US regulators are allowing imports of additional supplies of a cancer drug from China amid a nationwide shortage that has forced doctors to ration care, putting patients’ lives at risk.
(Bloomberg) — US regulators are allowing imports of additional supplies of a cancer drug from China amid a nationwide shortage that has forced doctors to ration care, putting patients’ lives at risk.
The Food and Drug Administration has allowed distribution of 10 more lots of cisplatin, an essential chemotherapy drug, from Qilu Pharmaceutical Co., an agency spokesperson said Monday. The FDA previously cleared four lots of Qilu’s version of the drug, which is unapproved in the US, but similar to approved cisplatin sold there.
The 10 new lots will arrive in the US this week, said a spokesperson for Apotex Inc., which distributes Qilu’s cisplatin in that country.
The current US shortage of cisplatin started at the beginning of the year when Intas Pharmaceuticals Ltd., the company that makes much of the country’s supply, shut down a factory in India after the FDA found that workers apparently destroyed documents. Soon after, carboplatin, another chemotherapy drug that can sometimes be used as a substitute, fell into short supply.
Shortages of generic drugs such as cisplatin are common in the US. Experts say the medicines don’t make enough money for companies to set up reliable supply chains. Drug shortages are at a five-year high, according to the University of Utah’s drug information service, which tracks the data. The FDA lists at least nine cancer drugs in short supply.
When there is a shortage of a medicine, the FDA regularly allows imports from companies that manufacture versions of the drug that aren’t approved in the US.
“We will continue the importation until approved manufacturers can meet all patient needs,” FDA spokesperson Chanapa Tantibanchachai said.
For some cancer centers, the availability of cisplatin and other generic cancer drugs is improving. Data from Premier Inc., which helps about half of US health systems buy medicines, show that shipments of cisplatin plummeted in January but rebounded by May.
Lee Wilke, senior medical director of clinical cancer services at UW Health, the University of Wisconsin’s health system, said that her center rationed carboplatin for two weeks in May and June but had a stable supply by the end of June. Sam Abdelghany, executive director of oncology pharmacy services at Yale New Haven Health, said there’s enough medicine on the market to treat his patients.
The “cisplatin shortage is a non-issue at this point,” Abdelghany said.
(Updates third paragraph with timeline and seventh paragraph with FDA comment.)
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