Adding Shades of Gray to Black and White: Proposal for a Tiered Pharmaceutical Labeling Scheme

Abstract

In the United States, $26-54 billions are spent every year on the marketing of pharmaceuticals. This article focuses on the scope and pros and cons of off-label use and marketing of pharmaceuticals, and proposes a new FDA regulatory structure to redirect the incentives to positives uses of off-label pharmaceutics. The policy concern is to encourage research, treatment, and innovation, without allowing pharmaceutical companies to leverage the exclusivity that FDA approval brings for unwarranted sales that put patients at risk. The present legal regime encourages the FDA and pharmaceutical companies into Prisoner's Dilemma, where companies have every reason to attempt to use marketing to end run the agency, and the agency has every incentive institutionally to issue regulations which does not effectively address the problem. The losers, however, are those afflicted with conditions whose treatment would be improved by medications that are presently not indicated for their population, and patients who are prescribed medications which have neutral to adverse outcomes. By expanding the tiers of labeling to encompass standard of care, experimental, and orphan uses, companies will have greater incentive to pursue research which solidly shows that particular products are beneficiary treatments for a wider range of target populations.