Speed Recall: Firms Get Just 24 Hours To Issue Requested Public Warnings

If US FDA asks firms to warn the public about recalls of dangerous drug or other FDA-regulated products, they must issue the warning within 24 hours or the agency may issue its own warning, draft guidance says.

If the US FDA asks a manufacturer to warn the public about a drug or other FDA-regulated product it's recalling, a Jan. 18 draft guidance document says the agency generally will give the firm just 24 hours before stepping in and issuing its own warning.

The agency added that it may supplement a firm's warning if it proves deficient.

"Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe products, are high priorities of mine," FDA Commissioner Scott Gottlieb said in a statement. "Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission and I take these obligations very seriously."

The draft guidance explains that public warnings are for urgent situations in which marketed product poses serious health hazards and private warnings won't suffice, for example, when retailers can't identify the recipients of drugs they dispensed.

Such situations mainly arise with recalls that FDA classifies as Class I, although they can occur with less serious Class II recalls as well.

The agency said warnings may be warranted in cases of serious hazards such as contamination of sterile injectable drugs with particulates or reports of deaths or other serious adverse events associated with drug products.

RECALL CLASSIFICATIONS
Classification	Risk	Definition
Class I	Highest	Reasonable probability that use/exposure will cause serious adverse health consequences or death.
Class II	Intermediate	Use/exposure may cause temporary or medically reversible adverse health consequences, remote probability of serious adverse health consequences.
Class III	Lowest	Use/exposure is not likely to cause adverse health consequences.
Source: FDA

How To Avoid Bad Publicity

FDA indicated that firms may be able to avoid the bad publicity that goes with public warnings if there are other ways to prevent use of recalled products, for example telephoning "direct accounts" such as wholesalers before they distribute or sell the products. Letters or emails wouldn't suffice due to delays and lack of confirmation receipt.

Similarly, if there are few users all of whom can be contacted directly, there would be no need for a public warning.

FDA expects firms to develop strategies for the recalls they initiate, and those strategies would include whether and how to issue public warnings.

FDA usually reviews and comments on recall strategies, although the draft guidance notes that the regulations governing recall strategy at Title 21, Section 7.42 of the Code of Federal Regulations don't require firms to delay recalls while FDA reviews their strategies.

What To Put In Warnings

Public warnings should include:

• Information such as images, numbers, packaging information or brand names that help people identify the recalled product;
• Geographic areas and dates of distribution;
• Details regarding the product defect, health hazard and reason for the recall;
• Name and contact information;
• Instructions to consumers;
• The number and nature of any illness, injuries or complaints associated with the product; and
• Common symptoms of any illness of concern.

What To Leave Out

There are also things public warnings should leave out. FDA told firms:

• Don't cloud or lengthen warnings with distracting messages;
• Don't promote the qualities of the recalled product, other products or the firm;
• Don't say they're conducting the recall out of "an abundance of caution" when illnesses or injury have resulted or when pathogens have been found in the product.

What do deficient warnings look like? FDA said they might be missing key information. They might fail to reach a target audience, such as a particular region or a Spanish-speaking community. Or they might contain factual statements that FDA can't verify.

How To Issue Warnings

FDA noted that traditionally, firms issue public warnings via press release to the general news media and the trade press.

The agency added that firms should match press release distribution to affected communities. For products bought online, warnings should appear online; for products used mainly in regional markets or by non-English speakers, there should be warnings targeting those regions or communities and written in the appropriate language.

Firms sometimes announce they're removing an FDA-regulated product from the market and FDA subsequently determines the removals were actually recalls. In such cases, the agency may post the announcements on its recalls website, even if a warning isn't warranted.

A Word About Recall Classification

After FDA finds that a firm has initiated a recall, the agency will add the recall to its weekly enforcement report. FDA will include "not-yet-classified" recalls in the report until it determines whether they are Class I, II or III based on health hazard and other factors.

It can take weeks or months to classify recalls, Douglas Stearn, director of the Office of Enforcement and Import Operations in FDA's Office of Regulatory Affairs, explained in a Jan. 18 blog post.

Note: The agency has published selected not-yet-classified recalls since September 2011.

How To Comment

Before publishing a final version of the guidance, FDA will consider all comments submitted by March 20 to the docket at: https://www.regulations.gov/comment?D=FDA-2016-D-3548-0002.

Note: The Office of Strategic Planning and Operational Policy in FDA's Office of Regulatory Affairs wrote the draft guidance in consultation with the agency's centers for drugs, biologics, medical devices, veterinary medicines, tobacco products and food.

From the editors of the Gold Sheet.

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