Questions Linger about Heparin Contamination and the Supply Chain

Congress looks for answers from FDA on the perpetrators behind what FDA calls “economically motivated adulteration.”

 

 

 

The Committee on Energy and Commerce in the House of Representatives has picked up the investigation into heparin contamination in 2008. On February 23, the committee, which has oversight over FDA and the Department of Health and Human Services, wrote to FDA Commissioner Margaret Hamburg asking for all documents related to FDA heparin-related inspections in China, the possible sources or means of contamination, and testing results data submitted by heparin providers.

The committee suggests that the U.S. drug supply chain is still at risk. “There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the U.S.,” reads the letter, which was signed by Fred Upton (R-MI), chairman, Cliff Stearns (R-FL), chairman, Subcommittee on Oversight and Investigations, and Michael Burgess (R-TX), member.

The committee questions FDA (and the Chinese government) for not identifying “those responsible for the contamination” as well as “how the heparin actually came to be contaminated,” the letter states. “It is important to determine how the adulteration happened so that industry and government can take more effective proactive measures to reduce the risk of such adulteration in the future.”

According to a GAO report issued in October 2010 on FDA’s response, FDA had actually been denied full access during certain inspections of heparin-producing companies in China. FDA had conducted 11 heparin-related inspections in China after what the GAO calls the “crisis.” “In two instances, Chinese crude heparin consolidators refused to provide FDA full access during limited inspections——in particular one consolidator refused to let FDA inspectors walk through its laboratory and refused FDA access to its records,” the report reads. FDA did not attempt to reinspect the facilities or place the firms on import alert. Rather, “FDA officials told us that the agency focused its efforts on the API manufacturers that these firms supplied,” GAO stated.
FDA also tried to conduct a criminal investigation in China, but Chinese officials “would not grant this request and denied that contamination took place in China,” read the report.

Other actions have been taken. FDA has since established an overseas office in China, with other locations to follow in India, Europe, Latin America, and the Middle East. The United States Pharmacopeia now requires all heparin makers to test for oversulfated chondroitin sulfate, which FDA believes was used to mimic heparin for cost-cutting reasons. “The agency has adopted a risk-model designed to identify other drugs that may be at increased risk for economically motivated adulteration,” according to comments on the GAO report provided by the Department of Health and Human Services.

HHS also points to legislative efforts to “require foreign and domestic drug manufacturers to implement quality systems and adopt plans to identify and mitigate hazards.”

These efforts could be “Drug Safety and Accountability Act of 2010,” which, according to Michael Bennet’s Web site (D-CO), could be reintroduced in the 112th Congress. He describes the bill as one that would “strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.” The bill would give FDA additional recall power.

FDA was given two weeks from the date of the Committee on Energy and Commerce’s letter to provide materials related to the heparin case.

 

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