Smith Joins Colleagues in Urging Passage of Holly's Law
to Suspend FDA Approval of RU-486
Unsafe poison pill responsible for numerous, cause of death for 5 women in US
WASHINGTON, D.C. --Rep. Chris Smith (R-NJ) joined Congressional colleagues, citizens, public interest groups and representatives from the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) in urging passage Holly's Law at press conference on Capitol Hill today.
The law, authored by Representative Roscoe Bartlett (HR 1079), would withdraw FDA approval of RU-486 and is named after 18 year old Holly Patterson who was killed by the dangerous drug. In the meantime, a drug that endangers women--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.
"The approval of RU-486 by the Clinton Administration was expedited for political gain at the expense of patient health. Every few weeks a new warning or tragic investigation reminds 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 investigations and warnings will it take before RU-486 is properly labeled as lethal and removed from the market?"
At the press conference, a new study by the AAPLOG that analyzed the deaths, life-threatening, severe and serious injuries to hundreds of women in the United States since the FDA approved the drug in September 2000 was discussed. 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.
"It seems rather questionable that these deaths are being reported solely in California," said Smith. "It is likely that similar tragedies caused by RU-486 ingestion have occurred in other states and are just not being investigated during or discovered during the autopsy process. RU-486 is neither essential nor is it medicine.
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;
· They endorsed the off-label use for misoprostol, the second drug in the Mifeprex program.
"The Clinton administration rushed RU-486 to approval for political purposes, and as a result numerous safety concerns were suppressed, trivialized and overlooked. 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.