Propofol Off FDA List but Manufacturing Issues Cause 75% of Shortages

By Dan Stanton contact

- Last updated on GMT

Related tags: Pharmaceutical drug, Food and drug administration

Propofol Supply Secured but Shortages Still Caused by Manufacturing Issues
Propofol Supply Secured but Shortages Still Caused by Manufacturing Issues
As propofol comes off its shortages list, the FDA says manufacturing problems still cause the majority of supply issues though legislation has helped to alleviate this.

Last July, the Food and Drug Administration Safety and Innovation Act (FDASIA) - aimed to tighten the grip on the global supply chain​ - was signed into law and included the requirement for pharmaceutical companies to notify the US Food and Drug Administration (FDA) of any anticipated shortages.

FDA spokesperson Lisa Kubaska told this publication that “since FDASIA was enacted, the FDA has been receiving daily calls and emails from manufacturers about potential problems.”

Though the legislation has led to closer cooperation between manufacturers and the FDA, Kubaska told us shortages are still an issue and “about 75 per cent of drug shortages are caused by manufacturing issues”​ and breakdowns in quality.

“Such breakdowns have occurred most often with manufacturers of sterile injectable drugs, including oncology drugs. These quality issues have included compromised sterility and the presence of glass, metal and other material inside drug vials.”

One recent example saw problems at Lonza’s Hopkington, Massachusetts​ site that led to shortages of Ibsen Biopharmaceutical’s growth failure treatment, Increlex.

Propofol Off Shortage List

One drug that has sat on the FDA’s drug shortage list for the past few years was propofol, the anaesthesia infamously associated with the death of Michael Jackson​.

The shortage had been caused by manufacturing issues first at Teva’s Irvine, California facility and then at Hospira’s Clayton, North Carolina​ plant, yet following the recent re-entry​ into propofol manufacturing by these two players, supply levels are, according to Kubaska, “anticipated by the firms to be more than adequate to meet demand.”

Last summer the only company manufacturing the drug was Fresenius Kabi, who worked with the FDA in order to ramp up capacity from two of its European sites.

Speaking with in-Pharmatechnologist.com, Senior Director, Communications & Government Affairs at Fresenius, Matt Kuhn said: “We have increased production each year since 2009, and on three occasions (2009, 2010 & 2012) also imported Propoven 1% in collaboration with and under the authority of the FDA.”

He added: “Fresenius Kabi will continue to work closely and collaboratively with the FDA on improving the supply of injectable drugs to both minimize the current drug shortages and more important, to prevent future shortages from occurring.”

Foreign Manufacturing

Last week the FDA allowed Fresenius to import trace elements and phosphate injections​ from its Norway plant in order to alleviate shortage of components of total parental nutrition (TPN).

Kubaska told us that the FDA actively searches foreign “companies willing and able”​ to temporarily import drugs in times of shortages.

By evaluating “the overseas facilities to make sure they meet FDA manufacturing standards and also make sure there are not any significant risks from the imported drug,”​ the FDA was “able to find firms to temporarily import 17 drugs in critical shortage over the past three years including propofol, doxorubicin liposomal injection​ and the recent TPN drugs.”

Related topics: Processing, Regulations, QA/QC

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