Non-binding Guidance: A Recall Readiness Rundown and Recent FDA Actions

This episode of Ropes & Gray’s podcast series Non-binding Guidance explores recent FDA guidance on recall readiness and other recall-related hot topics. In recent months, we have seen a trend of increased FDA inspection and enforcement activity as the impact from COVID-19 starts to lessen. Earlier this year, FDA also finalized guidance on the Initiation of Voluntary Recalls under 21 CFR Part 7, Subpart C, which explores FDA expectations regarding the process companies should already have in place ahead of a potential recall situation. Join Ropes & Gray FDA regulatory attorneys Josh Oyster and Beth Weinman as they provide a quick refresher on recalls and discuss the latest recall readiness suggestions from the Agency to help companies make decisions about how and when to recall their FDA-regulated products and how to involve FDA in that process. They also discuss FDA’s recent recall-related actions that invoked rarely-used legal authorities applicable to medical devices.

Transcript:

Josh Oyster: Hi, everyone—welcome to Non-binding Guidance, a podcast series from Ropes & Gray focused on current trends in FDA regulatory law and other important developments affecting the life sciences industry. I’m Josh Oyster, a partner in the life sciences regulatory and compliance practice at Ropes & Gray, based in Washington, D.C. And I’m joined today by my colleague, Beth Weinman, a counsel in our practice who’s also based in D.C. On today’s podcast, we’ll be discussing recent FDA guidance on recall readiness and other recall-related hot topics.

In recent months, we’ve seen FDA ratcheting up its inspection and enforcement activities as the impact from COVID-19 has started to lessen, and in this context, the decisions companies make about how and when to recall their FDA-regulated products, and how to involve FDA in that process, are more important than ever. We thought it made sense to provide a quick refresher on recalls and discuss the latest recall readiness suggestions from the Agency.

In early March 2022, FDA finalized guidance on the Initiation of Voluntary Recalls under 21 CFR Part 7. And this guidance describes FDA’s expectations regarding the processes firms should have in place to facilitate swift and effective recall actions.

Interestingly, 21 CFR Part 7 is, itself, Agency guidance and not a legally binding regulation. That means that this latest guidance from FDA is technically guidance on top of guidance—as opposed to guidance interpreting a regulation—but that should not reduce the amount of attention paid to it, as the failure to have processes in place to facilitate swift response to recall-worthy situations can lead to FDA action with serious consequences, as we’ll discuss shortly.

Before we get any further into the details though of this particular guidance—Beth, can you refresh our recollection on how FDA defines the term “recall”?

Beth Weinman: No problem. The term “recall” is often a source of confusion. People use the term colloquially to refer to situations where a product’s being removed from the market, but in FDA-speak, the term “recall” is actually broader than that, and it includes not only product removals but also “corrections” to marketed products. Specifically, FDA defines a “recall” as “a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the Agency would initiate legal action, (e.g., seizure).” And a “correction” means the “repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.” A common type of correction is a label change that addresses a safety issue associated with the product.

Josh Oyster: Thanks, Beth. Another foundational question we commonly encounter: can you explain what it means for a recall to be “voluntary?”  

Beth Weinman: Yes, that’s a good question, Josh. As you mentioned, the new guidance deals with voluntary recalls, but the overwhelming majority of recalls we see (I would say 99.9%) are technically voluntary, though they may not feel voluntary to the company. A recall is considered voluntary even when FDA suggests the recall, recommends the recall, requests it in writing, or otherwise pushes very hard for it—and obviously, it’s voluntary if a firm initiates it on its own accord.

FDA only has mandatory recall authority for certain regulated products—for devices, biologics, tobacco products, foods and controlled substances. And the statutory standard for mandatory recalls is very high—it’s generally centered around the reasonable probability for serious adverse health consequences or death. For example, with respect to devices, the standard is a “reasonable probability that a device intended for human use would cause” that standard we talked about—“serious, adverse health consequences or death.” For tobacco products, it’s slightly different—it’s a “reasonable probability that the tobacco product contains a manufacturing or other defect that’s not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death.” So rarely are these provisions invoked that mandatory recalls account for a vanishingly small portion of the total recalls that actually occur, which means that this new guidance is applicable to nearly all recalls a firm might ever have to handle.

And to clarify a common point of confusion between voluntary recalls and mandatory ones—just because a recall is voluntary, that does not mean that the recall is optional. If a distributed product is in violation of the law, or is or may be unsafe, there is an expectation that the product will be removed from the market or that the problem associated with the product will be corrected—and in fact, that is the very best way for a company to mitigate the enforcement risk that is associated with a non-compliant or unsafe product that’s in the public domain. As explained in 21 CFR Part 7, FDA may ask a firm to initiate a recall if it hasn’t already been initiated in certain circumstances, and there’s a standard for that. If a distributed product presents a risk of illness or injury or gross consumer deception and the Agency thinks that action is necessary to protect the public health and welfare, FDA can ask for the recall. But firms can, and frankly probably should, initiate voluntary recalls before ever being asked to do so by FDA.

Josh Oyster: Thanks, Beth. Another recall principle to recognize is that a “recall” has to involve a violative product in one form or another. FDA’s “recall” definition that we quoted a moment ago, specifically refers to the product being “in violation.” Additionally, FDA says that a “recall” does not include what’s called a “market withdrawal,” which is a removal or correction of a product that involves either a “minor violation” or “no violation” of FDA’s laws. Of course, the devil is in the details, and there is no guarantee that FDA will agree with a firm that its product removal or correction is a “market withdrawal” as opposed to a recall. But because true regulatory recalls deal with products that are violative and open up a firm to enforcement risk, it is crucial that firms are prepared to execute them effectively and efficiently—hence this new FDA guidance on how to do so.

Beth Weinman: That’s right, Josh. And it’s also important to note that, depending on the circumstances of a recall, a recall may need to be reported to FDA. For example, in the medical device context, if a firm initiates a recall to reduce a “risk to health,” or to remedy a violation that may pose a risk to health, that recall under the regulations needs to be reported to FDA (specifically, under Part 806). FDA’s new recall readiness guidance provides reminders that recall situations can also trigger non-recall specific reporting requirements—and I’m talking there about reporting an underlying issue that may or may not have prompted the recall. Some examples of these types of reports include notifying FDA of a planned discontinuance or interruption in the production of a life-saving drug, or when a firm becomes aware of a serious adverse event associated with a dietary supplement; for reportable foods, within 24 hours—the term is a “responsible party” (and that’s defined in the regulations)—if a responsible party determines that a food is a reportable food (meaning that there is a reasonable probability that use or exposure to the food will cause serious adverse health consequences or death), that also needs to be reported.

It is worth noting that even if a potential recall situation doesn’t trigger a mandatory reporting of the recall itself, a firm may still want to report that recall to FDA, and that decision is often based on what the firm’s investigation into the issue has uncovered. Firms need to make an educated judgement call as to whether they think FDA would want to know about the recall, and that is typically informed by the nature of the risk of the product at issue. The last thing a firm wants is for FDA to decide that a recall that’s been taken voluntarily, but not reported, was insufficient, and then have FDA take unilateral action like issuing its own safety communication that doesn’t consider input from the company.

Josh Oyster: That’s a great point. And let’s dive further into the key aspects of the new guidance now. As we already mentioned, the guidance is applicable to voluntary recalls, and it deals with all of the relevant products within the FDA’s jurisdiction. Beth, what are some of the practical steps that FDA outlines for how a firm can position itself to be recall-ready?

Beth Weinman: The guidance walks us through six practical steps that the Agency believes should be part of a firm’s recall readiness plan:

• First, the Agency says that a firm should identify the appropriate personnel to be assigned to recall-related responsibilities. Depending on the types of products the firm handles, this step may be more than just a best-practice suggestion because there are certain regulations for certain types of products (for example, the GMP regulations) that do require having competent people in place for specific responsibilities, and including for recalls. Firms should consider the need for alternate personnel in case folks are absent or there are other changes in employment. It may also be worth establishing a “recall team” rather than designating certain specific responsible individuals, particularly in the case of large or multi-tiered distribution chains.
• The next recommendation from the Agency is that identified personnel be trained on their respective responsibilities—again, sometimes this is required by law, aside from this guidance. But this training should not be limited to a one-time course—it should be repeated on a regular basis to ensure everyone has a thorough understanding of the procedures they need to execute. The training could include mock recalls—a mock recall can not only verify a firm’s readiness (or lack thereof), but it can also provide benchmarking data for improvement efforts.
• Third, the Agency suggests that firms establish a recall communications plan. Such a plan should include guides for messaging all along the supply chain and to the public about the recall, and it should also include plans for communicating with the FDA and inside the firm. Firms should identify specific points of contact for each type of communication, and should consider drafting templates to assist with the swift issuance of those communications in the event a recall is initiated. Firms should also think outside of a traditional mailbox-type of communication and consider FDA guidance on the use of electronic communications to communicate recall information.
• Fourth, as we’ve already mentioned, firms need to determine whether the recall action needs to be reported to FDA.
• Fifth, firms should ensure that they’re using adequate product coding (to the extent that coding or other identifiers are not otherwise already required for the product type). What this typically looks like in practice will vary by the product type, but whatever system is used, it needs to be a system that allows for the identification of production and control data for each batch, unit or lot of the product. This is really critical for effective recalls and for the accounting of all affected products. Accurate coding can also help limit the scope of a recall so that you can precisely identify which is the product that is affected, and it helps to facilitate the identification of that product all along the supply chain by consignees and also by the public.
• And the last recommendation in the guidance is about distribution records—firms clearly need to maintain records about the distribution of their products. This is another step that varies by product type—some types of products have regulatory requirements pertaining to recordkeeping in this regard. But even for products without such requirements, firms should make sure they know where and how their products are being distributed, so that in the event of a recall, they can swiftly locate affected items. These records should be retained for longer than the shelf life of the product and longer than the expected use of the product, and they should be detailed down to the level of the direct accounts that received the product. And direct accounts that further distribute the products, also should maintain their own records to ensure that recall instructions can be extended to all consignees in the distribution chain.

Josh Oyster: Thanks for all those great points, Beth. And though it sounds like a lot of work in advance of a recall—something most firms hope they will never have to initiate—it’s worth noting that much of the prep work is useful even in cases outside those of “true” recalls, for example, in situations involving market withdrawals, stock recoveries and the like.

Preparation is also critical for a firm when it faces the decision of whether to initiate a recall in the first place. Firms should maintain standard operating procedures on how a recall should be conducted, and these help minimize delays that can occur when there is uncertainty around if and how a recall should be initiated.

These SOPs can vary depending on what a firm’s distribution chain looks like, but generally should include a “recall strategy” that includes the factors to be evaluated when a firm is deciding to initiate a recall. That’s often a judgement call and there are very few clear-cut answers—the ultimate choice should be based on factors like the potential risk to individuals exposed to the product, the ease with which the impacted product can be identified, the severity of the harm, etc. The decision regarding whether or not to initiate a recall should be well documented and supported as should all other steps taken to effectuate a recall, to investigate the root cause of the problem leading to the recall, and to remediate the identified problem. Notably, FDA’s recent guidance states that a firm should not delay the initiation of a voluntary recall pending the completion of an investigation or consultation with the FDA if it believes a recall is warranted. The flip side of that is it’s often in a company’s best interest to get FDA input on a recall before it’s initiated to avoid FDA subsequently questioning a firm’s customer letter or FDA wanting to issue its own safety communication that may be inconsistent with what the firm said. So, although FDA pushes firms to not wait, sometimes it may still be in a firm’s best interest to make sure they have FDA’s input before initiating a recall.

Another point to note: firms should also have SOPs describing how they will use internal Health Hazard Assessments or Evaluations (known as HHAs or HHEs, depending on the firm) to determine the scope and severity of the problem at hand, because these not only inform a firm’s actions, but they can also provide concrete details for communications with FDA about a recall. FDA’s recent guidance unfortunately does not provide recommendations for how firms should perform HHEs or when it’s appropriate to engage third-party expertise to analyze potential safety risks and the likelihood of harm. For guidance on this issue, firms are left trying to apply the principles of FDA’s own internal guidelines on performing HHEs—those are contained in Chapter 7 of FDA’s Regulatory Procedures Manual—but those guidelines can at times be challenging to adapt to a manufacturer environment.

Furthermore, a firm might have SOPs outlining how the firm will cease distribution of the affected products, notify direct accounts about the recall, instruct direct accounts on communications that should be passed along to further recipients down the supply chain, and, when appropriate, notify the public directly about a product that presents a potential health hazard. On that last point, FDA even has a separate guidance document, titled Public Warning and Notification of Recalls that provides recommendations for firms.

Beth Weinman: Josh, you raised a really important point about lack of alignment between a firm and FDA on what’s needed for a recall, and we commonly get questions from clients asking what might happen or what can FDA do if the Agency thinks that a firm’s recall is inadequate. And in the area of medical devices, we’ve recently seen FDA dust off some very rarely-used statutory authorities to deal with this very issue. Can you tell us about those FDA recent actions and what they might mean?

Josh Oyster: Sure—absolutely. As you alluded to, FDA has certain authorities for medical devices under the FDCA—including authorities to order certain notifications or repairs/replacements/refunds of medical devices—that rarely ever garner attention because FDA, for all intents and purposes, never pulls those tools out of the toolbox. But in March of this year, FDA took a very unusual action when it issued a notification order under Section 518(a) of the Food, Drug, and Cosmetic Act to Philips Respironics regarding a recall that Philips had initiated in the summer of 2021 for millions of sleep apnea and ventilator devices. FDA’s authority to issue these 518(a) notifications arises in situations where use of a device presents an unreasonable risk of substantial harm to the public health, and such notification is necessary to eliminate the risk of such harm and is the most practical way to mitigate the risk.

518(a) notifications have been essentially once-in-a-generation occurrences in the world of recalls—the last time we saw one issued was in 1995 to a firm called Telectronics for some defective pacemakers, and that company ultimately ended up in a consent decree with the government. In Philips’ case, what happened is FDA monitoring had determined that Philips’ recall efforts were inadequate—FDA itself had received calls from patients and customers who had only received notice about the recall from third party sources and not Philips directly. FDA’s effectiveness sampling for the recall concluded that about 15% of the recall consignees had not received notice of the recall.

Subsequent to FDA’s issuance of this 518(a) order, in April, Philips disclosed that it had received a DOJ subpoena for information related to this particular recall. And then, in early May, FDA took another extraordinary step in this ongoing saga—it announced its intention to seek an order under section 518(b) of the Food, Drug, and Cosmetic Act that would require Philips to submit a “plan” for the repair, replacement or refund of those recalled devices. FDA issued a notice of opportunity for a hearing to Philips, which had then seven days to respond to that.

This development is significant because we’re not aware of any examples of FDA ever exercising its repair/replace/refund authority. We have found a couple of examples from the 1980s where FDA considered taking this type of action, but ultimately refrained from doing so. It will be very interesting to see how this situation further develops. And if anyone listening knows of an example where FDA has actually exercised its repair/replace/refund authority, we’d love to hear about it—please don’t hesitate to reach out by email.

Beth Weinman: This example is such a great case study in why it is so important to be recall-ready, and to consider FDA’s views and expectations seriously. The consequences of a failure to align with FDA’s expectations with respect to a “voluntary recall” can be very significant, both from a regulatory perspective as we’ve recently seen, but also from the perspective of hard-to-calculate public perception consequences. As with many situations, a firm’s ideal attitude towards recalls can probably be summed up best by the adage “plan for the worst, hope for the best.” Careful consideration of the recommendations of this new guidance can help firms position themselves to respond to recall situations quickly and effectively, and without getting cross-wise with FDA.

Josh Oyster: Thanks, Beth. That’s all the time we have for today’s episode, and we want to thank all of our listeners for tuning in. For more information about our practice or other topics of interest, please visit our FDA regulatory and life sciences practice pages at www.ropesgray.com. You can listen to Non-binding Guidance and other RopesTalk podcasts in our podcast newsroom on our website, or you can subscribe wherever you listen to podcasts, including on Apple and Spotify. Thanks again for listening.