The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how firms in a distribution chain can prepare when conducting a voluntary recall.

The guidance includes nonbinding recommendations and explicitly does not establish legally enforceable responsibilities on industry members or FDA staff. Instead, the guidance provides insight into the approach that FDA will take in working with industry to initiate voluntary recalls of products subject to FDA jurisdiction.

The guidance breaks the voluntary recall process into four aspects: 1) how a firm in a product distribution chain should prepare to facilitate timely initiation of a voluntary recall; 2) what a firm should do if it discovers a problem with a distributed product; (3) how a firm should initiate a voluntary recall; and (4) how the FDA will work with a recalling firm to initiate a voluntary recall in a timely fashion.

Firms in the product distribution chain

The FDA guidance tells firms in the product distribution chain that it is critical that they be “recall ready.” That is, firms should prepare for the possibility of a recall before a recall is actually initiated.

To accomplish this, the FDA urges firms to start establishing the framework for their recall team. That involves identifying and training appropriate personnel to be involved in a recall and to establish an internal and external communications plan about the recall, informing the FDA, direct accounts, and the public.

Additionally, firms are encouraged to prepare for the logistics of a recall. That includes identifying any reporting requirements for distributed products, using adequate product coding, and maintaining distribution records to facilitate the location of products being recalled.

Finally, firms in the product distribution chain should create a set of written procedures for a possible recall. This will allow the firm to make a timely recall of all products on the market and limit the amount of time that any violative products remain on the market.

Problems revealed in a distributed product

The FDA guidance has recommendations for what firms should do if there is an indication that a product may be in violation of the Food Drug and Cosmetic Act or any of the other statutes that the FDA administers.

The guidance recommends that the firm take the following steps when problems are revealed with a product:

  • Identify the problem
  • Investigate the problem
  • Make decisions and take action
  • Consult with the FDA

Companies face decisions such as whether to initiate a voluntary recall, the scope and depth of that recall, and the need to discontinue the production/distribution of the product.

FDA in its guidance says it is available for consultation while the product is being investigated, and offers a comprehensive list of FDA recall coordinators on its website.

Initiation of a voluntary recall

In its guidance, the FDA recommends that firms initiate a voluntary recall by promptly notifying each of its affected direct accounts and by making some form of public notice, such as issuing a press release. It is this first communication, either to the public or to the direct accounts that the FDA considers to be the initiation date of the recall, regardless of what time may have elapsed during the investigation of the problem.

The FDA also urges firms not to wait for FDA review of its recall procedures or communications to initiate a recall. This is why the guidance in an earlier part recommends that firms establish recall procedures and strategies in advance to be ready to start the process and remove the violative products from the market.

The guidance also requests that firms immediately notify the FDA of any voluntary recall effort.

FDA interaction on initiation of voluntary recall

The FDA pledged to work cooperatively with firms initiating voluntary recalls. To that end, the agency provides recall coordinators who can help review firm communications and advise on the process of destruction, reconditioning or disposition of the recalled product.

Additionally, the FDA included warnings about how and when the agency might request a firm to initiate a recall and whether the failure of a voluntary recall to sufficiently address the problem with the product could lead to additional actions.

Reed Smith will continue to follow this and other developments. If you have any questions about regulatory issues in general or FDA product recalls specifically, please reach out to the health care lawyers at Reed Smith.