Originally Published MDDI June 2005

NEWSTRENDS

Erin Bradford

If your product has a problem after its market launch, are you prepared to deal with the consequences? A recall is appropriate if the product violates the laws that FDA administers and if the agency would likely initiate legal action against the product.

But a recall may not be the best answer. Sometimes a market withdrawal or a stock recovery can do the job. However, if a recall is the appropriate choice, recall standard operating procedures (SOPs) are the most important tools a manufacturer can have, said Robert J. Bard. Bard, vice president of regulatory affairs and quality systems at Aastrom Biosciences Inc. (Ann Arbor, MI), gave this advice at the Regulatory Affairs Professional Society conference in San Francisco in March: “It is critical that recall SOPs have been created and are up to date,” he said.

The first step, Bard said, is to know how to handle a problem. “Preparing the recall SOPs well before they're needed should be a part of your overall QSR policy,” he explained. They should identify a decision-making team and outline the ways the team will determine whether a recall is appropriate. In addition, the SOPs should create a recall plan, a health hazard assessment plan, and a method for communicating the recall to the appropriate entities.

Identifying the recall team is critical. The team should be made up of people who will be available to make the decision as quickly as possible, Bard noted. The members can be from regulatory affairs, quality, legal, engineering, sales, marketing, and distribution departments. “The most important thing is that they should be able to provide answers to the ‘who,' ‘where,' and ‘how much' questions,” Bard said. “They need to know about the product. Who has it? Where is it? How much is there?” In addition to identifying a team, the SOPs should name a responsible party who may authorize the recall and be FDA's contact person in the company. Usually, this falls to an executive-level employee, like the president or CEO.

The team's job is not easy—determining a recall can be difficult. However, if a company's SOPs are in order, the team should be able to make that decision. The SOPs state the conditions and processes for making that determination. “You don't want to drag your feet, but you also don't want to move too quickly and make mistakes,” Bard said. “So when designing your SOPs, it's important to think about how your company is going to decide whether to issue a recall.”

Once a company has decided to issue a recall, it has a number of responsibilities. It must perform a health hazard analysis and report those findings to FDA. In addition, a company must be able to track the product through distribution. Difficulties can arise here as well. What if the recalled part is a component of a larger system? What if it's disposable? The depth of the recall depends on the distribution of the product: consumer, retail, or wholesale. The recall SOPs should include methods and processes for performing these tasks.

Finally, it's very important to decide who the company should notify to make sure the message about the recall gets out. In those messages, a company should identify what's wrong with the product—don't skirt the issue, said Bard. However, also make your plan of action, or what you're going to do about the problem, apparent.

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