Amsterdam’s AMC teaching hospital has been ordered to recall its own version of a licenced drug to treat a rare metabolic disorder because the raw materials might contain impurities.
Health inspectors have told the hospital to recall the drug henodeoxycholic acid or CDCA because the ingredient from China cannot be properly tested and, therefore, may not be pure.
The hospital has now stopped making the drug as a precautionary measure but stresses that further research will determine if the ingredient does actually contain impurities.
‘We have tested the ingredient thoroughly to ensure it meets European standards via a certified laboratory,’ board member Frida van den Maagdenberg said. ‘We are surprised that the inspectors have reached a different decision.’
The AMC has been producing the drug since April because it was no longer covered by health insurance after the price shot up.
CDCA is produced by Italian pharmaceuticals company Leadiant. On April 1, the company ramped up the price by around 500% so it now costs some €200,000 per patient per year. The hospital said at the time it could produce the drug for €25,000.
Hospital pharmacies make their own medicines more often but this case is unusual because of the financial considerations. The hospital is offering ‘a social and economically-responsible alternative to a registered medicine which is so expensive that it is inaccessible to patients,’ the AMC said in April.
Just 60 patients in the Netherlands suffer from the disease CTX which the drug is used to treat. The drug has been available since the 1970s but Leadiant only registered it as an orphan medicine with the European medicines agency last year.
Orphan status, given to drugs which are used to treat very specific and rare illnesses, means a drug cannot be copied for a 10-year period.
Health minister Bruno Bruins told RTL news in April that he preferred the use of registered medicines because of the tough procedures they have gone through. Nevertheless, he said, it is unacceptable that companies raise the price ‘to make fat profits’.
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