The FDA recently completed its “Internal Review of Agency Actions Related to the U.S. Infant Formula Supply.”
In general, this report has few real planned actions and does not fill me with the hope of internal changes driving improvement.
One of the recommendations really stood out to me. Finding 2 states “Inadequate processes and lack of clarity related to whistleblower complaints may have delayed the FDA’s response to those complaints. A complaint sent via mail and other delivery systems by a confidential informant to agency leaders at FDA’s White Oak campus was not delivered to the addressees.”
Recommendation: The FDA should identify clear definitions for the terms “whistleblower,” “confidential informant,” and “informant,” and develop policies and provide training to staff regarding how to identify, escalate, and appropriately manage confidentiality of such complaints. The agency should also consider connecting complaints from such individuals to information received from product safety complaints, and product manufacturing concerns systems to support more complete access to all safety information. The FDA is evaluating how best to integrate this data to gain a holistic view of all FDA-regulated products and/or manufacturing facilities. The FDA should also review and update its mail and package delivery procedures to ensure that all mail and packages are delivered and received by addressees in a timely manner.FDA Evaluation of Infant Formula Response
There is a real lack of whistleblower protection in this industry. Often when you hear about a crisis, from baby formula to Theranos to the opioid epidemic you have you have to ask “where were the good people at that company.” It can be rather disheartening. It has long been worrisome that the FDA does not have strong whistleblower protection in place, and to see how definitely that contributed to this debacle is just plain scary.