Pharmaceutical Recall Announcements

The U.S. Food and Drug Administration (FDA) and a pharmaceutical manufacturer have agreed that a drug recall is necessary because of the health risks to which consumers are exposed.

What happens next?

Importantly, a recall plan is finalized and implemented, in cooperation with the FDA. The goal is to advise the entire marketplace that the drug recall has occurred, and to disclose the steps that the regulators, manufacturers, and retailers are taking to guarantee an effective recall. Equally important, the FDA insists on the efficient communication of drug safety information to consumers, and what consumers may need to do to protect themselves.

In fact, in September 2009, the FDA further raised the standard in its “Strategic Plan for Risk Communication.” That document called for the agency to enhance its own public communications initiatives – even as it further identified the communications tools and resources that manufacturers and retailers must employ during a pharmaceutical recall.

These recall logistics can be very complex during a drug recall. The FDA will issue a public health advisory press release and post critical information on its website, but it is incumbent on the manufacturers and retailers to have a recall strategy in place that guarantees efficient recall notification.

Effective recall management requires manufacturers to have their pharmaceutical distribution lists immediately available in order to reach a typically far-flung network of retail outlets, hospital pharmacies, medical providers, and, first and foremost, all consumers.

Drug recalls require both outbound and inbound notification channels. Outbound notification immediately apprises all affected parties of the drug recall. A record of every outbound notification is required to meet FDA recall compliance standards.

Inbound notification channels field the thousands of drug recall questions that consumers, medical providers, and retail outlets will have as soon as a recall is announced. All inbound notifications need to be tracked for compliance with recall reporting guidelines.

Companies that fail to master the recall notification logistics, or who don’t have the in-house capacity for effective recall management, are at severe risk of non-compliance and, consequently, of suffering devastating harm to their brands. For manufacturers as well as retailers, the recall services of outside recall agencies are a critical resource for early preparation and recall planning well ahead of need.