May 17, 2006

FDA defends handling of RU-486 abortion pill

By Susan Heavey

WASHINGTON (Reuters) - A top U.S. Food and Drug
Administration official on Wednesday defended its handling of
the RU-486 abortion pill despite recent reports of deaths from
rare infections in a handful of women who took the drug.

The FDA has received reports of 12 deaths that may involve
use of the drug, including nine in the United States, FDA
Deputy Commissioner Janet Woodcock told a U.S. House of
Representatives Government Reform subcommittee hearing.

Of the U.S. cases, four resulted from infections with
Clostridium sordellii, a rare bacterium. A fifth case was
linked to a similar bacterial infection with Clostridium

The FDA concluded the other U.S. cases were unrelated to
use of the drug, Woodcock said. Three cases involved women in
Canada, Sweden and Britain.

"FDA responded aggressively to these reports," Woodcock
told the lawmakers. "What we don't know is whether or not
medical abortion increases the probability of getting this

The recent infections have prompted renewed concern among
conservatives who oppose abortion and want the drug removed
from the market. Criminal Justice, Drug Policy and Human
Resources Subcommittee Chairman Mark Souder said he called the
hearing because of other concerns.

"I would like to ban abortion, but this is not about
abortion. We can't ban abortion. This is a health question,"
the Indiana Republican said.

RU-486, also known as Mifeprex, or mifepristone, is used to
trigger an abortion when taken with another drug called
misoprostol. It is unrelated to emergency contraception called
Plan B, sold by Barr Pharmaceuticals Inc.

Its maker, New York-based Danco Laboratories LLC, estimates
about 575,000 American women have used the drug since it was
approved in 2000.

Danco declined to testify and has said there is no evidence
its drug has caused infection.

Democrats and a Republican who supports abortion rights
charged Souder with focusing only on the abortion pill and not
the increasing reports of infection in pregnant women overall.

"Our focus should be seeking the truth concerning the cause
of C.sordellii infection rather than attempting to bully the
FDA into taking action unsupported by science," Maryland
Democrat Elijah Cummings said.

Ohio Republican Rep. Jean Schmidt challenged Woodcock to
pull the drug, saying, "Just because you don't know how the
infection occurred, we do know that they took the drug and they

Woodcock said, "It is not possible at this time to
determine whether the current mifepristone/misoprostol regimen
resulted in an increased risk of C. sordellii infection or
whether reporting requirements have uncovered what is an
emerging risk in pregnancy overall."

Similar infections have also been seen in at least 10 other
women who have given birth or experienced miscarriages.

Last week, the FDA, the U.S. Centers for Disease Control
and Prevention and the National Institutes of Health held a
joint meeting to discuss the outbreak and concluded more
research and better surveillance was needed.