Thursday, October 23, 2014
July 2013 US Congress Concerns Over Potential Heparin Shortages Minimize



U.S. lawmakers are concerned that a Chinese's planned takeover of Smithfield Foods could affect the safety and availability of heparin

U.S. lawmakers are concerned a Chinese company's planned $4.7 billion acquisition of pork producer Smithfield Foods could affect the safety and availability of heparin. Members of the House Committee on Energy and Commerce wrote to Smithfield on July 24 asking the company to turn over information on its production of crude heparin, the raw ingredient used to make the drug. As well as being the world's largest pork producer, with more than 46,000 employees in 25 U.S. states and four countries, Smithfield is also a major supplier of crude heparin.

In a letter to Smithfield's Chief Executive Larry Pope, six Republican committee members said the proposed acquisition of Smithfield by Shuanghui International Holdings "raises questions related to the safety and adequacy of the U.S. heparin supply."

Smithfield said on Wednesday that the U.S. government has decided to take an additional 45 days to review the planned deal. Smithfield and Shuanghui submitted their proposal in June to the Committee on Foreign Investment in the United States, or CFIUS, an executive branch panel that examines foreign investment for potential threats to national security.

"The Committee's investigation indicates that the U.S. heparin supply is stressed, and could well be in shortage," the lawmakers' letter said. "China's heparin market is experiencing its own pressures, and Smithfield Foods under Shuanghui control may be pressured to export its crude heparin product to China instead of supplying U.S. companies." 

A spokesman for Shuanghui said the company had no comment.

Several deaths in the United States died in 2007 and 2008, and many suffered serious reactions, after they were treated with contaminated heparin, according to the U.S. Pharmacopeial Convention, the body that sets standards for drug quality and purity. The serious injuries and deaths were associated with the use of heparin that contained active pharmaceutical ingredient (API) from China, the FDA said.

The House committee is continuing a broader investigation into the FDA's handling of that event. "Because the contamination case was never adequately addressed by Chinese authorities, at least some of the bad actors responsible for the adulteration presumably are still operating in the Chinese heparin business, and there is little deterrence against, but high economic gain for, new heparin-contamination schemes," the lawmakers' letter said. The committee members asked Smithfield to provide details of its heparin operations, including the size of its production and a list of current heparin product customers, including any Chinese heparin customers. They also asked for the names of the key executives at Smithfield Foods involved in making and marketing heparin products, including pig intestines and crude heparin, and details of key managers at any Smithfield facility involved in manufacturing crude heparin. The Smithfield, Virginia-based company makes ham, sausage, bacon and other prepared meats under labels such as Eckrich, Gwaltney and Armor. It has argued the takeover deal is good for the United States because it will boost pork exports. - See more at:
http://www.porknetwork.com/pork-news/Smithfields-China-deal-spurs-heparin-heart-drug-safety-concerns-217089551.html#sthash.YlDFdaTD.dpuf


What we have learned from the "Heparin Tragedy"[1] is that unethical players and criminals will exploit the opportunity created by a shortage to make a quick profit without considering the consequences to human life.  Since the US Congress believes that the U.S. heparin supply is stressed, and China's heparin market is experiencing its own pressures, Rx-360 recommends the following:
Firms who use heparin or other porcine derived products should consider taking the following actions:
 
1. Contact your supplier and assure their ability to supply.

2. Assess and understand the entire supply chain, including workshops that provide crude heparin or intermediates to the API producers to identify vulnerabilities that could cause supply interruptions and product authentication concerns.  Assessments should also include a review to assure the supplier has an effective system to qualify their suppliers and to assure the traceability of drug components throughout production.

3. Secure your supply from a trusted supplier.

4. Conduct full analytical testing upon receipt of material using scientifically sound sampling plans and required methods.  Specifically for heparin, use approved methods to detect over-sulphated chondroitin sulfate.

5. Contact the appropriate regulatory authorities promptly if you suspect adulteration or a potential product shortage.

6. Review recommendations and screening methods for adulterants in heparin from the FDA and USP[2].

Rx-360 is continuing to monitor the situation and will publish updates as necessary.

To stay abreast of recent developments related to Rx-360 Alerts, 
click here.


References:
  1. Pew Health Group, “After Heparin – Protecting Consumers from the Risk of Substandard and Counterfeit Drugs”
  2. FDA Heparin Webpage 
  

October 2012: Rx-360 Alert on Potential Heparin Shortage Minimize


 

Droughts have led to higher corn and feed prices causing many farmers to decrease their swine herds which could result in shortages of heparin and other porcine derived products

 

 

A world shortage of pork next year is now unavoidable, says Britain's National Pig Association (NPA);[1].   The world’s pig farmers are warning of a shortage of bacon and pork next year because pig-feed has become unaffordable following disastrous growing and harvesting weather. Governments are becoming increasingly concerned. The pharmaceutical industry should be on alert as well - reductions in pig products could lead to shortages of heparin and other porcine products.  

Pharmaceutical-grade heparin is derived from mucosal tissues of harvested meat animals such as swine intestine or bovine lung.  The vast majority of pharmaceutical heparin is produced from swine. Roughly one swine is required to produce one human dose of heparin.

New data shows the European Union pig herd is declining at a significant rate.  This trend is being mirrored around the world. Pig farmers have reportedly been plunged into loss by high pig-feed costs, caused by the global failure of corn and soy harvests.  NPA estimates that pork production could fall by as much as 10 percent in the second half of next year.

Around the world, pig farmers are selling their herds because they can no longer afford to feed their pigs. In the United States the government has introduced a pork-buying program in a bid to keep its pig farmers in business. And the Chinese government is putting pork into cold storage, as a buffer against shortages next year.

We must learn from past events, conduct thorough risk assessments and implement risk mitigation activities to ensure the quality of our products and protect the patients we serve.  In 2007, a viral outbreak in the Chinese swine herd led to a pork shortage, creating an opportunity to exploit the heparin market.  Unethical individuals adulterated crude heparin with a cheaper abundant material (over-sulphated chondroitin sulfate).  The adulterated heparin eventually was administered to patients and subsequently a significant increase in patient adverse events was reported. [2][3][4] 

“The heparin crisis of 2008 is a vivid reminder of the importance of closely monitoring supply chains and assuring the ability of companies to maintain adequate supply,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Companies must be ever-vigilant in protecting the quality and supply chains of their products.” 


Rx-360 recommends the following:

Firms who use heparin or other porcine derived products should consider taking the following actions:
 
1. Contact your supplier and assure their ability to supply.
 
2. Assess and understand the entire supply chain, including workshops that provide crude heparin or intermediates to the API producers to identify vulnerabilities that could cause supply interruptions and product authentication concerns.  Assessments should also include a review to assure the supplier has an effective system to qualify their suppliers and to assure the traceability of drug components throughout production.

3. Secure your supply from a trusted supplier. 
 
4. Conduct full analytical testing upon receipt of material using scientifically sound sampling plans and required methods.  Specifically for heparin, use approved methods to detect over-sulphated chondroitin sulfate.
 
5. Contact the appropriate regulatory authorities promptly if you suspect adulteration or a potential product shortage.

6. Review recommendations and screening methods for adulterants in heparin from the FDA and USP[5][6].

Rx-360 is continuing to monitor the situation and will publish updates as necessary.

To stay abreast of recent developments related to Rx-360 Alerts, 
click here.


References:
  1. British National Pig Association 20-September-2012 Press Release
  2. Harris, Gardiner (April 22, 2008). "U.S. Identifies Tainted Heparin in 11 Countries". New York Times. Archived from the original on 12 June 2008. Retrieved 2008-06-11.
  3. Harris, Gardiner; Walt Bogdanich (March 6, 2008). "Drug Tied to China Had Contaminant, F.D.A. Says". New York Times. Archived from the original on 21 March 2008. Retrieved 2008-03-19.
  4. Pew Health Group, “After Heparin – Protecting Consumers from the Risk of Substandard and Counterfeit Drugs”
  5. FDA Heparin Webpage 
  6. USP Heparin Webpage

  

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