With a member of Congress charging that the FDA cares more about contact lens wearers with eye infections than women who die after a medical abortion, FDA deputy commissioner Janet Woodcock defended the agency’s handling of reports of deaths among women who had taken Danco Laboratories’ Mifeprex (mifepristone).
The FDA “responded aggressively to these reports,” Woodcock testified before a House Government Reform subcommittee in May. “What we don’t know is whether or not medical abortion increases the probability of getting this infection.”
Rep. Jean Schmidt (R-OH) contrasted the FDA’s hesitancy with its swift action on a limited number of serious but non-fatal infections in contact lens wearers that led to the recall of Bausch & Lomb’s ReNu with MoistureLoc lens cleaning solution. Rep. Mark Souder (R-IN) cited FDA reports of 950 cases of adverse reactions to the Mifeprex.
Meanwhile, as scientists disagreed over the role Mifeprex played in six women’s deaths, federal health officials said they were investigating a seventh. The debate took place at a joint meeting of FDA, Centers for Disease Control and Prevention and National Institutes of Health.
Brown University professor Ralph Miech said Mifeprex may suppress the immune system, which would increase susceptibility to bacteria already present in the vaginal canal. FDA Office of New Drugs deputy director Sandra Kweder said officials are increasingly asking whether factors other than Mifeprex played a role in the deaths.
From the July 01, 2006 Issue of MM+M - Medical Marketing and Media
