:

1. RU-486 was approved under a special “restricted distribution” approval process known as “Subpart H,” reserved only for drugs that treat “severe or life-threatening illnesses.”

2. The clinical trials to test the safety and efficacy of RU-486 were seriously defective. Neither the French nor the U.S. trials met FDA’s standards.

3. Nearly all the safety precautions the FDA recommended to protect women from being injured or killed by RU-486 were dropped from the final approval.

4. FDA ordered that a second drug, misoprostol (cytotec), be used in conjunction with RU-486, since RU-486 is not effective in completing an abortion alone. However, misoprostol is an ulcer medication and its manufacturer, Searle Laboratories, warned doctors it does not want it used for abortion.

5. The FDA waived the “pediatric rule” with no explanation. Any drug given to adolescents must be tested on adolescents.

6. Complications reported to the FDA demonstrate that RU-486 is a serious threat to the health and safety of women. In the CWA/AAPLOG/CMA citizen petition (in 2002!) were listed two fatalities and 20 other near-fatal complications including a heart attack, two cases of systemic bacterial infection in 15-year olds and several hospitalizations for hemorrhaging. The FDA and Danco sent a letter to physicians in April 2002 warning of the complications reported since the FDA approved RU-486. This alone would cause an ordinary drug to be removed from the market immediately.

7. Danco, the distributor of RU-486, has a legal obligation to ensure that the drug be administered only in accord with the procedures approved by the FDA. It is obvious that Danco is failing to live up to its post-approval obligations.