The Food and Drug Administration, the American drug regulator, is set to tighten controls on the safety of drugs so that adverse reactions can be identified more quickly.

The incentive to tighten controls, already more draconian than those in Britain, may have come from recent trials of the drug fialuridine, which resulted in five deaths.

The agency believes that new controls could have speeded up the recognition of serious toxic reactions, such as those with fialuridine.

Tighter controls could be introduced at the safety monitoring stage even before clinical trials had started with longer times given to follow up periods.

One worry for the drug companies is that the measures could provide valuable information to international competitors. In the past, drug companies have been able to segment the levels of information they have given out, depending on the demands of each country’s regulator.

l The FDA is looking at providing an inexpensive approval route for herbal medicines so that they can in time join the mainstream in the US. Herbal medicine already enjoys a $1500m retail market in the US, even though it is sold only through health stores and fewer than 1 per cent of doctors prescribe them. Manufacturers are also prohibited from making any health claims on labels.

This change of heart may be caused by pressure from Europe, where the EC is seeking to achieve harmonization of pharmaceutical standards. In Germany, 80 per cent of doctors prescribe herbal medicines, and the total retail market there is estimated to be worth around $3000m.

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Written by What Doctors Don't Tell You

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