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.

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. In the 19 years following its enactment, Hatch-Waxman has changed the landscape of the pharmaceutical industry and spawned a new, multi-billion-dollar generics industry. The law has been considered successful, by and large, in its attempts to balance innovation and competition. It's had plenty of detractors, however, all of whom have so far failed in efforts to change it.

An FDA rule announced in June and implemented August 18 aims to clear up some of the legal ambiguities that...

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