Update on the Lannett and Pharmadyne decisions

The implications of litigation concerning the authority of FDA in premarket approval of drugs are discussed. Since a recent paper on the Lannett and Pharmadyne decisions, several related court cases have been tried. The principal case discussed in Premo Pharmaceutical Laboratories, Inc. v. U.S., where the FDA's authority to require premarket approval of "me-too" drugs was temporarily thrown into jeopardy by a district court's decision involving Premo's Insulase brand of chlorpropamide tablets. However, an appeal, the decision was reversed and the case dismissed. The courts' opinions for these decisions are discussed, as well as related developments.