The FDA’s decision to collaborate with a foreign pharmaceutical company comes as the country struggles with a severe lack of more than a dozen cancer medications.
As a result of a persistent shortage of the medication in the United States, the Food and Drug Administration is collaborating with a Chinese pharmaceutical company to import the chemotherapy drug cisplatin.
According to James McKinney, an agency spokesperson, the FDA is also considering importing carboplatin, a different chemotherapy drug that is in short supply. The agency, according to McKinney of NBC News, is still unable to provide specifics regarding the potential supplier of that medication.
The FDA’s decision to collaborate with a foreign pharmaceutical company comes as the country struggles with a severe lack of more than a dozen cancer medications.
Since late April, there has been a shortage of carboplatin and cisplatin, respectively, in the US.
The pharmaceutical firm Qilu Pharmaceutical markets and manufactures cisplatin in China, but the FDA has not given the drug approval for use in the US. According to a letter from the company dated May 24, Qilu will work with the Canadian pharmaceutical firm Apotex to import and distribute the medication. Chinese-labelled 50-milligram vials will be used to package the medication.
According to McKinney, medical professionals should be able to begin writing drug orders on Tuesday.
Working with a Chinese pharmaceutical company to increase cisplatin supply is a smart idea, according to Eric Tichy, board chair of the End Drug Shortages Alliance, a group devoted to resolving issues with the drug supply chain.
According to the National Cancer Institute, 10% to 20% of all cancer patients are treated with platinum-based medications, such as cisplatin and carboplatin. They are applied to treat a variety of cancers, such as ovarian, testicular, lung, bladder, and cervical cancers.
Some patients will be left without their medication due to the shortage.
Anything the FDA can do to increase the availability of cisplatin in the U.S.S. will be beneficial, according to Tichy. When there is a severe shortage, the FDA “should consider importation when that option is available from a reliable source.”
It is unknown at this time whether the FDA will apply this strategy to cancer drugs other than cisplatin and carboplatin.
FDA Commissioner Dr. Robert Califf said the partnership with Qilu Pharmaceutical is temporary but will give patients access to a medication that may extend their lives in a tweet on Friday.
The public can be confident that we will continue to do everything in our power to assist the industry that produces and distributes these medications in meeting all patient needs for the oncology medications affected by shortages, he said.