FDA Calls on Drugmakers to Be 'Recall Ready'

Final guidance is available that clarifies the agency's expectations about voluntary product recalls.

The U.S. Food and Drug Administration recently finalized guidance urging companies to be "recall ready" to protect public health and outlined the steps to do so.

The 13-page final guidance document largely resembles the 2019 draft version, apart from several additions that provide further clarity on the agency's expectations when it comes to initiating voluntary product recalls. It speaks to how the agency had to shuffle around priorities because of the COVID-19 pandemic, though the draft was issued beforehand.

"Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe," said Judith McMeekin, FDA associate commissioner for regulatory affairs, in a press release. "It is critical that all companies in the supply chain are 'recall ready' to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain." The outlined policies are intended to be used across all FDA-regulated industries.

Recalls of prescription drugs, however, do not fall under FDA's legal purview like medical devices and other products, placing greater responsibility on drug manufacturers to initiate voluntary recalls. "We will continue to work with companies to improve their recall procedures and minimize Americans' exposure to potentially harmful products," McMeekin added.

The final guidance defines two new terms—correction and market withdrawal. It defines a correction as the repair, modification adjustment, relabeling, destruction, or inspection of a product without physically removing it. A market withdrawal refers to a firm's removal or correction of a product in distribution involving a minor violation of FDA regulations.

A total of 17 comments were submitted to the drafted guidance document by various stakeholders.

The FDA made some of the revisions requested. The main message of the guidance, which stresses that "it is critical for firms in a product distribution chain to be 'recall ready,' " remains the same as the draft version. Yet the following statement nixed the language about helping to "minimize public exposure to products that are in violation of the FD&C Act and other laws administrated by the FDA." It points to the list of general preparations that companies should have "as appropriate and applicable to its operations" and newly adds to the finalized version that they should apply the recommended preparations "in advance of when a recall may be needed."

The general preparations the FDA recommends include identifying appropriate personnel, training personnel on their responsibilities, establishing a recall communications plan, identifying reporting requirements for distributed products, using adequate product coding, as well as maintaining distribution records. The finalized version adds examples to the last two recommendations.

The Consumer Healthcare Products Association (CHPA), however, had argued against recommending specific coding or recordkeeping practices. "[I]t is unnecessary to include any additional coding or recordkeeping requirements in the Recall Draft Guidance," John Punzi, senior director of quality assurance and technical affairs at CHPA, wrote in the group's submitted comment. "Current recall processes and procedures have worked well in the past and remain effective today. Recalls of OTC products are rare, and little benefit would be seen with an added burden of additional coding," he added. Yet implementing FDA guidance is not required.

"While this guidance is nonbinding, manufacturers and companies within a product's distribution chain should keep FDA's recommendations (and applicable recall-related regulations) in mind when planning for or initiating a voluntary product recall," noted global law firm Faegre Drinker.

Additional policies set forth via the guidance document relate to procedures for initiating a recall, what to do if there is an indication of a problem with a distributed product, and how the FDA works with a firm recalling a product to ensure the recall is initiated in a timely manner.

As requested by the International Society for Pharmaceutical Engineering and others, the final guidance clarifies that a comprehensive list of contact information for FDA recall coordinators is available on the FDA's website in recommending consulting with agency staff about the problem. 

The guidance also coincides with a decrease in the number of FDA-reported product recalls for FY 2021, ending in September 30. The agency's recall data dashboard indicates 5,310 products were recalled in 2021, down from 7,252 in 2020. The drop represents the lowest number of annual recalls since the FDA first started making recall data publicly available in 2012, with 3,208.