Battle Over US FDA’s ‘Intended Use’ Rule Continues
Executive Summary
PhRMA and Pfizer attorneys criticize the rule’s broad evidence standard, lack of safe harbors, and disregard of the First Amendment. Opposition to the rule is expected to continue to play out in lawsuits.
You may also be interested in...
Off-Label Use Final Rule: US FDA Declines To Focus Solely On Promotional Claims
In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.
Rx Data Mining Opponents Will Need New Pitch After Supreme Court Strikes Down Vermont Law
The court affirms the Second Circuit's ruling that a Vermont statute prohibiting drug companies from using Rx data to market to doctors imposes an impermissible restriction on free speech.
Social Media Data Gains Prominence In Patient-Focused Drug Development
FDA guidances have provided ‘major step forward’ for use of social media data, Roche researcher notes. Agency staffer offers checklist for collecting patient experience data in this realm.