Escalating health care expenditures are rekindling regulatory interest in the pharmaceutical industry on both sides of the Atlantic. The focus is increasingly on off-label drug use, i.e. the use of a drug for indications different from those for which it has officially been approved – witness the recent rejection by a German court of law of a pertinent legal case brought by Novartis. The very same case in the USA has already created new market realities and potentially far-reaching regulatory challenges. This article looks at developments there in order to assess potential policy scenarios for Europe.
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