Capital Video: Europe withdraws 400 drugs from the market: towards a new health scandal?
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– The European Commission has ordered the withdrawal of 400 generic drugs from the market.
Big haul. There European Commission ordered the marketing authorization of 400 generic medicines. The reason: the generics would have obtained their marketing authorization after the presentation of an evaluation carried out by Synapse Labs. The Indian company provided “erroneous studies”, says the European Medicines Agency (EMA). On the 400 products concerned, 72 are marketed in France, reports Les Échos, June 19, 2024. It is now up to the National Medicines Safety Agency (ANSM) to study each of the specific cases. And for good reason: we cannot withdraw a generic from the market when there is no alternative, whether it is another generic, or the original drug is no longer sold.
If the alert was launched by theEuropean Medicines Agencyit is this same EMA which tries to temper its remarks: “There is no evidence that the drugs in question are harmful or ineffective.” The damage could still already be done. Because beyond the harmfulness of this or that generic, a feeling of distrust could arise within the population, which discovers an entire system. Indeed, unlike originator drugs, generic drugs do not need to undergo clinical trials. They must receive an evaluation by a CROa contract research organization.
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Banned in France but very widespread in Spain, this drug is the subject of an investigation
A two-year period granted if the generic has no alternative
Despite its desire to be sovereign in health matters, this is far from being the case. CROs are mainly non-European and are based in North America, South Africa and India. Synapse Labs “not considered reliable”, indicates the EMA. If, unfortunately, the generics concerned have no alternative, the European Medicines Agency assures that national authorities will be able to postpone “suspension for a maximum period of two years”And this, “in the interest of patients”.
For its part, the ANSM indicated that “some laboratories have already submitted the results of new bioequivalence studies. We are currently evaluating this data”. Thus, generic manufacturers had been warned in the summer of 2023 by the EMA, almost a year before the matter was made public by the Agency.
