Reforming--Balancing, Ruining, Whatever--Hatch Waxman

Efforts to fix perceived imbalances in the Hatch-Waxman Act once again are underway in Washington and, for the first time, some of them are likely to have an impact on both the brand-name and generic drug industries. An FDA rule announced in June and implemented in August aims to clear up some of the legal ambiguities that have played a critical role in shaping corporate strategies. A bill pending in Congress would further modify the act, if it passes.

More from Business Strategy

More from In Vivo