FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EC Report Recommends Policy Actions on Off-Label Use

March 10, 2017
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Regulations on off-label use are not harmonized across the European Union — only 10 out of 21 surveyed member states have specific policies, according to a European Commission report.

Off-label use is prevalent to some extent across most of Europe, in both out- and in-patient settings, and is especially high for pediatric populations. A review of studies found that off-label use was more frequent in oncology and hematology, as well as psychiatry and rheumatology. EU laws do not regulate off-label drug use in medical practice in individual countries.

Currently, there are limited incentives for the pharmaceutical industry to get off-label uses approved.  EU legislation allows a one-year extension to market protection if a new indication is added within eight years of product approval. Off-label sales would still continue, the report said, and off-patent medicines that already face generic competition could be a harder sell for more research investment.

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