Agency s use of outside experts violated ethics rules
Although the U.S. Food and Drug Administration s (FDA) response to the contamination of heparin sodium in 2008 helped protect the public health, the agency violated government-wide ethics standards in doing so, stated a report from the Government Accountability Office (GAO). In addition, the report noted that the FDA continues to face challenges in monitoring foreign facilities that manufacture crude heparin.
With the help of external entities, [the] FDA identified the unknown contaminant and developed tests to screen all heparin products, said the October GAO report. However, some of the outside experts the FDA used had ties to heparin manufacturers, and the agency did not address risks related to working with certain external entities with ties to heparin firms, the report said.
In response, the FDA stated that it was responding to an emergency, and it has since implemented a policy to address the ethics issue. [The] FDA was confronted with an escalating public health emergency. [The] FDA needed to quickly identify and enlist the help of the world s leading experts in the field of the molecular characterization of heparin, said Karen Riley, an FDA press officer, in an e-mail to PFQ.
Working with outside volunteer experts, FDA scientists developed screening methods to identify the contaminant, oversulfated chondroitin sulfate, and formulated the higher standards that are now applied to the drug, Riley said. An Oct. 15 draft guidance for FDA staff outlines a policy addressing the risks involved in using outside experts.
The FDA still faces challenges in dealing with foreign suppliers, the GAO report said. Some Chinese crude heparin consolidators refused to permit inspections during the crisis. The FDA instead focused on the manufacturers of active pharmaceutical ingredients supplied by these firms, the GAO noted.
SOURCE:PFQ
