PhRMA, AdvaMed Say FDA’s Intended Use Final Rule Could Chill Speech

PhRMA and AdvaMed expressed “grave concerns” about the FDA’s final rule clarifying when tobacco products are regulated as medical products, saying that the rule’s altered “intended use” definition is overbroad in its restriction of communications.

The final rule establishes that, while the agency would not take enforcement action entirely on the basis of a drugmaker’s knowledge a product was used in an unapproved manner, the FDA may consider manufacturer knowledge in combination with other evidence.

The final rule’s broad “totality of evidence” standard for establishing an intended use is unsupported by case law, the trade group argues, and would allow the agency to establish an “intended use” even if the manufacturer made no internal claim of that use.