FDA, manufacturers make progress in resolving key cancer drug shortages: White House

While there's certainly more work to do, the U.S. FDA and pharma manufacturers are making headway in their push to resolve a nationwide shortage of popular cancer drugs, according to the White House.

Their efforts have brought the U.S. supply of the chemotherapy cisplatin to nearly 100% of pre-shortage levels, according to a White House press release. The moves are “greatly alleviating the shortages of carboplatin,” too, the White House said.

Amid a shortage of 15 cancer drugs because of manufacturing and supply chain issues, the FDA has been working closely with cancer drug manufacturers to boost production capacity, the White House said.

The regulator has also been angling to bring companies back into the manufacturing fold who’d previously stopped producing the chemotherapies for the U.S. market.

Further, the FDA has arranged for an unnamed manufacturer to import 14 lots of cisplatin from an FDA-registered facility outside the U.S. 

Back in June, a survey by the National Comprehensive Cancer Network Best Practices Committee found that 70% of member centers were experiencing a cisplatin shortage. Nearly all were seeing carboplatin shortfalls.

To help fill supply gaps, the FDA previously cleared cisplatin to be imported to the U.S. from Chinese manufacturer Qilu Pharmaceutical. The agency is also allowing India’s Intas Pharmaceuticals to resume shipping cisplatin, carboplatin and 14 other injectables to the U.S.

As for another cancer drug, methotrexate, the FDA has “worked closely” with five generics manufacturers to help increase supplies during the shortage, the White House said.

Still, despite making “meaningful progress” on the issue, shortages have not been fully resolved.

Several generic cancer drug makers have discontinued products for “economic reasons,” and, in the last year, manufacturing site closures have cut the U.S. supply of cisplatin, carboplatin and methotrexate nearly in half.