White House reports progress on easing cancer drug shortages with FDA, manufacturers

US FDA, drug shortage, Cisplatin, pharma manufacturers

The US FDA and pharmaceutical manufacturers are making significant strides in addressing the nationwide shortage of popular cancer drugs, as reported by the White House. Their collaborative efforts have substantially increased the supply of the chemotherapy drug cisplatin, nearly restoring it to 100% of pre-shortage levels, and have also greatly alleviated shortages of carboplatin.

A shortage of 15 critical cancer drugs had been plaguing the country due to manufacturing and supply chain challenges. In response, the FDA has been working closely with cancer drug manufacturers to enhance production capacity and has endeavored to bring back companies that had previously halted the production of these chemotherapies for the US market.

Furthermore, the FDA has facilitated the importation of 14 batches of cisplatin from an FDA-registered facility outside the US, although the manufacturer’s name remains undisclosed. Back in June, a survey by the National Comprehensive Cancer Network Best Practices Committee found that 70% of member centers were grappling with a shortage of cisplatin, with nearly all experiencing shortfalls in carboplatin.

To address these supply gaps, the FDA had previously authorized the importation of cisplatin from the Chinese manufacturer Qilu Pharmaceutical and allowed India’s Intas Pharmaceuticals to resume shipments of cisplatin, carboplatin, and 14 other injectables to the US.

Regarding another vital cancer drug, methotrexate, the FDA has collaborated closely with five generic manufacturers to augment supplies during the shortage. Despite making meaningful progress, the issue of drug shortages has not been completely resolved. Economic factors have prompted several generic cancer drug manufacturers to discontinue products, and the closure of manufacturing sites in the past year has nearly halved the US supply of cisplatin, carboplatin, and methotrexate.

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