FDA Asks Maker of Abortion Drug Mifepristone for Safety Plan by September
by Steven Ertelt | WASHINGTON, DC | LIFENEWS.COM | 3/30/08 9:00 AM
by Steven Ertelt
March 30, 2008
Washington, DC (LifeNews.com) — The Food and Drug Administration has asked the makers of 25 drugs, including the dangerous abortion pill mifepristone (RU 486), to submit safety plans later this year. The FDA published the list of drugs needing safety plans in the latest issue of the Federal Register and abortion drug maker Danco Laboratories made the list.
The drug manufacturers must devise a Risk Evaluation and Mitigation Strategy (REMS) plan and submit it to the agency by September 21. Those who don’t comply by the deadline face "enforcement action," which could include monetary penalties from FDA officials.
According to the medical web site MedPage, amendments to the Food, Drug and Cosmetic Act are requiring the safety plans. They enable the FDA to require plans from makers of new drugs just appearing on market or those with safety issues.
Jane Axelrad of the FDA’s Center for Drug Evaluation and Research, told the web site, the safety plans help patients and physicians know the dangers of a drug used improperly.
"These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use," Axelrad said. "The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS."
The RU 486 abortion drug has had significant safety issues since its initial approval at the tail end of the Clinton administration.
To this point, the RU 486 abortion drug has killed 13 women worldwide.
According to FDA reports as of December 2006, there have now been eight known deaths associated with mifepristone in the U.S., nine life-threatening incidents, 116 blood transfusions, and 232 hospitalizations.
In total, more than 1,100 women have had medical problems after using the drug as of that date.
The first victim of RU 486 was a Tennessee woman who died after using the abortion drug. She had an undetected ectopic pregnancy, and the drug is not supposed to be used in such situations.
Following her death, four California women died from using the abortion drug and the FDA announced last year that a Colorado woman had died as well.
Women have died from using the abortion drug in Canada, England, France and Sweden.
In January, Danco Laboratories announced that approximately 13 percent of all abortions in the United States involve mifepristone — a number that may seem low but it is double the number of women who used the abortion drug in 2001.
The report also showed that 57 percent of places that do abortions now have the abortion drug, compared with just 33 percent in 2001.
Danco said about 80 percent of facilities that only do abortions now have the Mifeprex abortion drug. It said the number of women using the abortion drug would increase as they opt for abortions earlier in pregnancy.
Ultimately, Danco indicated that 840,000 women in the United States have had abortions with its dangerous drug.
An FDA panel eventually investigated the deaths and found that the vaginal, rather than oral, use of the abortion drug was likely contributing to the deaths.
Planned Parenthood had been going against the FDA guidelines on using the abortion drug and changed its protocols to allow for oral use after women died at their facilities.
Danco Laboratories has been granted an exclusive license from the Population Council, a pro-abortion group, to manufacture, market and distribute Mifeprex in the United States.