FDA Has an Early Approvals Thesis

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This situation illustrates the difficulties in navigating an uncertain regulatory environment.

3. It is reasonable that the WHO guidelines are used as the framework for U.S. policy. The U.S. system, however, is unique in certain ways. You alluded to the need to encourage innovation. The balance between innovation and cost control is different in the U.S. than in Europe, so I think that is why U.S. policy will look slightly different than European policy.

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It will be interesting to see how that plays out. In Europe, there has obviously not been much innovation in this field in the past few years, if new product introductions are any indicator. If the U.S. system can stimulate more innovation, that can actually be used to demonstrate the power of the American model and perhaps drive changes in Europe, rather than the other way around.

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