EFPIA Disapproves of French Off-Label Initiative

On July 8, 2014, the French National Assembly voted a draft law proposal that would potentially allow healthcare professionals to prescribe off-label drugs, even if there is an approved drug available for treatment. The draft law specifically references Avastin, a Roche cancer drug, as an alternative eye treatment for wet age-related macular degeneration, an indication for which the drug is not approved and for which two authorized alternatives exist. EFPIA, the European Federation of Pharmaceutical Industries and Associations, harshly criticized the proposal. Richard Bergström, EFPIA Director General, said: "A worrying trend is growing across Europe with governments bypassing important health safeguards and making public health decisions based purely on short-term economic considerations. This move is a material breach of the regulatory framework created to preserve the highest standard of patient safety in Europe." "This is a serious public health issue which the European Commission must address urgently before it becomes more widespread," stated Bergström. "EU Member States should not be creating secondary, national marketing [authorizations] for reasons that undermine the EU regulatory framework and could potentially put patients at risk, and deliver only short-term economic gains."  Bergström concluded: "If public authorities continue to promote off-label use of other, less costly, medicines that have not undergone stringent safety and efficacy assessments, ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs