When importing drugs, the FDA stressed that regulators carefully assess product quality and manufacturing processes to ensure patient safety
By Physician’s Briefing Staff HealthDay Reporter
MONDAY, June 5, 2023 (HealthDay News) — With the United States facing a high number of drug shortages, a Chinese company may help to boost the supply of one in particular, the chemotherapy agent cisplatin.
The U.S. Food and Drug Administration is working with the Chinese drugmaker Qilu Pharmaceutical to import the widely used cancer drug. The Canadian pharmaceutical company Apotex will distribute the medication in 50-mg vials, CNN reported. Health care providers can begin ordering the drug on Tuesday.
“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,” said FDA Commissioner Robert Califf, M.D., 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.”
Califf stressed that in these situations regulators 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,” he added.
The near-record number of drug shortages has had a big effect on cancer treatments, with about two dozen chemotherapy drugs in active shortage this spring, CNN noted, citing data from the University of Utah Drug Information Service. Lawmakers criticized the FDA for falling behind on inspections of international facilities in a hearing last month, but the agency said much of the shortages were due to economics.
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