GAO Evaluates FDA's Response to 2008 Heparin Crisis

Nov 18, 2010

During the 20 months before the crisis of contaminated heparin in early 2008, the US Food and Drug Administration did not inspect any Chinese heparin firms, according to a US Government Accountability Office, (GAO) report. During and after the crisis, FDA conducted 14 inspections of 11 heparin-related Chinese firms. Of the Chinese firms that FDA inspected, only two had been inspected before the crisis, according to the report.

FDA officials told GAO that legal and practical challenges continue to hamper their inspections of crude heparin manufacturers. For example, during the crisis, two Chinese crude heparin consolidators refused to grant FDA full access to their facilities during limited inspections, according to the report. One consolidator did not let FDA inspectors walk through its laboratory and refused to let the agency review its records. FDA classified both limited inspections as “no action indicated” and did not attempt to reinspect the facilities, document any objectionable conditions, or place the firms on import alert. Instead, the agency shifted its attention to the active pharmaceutical ingredient manufacturers that bought materials from these companies.

In addition, the Chinese government hindered FDA’s response to the crisis in certain respects, according to the report. China’s State Food and Drug Administration sealed some companies’ heparin and instructed the firms not to open these seals. As a result, at least one firm could not determine conclusively which of its crude suppliers were associated with contamination, the report said.

After its preliminary investigation concluded that contamination did not take place in the US, FDA asked the Chinese government for jurisdiction to conduct a criminal investigation in China to determine the source of contamination. Chinese officials did not grant this request and denied that contamination took place in China, according to the report.

In addition to detailing the challenges that FDA faced, the GAO report also criticized certain aspects of the agency’s response to the crisis. During the crisis, FDA sought the advice of external scientists because it lacked the necessary instrumentation and expertise to identify and detect the contaminant. Two of the scientists, whom the agency characterized as volunteers, had professional and financial ties to heparin firms. FDA officials were aware of these ties, but the agency did not take adequate steps to follow its internal guidance or to avoid the appearance that its programs or operations might be compromised, according to GAO.

FDA’s acceptance of voluntary services also exposed the agency to potential claims for payment, said GAO. “While the existence of an emergency would provide a legal basis for agencies to accept voluntary services, it would not protect them from subsequent claims for payment. To the contrary, the acceptance of services under the emergency exception would give rise to obligations— that is, financial liabilities—for which claims for payment could be made,” according to the report.

GAO compiled its report in response to Rep. Joe Barton’s (R-TX) request that it review FDA’s management of the contaminated heparin crisis. To write its report, GAO reviewed FDA documents, analyzed FDA data, and interviewed FDA officials and other experts involved in the crisis. GAO concluded that FDA’s response had helped to protect public health, but recommended that the agency apply its standards for collaborating with external entities in all situations, including those that entail time pressures.

See related PharmTech articles:
Memo to Congress: Hands off FDA (blog post)

GAO Says FDA Should Improve Its Rate of Foreign Inspections (ePT)

CDC Identifies Cause of Heparin-Related Reactions (ePT)

lorem ipsum