Posted on behalf of Barbara Casassus.
The European Union (EU) has tightened oversight rules for drugs, in response to the scandal over the anti-diabetic medicine Mediator that erupted in France two years ago (press release).
The European Parliament and EU council of ministers yesterday agreed amendments to a regulation and directive making evaluation and possible market withdrawal of a drug automatic throughout the EU if a safety alert is issued in one of the 27 member states.
The move follows France’s withdrawal of Servier’s Mediator, or benfluorex, from the French market in November 2009, 33 years after it was launched and several years after it was pulled from Portugal, Luxembourg, Greece, Italy and Spain. Authorized to help treat type 2 diabetes, the drug was widely prescribed as an appetite suppressant to non-diabetics and is estimated to have caused 500 to 2,000 deaths from heart valve disease.
The new monitoring rules, which will come into force in 2013, will also apply to non-renewal of authorization for safety reasons. Pharmaceutical companies will have to declare why they are withdrawing a drug, because they are sometimes suspected of citing commercial reasons to mask possible health risks. EU pharmacovigilance rules were upgraded in 2010, but subsequent ‘stress tests’ revealed more potential loopholes.
“It’s a shame that it often takes a scandal to bring about higher standards in legislation,” says rapporteur Linda McAvan, British Socialist and Democrat Member of the European Parliament. The updated rules “will have no impact on the initial authorization process, but regulators will be able to ask for a post-marketing study and until that is done, the drug will remain on the additional monitoring list,” she told Nature. The European Medicines Agency (EMA) will have to create a black symbol to appear on the packaging of any drugs with ongoing safety concerns.
Drug regulators have been accused of dragging their heels over Mediator. The Italian Medicines Agency warned in 2000 that the drug was possibly dangerous, but the EMA did not complete its report on the question until 2006.
The affair is far from over. Legal hurdles have been cleared for victims to bring the first of two cases against Servier to the courts. The trial is scheduled to open next April in the Paris suburb of Nanterre.