All are affected by insufficient stocks of drugs said to be “of major therapeutic interest” and the lack of which could “put life at risk”.
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The French National Agency for the Safety of Medicines and Health Products (ANSM) imposed a fine of 8 million euros on 11 pharmaceutical laboratories on Tuesday, September 24, franceinfo learned. This amount is up 14% compared to last year.
The drug regulator is criticizing these laboratories for not having built up a four-month safety stock for certain drugs deemed essential. This is a mistake because these stocks are mandatory.
The Biogaran laboratory received the biggest penalty with a fine of 4 million euros. It did not have the required stocks of Irbesartan, a drug against hypertension. Other pharmaceutical companies are being singled out, such as Viatris for Methylprednisolone – a corticosteroid – and Sanofi for two drugs: Jevtana used against cancer and Rifinah prescribed against tuberculosis. All are part of the list of 748 drugs said to be of “major therapeutic interest” and which have already been the subject of a supply shortage or a risk of shortage over the last two years.
A drug of major therapeutic interest is a drug for which “an interruption of treatment is likely to put the vital prognosis of patients at risk in the short or medium term”explains the ANSM on its website. These stocks should make it possible to better cover the needs of patients in the event of a major blow to the supply, or in the event of a major epidemic. In 2023, the ANSM managed nearly 5,000 reports of stock shortages and risks of shortages, i.e. a third more than in 2022 and six times more than in 2018.