US seeks new suppliers of highly used cancer drug methotrexate in short supply

[June 10, 2023]  By Julie Steenhuysen and Michael Erman

(Reuters) - The U.S. Food and Drug Administration said on Friday it is seeking new suppliers to ease shortages of methotrexate, one of the most commonly used cancer drugs, building on its push to shore up two other scarce chemotherapy medicines.

An FDA spokesperson told Reuters the agency is looking for temporary importation options for the drug, which has been in shortage since March.

Methotrexate is an injected drug used to treat a wide variety of cancers ranging from acute lymphoblastic leukemia in children, breast cancer, lung cancer, bone cancers and certain types of head and neck cancers, according to the National Cancer Institute.

Last week, the FDA said it was looking for additional temporary suppliers for two other cancer chemotherapies, cisplatin and carboplatin. It has already signed off on allowing cisplatin made by China's Qilu Pharmaceutical to be sold in the country.

The FDA had not previously disclosed it is also looking for new methotrexate sources.

Some cancer drugs have been hard-hit by ongoing shortages in the United States, prompting doctors to ration drugs and complicating treatment plans for patients.

According to information released by U.S. Senators Gary Peters and Debbie Stabenow, shortages have been exacerbated by a disruption in supply from India-based manufacturer Intas Pharmaceuticals, which provides the U.S. market through its Accord Healthcare unit.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

There are more than 130 drug formulations currently in shortage in the U.S., according to a list maintained by the FDA.

When faced with shortages, the FDA can make exceptions to allow products to be sold here outside of its usual oversight. A recent high-profile example was its opening of the baby formula market to additional manufacturers.

The regulator generally requires extra testing and oversight of new suppliers before signing off on them.

"The FDA may inspect the facility and conduct FDA sampling and testing as an additional level of oversight. The agency is doing both in this case," the regulator said in a statement when asked about the Qilu exemption.

Methotrexate works by slowing or stopping the growth of cancer cells and suppressing the immune system.

According to the American Society of Health-System Pharmacists, suppliers with methotrexate injections in shortage or on back order include Accord Healthcare, Fresenius Kabi, Pfizer, Teva and Hikma Pharmaceuticals .

Methotrexate is also commonly used to treat autoimmune diseases such as rheumatoid arthritis.

(Reporting by Julie Steenhuysen in Chicago and Michael Erman in New Jersey; Editing by Bill Berkrot)

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