FDA AUTHORITY ON RECALLS

To strongly encourage the Food and Drug Administration (FDA) to develop a standard recall notification process and format to be used by all manufacturers to facilitate the timely removal of recalled drugs; further,

To advocate that such notification should (1) come from a single source, (2) clearly identify the recalled product, (3) explain why the product is being recalled, (4) provide a way to report having the recalled product, (5) give instructions on what to do with the recalled product, and (6) be provided concurrently to all entities in the supply chain; further,

To advocate that the FDA be given the authority to order mandatory recalls of medications; further,

To urge the FDA to require drug manufacturers and the computer software industry to provide bar codes and data fields for lot number, expiration date, and other necessary and appropriate information on all medication packaging, including unit dose, unit-of-use, and injectable drug packaging, in order to facilitate compliance with recalls or withdrawals and to prevent the administration of recalled products to patients; further,

To urge the FDA to encourage postmarketing reporting of adverse events and product quality issues to enhance the recall system.

Rationale

A recall is a manufacturer or distributor’s voluntary removal or correction of a marketed product. The Food and Drug Administration (FDA) may request a recall in “urgent situations.” For each recall, the manufacturer or distributor develops a recall strategy based upon guidance from the FDA; there is no standard format for recall notices, and communication timelines, format, content, and distribution vary. 

Managing product recalls within hospitals and health systems is a complex process. Past recall events have highlighted the complexity of the process and demonstrate the need for improvements to ensure that recalled product can be removed effectively and efficiently to protect patients from inadvertent administration. During the 2008 recall of heparin, for example, 94 hospitals were found to have recalled product remaining on their shelves. Further evaluation of how the recall was implemented revealed flaws in the system. Some pharmacy departments reported that they never received the recall notice; in other cases, recalled product was shipped to the pharmacy after the hospital had completed its review of supplies and quarantined all recalled product. 

The FDA must have the authority to clearly communicate with stakeholders about recalls of marketed products. Inconsistent, unclear, and confusing information has been communicated during past recalls. A standardized recall notification process and format would enable practitioners and others in the drug distribution chain to readily identify and respond to a recall. Such a notification process should contain the following elements: a single source to designate a point of contact and control communication, clear identification of the recalled product to assist in removing the product from stock, an explanation of why the product is being recalled in order to understand the nature of the recall and communicate with patients and other stakeholders, a feedback mechanism (a reporting loop) so manufacturers and the FDA know where recalled product is located, instructions on how to return or dispose of the recalled product, and concurrent notification of all entities in the supply chain.
ASHP advocates that the FDA be given the authority to order a mandatory recall of a product to avoid the miscommunication that has occurred in past voluntary recalls. In addition, ASHP has long encouraged the FDA to require that lot number, expiration date, and other necessary information be provided electronically (e.g., by bar code or radio frequency identification) as part of the manufacturer’s information on all unit dose, unit-of-use, and injectable drug packaging.

Finally, postmarketing reporting of adverse events and product quality issues must be encouraged. Voluntary reporting will provide information for FDA to analyze to determine with the manufacturer the correct course of action.