Lack of FDA leader hinders drug industry
on the role of head of the US Food and Drug Administration (FDA),
reports the Financial Times.
President Bush is being put under pressure to find someone to take on the role of head of the US Food and Drug Administration (FDA), reports the Financial Times.
The low number of products being cleared for the market led drug manufacturers to send a letter to the president last week, urging him to speed up the recruitment of an FDA chief, claims the report. The organisation has been without a commissioner for 18 months.
The companies fear that lack of a FDA leader is having a negative impact on drug approvals. "Without a strong leader, people have a tendency to be extremely risk-averse," Jonathan Rothberg, chief executive of biotechnology group CuraGen, told the newspaper.
The report notes that last year just 24 new drugs were cleared for sale in the US, compared with 27 in 2000 and 35 in 1999. There has also been a slight increase in the amount of time needed to review new treatments - currently it takes just over 12 months.
The FDA wields a great deal of influence, overseeing drugs, food, dietary supplements and medical devices - 25 per cent of all US consumer expenditure. However the report argues that the post of commissioner has become so highly politicised in recent years that finding a candidate capable of obtaining congressional approval is a challenge.
"It's unclear if anyone could fulfil the desires of all sides," Carl Feldbaum, president of the Biotechnology Industry Organisation, told the paper.
The report suggests that conservative politicians are worried about a new appointee's position on genetically engineered food and herbal medicines.
There has even been speculation that no leader will be appointed throughout Bush's term in office. "Getting someone to take the job with just two years left of the Bush administration is difficult, because they might not be able to achieve what they want," said Dr Alistair Wood.
The report continues that the biotechnology industry, in particular, is suffering from the lack of FDA leadership, and that it needs more guidance on clinical trials, and in emerging fields like genomics.
"We would have supported both Dr Wood's or Dr Astrue's nomination," said Feldbaum. "Simple instinct and intuition tell you that it's advisable to have someone at the top."
