Moving the EMA to the vanguard of the transparency movement
Name: Guido Rasi
Title: Executive Director, EMA
When Guido Rasi was named in November 2011 to lead the European Medicines Agency (EMA), he was selected in part to calm the waters after the previous director left for an industry job, raising a stink in Europe about the coziness of regulators and the regulated.
Six months later, Rasi put his name to an article with other regulators endorsing the idea that clinical data should be made publicly available, inserting himself into the middle of a contentious industry issue. And 7 months after that, the EMA was hosting a seminar on how it would proceed. "The European Medicines Agency is committed to proactive publication of clinical trial data, once the marketing-authorization process has ended. We are not here to decide if we publish clinical trial data, but how," he said at that event.
It is an area that has been hotly debated in academic and industry circles and one that has heated up around questions from the Cochrane Collaboration about the effectiveness of Roche's ($RHHBY) Tamiflu. A year before Rasi's appointment, the EMA said it would begin making clinical info available, but his name on a journal article was like a signature on a promissory note. No equivocating now.
As a physician and a former researcher himself, this might not be such a big surprise, but it does put him and the EMA at the vanguard of a movement that industry is not entirely comfortable with. His position clearly established that the agency was independent. The move also put the EMA ahead of the FDA in this regard, something that has got to chafe some at the U.S. agency, which likes to see itself as the leader in all things regulatory.
Rasi was head of Italy's drug oversight agency before being appointed executive director of the EMA in 2011. As such, he sat on the EMA board and it was fellow board members who nominated him. While he is now closely linked to the transparency issue, he is still working on his other priorities. The agency responded immediately when new data on Merck's ($MRK) drug Tredaptive for raising good cholesterol failed in a large-scale study while raising health concerns. Merck pulled the drug. And at the request of France, it recently said it would launch its own review of blood-clot risks posed by third- and fourth-generation birth-control pills.
Meanwhile, Rasi has the EMA moving steadily forward on proactive disclosure. Five advisory groups are working on recommendations to be submitted by the end of April, and the EMA says it will put the new process into action come Jan. 1, 2014.
-- Eric Palmer (email | Twitter)