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Smith Urges Passage of Holly's Law After RU-486 is Linked to Additional Deaths of Women

Location: Washington, DC

Smith Urges Passage of Holly's Law After RU-486 is Linked to Additional Deaths of Women

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 California women. In the meantime, this drug that endangers women's lives - there is a known total of 5 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.

"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 United States since the FDA approved the drug in September 2000. Between November 15, 2004 and July 19, 2005, the FDA has twice ordered alterations of the RU-486 "black box" warning label.

In California, the rare bacterium Clostridium Sordellii was found in the bloodstreams of two of the women that died of infection. Investigators are trying to determine whether the other women showed evidence of the same bacterium, which produces an effect similar to toxic shock syndrome. California is widely recognized as having one of the top coroner's offices in the United States, which raises the concern that other states may not be identifying or reporting similar RU-486 fatalities.

"RU-486 was rushed to approval for political purposes by the Clinton Administration, and as a result numerous safety concerns were suppressed, trivialized and overlooked," said Congressman Smith, Co-Chairman of the Pro-Life Caucus in the House of Representatives.

The FDA, under the Clinton Administration, violated their 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.

"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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