Pro-Lifers Criticize FDA for Poor Monitoring of RU-486

By Robert B. Bluey | July 7, 2008 | 8:04 PM EDT

( - Pro-life advocates want the Food and Drug Administration to improve its monitoring of abortion drug RU-486 to make sure clinics like those operated by Planned Parenthood aren't misleading women about its proper use.

The Sept. 17 death of Holly Patterson, an 18-year-old California woman who took RU-486, has prompted Concerned Women for America (CWA) and the American Life League to harshly criticize the FDA for not pulling the abortion drug from the market.

CWA was one of three pro-life organizations to file a citizen petition with the FDA in August 2002 outlining the threat that RU-486, otherwise known as mifepristone, poses to women.

"We've already given the FDA enough evidence that gives them the authority to pull the approval of the drug," said Wendy Wright, senior policy director for CWA. "We gave the FDA evidence a year ago that clinics were not following the regulations."

Information on the website of Planned Parenthood Golden Gate - the clinic where Patterson received mifepristone - contradicts the FDA's guidelines, Wright said. The FDA, for instance, advises that mifepristone shouldn't be administered once a pregnancy has advanced more than 49 days, and the subsequent dose should be taken under the supervision of a doctor.

Planned Parenthood Golden Gate's website, however, informs women that RU-486 can be taken "up to 63 days after the last period begins." After taking the medication from a doctor, in two days, "you will insert another medication called misoprostol as a vaginal suppository."

RU-486 consists of two pills. Women take mifepristone first to kill the baby and then, two days later, take misoprostol, which induces labor and forces out the baby's remains. The FDA approved mifepristone as an abortion drug, but misoprostol was designed to treat ulcers.

The details surrounding Patterson's death remain unclear, but she did administer the misoprostol at home and not at the abortion clinic. Monty Patterson, the woman's father, said his daughter was seven weeks pregnant, but it is also unclear whether she surpassed the 49-day timeframe.

Monty Patterson told The Associated Press that he wished his daughter had not kept the abortion a secret from him. He said a lack of information about RU-486 could be blamed.

"What's disturbing is these young couples, they are relying upon what they think is good, solid info, and relying on what they think is a supportive network telling them everything is OK," Patterson told the AP. "I would have said, 'You know what? They don't know everything. Let's get more information.'"

Even though the FDA has not connected any deaths in the United States to RU-486, there is one other known instance where the drug could have played a role.

Brenda A. Vise, a 38-year-old Tennessee woman, died Sept. 12, 2001, five days after she took the RU-486 combination. Her estate filed a lawsuit alleging that a massive infection was the result of a ruptured ectopic (tubal) pregnancy. The FDA warns women with tubal pregnancies not to take RU-486.

Wright said the citizen petition filed in August 2002 details the problems with RU-486, including the misinformation presented on the Planned Parenthood Golden Gate website. Danco Laboratories, the maker of mifepristone, is responsible for monitoring that information.

"If clinics are not following the restrictions, then Danco is required to not distribute to that clinic," Wright said. "If Danco continues to distribute to that clinic, the FDA can pull its approval of the drug."

A spokeswoman for Planned Parenthood Golden Gate referred questions to Planned Parenthood's national headquarters, which referred to a three-paragraph statement released by Dian Harrison, president and CEO of the San Francisco clinic.

"We extend our deepest sympathies to the family," Harrison said. "We wish them strength and support in this tragic time."

Neither the FDA nor Danco Laboratories responded to requests seeking comment.

Meanwhile, CWA is planning to again highlight its concerns about RU-486 in an upcoming letter to the FDA. The American Association of Pro Life Obstetricians and Gynecologists and the Christian Medical Association helped organize the original citizen petition.

President Bush should also expect to face increased pressure from pro-life groups in the wake of Patterson's death, said Ed Szymkowiak, national director of American Life League's STOPP International.

"If [Bush] is really pro-life, as he claims he is, he should take this opportunity, this death of this poor young girl from California, to do something," Szymkowiak said. "It's the perfect moment for him to say, 'In light of Holly's death, in light of this petition, I'm directing the FDA to pull mifepristone off the market.' "

See Earlier Story:
Lawsuit Alleges Medical Malpractice in RU-486-Related Death
(Sept. 3, 2002)

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