FDA to allow temporary overseas production to shore up supplies of chemo drug

The head of the FDA said that to bolster supplies of the injectable chemotherapy drug cisplatin, the agency will permit temporary importation of 50-milligram vials from a Chinese manufacturer to aid cancer patients.

The FDA will, on a temporary basis, allow Qilu Pharmaceutical to import the drug, which will be distributed in the U.S. by Canadian-based Apotex Corp.

“Today, we’ve taken steps for temporary importation of certain foreign-approved versions of cisplatin products from FDA-registered facilities and used regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs,” Robert Califf, M.D., the FDA commissioner, said in a June 2 social media post.

Califf went on to say, “The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs for the oncology drugs impacted by shortages.”

The head of the FDA's Oncology Center of Excellence, Richard Pazdur, M.D., recently told the The Cancer Letter that the root cause of chemo drug shortages was a failure by the drug manufacturing industry to build out its capacity.

As for cisplatin, he said, an inspection that uncovered quality issues at a facility producing the chemo drug that forced it to shut down production created a “ripple effect" in the supply chain.

That ripple has also had an impact on drugs produced by more than one manufacturer, because most manufacturers are currently operating near capacity, which means they are unable to produce additional supplies if another plant shutters production, Pazdur said.

Some manufactures have told the agency that their costs have risen beyond sales prices, and that has forced them out of the market.

Additionally, in order to alleviate the shortages, the agency wrote a letter last week to India’s Intas Pharmaceuticals that said it could resume shipping cisplatin, carboplatin and 14 other types of injectable medications to the U.S. despite the company having been cited for manufacturing deficiencies found during an inspection last year. As part of the new deal, Intas will be required by the FDA to complete a third-party review and testing of any imported products.