Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use

11 Pages Posted: 11 Jul 2013 Last revised: 7 Dec 2015

Marc A. Rodwin

Suffolk University Law School; Harvard University - Edmond J. Safra Center for Ethics

Multiple version iconThere are 2 versions of this paper

Date Written: August 1, 2013

Abstract

Prescribing drugs for uses that the FDA has not approved – off-label drug use – can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight by prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers’ conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use.

Suggested Citation

Rodwin, Marc A., Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use (August 1, 2013). Journal of Law, Medicine and Ethics, Vol. 41, p. 654, Forthcoming; Suffolk University Law School Research Paper. Available at SSRN: https://ssrn.com/abstract=2292037

Marc A. Rodwin (Contact Author)

Suffolk University Law School ( email )

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Harvard University - Edmond J. Safra Center for Ethics ( email )

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