NEW FDA HEAD GIVES BAXTER EXCLUSIVE RIGHT TO IMPORT SALINE BAGS IN WAKE OF DRUG SHORTAGES. BAXTER’S IMPORTS DIFFER FROM FDA APPROVED PRODUCTS. QUALITY CONTROLS IN PLACE?


FDA Commissioner Scott Gottlieb has given Baxter, a company headquartered in Deerfield, beside Chicago in Illinois, the sole right to import mini bags of saline solution vital for hospitals following the destruction of large numbers of pharmaceutical manufacturing facilities in Puerto Rico due to a hurricane.

“Devastation of infrastructure could result in critical shortages of common medicines, including Crestor and Humira, produced in Puerto Rico, one of the world’s biggest centres for pharmaceutical manufacturing.”

http://www.pharmaceutical-journal.com/news-and-analysis/news/puerto-rico-hurricane-damage-could-lead-to-drug-shortages/20203703.article

Baxter is allowed to import from its facilities in Ireland and Australia saline bags, which differ from the ones which have received FDA approval,  ostensibly as an emergency measure.

Baxter contaminated 72 kilos of seasonal flu with the deadly bird flu virus in 2009 in its biosecurity level 3 facilities in Orth an der Donau, nearly starting a bird flu pandemic.

If there is a shortage of saline bags, why has Gottlieb not asked other pharmaceutical companies to supply them and only Baxter?

If the Baxter imports differ from the FDA approved bags, in what way do they differ?

Are adequate quality controls in place to ensure they are not contaminated with some disease or diluted?

From Oncology Nursing News

Nearly a month after Hurricane Maria left a path of destruction in Puerto Rico, the island is still trying to pick up the pieces.

 Newly reported by The Washington Post, is the disruption in production of mini-bags of IV solutions of normal saline and dextrose in water, which are manufactured by Baxter International.

 The healthcare company is headquartered in Deerfield, Illinois, but has manufacturing sites in Puerto Rico where these mini-bags are produced. In a press release from Baxter International, the company stated that limited production at its facilities resumed a week following the Category 4 storm, powered by diesel generators.

 To combat the shortage, Baxter International initiated an allocation system for hospitals and clinics based on past purchases.

 And, as of last week, the Food and Drug Administration (FDA) gave the company permission to import normal saline and other solutions from its manufacturing facilities in Australia and Ireland to help ease shortages in the United States. 

 In addition, The Washington Post said that more than four dozen FDA-approved drug making facilities are located in Puerto Rico, including ones owned by Pfizer Inc., Merck, Eli Lilly, Johnson & Johnson, Bristol-Myers Squibb and Amgen. Many of these manufacturers produce agents used in the treatment of cancer, and it is unclear at this point if weather-related disruptions will affect the manufacturing of these agents.

“Baxter remains focused on helping ensure patients have continued access to the products and therapies they need,” stated the press release.

http://www.oncnursingnews.com/nurse-blogs/lisa-schulmeister/1017/hurricane-maria-leaves-shortage-of-minibag-iv-solutions

From Statnews

In letters dated Monday, the company, Baxter International, informed its customers that they could now order bags of saline solution that are manufactured abroad even though they are not FDA-approved because they are not marketed in the United States. Saline solution, given intravenously, is used for hydration and to dilute drugs.

 

https://www.statnews.com/2017/10/10/fda-permits-importation-saline-bags-address-shortages-exacerbated-hurricane-maria/

Baxter Healthcare said in letters to health care professionals dated Monday that it is working with the US Food and Drug Administration (FDA) to import sodium chloride and glucose intravenous infusion products from Ireland and Australia to address shortages because of Hurricane Maria.

The temporary imports are manufactured at Baxter facilities in Ireland and Australia and the company notes that at this time, “No other entity except Baxter is authorized by the FDA to import or distribute these products in the United States.”

….

All four of the letters sent by Baxter on Monday also noted some of the differences between the FDA-approved products and the imports.

http://www.raps.org/Regulatory-Focus/News/2017/10/11/28653/FDA-Allows-Temporary-Saline-Imports-to-Deal-With-Shortages-Caused-by-Hurricane-Maria/

The head of the U.S. Food and Drug Administration said the agency was working with several pharmaceutical and medical device companies in Puerto Rico to prevent shortages of medical products in the United States as it joins a massive effort to help rebuild the island that was ravaged by Hurricane Maria.

FDA Commissioner Scott Gottlieb said the agency has been monitoring more than 40 drug products in Puerto Rico, where 10 percent of the drugs prescribed in the United States are made.

Gottlieb said last week that the United States may face a small number of drug shortages due to delays in restoring manufacturing operations in the island.

There are currently more than 50 medical device making plants in Puerto Rico, employing about 18,000 people.

The regulator is taking steps to mitigate shortages by importing devices from outside the United States or allowing manufacturers to shift production to alternative sites, the FDA said.

https://www.reuters.com/article/us-usa-healthcare-gottlieb-puertorico/fda-teams-with-medical-companies-in-puerto-rico-to-tackle-shortages-idUSKBN1CP23W

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