FDA Guidance Addresses Vaccine Labeling

New document reviews agency’s requirements. 

Ben Van Houten
Senior Editor


In the wake of the widely publicized flu vaccine contamination, FDA has issued a vaccine labeling guidance. The document, “Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information,” provides vaccine manufacturers, medical practitioners, and consumers an overview of the agency’s vaccine labeling review process. It also provides a discussion of FDA’s review of childhood vaccine labeling and the data that it examines when determining the adequacy of vaccine labeling. The guidance is being implemented immediately.

The guidance was issued by FDA’s Center for Biologics Evaluation and Research (CBER). “FDA continues to engage in an ongoing, case-by-case review of all vaccine labeling and routinely requires revision of labeling that is found to be inadequate to warn healthcare providers of the risks associated with the use of a particular vaccine,” writes the agency in an introduction to the guidance.

The document gives a comprehensive, detailed description of FDA’s process for vaccine labeling review. That process covers:

• Preapproval review of labeling. This section includes the agency’s guidelines on inserts. “An important part of vaccine labeling is the package insert,” write the document’s authors. “If we conclude that a proposed vaccine package insert does not contain adequate warnings, use instructions, and precautionary information, we communicate such findings to the manufacturer as soon as is practicable.” This section goes on to explain that FDA makes sure revisions are done, and then formally approves the final draft labeling.
• Postapproval surveillance. In this section, FDA explains how it takes into account various sources of information during surveillance and review of vaccine labeling requirements. These sources include existing labeling requirements, epidemiological information, medical literature reports, and other literature. Most importantly, FDA points out that it notifies manufacturers if package inserts do not reflect currently available information regarding the warnings, use instructions, and precautionary information. In such cases, FDA typically recommends that appropriate revision is necessary.

The guidance also contains a detailed update on FDA’s process for conducting the National Childhood Vaccine Injury Act (NCVIA) labeling review, a case that serves as an excellent example of the agency’s review process. In this 1992 incident, FDA conducted a review of vaccine labeling through a process that involved extensive opportunities for public comment on childhood vaccine labeling. The agency created draft summaries of important information for each applicable vaccine after applying existing drug labeling regulations, current labeling as supplied by the manufacturer, and a survey of medical manufacturers.

During its review of childhood labeling, FDA took into account the views of two public panels. Both panels’ reviews resulted in a proposed order that was published in the Federal Register. In addition, both reports recommended that information in the package insert be presented in a clear, unambiguous, and accurate manner.

In its conclusion to the guidance, FDA states that its “continuing review of warnings and precautions and use instructions sections of the label helps assure that labels in distribution are adequate to inform healthcare providers of the risks of vaccines.” FDA then states that it continues to review vaccine labeling, taking into account timely information provided through, among other things, recommendations and reports of the Advisory Committee on Immunization Practices, reports in the medical literature, epidemiological information, and summaries from the Vaccine Adverse Event Reporting System (VAERS).

The full document is available at www.fda.gov/cber/guidelines.htm.

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