Judicial Watch Continues Investigation of Abortion Pill RU-486
FDA Refuses to Turn Over More Than 6,000 Documents


While Judicial Watch continues to investigate the Food and Drug Administration’s (FDA’s) expedited and hasty approval of the abortion pill RU-486, the FDA continues to stonewall. The agency has withheld more than 6,000 documents pertaining to its approval process. Furthermore, the FDA filed a motion for summary judgment that, in effect, would result in the dismissal of the case. Judicial Watch has filed the appropriate motions in court to keep the case open and its investigation moving forward.

"The American people deserve to know the truth about this new and dangerous drug," said Judicial Watch President Tom Fitton. "The Clinton FDA failed to protect the American people by putting RU-486 on the fast track, and now they’re trying to cover up the truth about their reckless disregard for public safety."

Many people believe the Clinton Administration rushed through approval of the dangerous drug to appease their radical feminist supporters. Furthermore, Clinton FDA Commissioner Jane Henney admitted that "the agency broke precedence" by not publishing the names of the experts who reviewed the drug, or the name of the company that would manufacture the drug. By so doing, the agency seeks to protect the manufacturer and those who reviewed the drug from the deluge of liability claims that are sure to follow.

Despite the fact that the FDA has withheld key documents, Judicial Watch has forced the release of more than 9,300 pages of documents. Among the discoveries made by Judicial Watch during its investigation:

* The FDA approved RU-486 under the "Accelerated Approval of New Drugs for Serious or Life-threatening Illnesses," a measure intended to apply to drugs for illnesses such as cancer and AIDS. RU-486 does not treat any illness, serious or otherwise. It is designed for the expressed purpose of terminating life.

* RU-486 is insufficient to complete the abortion. It must be used in combination with a drug called Cytotec which, according to Searle, the company that manufactures the drug, "is not approved for the induction of labor or abortion." Cytotec is only approved for the treatment of gastric ulcers.

* RU-486 is the source of significant health hazards. Women who have used RU-486 have experienced extreme instances of nausea, vomiting, and heavy bleeding along with the passing of large blood clots. In U.S. clinical trials, five percent of the women experienced hemorrhaging and eight percent experienced incomplete chemical abortions that later required surgical interventions.

* Women who use RU-486 experience significant psychological trauma. According to the original manufacturer of the pill, "RU 486 is not at all easy to use… a woman who wants to end her pregnancy has to ‘live’ with her abortion for at least a week using this technique. It’s an appalling psychological ordeal."

* RU-486 is not 100% effective. Some of the babies live through the attempt to kill them, and are born with serious birth defects.

As a result of the information uncovered by Judicial Watch about RU-486, President Bush has been called upon to review the safety and effectiveness of RU-486 and is educating the public of the health hazards associated with drug.

"Everyday the FDA continues to hide the truth about the dangers of RU-486, they place the health of thousands of women and unborn children at risk," continued Mr. Fitton.




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