by Steven Ertelt
November 18, 2004
Washington, DC (LifeNews.com) — A leading FDA official says the drug agency is still evaluating a citizens petition filed by a pro-life women’s group and a doctors association asking it to take the dangerous RU 486 drug off the market while it reviews its safety.
Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, told the Contra Costa Times newspaper, "It’s very complex and we’re still working our way through it."
The FDA issued a strengthened warning label on Monday, telling women considering using the drug that it could lead to infections that cause death and that the normal telltale signs of an infection may not appear.
"We feel the safety profile of this drug, along with the steps we’re taking (to increase warnings) … are adequate to allow the drug to be used safely," Galson said.
"We’ll continue to monitor it. We do understand there are those concerns out there," he told the Times newspaper.
David Stevens, M.D., president of the Christian Medical Association, one of the groups that filed the citizens’ petition, said he was concern the FDA is dragging its feet.
"We joined other physicians and the nation’s largest women’s policy group, Concerned Women for America, in pressing the FDA in August 2002 to recall the drug for safety reasons," Dr. Stevens said. "FDA officials still have not responded to that 90-page petition."
Stevens said the FDA came under political pressure from the Clinton administration to approve the drug shortly before the former president left office. That led to rushed clinical trials that didn’t fully explore the danger of the abortion drug for women.
"The RU-486 trials used in securing FDA approval were not even blinded, randomized, or concurrently controlled," Dr. Stevens indicated.
Americans United for Life, another pro-life organization, filed a citizens petition as far back as 1995 asking the FDA not to approve the abortion drug and outlining many of the medical concerns the FDA is now addressing.
"The original citizens’ petition filed by Americans United for Life in 1995 called on the FDA to not approve the drug because of the obvious and substantial danger to women," said Paige Cunningham of AUL.
"We documented all of these risks before this drug was approved. We want the drug off the market for the safety of American women," Cunningham said.