European Medicines Agency agrees to release adverse reaction reports on Roche's acne drug Accutane; with FDA, seeks company candidates for GMP progr

Agreeing to open up its drug safety files for the first time, the European Medicines Agency (EMEA) has said that it will release documents related to a drug used to treat severe forms of acne. This is with respect to a complainant, an Irish citizen, who had asked for the release of reports concerning suspected adverse reactions to the drug and, earlier this year, European Ombudsman P Nikiforos Diamandouros told the Agency to reconsider its policy (The Pharma Letter May 12).

The EMEA initially refused access, arguing that European Union transparency rules do not apply to adverse reaction reports. The Ombudsman did not agree. He called on Agency to give access to the documents. The EMEA accepted the Ombudsman's recommendation and announced the release of the reports yesterday.

The decision was welcomed by Mr Diamandouros, who said: "I commend EMEA's constructive approach in this important case. The EMEA's work has a direct impact on the health of European citizens. It is, therefore, crucial to give the widest possible access to documents and to pursue a pro-active information policy for the benefit of citizens."