Off-Label Drug Promotion and the Use of Disclaimers

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  • August 3, 2015

Under the current enforcement system, promoting a drug for unapproved, “off-label” uses is a violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Ms. McKenney’s Note begins by examining the current regulatory scheme in place for off-label promotion and the possible benefits and consequences of allowing the promotion of off-label uses. Ms. McKenney then discusses how current case law regarding commercial speech threatens the government’s off-label promotion prosecution scheme. Finally, Ms. McKenney proposes a two-tiered disclaimer system that reconciles the potential harm with the noted benefits and addresses widespread concerns about the constitutionality of the current system. Under this system, basic disclosure requirements would apply to all off-label promotions of drugs. A heightened, second level of disclosure requirements would apply if a pharmaceutical company is not currently seeking FDA approval for the off-label use. The effect of such a system would be to increase data transparency about the claims of off-label efficacy while simultaneously encouraging drug companies to seek FDA approval for off-label uses.