Orphan Drugs: Creating a Policy

Abstract

Ensuring the development and availability of drugs that are medically important but commercially unprofitable poses a significant problem in our free market economy. Recent attempts by the federal government to develop a policy regarding these "orphan" drugs provides an important first step. The federal Interagency Task Force on Drugs of Limited Commercial Value recommendations propose initiation of a wide spectrum of administrative and legislative changes; these are designed to create incentives for industry to cooperate with government in developing and making orphan drugs available to those who need them. But before the proposed recommendations are accepted or rejected, a clearer understanding is needed of the nature of interrelated problems of orphan drugs. Thereafter, the wide spectrum of "stakeholders" involved in and affected by orphan drug policies or programs should seek means for interactive planning to determine desired ends and to devise means for achieving them.