Achieving Equilibrium: An Examination of the FDA’s Attempt to Balance Patient Safety with Access to Innovative Treatments Through the Off-Label Marketing Regulations

Abstract

The FDA maintains almost complete control over the approval, labeling, and marketing of prescription drugs. Pharmaceutical companies are generally prohibited from promoting their products to doctors for any use other than the ones that have been explicitly approved by the FDA. However, doctors may prescribe drugs that have been approved by the FDA to their patients for any purpose for which they believe it will be beneficial. In 1997, Congress passed the Food and Drug Modernization Act (FDAMA) which created a limited exception that allows drug manufacturers who submit a supplemental new drug application to the FDA for a new use of an approved drug to send limited materials directly to doctors. In enacting the provisions, Congress sought to balance the competing interests of patient access to innovative treatments with consumer protection and patient safety. However, these provisions and the regulations the FDA promulgated under them have drawn significant criticism. Certain critics contend that the restrictions on off-label marketing stifle innovation and keep beneficial treatments from patients who need them. Others argue that these exceptions expose patients to significant risk by encouraging them to take drugs that have not been proven safe and effective under the FDA standards. This paper argues that the regulatory scheme developed under the FDAMA represents a proper balance between patient safety and access to innovative drugs because it seeks to facilitate the education of doctors rather than the promotion of drugs. However, the FDA can go further under the current regulatory scheme to find affordable ways to get reliable information to doctors, while still protecting patient safety. By focusing on finding new means to provide doctors with reliable, unbiased information the FDA can do just that.