News From The Front Line About Current Med Shortages
The FDA Is Considering The Temporary Use Of Drug Imports From Unapproved Companies
According to recent reports, the FDA is considering the temporary allocation of cancer therapeutics from unapproved organizations overseas, this in response to current shortages in the United States.
At least 14 medicines used in the treatment of cancer are in short supply. There is no information at this time on which foreign drug manufacturers would be considered.
Members of the American Society of Clinical Oncology note that shortages are anticipated to last through June. Because cisplatin and carboplatin are such essential medications, doctors have identified the shortages as being especially severe for these drugs.
Updates
In an FDA letter dated May 24, 2023, from Qilu Pharmaceutical Co., the organization reported to industry leaders that, as a result of critical shortages of certain chemotherapeutics, the company, in conjunction with Apotex Corp., is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of cisplatin.
Qilu initiated the temporary importation of CISplatin Injection. They make note in the letter that the (50 mg/50 mL) vials and carton labels are being sent with Chinese labeling into the U.S. market. The letter also ststes that the CISplatin Injection from Qilu is marketed and manufactured in China and is not FDA-approved.
Learn more here about the notice:
https://www.fda.gov/media/169001/download
Learn more about the FDA and the drug shortages here:
https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
Shortage notifications and updates may be reported to FDA at drugshortages@fda.hhs.gov.
More news on this important topic is available here:
https://www.beckershospitalreview.com/supply-chain/fda-weighs-importation-of-chemo-drugs-from-unapproved-manufacturers-amid-shortage.html