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 Channel

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...