FDA Proposing New Rule For Drug Label Modifications

Scott Kappes

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A new rule being proposed by the FDA would be welcomed by drug companies and could be a thorn in the side of plaintiffs' lawyers everywhere. The new rule would establish narrow guidelines under which drug companies can make changes to drug labels on their own. It may seem somewhat odd that drug companies would approve a narrowing of guidelines by the FDA, but it makes perfect sense when analyzed. Under current rules drug companies have a generous amount of latitude to make changes to labels without being first approved by the FDA. Plaintiffs' attorneys often claim that since drug companies have the ability to update label as they see fit, the responsibility to warn consumers about new information can also be the responsibility of the drug companies.

The FDA's proposal lays out a relatively limited set of circumstances under which it thinks drug companies should be able to change drug labels without the agency's prior approval. The main reason that would remain: concerns about "newly acquired safety information." So the plaintiffs bar may still be able to ring the undisclosed-risk bell.

It is not clear how judges and juries will view the situation but, it is clear that the news has raised eyebrows in the pharmaceutical and legal fields.

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.