FDA Eases Shortage Crisis by Importing Additional Cancer Drugs from China

In response to a critical shortage of cancer drugs in the United States, the Food and Drug Administration (FDA) has granted permission for the importation of additional supplies of a crucial chemotherapy drug from China. This move aims to address the nationwide scarcity that has forced doctors to ration care, putting the lives of cancer patients at risk.

The FDA spokesperson announced that the agency has approved the distribution of 10 new lots of cisplatin, an essential chemotherapy drug produced by Qilu Pharmaceutical Co. This follows the clearance of four lots of Qilu’s version of cisplatin, which, although not approved in the US, bears similarities to the approved cisplatin sold in the country. Apotex Inc., the distributor responsible for Qilu’s cisplatin in the US, has confirmed that the new lots will arrive this week. This importation of additional supplies from China is a crucial step in addressing the shortage and ensuring that cancer patients have access to the necessary medications.

The shortage of cisplatin originated earlier this year when Intas Pharmaceuticals Ltd., a major supplier of the drug in the US, closed its Indian factory. The closure was prompted by the FDA’s discovery of document destruction by workers at the facility. As a result, carboplatin, another chemotherapy drug that can be used as a substitute, also experienced a shortage. The scarcity of generic drugs, such as cisplatin, is a common issue in the US healthcare system. The low-profit margins associated with these medications discourage companies from establishing reliable supply chains. According to the University of Utah’s drug information service, the US is currently facing a five-year high in drug shortages, with at least nine cancer therapies listed as being in short supply.

Improving Availability and FDA’s Importation Policy for Cancer Drugs

To mitigate the impact of medicine shortages, the FDA has a regular practice of allowing the importation of drugs from companies that manufacture versions of the drug not approved in the US. The FDA spokesperson, Chanapa Tantibanchachai, emphasized that the importation will continue until approved manufacturers can meet the needs of all patients. Encouragingly, some cancer centers have already witnessed improvements in the availability of cisplatin and other generic cancer drugs. Data from Premier Inc., which assists numerous US health systems in purchasing medicines, indicates that while cisplatin shipments experienced a significant drop in January, they rebounded by May.

FDA’s Decision Reflects Ongoing Efforts and Challenges in Cancer Drug Supply Lines

Lee Wilke, senior medical director of clinical cancer services at UW Health, reported that her center experienced a two-week rationing of carboplatin in May and June but managed to stabilize the supply by the end of June. Similarly, Sam Abdelghany, executive director of oncology pharmacy services at Yale New Haven Health, expressed confidence in the market’s ability to provide sufficient medicine for his patients, stating that the cisplatin shortage is now a non-issue. These accounts highlight the positive developments seen in some cancer centers regarding the availability of the drugs, offering hope that the situation is improving.