FDA Allows Oncology Drug Imports amid Shortage
07.06.2023 - To boost supply of the injectable chemotherapy drug cisplatin – the US is facing a shortage of oncology treatments – the Food and Drug Administration (FDA) will temporarily allow imports of 50-milligram vials from Chinese manufacturer Qilu Pha. Canada’s Apotex would distribute.
To boost supply of the injectable chemotherapy drug cisplatin – the US is facing a shortage of oncology treatments – the Food and Drug Administration (FDA) said it will temporarily allow imports of 50-milligram vials from Chinese manufacturer Qilu Pha.
The drug would be distributed in the US by Canada’s Apotex.
Posting on Twitter, FDA commissioner Robert Califf said the agency “has taken steps for the import of certain foreign-approved versions of cisplatin products from FDA-registered facilities and is using regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs.”
Califf said 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.”
US oncology specialists are said to have begun rationing critical platinum-based cancer drugs.
As the crisis worsens, the search for scapegoats is intensifying. Richard Pazdur, head of the FDA's Oncology Center of Excellence, has identified as the root cause a failure by drugmakers to build out capacity.
As regards cisplatin, however, quality issues that shut down a facility producing the drug are said to have created a “ripple” with devastating consequences.
The knock-on effects of the plant shutdown have been so severe, reports said, because most manufacturers are currently operating near capacity and thus are unable to fill the gap.
In their defense, some pharmaceutical companies are said to have told the agency that selling prices for oncology treatments have not caught up with rising production costs and this has forced them out of the market.
In another attempt to make up for the shortages, the FDA has also notified India’s Intas Pharmaceuticals that it can resume shipping cisplatin, carboplatin and 14 other types of injectable medications to the US. agency had banned them after the company was cited for manufacturing deficiencies found during an inspection last year.
In return for the import greenlighting, the FDA said Intas would be required to complete a third-party review and carry out testing of any imported products. It added that the US would revoke the permit if shortage and medical necessity implications change.