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How off-label marketing can lead to products liability suits

If you have watched any of the NBA playoff games, or a golf tournament on a Sunday afternoon, it is hard to ignore the commercials for prescription drugs. From Lexipro to Propecia to Flonaze to Lipitor, drug manufacturers spend billions on television advertising each year. The same could be said about radio ads (even though radio time isn’t as expensive.)

The frequency of advertisements has put more of a focus on off-label marketing; which is defined as the promotion of pharmaceutical drugs outside of their original purpose, or the purpose of approved use by the Food and Drug Administration. Federal rules prohibit the marketing of drugs that have not been approved by the FDA, even though there may be an alternate use for them. 

A perfect example is the early use of the drug, Viagra. It was originally approved for improving cardiovascular performance. However, once it was found that it could improve another type of “performance,” a new market was created for which approval was necessary. Viagra’s popularity ostensibly began because doctors may prescribe a medicine for off-label uses if they believe that it can safely be a benefit to a patient.

So while it may be against federal rules to advertise off-label uses through regular media, drug makers may contact physicians directly to taut the benefits of their products. While this may bypass the traditional commercial channels, it still may result in harm to unsuspecting patients.

If you have questions about whether off-label marketing can lead to a products liability lawsuit, an experienced attorney can help. 

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