United States: FDA Releases Draft Guidance on Voluntary Recalls

The Food and Drug Administration (FDA) recently released a draft guidance on voluntary recalls urging companies to institute recall plans and procedures in advance to ensure quick and effective execution when a recall is necessary: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. FDA broke the guidance into four main parts: (1) preparation for a recall; (2) response to a reported problem with a product; (3) initiation of a recall; and (4) FDA's role in initiation of a recall. As firms develop plans for voluntary recalls, we recommend that they consult with counsel to ensure that they comply with regulatory requirements and appropriately address the concerns raised by the FDA in this draft guidance.

Preparation for a Recall

Personnel

The FDA recommends that specific personnel should—and sometimes must—be assigned responsibilities and authority in the event of a recall. In determining whom to task with these roles, the company should consider the need for alternate employees as well as a "recall team" if the complexities of the product distribution demand. Companies must also train personnel to carry out these tasks.

Communications and Reporting

The recall plan should address communications protocols for dealing internally, with the FDA, with direct accounts and with the general public. It is advisable to identify contact points and maintain draft templates so that communications can occur swiftly and accurately. The recall plan should identify and plan for instances where the company or a specific product has reporting requirements to the FDA (e.g. a Field Alert Report for a human drug or an obligation to report in advance an interruption in the availability of a life-saving drug).

Recordkeeping

Even when not required, firms should use coding to allow for identification of production and control data created for each lot, batch or unit. This allows for more targeted and streamlined recalls. Records of distribution that identify when and to whom a product was delivered should be created and retained for a time period exceeding the shelf life and expected use of the product.

Specific Recall Procedures

FDA recommends that firms create written recall procedures and suggests addressing the following actions at a minimum:

  1. Ceasing distribution, shipment and/or sales of affected products;
  2. Developing a recall strategy;
  3. Notifying direct accounts about the product being recalled (including what to do with the product); and
  4. Notifying the public about a product that presents a health hazard.

Responding to a Reported Problem with a Product

In addition to any specific regulatory requirements that firms may face in conjunction with their specific products, the FDA suggests all firms take the following steps:

  1. Identify the problem: Consumer complaints and inspections by regulatory authorities can serve this purpose;
  2. Investigate the problem: The firm should establish concrete steps for timely and prompt evaluations based on established criteria and performed by qualified personnel;
  3. Make decisions and take action: The firm should identify, in advance, what will trigger a voluntary recall and how to assess the scope and depth of a recall. It should also include an assessment of when to discontinue production and distribution; and
  4. Consult with FDA about the problem: The FDA encourages firm contact during investigation and implementation of recalls.

Initiating Recalls

The FDA points first to its regulations at 21 CFR §§ 7.46 and 7.49 as guiding principles that firms should follow in initiating a recall. It also notes that firms need not delay the initiation of a recall pending FDA approval of the recall plan. Further, direct accounts and consignees may need to implement their own recall initiation procedures, and firms should be sure to follow up when they do not receive a response from a recall communication to one of these parties.

FDA Role in Recall Procedures

The FDA strongly encourages firms to work in concert with FDA recall coordinators, who are organized by product type and stationed around the country. These coordinators can assist a firm in determining whether specific regulatory requirements apply and what recall strategy is best. Additionally, they are equipped to review recall communications and monitor destruction or appropriate disposition of recalled products.

Comments to the Agency

The FDA is accepting comments and suggestions regarding this draft guidance until June 24, 2019. Comments may be submitted through regulations.gov and should be identified with docket number FDA-2018-D-2074.

For Further Information

If you have any questions about this Alert, please contact Frederick R. Ball, Ryan Wesley Brown, any of the attorneys in our Life Sciences, Biotech, Medical Devices, Pharmaceuticals and Biologics Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.

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