33 Pages Posted: 23 Mar 2014
Date Written: March 18, 2011
In this article, I first discuss the complex intersection of the drug label and evidence-based medicine. Next, I review the phenomenon of off-label promotion and the controversy that has arisen over FDA regulations related to this field. The controversy over the FDA's authority to regulate off-label promotion can be traced to the essential mismatch between appropriate drug uses and the label. Thus, in the final section, I examine ways to resolve this conflict through changes to the supplemental new drug approval process that can better align restrictions on promotion with knowledge about evidence-based medicine.
Keywords: Prescription drug, FDA, off-label, pharmaceutical marketing
JEL Classification: H51, I11, I18
Suggested Citation: Suggested Citation
Kesselheim, Aaron S., Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech (March 18, 2011). American Journal of Law and Medicine, Vol. 37, No. 2-3, 2011. Available at SSRN: https://ssrn.com/abstract=2411145