The underlying theme in the development of FDA reform has been predictability. This is exemplified by a provision in the FDA Modernization Act of 1997 that requires FDA to provide a binding commitment, with some caveats, to approve and grant pre-specified label indications to a drug or biological product if Phase III trials achieve pre-set targets.

Taken at face value, the opportunity seems amazing, even given the scope of the reform act itself. For starters, the law requires the FDA to provide - within 45 days of a sponsor's request - an evaluation of protocols to assess whether the design is adequate to meet scientific, regulatory and labeling requirements. Such an assessment (again with caveats) can be applied to Phase III protocols that will form the primary basis for an efficacy claim.