The issues of orphan products include an inadequate definition of orphan status that hampers implementation of the legislation, difficulties in evaluating the products themselves in order to ensure safety and effectiveness, neglect in developing orphan devices, and conflict over creating unnecessary monopolies and excessive profits. However, it has been demonstrated that the ODA is effective in stimulating the development of these much needed drugs and devices. The next efforts therefore can be directed toward increasing the effectiveness and ensuring the equity of the program.