France adopts draft law on off-label use of drugs

The French National Assembly yesterday voted on the draft law proposal, which would potentially allow doctors to use off-label drugs even if there is an alternative drug approved. This draft law has still to be reviewed by the French Senate and a review by the French Constitutional Court is also possible.

The draft law specifically references Swiss drug major Roche’s (ROG: SIX) cancer drug Avastin (bevacizumab) as an alternative eye treatment for wet age-related macular degeneration (AMD), an indication for which the drug is not approved and for which two authorized alternatives exist.

Following similar recent action by the equivalent Italian body, the  French competition authority launched an investigation into possible anti-competitive practices by Roche and fellow Swiss drugmaker Novartis (NOVN: VX) relating to their ophthalmic drug Lucentis (ranibizumab), which is approved for the treatment of wet-AMD and other eye conditions. More recently, the Italian Medicines Agency, AIFA,  endorsed the off-label use of bevacizumab in its decision to reimburse the drug for ophthalmic use.