Political interference and low morale are blighting the work of US drug regulators. That is the conclusion of an anonymous survey of scientists at the US Food and Drug Administration (FDA).
The Union of Concerned Scientists, a lobby group, sent questionnaires to nearly 6000 FDA scientists, 997 of whom replied. Almost one-fifth of those involved in regulatory decisions said that they had been asked, for non-scientific reasons, to inappropriately exclude or alter technical information, while 61 per cent said they knew of cases in which 鈥減olitical appointees have inappropriately interjected themselves into FDA determinations or actions鈥�.
Given such figures, it is not surprising that 40 per cent of respondents described morale within their office as 鈥減oor鈥� or 鈥渆xtremely poor鈥�, compared with just 26 per cent who rated it 鈥済ood鈥� or 鈥渆xcellent鈥�.
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Public confidence in the FDA has been shaken by scares such as the withdrawal of Vioxx, a painkiller approved by the agency that was later found to increase the risk of heart attack. 鈥淭here is a remarkable amount of pressure to find 鈥榗reative鈥� ways to approve problematic drugs,鈥� one FDA scientist wrote.
