First Amendment Does Not Block Off-Label Enforcement Actions, FDA Reiterates
Agency memo on manufacturer communications about unapproved uses says new court rulings and studies on off-label uses and adverse reactions support restrictions; whether agency’s new leadership has the same view remains to be seen.
You may also be interested in...
Multiple unfavorable court decisions have forced the agency to adjust its advertising enforcement strategies.
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.
A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.