Overhaul Urged for US Food and Drug Watchdog ; BUSINESS ANALYSIS Trusted Regulator Torn Apart by Internal Dissent

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THE UNITED States' Food and Drug Administration used to be a regulator so trusted that when it waved through the introduction of genetically modified foods, there was little resistance from American consumers. Now, the body that oversees what the nation eats and takes as medicine is so bedevilled by criticism and self-doubt that even its own people are launching damning critiques of its methods.

Last week, a senior scientist at the FDA, David Graham, issued a warning about the body to a Senate committee that had been called to investigate the withdrawal of the arthritis drug Vioxx from the market by its maker, Merck, because it increased the risk of heart attacks.

Mr Graham, a long-established employee of the FDA and a member of its office monitoring drug safety, said: "The FDA as it is presently configured is incapable of protecting America against another Vioxx. We are virtually defenceless."

The body was quick to respond that Mr Graham's views, which included warnings about other drugs on the market, including AstraZeneca's anti- cholesterol medicine Crestor, were "junk science". But with the share price of drugs companies tumbling, and US politicians taking an increasing interest in what is going on within the corridors of the FDA, there is little doubt the regulator will need to reform itself, or will find change imposed from outside.

According to its critics, the FDA is as much to blame for the continued sale of Vioxx despite signs that it harmed some patients' hearts as was Merck itself.

That is because the structure of what was once seen as the gold standard of regulators is flawed, some say. Indeed, the respected Journal of the American Medical Association argued yesterday that the monitoring of Vioxx and Baycol, made by Germany's Bayer, was flawed. "It is unreasonable", editors of the influential journal wrote, to expect the body which is responsible for approving a drug to "also be actively committed" to acting on evidence that the decision might have been wrong and that the drug should be withdrawn.

In the eyes of Charles Grassley, the Republican senator who chaired the Vioxx hearing, the current set-up makes the regulator "too cosy" with the drugs companies it monitors. This is a criticism which has grown in currency in the past 10 years since the Prescription Drug User Fee Act (PDUFA) was introduced, which put funding costs for drug applications on to the industry, and as a consequence increased pressure on the regulator to speed up approvals.

If it is open season on the FDA in the US, this is a situation that is beginning to have echoes on this side of the Atlantic, where there has been criticism of the UK's regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA).

Campaigners against Seroxat, GlaxoSmithKline's antidepressant, who say the drug can lead to suicidal behaviour, have turned their fire on the MHRA. They say the agency overlooked vital safety data for more than a decade. …