Tough times for medicines regulator

Emerging uses of EMA Approved Drugs – by Gary Finnegan – The European Medicines Agency is emerging from a turbulent spell which has seen the departure of one of its most senior experts, controversy over its former director’s new job, and repeated clashes with the European Parliament.

In May, Members of the European Parliament (MEPs) refused to sign off on the Agency’s annual accounts over criticism of procurement procedures at the EMA and, more significantly, amid concerns about the independence of the experts working for the regulator.

Relations between the London-based EU agency and Brussels authorities are fraught after a string of public disagreements. Last year MEPs directly criticised an EMA expert for a scientific report he had written in the 1990s on a drug which has since been withdrawn from the market.

The European Commission also crossed swords with the EMA over the salary available to recruit its new executive director.

The recruitment row delayed the appointment of a permanent figure-head at the Agency for most of a year and. Separately, the agency was forced to sanction its former executive director after media reports that he had taken up a consultancy job advising the medicines industry.

In April, the Agency suffered another blow when one of its most influential figures, Dr Eric Abadie, abruptly resigned with immediate effect.

Dr Abadie had chaired the key EMA committee which decides what medicines can be sold in Europe, and also sat on a number of other sub-committees on orphan drugs and pharmacogenetics.

His decision to quit followed the termination of his contract at the French medicines regulator which is undergoing a major restricting.

Abadie’s work at the EMA was unpaid – he drew his salary from the French authorities – and his recent attempt to secure direct payment from the European agency in light of his departure from the regulator in France was rebuffed.

Meanwhile, a new report by researchers at Yale University and the Mayo Clinic said the EMA is slower to approve medicines than its US counterpart, the FDA, adding to the costs for companies and forcing patients to wait longer for innovative drugs.

Newly-installed EMA Executive Director Guido Rasi is pledging to restore confidence in the Agency by making it more transparent and improving efficiency. In May, the regulator launched a series of new features on its website which will see it publish more details of how it reaches decisions.