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Smith Urges Passage of Holly’s Law After |
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WASHINGTON, D.C. – Rep. Chris Smith (R-NJ) urged that Congress take action and pass Holly’s Law today after the US Food and Drug Administration (FDA) learned of two additional deaths following medical abortion with mifepristone (Mifeprex, or RU-486). The announcement of these unfortunate deaths comes after 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 “Sadly, the tragic and preventable deaths of these two women remind us that not only is RU-486 used to kill babies, it is a poison that harms and kills women,” said Congressman Chris Smith, Co-Chairman of the Pro-Life Caucus in the House of Representatives. “How many deaths, investigations and warnings will it take before RU-486 is properly labeled as lethal and removed from the market?” Holly’s law, authored by Representative Roscoe Bartlett (HR 1079), 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 dangerous drug. In the meantime, a drug that endangers women remains available. Last month, a new study by the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) analyzed the deaths, as well as life-threatening, severe and serious injuries to hundreds of women in the In “RU-486 was rushed to approval for political purposes by the
· 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. “RU-486 is not therapeutic, it was developed to kill, which should – by the definition of a drug – be reason enough for the FDA to ban its use,” Smith concluded. | ||
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For Immediate Release: March 17, 2006 Contact: Brad Dayspring (202) 225-3765 |
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