Gingrey calls for RU-486 to be pulled from market

“Abortion pill” linked to 2 deaths in March

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Washington, Mar 30, 2006 | Becky Ruby ((202) 225-2931) | comments

U.S. Congressman Phil Gingrey, M.D. yesterday called for House leadership to quickly schedule a vote and pass H.R. 1079, Holly’s Law. This legislation would pull RU-486 – the “abortion pill” – off the market. This month, two women died after taking RU-486, raising the total to 7 known cases of death from this drug in the United States.

As a pro-life OBGYN physician, Congressman Gingrey made the following comments during a news conference at the U.S. Capitol:

“We now know that RU-486 is killing not only unborn children, but their mothers as well,” said Gingrey. “These tragedies could be stopped if RU-486 was pulled off the market. It’s not often that Congress passes legislation to directly prevent our citizens from dying, but Holly’s Law does just that. The sooner we vote on this legislation, the sooner the FDA pulls the drug and the sooner young women will stop dying from this dangerous medication. There’s no doubt in my mind that if RU-486 was a diet pill or a cholesterol-lowering drug, the FDA would have already pulled it off the market. How many of our daughters have to die before we put women’s safety over the politics of abortion? Anyone who stands for women’s rights should stand up now and demand Congress vote on Holly’s Law.”

Please see attached photographs of Congressman Gingrey speaking at the news conference outside the U.S. Capitol.

BACKGROUND:

Less than two weeks ago, the US Food and Drug Administration learned of two more women’s deaths following medical abortion with mifepristone (Mifeprex, or RU-486). The announcement of these unfortunate deaths comes on the heels of a warning by the FDA about the dangers of RU-486. The Centers for Disease Control continue to investigate into the role of RU-486 in the death of four California women. In the meantime, this drug that endangers women’s lives – there is a known total of 7 deaths in the United States and at least 3 overseas – remains available despite ongoing investigations and continued warnings that have made it clear that the drug is not safe and should not remain available.

Holly’s law (HR 1079), authored by Representative Roscoe Bartlett and co-sponsored by Representative Gingrey, would withdraw FDA approval of RU-486 and subject it to a thorough review, which it did not receive for its present approval. The law is named after 18 –year-old Holly Patterson who was killed by the drug. In the meantime, a drug that endangers women remains available.

The FDA, under the Clinton Administration, violated their own standards and federal law by approving RU-486:

· They approved Mifeprex without the submission of data from adequate and well-controlled clinical trials;

· They created a final approval regimen for the use of Mifiprex that does not reflect safeguards employed in the clinical trials on which FDA relied (they eliminated the requirement for use of ultrasound to both date and locate a pregnancy);

· They approved RU-486 using the expedited “subpart H” process, which is only supposed to be used to approve drugs to treat serious or life-threatening illnesses;

· In violation of their own pediatric rule, they never tested the drug on adolescents, even though it is being used by adolescents;

· They have failed to impose and enforce restrictions on the use of Mifeprex commensurate with the risk it poses to women;

· They failed to require the Population Council to honor in full its post-approval safety study commitments; and

· They endorsed the off-label use for misoprostol, the second drug in the Mifeprex program.

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Tags: Pro-Life