Marketing Off-label Drug Use

RedWrenchA Federal District Judge in Manhattan just threw another wrench in the Food and Drug Administration’s (FDA) enforcement mechanism.

The court decision said the FDA could not prohibit the truthful promotion of a drug for unapproved uses because doing so would violate the protection of free speech.

This decision is the second in a string of cases chipping away at a powerful weapon wielded by the FDA which requires drug companies to obtain FDA approval before promoting a specific use of a drug.

Physicians commonly prescribe drugs for uses other than for which drugmakers have obtained FDA approval, but the FDA has taken the position that it is illegal for drugmakers to actively promote that “off label” use.

This recent decision and the prior decision squarely challenge the FDA’s position.

Drugmakers are likely to proceed cautiously. No doubt the industry will be watching for additional challenges by drugmakers to further define the groundrules.

To read an article in the New York Times on the issue and this recent case, click here.