The Food and Drug Administration (FDA) should make its recall process public and provide industry guidance on the issue, according to a recent report by the U.S. Government Accountability Office (GAO). The GAO also recommends that the FDA update its communications policy to ensure that accurate data reaches the public during a recall.
According to the report, the FDA has an internal process for determining when to recall a product, including determining what evidence is sufficient to order a recall, offering a company the chance to issue a voluntary recall, and providing a company the opportunity to challenge a recall decision. However, the GAO notes that these procedures have not been made public nor has industry guidance been drafted to clarify the process.
The FDA’s internal reporting of recalls is also problematic, according to the report. For example, when conducting research, the GAO was told by one FDA office that there had been nine recalls of medical devices in the agency's history and none between 2006 and 2010. However, another office told the GAO that three of these recalls had been between 2006 and 2010. Such discrepancies make accurate records difficult, noted the report.
The GAO also recommended that the FDA develop a more balanced communications program to notify the public during a recall. The FDA needs to balance technical accuracy with timeliness, says the GAO, and coordinate messages with other agencies to ensure that the needs of diverse audiences are met.
Of the FDA, the report says: “The agency has taken steps to begin meeting these challenges but has yet to fully address recommendations from GAO and others to fashion a comprehensive food recall communications policy and related implementation plans.”
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