Court overturns ban on obesity drug

Published: 1-Mar-2003
Regulatory


The EU's Court of First Instance has overturned a ban imposed by the European Commission (EC) on a class of obesity drugs related to the popular 'fen-phen' cocktail that was withdrawn from the US market in 1997 due to links to heart problems. This reverses a March 2000 decision by the EC to withdraw substances containing dexfenfluramine and fenfluramine from member state markets. The drugs are produced by Laboratoires Servier, of Paris, which supplied fenfluramine to Wyeth,which produced the diet pills Redux and Pondimin.

Six million Americans took Pondimin, the 'fen' in the fen-phen cocktail, or its chemical cousin Redux before Wyeth withdrew them in 1997 amid claims of links to heart-valve disease. By the end of 2002, Wyeth had paid out US$12.6bn (€11.7bn) to settle diet-drug litigation

Soon after the US requested a halt to the drugs, marketing authorisations for the sale of products containing dexfenfluramine or fenfluramine in Europe were suspended and then definitively withdrawn in 2000.

Immediately afterwards, Servier appealed against the decision to the European court, arguing that the member states and not the Commission had jurisdiction over drug authorisations. It also argued that the scientific assessment by the EC didn't sufficiently consider how the positive effects of considerable weight loss might counterbalance a higher risk of heart problems due to the drugs. The court agreed that the EC lacked jurisdiction. It also ruled that Servier can conduct new trials and apply for permission to market the drugs in the various member states.

The Commission said it will appeal against the decision. 'We feel that there is sufficient evidence that these drugs are dangerous and should be banned in order to protect European citizens,' said Per Haugaard, spokesman for the EC.

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