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FDA heparin crisis response criticised

The Government Accountability Office has issued a report critical of the US FDA's management of the 2008 heparin contamination crisis

The Government Accountability Office (GAO) has issued a report that is critical of certain aspects of the US Food and Drug Administration's (FDA) management of the heparin contamination crisis that occurred in early 2008.

The report charges that the FDA accepted voluntary help in managing the crisis from external scientists who had ties to companies that manufactured heparin, in violation of the agency's own standards of ethics regarding collaboration with external entities. Collaborating with the volunteer scientists also violated government-wide standards banning the acceptance of services provided free of charge in case financial claims are made by the volunteers later on, the report noted.

In responding to the crisis, the FDA accepted the assistance of five external scientists, whom the agency said were needed because the government lacked the expertise to indentify the specific contaminant of the heparin. The volunteers were identified by the FDA through informal procedures, according to the report. The FDA communicated frequently with these scientists during the crisis and held in-person meetings with them, the GAO said.

The FDA was aware that several of the scientists had ties to companies manufacturing heparin, but did not take steps to ensure that these ties would not interfere with the integrity of the investigation or cloud the public's perception of the investigation's integrity, the report states. Two of the scientists served as paid consultants for heparin manufacturers, and one was a co-founder and member of the board of a company that had a US marketing application pending for a heparin product. 

The decision to work with the scientists in spite of these concerns "could have affected the public's confidence in FDA's response efforts and in its other activities related to the regulation of heparin products and also left FDA open to claims for payment for services that these external entities provided to FDA," the report states.

By way of explanation, the FDA stressed the emergency nature of the situation, which it said circumvented certain usual procedures, according to the GAO.

The GAO noted that in the time since it had submitted a draft of its report for comment earlier this year to the US Department of Health and Human Services, which houses the FDA, the FDA has issued new guidance for its staff to follow when working with external scientific and other experts in emergency situations when the services are provided on a gratuitous basis.

11th November 2010


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