A Six-fold Increase in Manufacturing Discontinuance Notices Helps FDA Ease Drug Shortages, Agency Reports at House Hearing

FDA has experienced a six-fold increase in notifications of product discontinuance or other problems that could cause a potential prescription drug supply disruption since an executive order and a follow-up agency letter to manufacturers were issued at the end of October.

The executive order directed FDA and the Department of Justice (DoJ) to take action to help further reduce and prevent drug shortages, protect consumers, and prevent inappropriate stockpiling and exorbitant pricing of prescription drugs in shortage situations. The order also directed the agency to use all appropriate administrative tools to require drug manufacturers to provide adequate advance notice of manufacturing discontinuances that could lead to shortages of drugs that are life-supporting or life-sustaining, or that prevent debilitating disease.

The follow-up letter sent by FDA to pharmaceutical manufacturers reminded them of their current legal obligations to report certain discontinuances to the agency and urged them to voluntarily notify it of all potential disruptions of the prescription drug supply to the US market, even where disclosure is not currently required by law.

The executive order and the FDA letter resulted in an immediate spike in the number of potential shortages reported to FDA that has continued into 2012.

In the ten months preceding the actions (January through October 2011), FDA received an average of approximately ten notifications per month. In the month following the letter and the executive order, the agency received 61 notifications.

[A report on the discussions at a February 9 House hearing regarding drug shortages and links to the prepared testimonies are provided for subscribers here.  Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (Jonathan@ipq.org).  For subscription/license information, click here.]