All Change at the Top
The EMA fights to reinstate its former executive director – and the FDA’s new leader is still unconfirmed
The European Medicines Agency (EMA) has nominated Guido Rasi (pictured) as its new executive director and expects him to be appointed following a hearing at the European Parliament. Actually, it’s not Rasi’s first time in the executive director’s seat; he was appointed to the role in 2011 and then forced to step down in November 2014 after a European Union Civil Service Tribunal ruled that he had been improperly selected in 2011. The EMA, which says the decision related to the formalities of the recruiting procedure and was not a reflection of Rasi’s abilities, has been fighting to get him back ever since. The agency is trying to implement a new controversial transparency policy for clinical trials, so it’s not been a good time to be without a leader.
In a statement, the EMA described the nomination as being the “result of a robust recruitment process” (1) – presumably with the hope of avoiding further tribunals. The original tribunal was initiated by Emil Hristov, who applied for the executive director post but failed to make the shortlist. He believed that there was a conflict of interest during the recruiting process as two members of the EMA’s management board were on the European Commission committee that drew up the shortlist.
Meanwhile, the US is still looking for the right candidate to head up the FDA. Margaret Hamburg stepped down from the role of FDA commissioner earlier this year and since then Stephen Ostroff has taken on the role of acting commissioner. In September, President Obama nominated Robert Califf to take the FDA’s reins. Califf is a cardiologist and currently the deputy commissioner for medical products and tobacco. At the time of the nomination, no one expected significant opposition to the move. But since then, concerns have been raised over Califf potentially being too close to the industry; Califf has worked with pharma companies both as a consultant and through his research, whereas most FDA commissioners come from a public health background. Nevertheless, the Department of Health and Human Services has stated that Califf has passed a screening process for conflicts of interest.
- EMA, “European Medicines Agency’s Management Board Nominates Guido Rasi as Executive Director,” (October, 2015). www.ema. europa.eu
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