National Agency for Medicines disapproves of new OTC weight-loss pill

European Commission approved over-the-counter sales in January, despite objections from some member-states

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The experts of the National Agency for Medicines would not have granted a marketing authorisation to a new over-the-counter weight-loss pill Alli. Nevertheless, the new OTC drug is to be introduced by Finnish pharmacies in the course of the upcoming spring.
     
The European Commission approved Alli for over-the-counter sale to overweight adults in the European Union in January, regardless of the fact that authorities in several member-states, including France, regarded the decision with disfavour.
      The approval was based on a ruling made by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency EMEA.
      The National Agency for Medicines reports that they will abide by the EMEA’s decision, even though they are displeased about it.
     
”Our idea of drugs that are suitable for self-treatment medication differs from that of the CHMP”, says professor Pekka Kurki, the Head of Department responsible for Marketing Authorisation at the National Agency for Medicines.
      According to the National Agency for Medicines, the new anti-obesity drug should be used only after a thorough medical check-up and in conjunction with a treatment plan that is to be monitored carefully.
      The controversial weight-loss medicine is the reduced-strength version of Orlistat, a prescription drug to treat obesity.
      Alli is manufactured by the UK-based pharmaceutical company GlaxoSmithKline, and according to the manufacturer, the drug is designed to treat obesity and intended for use in conjunction with a low-calorie, low-fat diet, and regular exercise.
     
In the future, Finnish pharmacies are also expected to sell several other self-treatment medicines which have been evaluated at the EMEA instead of the National Agency for Medicines.
      Following an amendment to the EU Directive on human medicines in 2005, a company that wishes to bring a medicine to the market may submit a single application to the EMEA for a marketing authorisation that is valid simultaneously in all EU member states.
     
Finland’s National Agency for Medicines has granted licences primarily for drugs that are designed to treat short-term symptoms, for example for mild painkillers.
      Only very few pharmaceutical preparations, including vitamins, have been approved for long-term self-treatment.
      According to the EMEA, further self-treatment medicines likely to be evaluated in the future include for example drugs designed for erectile dysfunction and high blood cholesterol.
     
According to professor Kurki, one positive decision does not indicate that Finland should change its policy relating to self-treatment preparations.
      ”However, in the long-run the decision may have an impact on our course of action”, Kurki admits.
     
Compared with Finland, OTC medication is much more common in many other European countries.
      ”We have considered that drugs are only part of the treatment. We do not regard medicalisation as a good thing”, Kurki concludes.
      Considering the very strong reaction to the decision in France, Kurki says he is surprised that more pressure was not exerted in the permanent committee stage by EU countries objecting to the OTC ruling.


Links:
  Orlistat (Wikipedia)
  National Agency for Medicines
  European Medicines Agency EMEA

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