FDA Targets Rx Cold Meds for Removal from Market

By Mike Rozembajgier

The U.S. Food and Drug Administration (FDA) announced last week that it is going on offense, targeting nearly 500 cold, cough, and allergy drugs that are on the market but that the agency says it has never approved. Concerned about the effectiveness and overall safety of medications, the agency is expecting manufacturers to take appropriate action – which could mean a withdrawal or recall. While the companies that manufacture products targeted by the FDA are already aware of the scrutiny and risks associated with this announcement, they need to understand that this is just the beginning. Their recall management will be closely monitored, and anything less than full compliance could mean further regulatory action.

With this announcement the FDA is publicly cracking down on non-compliant companies – both foreign and domestic – that have failed to register products that have been “repacked, and or re-labeled.” While some of these products may have been approved when they first came on the market, failure to update drug listing information with the FDA is a violation that can lead to tough regulatory action. According to the FDA, products that have been repackaged or relabeled without being properly listed with the agency are considered misbranded.

But repackaging and relabeling issues are not the agency’s only concern. According to Deborah Autor, director of compliance at the Center for Drug Evaluation and Research, the unapproved products pose a variety of concerns such as “excessive amounts of active ingredients or extended-release formulas that don’t function properly.”

This FDA initiative forces manufacturers to think about how they can stay in compliance. How to notify direct accounts and customers who have these products may be one concern.  Additionally, manufacturers must consider how they could remove and retrieve these products from the marketplace if needed. Product retrieval is a complicated and time consuming process that takes careful planning and precise execution to ensure all affected products are removed.

This latest attack on prescription products stems from the agency’s Marketed Unapproved Drugs – Compliance Policy Guide (CPG). Since the guide was issued in 2006, the agency has taken action against unapproved drugs 17 times. In this particular case, manufacturers must take several actions. Companies are required to stop manufacturing the repackaged or re-labeled drugs within 90 days. Shipments of the products must be stopped within 180 days. Manufacturing and shipping of drugs never previously registered with the FDA must be stopped immediately.

This recent announcement by the FDA is another reminder that it is not always the discovery of a severe health or safety risk that leads to withdrawals and recalls. There are plenty of regulations surrounding the manufacture, approval, and sale of products that could force a company to manage a recall. Take the time now to review your recall plans and conduct a mock recall to ensure that when you are faced with managing a recall, your team is ready.