The U.S. Food and Drug Administration (FDA) is easing rules on importing certain chemotherapy drugs to address a shortage of anti-cancer drugs, the Wall Street Journal reported on June 3.


The agency said it will allow Chinese drugmaker Qilu Pharmaceutical to ship a chemotherapy injection called cisplatin to the U.S., even though the product has not yet been approved by the FDA and the vials are labeled in Chinese.


The FDA also said on Feb. 2 that it will also allow an Indian plant that was recently temporarily shut down for production violations to resume exporting certain anti-cancer drugs to the U.S., as long as the latter meets conditions such as third-party certification of their quality.


The agency said it will also have the flexibility to increase the supply of other cisplatin products and chemotherapy drugs.

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Cisplatin is a widely used chemotherapy drug, according to the report. According to the National Cancer Institute, 10 to 20 percent of all cancer patients are treated with the drug.


Cisplatin is also used to treat lung, bladder, cervical and ovarian cancers. It has been in short supply since February, according to the Drug Enforcement Administration.


Doctors have had to ration some cancer drugs in recent months, the report said.


In a tweet, FDA Director Robert Califf said, "The FDA recognizes the importance of a stable, safe supply of critical drugs for oncology, especially those used for potential cures or to extend life."


Califf said the agency will ensure that the products used during the shortage are safe for patients.


American Cancer Society CEO Karen Knutson said last month, "Shortages of certain anti-cancer drugs have become a serious and life-threatening problem for cancer patients across the country. There are no effective alternatives to many of the drugs in short supply."


According to the American Society of Clinical Oncology, the shortage of cisplatin supplies intensified in late March and early April.

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In a recent interview published in Cancer Communications Weekly, Richard Pazdur, head of the FDA's cancer program, said the shortage of cisplatin is due to the manufacturer's failure to invest in capacity.


According to an agency inspection report, the shortage of cisplatin began after the FDA found quality problems at an Indian manufacturing plant last November, the report said.


Erin Fox of the University of Utah Health Center, a clinical pharmacist who tracks drug shortages, said the plant, owned by India's Intas Pharmaceuticals, supplies about half of the cisplatin in the United States. An FDA spokesman said Intas Pharma shut down production of cisplatin and a similar drug called carboplatin at the plant. Fox said other drugmakers were unable to fill the gap, prompting many doctors to use carboplatin, another chemotherapy drug that is also now in short supply.


The FDA monitors drug shortages and works with companies and doctors to alleviate the situation, but it has no authority to force manufacturers to make the drugs or take other drastic measures.


Pazdur told Cancer Newsletter that the FDA has offered to help cisplatin makers increase supplies. The agency is also exploring the possibility of extending the expiration dates of agents already distributed.