In order to meet the domestic need for an anti-cancer drug in the US, Cisplatin, the U.S. Food and Drug Administration has allowed temporary importation of the injectable drug from overseas manufacturers.
Chemotherapy
Cisplatin is a chemotherapy drug that is used to treat various cancers. It is one of the many drugs that are going through a period of shortened supply in the US. These shortages are occurring due to manufacturing failures across the US. Companies have failed to increase their production capacities and that is resulting in shortages across the country.
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According to FDA officials, the shortage of Cisplatin resulted due to the detection of quality issues in a manufacturing process of a company. The company producing Cisplatin had to shut down its manufacturing process to address the concerns put forward due to the investigation. This created a ripple effect as other manufacturers couldn’t match the demand for the drug as they were already functioning at their capacity. Additionally, some manufacturers have informed the FDA that their production costs have become higher than the sale prices of the drug which is forcing them out of the market.
To tackle the shortage, the FDA has approved the temporary importation of Cisplatin from Qilu Pharmaceutical, a Chinese manufacturer. The injectable drug will be imported in 50 mg vials. The drug will be distributed in the US by a Canadian company, Apotex Corp.
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The FDA officials have assured the public that they are committed to meeting the patients’ needs for this drug by ensuring the continued supply of Cisplatin. They also mentioned that FDA will continue their efforts to facilitate the industries manufacturing and distributing this drug to help manage shortages.
FDA commissioner Robert Califf has assured the public that the FDA will assess the quality of imported products keenly and will recommend measures to the manufacturing companies to ensure that the products are safe for patients.
In addition to this, the FDA has written a letter to an Indian company, Intas Pharmaceuticals to resume the shipping of Cisplatin. The FDA requires that the Indian company complete a third-party review of the imported products to meet the deficiencies found on an inspection last year. If the company meets the quality requirements of the FDA, the FDA will allow it to import Cisplatin to the US.
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According to the Apotex Spokesman, the shipping of Cisplatin will begin this week and patients should be able to access the drug later this week.
References
Chemocare. (n.d.). Cisplatin. Retrieved June 10, 2023, from https://chemocare.com/chemotherapy/drug-info/cisplatin.aspx
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