Pharmaceutical recalls are disruptive to the normal course of business and can result in heightened regulatory scrutiny. Nonetheless, they are necessary to ensure continued patient safety. Given the impact on business operations, companies must first decide if a recall is warranted and, if so, have a plan for execution and a strategy for mitigating any potential damage caused by the recall.

Recall Basics

Generally, companies should remove from the market any products in distribution that are beyond their control and that are determined to be in violation of the Federal Food, Drug, and Cosmetic Act or U.S. Food and Drug Administration (FDA) regulations. The mechanism used to remove the violative product from the market will depend on the nature and extent of the violation. The two primary mechanisms are recall and market withdrawal.

“Recall” is the “removal or correction” of a marketed product that FDA would deem to violate the law (e.g., that is adulterated or misbranded). If FDA chose to do so, it could take enforcement action against the product because of its statutory powers and could mandate a recall. In most cases, however, companies choose to conduct voluntary recalls. For example, an out of specification result during expiration testing that occurs at a time period before the labeled expiration date would be considered a recall situation.

Any company deciding to voluntarily initiate a recall must notify FDA and provide certain information outlined in the regulations, including the product involved and the reason for recall; the company's risk evaluation of the problem; the total amount of product in distribution; the proposed recall strategy; and a copy of the proposed or distributed recall communication. In conjunction with FDA, companies typically consider whether the recall is considered a Class I, II, or III recall event. Classification is necessary to determine how “deep” a recall extends (e.g., to direct accounts or to the consumer level) and what the recall follow-up plan should look like.

If a company does not voluntarily conduct a recall that FDA believes is warranted, then FDA can mandate the recall. In this case, FDA will conduct a health hazard evaluation to determine the recall class and will inform the company of its decision.

In contrast to a recall, a “market withdrawal” is the “removal or correction” of a marketed product involving either no violation (e.g., normal stock rotation) or only a “minor violation” that would not make the product subject to FDA enforcement action. Unlike recalls, market withdrawals do not require FDA notification.

Recommendations

When considering whether a recall is warranted—and, if so, what steps to take—companies should keep several things in mind.

  • If a recall is warranted, prepare the information that FDA will require for a voluntary recall, but do not unnecessarily delay. Companies may need some time for an expert to assess the situation, but do not take undue time before contacting FDA.
  • Ideally, draw upon a prepared recall action plan or recall standard operating procedure (SOP). A strong plan will include such things as who constitutes the company's recall team; who is the contact person with FDA; how and when recall notifications will be provided; and who will be responsible for recall logistics, including accepting returned product and product destruction (if appropriate). Plans may also include direct account contact information to streamline the recall process.
  • Consider the need for a PR or crisis management team. Importantly, recall communications must be straightforward and factual and cannot contain extraneous or self-serving company or product statements. However, depending upon the prominence of the brand and potential media coverage of the recall, it may be important to have a plan to avoid loss of consumers.
  • Plan for the future. For example, consider strengthening your contract with a contract manufacturer to explicitly state which party determines when a recall is necessary and conducts the recall, and how recall costs will be allocated.

Thankfully, recalls do not happen every day. When they do, they are stressful events that take resources and people away from their normal business activities. It is therefore important to make sure that you understand what is required during a recall and have an experienced team in place to execute on a recall plan.

Originally published by Stericycle Expert Solutions, Apr 10 2020.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.