FDA defends handling of RU-486 probe

Share this article:
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.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in News

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.