Implications of Regulatory Policies on Off-Label Uses for Industry Competitiveness

Abstract

Regulatory policy with regard to off-label uses is discussed from the perspective of a research and development-oriented pharmaceutical manufacturer. Opening up the policy on dissemination of information on off-label uses will affect incentives to go after orphan-specific labeling and poses an issue for industry competitiveness because multiple sponsors for the same drug with different indications can benefit from the work of the first sponsor. When opening up dissemination, strict guidelines must be employed to preserve incentives for research that will benefit patient populations being targeted.