Industry Attorneys Ask FDA to Narrow Off-Label Communications Guidance

Recent action from a state legislature, as well as objections from industry groups, suggest the FDA should narrow its guidance for off-label claims, according to two prominent labeling attorneys.

The activities complicate the FDA’s efforts to establish rules on such communications, said attorneys Alan Minsk and Elizabeth Mulkey of Arnall Golden Gregory, in a presentation at RAPS’ 2017 Regulatory Convergence.

For example, the Free Speech in Medicine Act, which recently passed in Arizona, allows drugmakers to engage in “truthful promotion” of off-label uses — although the law fails to define what would be considered sufficient evidence that the information is truthful.