Issue: 49 Food and Drug Law Journal 213-236 (1994)
For many reasons, historic and scientific, the regulatory restrictions that control biologics manufacturing are more limiting than those that control drug manufacturing. Recently, the Center for Biologics Evaluation and Review (CBER) revised its policy on cooperative manufacturing arrangements for biologics, to ameliorate some of the effects of preexisting policies. However, other changes are needed and justified by modern biopharmaceutical manufacturing technology. This article address the question of whether unique regulation of biologics under the Public Health Service Act section 351 continues to serve a useful purpose. It suggests that regulatory and public health goals might be better served by consolidation of biologics regulation with the controls placed on pharmaceutical manufacturing under the Federal Food, Drug, and Cosmetic Act.