The US Food and Drug Administration is working with Chinese drugmaker Qilu Pharmaceutical to import the cancer medication cisplatin to boost supply amid an ongoing shortage.
Canadian pharmaceutical company Apotex will distribute the injectable medication in 50-milligram vials on a temporary basis. It will be available for order by health care providers starting Tuesday.
Cisplatin and other platinum-based drugs are prescribed for 10% 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, gastric, breast, and head and neck cancers.
Cancer treatments are among the hardest-hit as the US faces a near-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 shortages, lawmakers criticized the FDA for falling behind on inspections, especially of international facilities. But FDA Commissioner Dr. Robert Califf said that the agency is doing what it can even though the economic issues underlying shortages are not in its purview.
“The FDA recognizes the importance of a stable, safe supply of critical drugs used in oncology, especially those used in potentially curative or life-extending situations,” Califf said on Twitter late Friday. “Today, we’ve taken steps for temporary importation of certain foreign-approved versions of cisplatin products from FDA-registered facilities and used regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs.
“In these situations, we very carefully assess product quality and require companies to take certain measures to ensure the products are safe for patients. The public should rest 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 the oncology drugs impacted by shortages.”
The severe shortage of cisplatin and carboplatin, “the chemotherapy backbone,” is affecting hundreds of thousands of patients across the US, Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine, said Friday.
“Substitutions are sometimes required,” she said. “And in many cases, these drug substitutions are going to be as effective in terms of the response to the treatment. … However, many of these drugs may carry worse side effect profiles or different dosing schedules that require two to three times longer to administer.”
Imports of foreign medications have 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 over a year. “The drugs do need to pass the same rigorous inspections and requirements as conventionally FDA-approved drugs, so that process does take time,” she noted.
Source : CNN