![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » EC Report Recommends Policy Actions on Off-Label Use
EC Report Recommends Policy Actions on Off-Label Use
![](https://www.fdanews.com/ext/resources/test/Drug-Images/Pharma-Labels.gif?t=1433873566&width=430)
March 9, 2017
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.
Upcoming Events
-
21Oct