Washington Report: Labels and Liability - Pharmaceutical Executive


Washington Report: Labels and Liability
A new guidance aims at better communication of risks. But it creates some, too.

Pharmaceutical Executive

To address these concerns, FDA added to the preamble of the final rule (published in the January 24, 2006 Federal Register) a discussion of how FDA-approved drug labeling—in both old and new formats—preempts conflicting or contrasting state consumer protection laws that add warnings and other information to drug labels. FDA states that it has prime responsibility for determining the content and scope of drug labeling, and that states may dilute important safety information by requiring extraneous or unscientific material.

In fact, some state requirements might compel a manufacturer to make unsubstantiated statements that violate FDA policy, pointed out attorney Richard Kingham at a recent Drug Information Association meeting. He considers FDA's preemption statement a "very important development," but one that makes it critical for companies to keep approved labeling accurate and up to date. Plaintiffs' lawyers will be looking hard for omissions in safety information submitted to FDA in bringing liability cases, he notes. In addition, some members of Congress have called for legislation to remove the preemption language in response to charges from state officials that FDA is overstepping its authority.

One immediate result will be more intense labeling negotiations between sponsors and FDA reviewers. Pharma companies want to highlight as many adverse events as possible, while FDA seeks to reduce the clutter that detracts from serious safety messages. There will be a lot of discussion about which precautions and warnings go where, and what clinical study data can be cited to support marketing claims.

The final rule should support expansion of FDA's e-labeling program, designed to transmit approved labeling to the DailyMed online health information clearinghouse operated by the National Library of Medicine. The e-labeling system benefits marketers by permitting them to revise sections of approved labeling without changing the entire document, and electronic tags on label data will allow physicians to search for information by indication and by product. Eventually, this data will populate a "facts@fda" website offering comprehensive information on all FDA-regulated products. E-labeling also will support a paperless labeling initiative that manufacturers have been developing for the past decade and e-prescribing activities, which promise to reduce prescribing errors and inappropriate drug use.

Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at


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