Intas Pharmaceuticals in India made a widely used cancer drug in the U.S. An inspection exposed problems — and the fragility of the U.S. generic-drug supply.
cisplatin from a Chinese supplier and is exploring more such options. The agency has 14 cancer drugs on its shortage list.But ending the nation’s chronic drug shortages will require a fundamental shift in how generic drugs are made and bought, experts say. Apublished Wednesday by the Brookings Institution’s Hamilton Project argues that the U.S.
Hospital purchase groups, wholesalers and distributors that buy drugs from Teva and other drugmakers have consolidated, leaving a few large players with greater leverage to drive hard bargains. FDA regulations and policies have also led to increased competition for generic drugs, putting further pressure on manufacturers to offer ever-lower prices.
“Pretty much nobody is making money in the generics business in the U.S.,” said Carlo de Notaristefani, who oversaw global operations at Teva until 2019. The lack of profits makes it hard for manufacturers to invest in upgrading older factories, he said, creating another risk for disruption along with shortages of raw materials and complying with regulations. “As plants get older, they are more susceptible to unexpected breakdowns.
Because of the meager profits in the United States, “US plants continue to close, while an increased number of sites are being opened in India with Indian government support,” the study says.. Before the November inspection, the last time the Intas plant was inspected was in February of 2020, which uncovered problems but didn’t result in regulatory action.
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