This Essay posits that the FDA should protect the current regime put in place by the Kefauver-Harris Amendments and continue to prosecute drug and device companies and their employees for putting patient lives in danger by marketing their products for off-label use. The Essay focuses on the pharmaceutical companies, but device companies are subject to the same regulations. In fact, in 2015, the Department of Justice filed charges, including claims for putting misbranded and adulterated products in interstate commerce, against two Acclarent executives, William Facteau and Patrick Fabian, for the promotion of a device approved as a sinus spacer for unapproved use as a steroid delivery system. As this Essay makes clear, legislative efforts to allow broader off-label marketing are short-sighted, ignoring both the terrible consequences visited on patients prior to the Kefauver-Harris Amendments.
Don't Fix What Ain't Broken--Off-Label Marketing, the FDA's Regulatory Regime, and the First Amendment,
Emory Corp. Governance & Accountability Rev.
Available at: https://scholarlycommons.law.emory.edu/ecgar/vol5/iss1/2