REMS as a Competitive Tactic: Is Big Pharma Hijacking Drug Access and Patient Safety?

Abstract

Recent amendments to the Food, Drug, and Cosmetic Act give authority to the Food and Drug Administration (FDA) to require risk evaluation and mitigation strategies (REMS) either as a condition for new drug approval or for continued marketing and distribution of an existing drug. The goal of instituting REMS for particular products is to provide ongoing assurance that the benefits continue to outweigh the risks once a drug is on the market and in widespread use by consumers. REMS take many forms and may require a medication guide for patients; prescription physician information; communications to health care providers and pharmacies; limitations on labeling, promotion, and prescribing to assure safe use by patients; and a detailed plan for REMS implementation. The FDA has since effectuated over 70 REMS programs for new and already-approved drug products, with over 30 of those REMS containing requirements setting limitations on distribution, access, and use.

While the implementation of REMS has strengthened the post market oversight of drug products, there is concern that the statutory provisions are also being utilized defensively by pharmaceutical companies to hinder generic competition. This article examines the competitive use of REMS by brand name pharmaceutical companies to inhibit generic drug competition, highlighting two rising practices: (1) the refusal to supply generic competitors with drug samples for use in bioequivalence testing citing REMS distribution restrictions; and (2) the assertion of patent rights over comprehensive patient treatment and delivery methods contained in FDA-approved REMS. The article offers several approaches to address these current concerns.

Keywords: FDA, risk evaluation and mitigation strategies, REMS, anticompetitive, labeling, postmarket, generic drugs, drug approval