal of a product from the marketplace -- including removal from retailer and wholesaler stock and, when called for, retrieval from consumers having purchased the product prior to the recall having been issued. Recalls are a significant undertaking and are initiated in response to a consumer safety concern resulting from a defective or potentially harmful product determined to be in violation of the laws and regulations administered by the Federal Drug Administration (FDA).
A drug recall is most often initiated as a voluntary action by the manufacturer but may be requested by the FDA. While the FDA does not “physically” participate in a recall, the agency does classify the recall, oversee a company’s recall strategy, and assess the adequacy of the company’s efforts in removing the defective product from the marketplace. And, if a recall is determined by the FDA to be inadequate, the agency will request the company involved take additional actions to ensure every effort has been made to effectively protect public health.
Withdrawal
While sounding somewhat ominous, and involving removal of a product from retailers’ stock, a market withdrawal does not share the more serious origins of a recall nor does it involve oversight or assessment by the FDA.
A market withdrawal is a voluntary removal of a product by its manufacturer when the product does not violate relevant regulations or pose a serious health risk. Rather, it is a business-focused effort addressing routine issues such as stock rotation and equipment repair or adjustment.
Correction
A correction is another business-first action taken by a manufacturer to address minor product needs. It does not involve the physical removal of the targeted product and does not relate to regulatory matters.
Corrections occur much less frequently than either of the other two market actions -- largely because of alternative strategies available to address identified issues.Typically, these market actions involve overlabeling a product or replacing included literature with updated or correct materials.
It is the case, most often, that manufacturers -- out of consideration for their retail trading partners -- will opt to execute a market withdrawal to make any needed corrections.
Market actions, for better or worse, are the cost of doing business for pharmaceutical manufacturers. However, understanding their different attributes can help manufacturers better manage that cost.