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New FDA commissioner

After just a three-month spell at the top, Lester Crawford has resigned as the head of the Food and Drug Administration with immediate effect

After just a three-month spell at the top, Lester Crawford has resigned as the head of the Food and Drug Administration (FDA) with immediate effect.

The announcement of his departure caught many in the industry by surprise, despite the continued insurgence of pharma lobbyists accusing the FDA of failing to address recent high profile drug safety breaches and of being too slow to reform its related practices.

The White House was quick off the mark in announcing Crawford's likely full-time replacement as Andrew von Eschenbach, formerly director of the National Cancer Institute, who will join the Bush Administration for the time being as Acting Commissioner at the FDA.

Having served the agency as deputy-, acting- and full-commissioner, in a memo sent to FDA employees Crawford reportedly wrote that `it is time, at the age of 67, to step aside'. The most recent months of his three and a half year tenure as one of the most senior FDA officials were arguably the best and worst of his career there.

In response to harsh criticism following the withdrawal of Vioxx, and regarding the earlier controversy surrounding the side effects of SSRIs in children and on withdrawal from adults, he attempted to tighten up advertising practices and had recently supervised the implementation of new pharmacovigilance measures.

However, FDA critics have regarded his leaving as a triumph. Detractors had called for the agency to straighten out and strengthen its relationship with the industry as well as being overtly more transparent in its decision making, while Crawford had been accused of impeding reform and preventing the agency from moving forward in step with the changing environment.

Accusations that the FDA had also squashed reports from internal scientists, which are said to have highlighted critical drug safety issues, were also levelled at the beleaguered agency.

Speaking of Crawford's exit, chairman of the Senate finance committee, Charles Grassley, noted that the opportunity to bring in a new Commissioner is a ìchance to take the agency in a necessary new directionî. He admitted in the Financial Times that in recent years, ìthe FDA has demonstrated a too-cosy relationship with the pharmaceutical industry and an attitude of shielding, rather then disclosing, informationî.

A source in the UK industry commented: ìThe European Medicines Agency and the MHRA have appeared openly to adapt to pressures and changes around them in recent months. The FDA has implemented a number of measures even before late last year [since the withdrawal of Vioxx], but a big change at the top will help to instil a sense of new direction in its employees and will continue to drive the enhancements in terms of conducting drug safety reviews quickly but candidly, with a full appreciation of every piece of information provided.î

He added: ìA lot of the world's regulatory agencies are undergoing some serious changes at the moment, but it's the FDA that has taken the brunt of the big recent safety problems.î

New Deputy

Another high profile recruitment at the FDA is Dr Douglas Throckmorton, as deputy director of the Center for Drug Evaluation and Research. Dr Throckmorton will also continue in his role as a founding member of the agency's new Drug Safety Oversight Board.

Crawford said of him: ìHe is a champion of our efforts to improve tools for communicating drug safety information to patients, and for improving the process for getting safe and effective drugs to patients who can benefit from them.î

30th September 2008

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