FDA Risked Integrity During Heparin Crisis

FDA took several actions in early 2008 to protect public health in response to a crisis involving contaminated heparin. But the agency might have shattered public confidence in its response efforts by not considering conflict-of-interest risks related to working with external companies, a report from the Government Accountability Office concludes. The report (GAO-11-95) finds that FDA worked with scientists at the biotech company Momenta Pharmaceuticals during the crisis to identify the heparin contaminant. At that time, Momenta had an application pending at FDA to market a generic version of the blood thinner Lovenox. The agency granted Momenta first rights to market the generic drug in July. The GAO report finds that FDA risked its scientific integrity and created the appearance of favoritism by accepting free consulting services from Momenta for several months during the heparin crisis and later approving its generic drug. In response to the report, FDA issued to its staff new guidance for working with external experts during emergencies.