EU prepares tougher drug recall standards

In another response to questionable oversight by drug regulators in Europe, the EU is looking at more stringent regulations for requiring drug manufacturers to recall products.

In the European Union right now, if a drug company decides one of its drugs should no longer be manufactured because of health risks, there is no requirement that it give a reason or pull product already in the marketplace.

The proposed rules take aim at the scandal that has blown up around Mediator, the Type 2 diabetes drug made by French  drug maker Servier. The drug was widely dispensed in Europe, particularly in France, as a weight loss drug, even though it was linked to heart valve disorders as early as 1998. Servier removed the drug from the French market in 2009 and by that time there were reports that it was tied to the deaths of up to 2,000 users.

But, Pharma Times points out, Servier stopped producing the drug for Spain and Italy in 2003. It didn't have to say why and the decision did not trigger an investigation. Existing product was not removed from the market.

Under the proposed rule, a company would have to declare whether safety concerns factored into a decision to drop a license for a drug in a country, and regulators could then order a recall. They also call for a more extensive list of drugs that need close monitoring for health risks. The proposed rules have been included in new legislation and are set to go into affect in July, Pharma Times reports.

Outrage over what is seen as lax oversight of Mediator and the failure of French and other regulators to get a handle on PIP breast implants until they began to rupture, led France to dissolve its existing drug oversight agency and replace it with a new one with more power. The scandals have raised all sorts of questions about the EU's system of relying on the oversight of one country for approvals in another.

- read the Pharma Times story

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