New FDA head promises improvements for workforce

pharmafile | October 21, 2003 | News story | |   

The new FDA Commissioner, Dr Mark McClellan, has pledged that improvements in the working lives of staff will be a top priority.

Morale at the US drug, food and cosmetics regulator has suffered during the 20-month period in which it had no permanent head.

Allegations of FDA staff involvement in the ImClone affair and an apparently slower product approval rate has drawn criticism and undermined the Agency's reputation for excellence, which Dr McClellan has now pledged to restore.

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Dr Peter Lurie, spokesman for US pubic interest group Public Citizen, said recently: "[Dr McClellan is] inheriting a situation with low morale, due on our view to a sweatshop atmosphere that now exists at the agency, which requires both a management and stronger scientific response."

The FDA is currently scattered in 40 different sites around Washington DC, and is in the process of building new facilities to bring its staff together on one purpose-built site.

Dr McClellan made his inaugural speech at the new White Oak Campus, saying: "Our mission depends on a solid cadre of experienced scientists, physicians, mathematicians and other highly qualified and dedicated professionals. Their expertise is essential for making our regulatory decisions balanced and fair, and for keeping us on the cutting edge of the technology and sciences used by industry."

The agency plans to further its reward scheme for employees, including incentives for high performing staff and extra rewards for its best medical experts to counteract poaching by other employers, including the pharmaceutical industry.

"On the one hand, I'm glad that so many of our employees have other good options. That tells me we are attracting very talented people. On the other hand, I don't want to lose them", he said.

Dr McClellan also signalled the FDA's drugs review process may have to undergo radical review because of the changing technological nature of new drugs, medical devices and biotech products.

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