FDA allowing more cancer drug imports from China amid US shortage

By Ike Swetlitz | 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 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 like 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 importation from companies that manufacture versions of the drug that aren’t approved in the US.