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FDA allows import of cancer drug from China amid ongoing shortage




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Qilu Pharmaceuticals’ cisplatin will be temporarily imported into the US as shortages of the drug continue.



CNN
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The US Food and Drug Administration is working with Chinese drugmaker Qilu Pharmaceutical to import the cancer drug cisplatin to boost supply amid an ongoing shortage.

Canadian pharmaceutical company Apotex will distribute injectable drugs in 50 milligram vials on an interim basis. It will be available for ordering by healthcare professionals from Tuesday.

Cisplatin and other platinum-based drugs are prescribed for 1[ads1]0% to 20% of all cancer patients, according to the National Cancer Institute. Cisplatin has a cure rate of over 90% when used to treat testicular cancer. It also treats bladder, cervical, ovarian, lung, stomach, breast and head and neck cancers.

Cancer treatments are among the hardest hit as the US faces an almost record number of drug shortages. As of the end of March, about two dozen chemotherapy drugs were in active shortage, the fifth most of any drug category, according to data from the University of Utah Drug Information Service.

At a hearing last month on the shortage, lawmakers criticized the FDA for falling behind on inspections, particularly of international facilities. But FDA Commissioner Dr. Robert Califf said the agency is doing what it can even though the financial problems underlying the shortage are not within their purview.

“The FDA recognizes the importance of a stable, secure supply of critical drugs used in oncology, particularly those used in potentially curative or life-prolonging situations,” Califf said on Twitter late Friday. “Today, we have taken steps to temporarily import certain foreign-approved versions of cisplatin products from FDA-registered facilities and used regulatory discretion to continue supplying other cisplatin and carboplatin products to help meet patient needs.

β€œIn these situations, we assess product quality carefully and require companies to take certain measures to ensure that the products are safe for patients. The public should be 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 oncology drugs affected by shortages.”

The severe shortage of cisplatin and carboplatin, the “chemotherapy backbone,” is affecting hundreds of thousands of patients across the United States, Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine, said Friday.

“Replacements are sometimes necessary,” she said. “And in many cases, these drug replacements will be just as effective in terms of response to treatment. … However, many of these drugs may have worse side effect profiles or different dosing schedules that require two to three times longer to administer.”

Importing foreign medicines has helped in similar cases before, Fader said. A decade ago, the FDA allowed foreign companies to import the chemotherapy drug Doxil amid a shortage that lasted more than a year. “The drugs need to pass the same rigorous inspections and requirements as conventional FDA-approved drugs, so the process takes time,” she noted.

CNN’s Jen Christensen contributed to this report.





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