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The European medicines regulator will “name and shame” pharmaceuticals companies if they do not pass on information about problem side-effects with new drugs once they have been launched.
The European Medicines Evaluation Agency (EMEA) is also pushing for a near doubling of its budget from Brussels, partly to boost its monitoring of newly released drugs.
The moves reflect the growing anxiety of regulators on both sides of the Atlantic about the lack of surveillance of new medicines during their first months on the market when unforeseen side effects can emerge.
“The systems and resources that we have at the moment are not enough to fulfil our objective of protecting public health,” said Thomas Lonngren, the EMEA’s executive director.
Regulators have come under particular pressure since withdrawal last August of Baycol, a cholesterol-lowering treatment, after it had been linked with 30 deaths. Clinical trials used to test the drug safety are often too small to pick up all potential problems.
The EMEA has promised to take a tougher stand with companies, which it says have the ultimate responsibility for the safety of drugs.
“It is very much a mixed picture at the companies,” said Noel Wathion, head of the EMEA’s post-evaluation unit. Some are pro-active at providing information and some are a complete disaster,” he said. “As a last resort, we can adopt a name and shame policy.”
The EMEA has set up a database of information on approved drugs which will collect all reports of side effects. It is also setting up networks of physicians and other medical experts to provide early signals of potential problems.
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