FDA Turns to China for Chemotherapy Drug Imports Amidst Shortage

In a statement issued on May 24, 2023, Qilu Pharmaceutical Co, a Chinese pharmaceutical company, will export cisplatin, a chemotherapy drug, to the United States. Amidst shortages that began in early February, the FDA is turning to China for imports to help stabilize the domestic supply of the drug.

The National Cancer Institute (NCI) notes that cisplatin is a standard chemotherapy drug used to manage or treat multiple kinds of cancer, including bladder, ovarian, and testicular cancer. According to the American Society of Health-System Pharmacists (ASHP), the only available forms of injectable cisplatin are the 1 mg/mL 50 mL vials manufactured by Teva Pharmaceuticals.

However, Teva and multiple other manufacturers, including Accord, Fresenius Kabi, Hikma, and WG critical care, are experiencing shortages in additional doses. While the reasons for the shortage are not fully understood, Accord has cited manufacturing delays as a primary cause. Additionally, Fresenius Kabi, Hikma, and WG have reported increased demand as the root cause for shortages.

Regardless of the reason, oncologists and other cancer professionals cannot wait for the shortage to be over to treat their patients. In cancer care, every second counts, and patients’ prognoses are much better with prompt and proper treatment initiation.

Understanding the urgency of this medical specialty, the FDA has allowed the distribution of cisplatin from a Chinese company. Qilu Pharmaceuticals noted the following in its recent statement:

“Due to the critical shortage of cisplatin injection in the United States (US), Qilu Pharmaceutical Co. Ltd (Qilu), in conjunction with Apotex Corp., is coordinating with the US Food and Drug Administration (FDA) to increase the availability of the drug. Qilu has initiated temporary importation of cisplatin injection (50 mg/50 mL) with vial and carton labels in Chinese into the US market. The cisplatin injection from Qilu is marketed and manufactured in China and is not FDA-approved.”

According to the FDA drug shortages list, Qilu’s cisplatin became available to order on June 6, 2023. Although finding tools to address this shortage is critical, this decision has led to multiple concerns by healthcare professionals and industry experts.

The primary concern of many is that this option does not provide a long-term solution to drug shortages. Recent data by the Atlantic Council highlighted issues in the US pharmaceutical supply chain, pointing to an increased reliance on the Chinese pharma supply chain. Despite the benefits of global collaboration across the supply chain, many researchers worry about vulnerabilities linked to foreign importation.

Beyond supply chain concerns, Qilu’s distributor, Apotex Corp, was recently caught in a whirlwind of eyedrop recalls caused by bacterial contamination. While Apotex was not the primary offender in the 2023 eyedrop recalls, it may be a conflict of concern.

Even with these concerns, many healthcare professionals will have no choice but to use these imported products. In the meantime, the Society of Gynecological Oncology recommends that organizations minimize non-essential platinum when possible. Additional recommendations include reducing the dose or widening the interval between treatments.