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Medical questions, legislative battles fester as abortion pill enters U.S.

WASHINGTON (BP)–After years of mishaps and misadventures, the abortion pill RU-486 is facing more trouble in its American debut, the Internet news site CNSNews.com reports. This time, the problems are coming from an unlikely cast of characters: the maker of an ulcer drug and, potentially, the maker of RU-486 itself, as well as some doctors and college health clinics.

Media reports have described a new reluctance on the part of some doctors to continue prescribing a second drug used with RU-486 in the abortion process. That’s because the maker of misoprostol, a drug marketed for treatment of ulcers, sent a much-publicized letter to 200,000 health care providers in August warning them that the drug was not meant for use by pregnant women. Doctors have prescribed misoprostol not for abortion, but to induce labor in a wanted pregnancy.

The letter to doctors, from the drug maker Searle, warned of “serious adverse events,” such as “uterine hyperstimulation, rupture, and perforation,” for off-label use.

The company also cautioned that the long-term effects of misoprostol on children is unknown. Searle, which merged with several other companies last spring, maintained that the company had been working on a draft letter for two years in conjunction with the FDA.

The abortion pill RU-486, marketed as Mifeprex, is an artificial steroid that kills a fetus by preventing it from receiving necessary nourishment. In order to eject the fetus, RU-486 is used in conjunction with the ulcer drug misoprostol, which causes uterine contractions.

The American College of Obstetricians and Gynecologists questioned the content, timing and tone of Searle’s letter, writing a letter to the FDA in late October stating that the drug “is a safe and effective agent for cervical ripening and labor induction when used appropriately.”

A spokesperson for the Population Council, the organization primarily responsible for bringing the abortion pill to the American market, indicated that the ulcer drug has a safe track record in Europe and now has gained the FDA’s seal of approval.

“The FDA approved the drug for use together. It’s been used this way for at least 10 years in France and Europe,” PC spokeswoman Sandra Waldman told CNSNews.com.

But there are other problems for RU-486 looming on the horizon.

The chairman of the House Commerce Committee, Rep. Tom Bliley, R.-Va., raised questions and concerns about the Chinese company rumored to be manufacturing RU-486, Hua Lian Pharmaceutical Company. Bliley sent an Oct. 18 letter to the FDA asking about incidents in which the company allegedly sent a falsely labeled and branded drug into the United States. The letter further pointed out that the company has not gained FDA approval for manufacturing and exporting drugs to this country and questioned whether the company had a history of exporting contaminated drugs.

The Population Council isn’t confirming the identity of the drug manufacturer or commenting on Bliley’s concerns. Waldman said only that, “The FDA inspected and approved the factory manufacturing this drug, and they deemed it was being manufactured according to required practices.”

Some college health centers reportedly won’t be prescribing the drug, either because they cannot meet FDA guidelines in administering the drug or because of objections to the drug.

Heather Cirmo, a spokesperson for the Family Research Council, cited news reports of doctors balking at the protracted process of administering the abortion drugs. The FDA requires three doctor visits that Cirmo said some doctors may object to as time-consuming, “hand-holding” requirements.

On the legislative front, pro-life and pro-choice groups say they plan to take up the case of RU-486 in state legislatures where there may exist some leeway in regulating, or facilitating, access to abortion.

Pro-life groups are developing their strategy for the states, Cirmo told CNSNews.com. She pointed out that the states have the authority to subject the abortion pill to parental notification and consent laws. Also, states may be able to further regulate the pill as a drug, which is something they cannot do with surgical abortions.

However, much will depend on the Nov. 7 presidential election, Cirmo said.

“Obviously, the election could … change things,” she said. “The strategy [of the pro-life groups] depends on the administration that comes in. We could have a relatively friendly administration or a pretty hostile administration, so the ball game will be completely different.”

Neither the American College of Obstetricians and Gynecologists nor the National Abortion and Reproductive Rights Action League (NARAL) returned CNSNews.com’s calls seeking comment.
Hall is a staff writer with CNSNews.com. Used by permission.

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  • Christine Hall