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Qilu Pharmaceutical’s cisplatin will be temporarily imported into the United States due to continued shortages.
CNN
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U.S. Food and Drug Administration is working It has partnered with Chinese pharmaceutical company Qilu Pharmaceutical to import the anti-cancer drug cisplatin to increase supply amid ongoing shortages.
Canadian pharmaceutical company Apotex will temporarily distribute the injectable drug in 50-milligram vials. It will be available for ordering by health care providers starting Tuesday.
Cisplatin and other platinum-based drugs are prescribed to 10% to 20% of all cancer patients, according to the WHO. National Cancer Institute. Cisplatin has a cure rate of over 90% when used to treat testicular cancer. It also treats bladder cancer, cervical cancer, ovarian cancer, lung cancer, stomach cancer, breast cancer, and head and neck cancer.
The United States is facing record drug shortages, with cancer care being hit hardest. About 24 chemotherapy drugs were in acute shortages at the end of March, the fifth highest among all drug categories, according to data from the University of Utah Drug Information Service.
At last month’s public hearing on the shortage, lawmakers criticized the FDA for lagging behind, especially in testing international facilities. But FDA Commissioner Dr. Robert Calif said the FDA is doing all it can, even though the economic issues underlying the shortage are outside its jurisdiction.
“FDA recognizes the importance of a stable and safe supply of critical drugs used in oncology, especially those used in potentially curative or life-prolonging settings,” said Caliph. rice field. said on twitter late friday. “Today, we have taken steps to temporarily import certain versions of our internationally approved cisplatin products from FDA-registered facilities to meet patient needs, and have regulatory restrictions on the continued supply of our other cisplatin and carboplatin products. exercised its discretion.
“In such circumstances, we require companies to evaluate product quality very carefully and take certain steps to ensure that their products are safe for patients. We ask that you continue to do everything within our power to ensure that the industry that manufactures and markets these drugs meets all patient needs for oncology drugs affected by shortages. Please rest assured.”
Dr. Amanda Fader, a professor of medicine at Johns Hopkins University, said Friday that acute shortages of cisplatin and carboplatin, “the cornerstones of chemotherapy,” are affecting hundreds of thousands of patients across the country.
“Sometimes we need to make substitutions,” she said. “And in many cases, these drug replacement therapies are equally effective in terms of response to treatment …but many of these drugs have worse side effect profiles or different dosing schedules. , it can take two to three times longer to administer.”
Importing foreign drugs has helped in similar cases before, Feder said. A decade ago, the FDA allowed foreign companies to import the chemotherapy drug Doxil after more than a year of shortages. “The process is slow because these drugs must pass the same rigorous testing and requirements as traditional FDA-approved drugs,” she noted.
CNN’s Jen Christensen contributed to this report.
