Rx-360 July 2013 US Congress Concerns Over Potential Heparin Shortages

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