US imports chemotherapy drug from China due to critical shortage

Key takeaways:

• Qilu Pharmaceutical is coordinating with the FDA to increase the availability of cisplatin in the United States.
• The FDA commissioner emphasized the agency’s commitment to quality and safe products.

Amid an ongoing drug shortage, the FDA is allowing the chemotherapy drug cisplatin to be imported from China.

The Chinese manufacturer Qilu Pharmaceutical Co., Ltd., alongside its distributor Apotex Corp., is coordinating with the FDA to increase the availability of cisplatin 50 mg/50 mL (1 mg/mL) vials, the FDA said. The treatment will be available for ordering on June 6.

Cisplatin is used alone or in combination with other drugs as a treatment for various cancers, including bladder, ovarian and testicular cancers, according to the National Cancer Institute.

Qilu initiated the temporary importation of cisplatin with vial and carton labels into the United States market, according to a letter to health care professionals from the company. The FDA has only authorized Qilu or Apotex to import or distribute the cisplatin injection in the United States.

FDA Commissioner Robert M. Califf, MD, MACC, said on Twitter that the agency “recognizes the importance of a stable, safe supply of critical drugs used in oncology, especially those used in potentially curative or life-extending situations.”

“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,” he wrote.

In these situations, he added, FDA requires companies to take specific measures to ensure that the products are safe for patients. The agency also carefully evaluates product quality.

“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,” he wrote.

References:

• Cisplatin. https://www.cancer.gov/about-cancer/treatment/drugs/cisplatin. Accessed June 5, 2023.
• FDA drug shortages. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Cisplatin%20Injection&st=c. Accessed June 5, 2023.
• Letter to health care professionals. https://www.fda.gov/media/169001/download. Accessed June 5, 2023.
• Twitter. https://twitter.com/DrCaliff_FDA/status/1664786509780615170?s=20. Published June 2, 2023. Accessed June 5, 2023.