House legislators are bringing new and critical attention to a proposed purchase of Virginia-based Smithfield foods, the world's largest pork processor, by Chinese company Shuanghui International, citing a past healthcare product regulation scandal that left dozens dead and few questions answered.
In 2007 and 2008, regulators were left scrambling as dozens US citizens died after consuming products contaminated with adulterated heparin, a substance derived from pigs intestines and used in anticoagulant products. The contaminated heparin was ultimately linked to dozens of Chinese companies, and an investigation concluded that over-sulfated chondroitin sulfate had been placed in the products on purpose to save money, and was not the result of any manufacturing problem.
While FDA's investigation into the adulteration led to congressional hearings, product seizures and Warning Letters to companies, the accused manufacturers were subject to little in the way of consequences.
Concern about Heparin Quality
The episode has not been forgotten by US legislators, and in particular those on the Energy and Commerce Committee, who on 24 July 2013 sent a letter to Smithfield Foods CEO Larry Pope.
In the letter, they said the proposed purchase of the US companies "raises questions related to the safety and adequacy of the US heparin supply." From the perspective of supply, the legislators noted that the company is a "major supplier of crude heparin used in the manufacturing of heparin in the US," and said they were concerned that the already-stressed heparin supply in the US could experience a shortage situation if Shaugnghui were pressured by Chinese government officials to export more of that heparin to China.
And even if the heparin was only exported to China for further processing, legislators said the events of 2007 and 2008 raised the most serious concerns of all. "The contamination of US heparin with overly sulfated chrondroitin sulfate (OSCS) is believed to have occurred somewhere in the Chinese heparin supply chain," they wrote. "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 especially where there is inadequate traceability."
Other Drug Scandals
Those concerns are heightened, legislators charged, by Shanghui's apparent involvement in another drug scandal involving clenbuterol, a banned drug supplement used to increase the lean mass of animals. The drug was found to be present in pork processed by Shuanghui as recently as 2011, raising questions regarding the quality controls practiced by the company and other adulterants that could affect heparin quality, the legislators wrote.
"The impact of this pending acquisition on the availability of US heparin is critical," they wrote. "Heparin is still widely used for heart surgery and dialysis patients."
The letter goes on to request a number of pieces of information from Smithfield, including a list of all companies that Smithfield supplies crude heparin to, documents related to audits of the Smithfield Foods manufacturing facility, and the company's current export practices.
The focus on Heparin comes just as the US Food and Drug Administration (FDA) has finalized a new guidance document meant to increase industry oversight of the ingredient.
"The control of the quality of crude heparin is important to ensure the safety of drugs and devices and to protect public health," FDA wrote in a Federal Register notice announcing the final guidance. "FDA developed this guidance to alert manufacturers to the risks of crude heparin contaminants and to recommend strategies to ensure that the heparin supply chain is not contaminated with OSCS or any non-porcine ruminant material (unless specifically approved as part of drug or medical device application)."
The final guidance makes several recommendations, including:
- Manufacturers should test and confirm the species origin of crude heparin using a qualified testing method before it is used in the manufacturing process of a drug or device.
- All heparin lots should be tested for OSCS before use, again using a qualified test method.
- All heparin lots should be tested for other ruminant mucosa. Lots found to contain such ruminants should be rejected and FDA alerted to the finding.
- Heparin suppliers should be audited on a regular basis to "ensure conformance to appropriate quality standards."
Another standard published by the US Pharmacopoeia is also meant to test for OSCS and other protein and nucleic impurities.
Letter to Smithfield