In Brief: Bristol-Myers Squibb v. Shalala

Executive Summary

Bristol-Myers Squibb v. Shalala: Third of three cases brought by Bristol on bulk bleomycin sulfate dismissed July 21 by D.C. federal court Judge Stanley Harris. Bristol had challenged FDA's decision that it is authorized to approve AADAs for generic bleomycin sulfate products made from a bulk substance that does not conform to the bulk substance used to make Blenoxane. The company also asserted that FDA should not approve the new bulk substance before producing a monograph ("The Pink Sheet" April 10, T&G-22). The court ruled that Bristol "lacks constitutional standing to challenge FDA's position until the agency actually approves an application for the bulk substance," according to FDA...