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FDA boosts collaboration with manufacturers to overcome ongoing cancer drug shortages

The supply of cisplatin, carboplatin and methotrexate has nearly halved in the past year

US Food and Drug Administration

The US Food and Drug Administration (FDA) has increased its collaboration with cancer drug manufacturers in a bid to overcome the country’s ongoing drug shortage problem and reduce impacts on patients.

The US is currently experiencing a shortage of 15 cancer drugs as a result of manufacturing and supply chain issues. Three of these drugs – cisplatin, carboplatin and methotrexate – have been staples of cancer treatment for decades, but their supply in the US has nearly halved in the past year.

To help alleviate the shortages of carboplatin and cisplatin, the FDA has been working closely with manufacturers to identify opportunities to increase manufacturing capacity and bring companies that had stopped producing those drugs back to the US market.

Additionally, the agency “exercised enforcement discretion” for a manufacturer to import 14 lots of cisplatin from an FDA-registered facility outside of the US.

Together, these actions brought the cisplatin supply back to nearly 100% of the pre-shortage levels and are reportedly significantly relieving the shortages of carboplatin.

The FDA also boosted its collaboration channels with the five manufacturers of generic methotrexate for injection to help increase supplies.

Despite the progress, the Biden-Harris administration has emphasised that “there is more work to do”.

“While meaningful progress has been made for patients across the US, shortages have not been fully resolved and the FDA continues to work with drug manufacturers and health care providers to help restore access to essential cancer treatments and other medicines that are currently in short supply,” the administration said in a statement.

Drug shortages have been an ongoing global issue. At the beginning of this year, the EU said it would be revising its pharmaceuticals law amid a growing number of antibiotic shortages.

French President Emmanuel Macron also unveiled plans in June to relocate the production of key medicines to France.

Macron, who was visiting pharmaceutical laboratories in southeast France, explained that the government had created a list of 450 molecules that are key to securing pharmaceutical supply chains in the country. Within the list were 50 drugs, including morphine and six anti-cancer medicines, which would see their production relocated to France or significantly increased as a priority.

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