Sept. 25, 2000 (Washington) -- It has been used by more than 500,000 European women. Even China has a generic version. But there is a chance that the highly controversial abortion pill RU-486 may never see the light of day in the U.S.
After four years of delays, U.S. health officials are expected Wednesday or Thursday to approve the highly controversial abortion drug. If that happens, the approval would mark the end of a decade-long struggle by pro-choice forces to market RU-486. But political concerns once again threaten to interfere with that regulatory process and, in effect, at least limit Americans' access to the politically charged morning-after pill.
The road for RU-486 in the U.S. has been bumpy, to say the least. In 1989, the FDA imposed an import ban on RU-486 when George Bush was in the Oval Office. And in 1993, President Clinton, after lifting the ban, ordered the Department of Health and Human Services to essentially accelerate its review of the abortion pill. Not to be left out, congressional Republicans have made two attempts at passing an amendment to the agricultural appropriations bill, forbidding the approval of RU-486.
Whether Democratic candidate Vice President Al Gore or Republican candidate Texas Gov. George W. Bush is elected president also might impact the fate of RU-486, says Wendy Chavkin, MD, MPH, a professor of public health at New York's Columbia University and recognized expert on reproductive issues.
"If George Bush gets elected, it would be a significant setback," Chavkin tells WebMD. For instance, should the FDA delay the decision past September, Bush, as president, could further stall the approval process through his selection of an FDA commissioner and secretary of Health and Human Services (HHS), Chavkin explains.
"Who is elected will have consequences," agrees Heather Cirmo, a spokeswoman for Family Research Council, a conservative anti-abortion rights group that has helped lead the fight against the approval of RU-486. If Bush is elected, anti-abortion rights forces might even be able to reverse the tables on a favorable FDA decision, Cirmo says. "We would support, encourage him to overturn the approval," she tells WebMD.
But a more likely consequence probably will be the passage of rules limiting the use and distribution of RU-486. In June, the FDA confirmed that it was considering a set of restrictions that would -- among other things -- require physicians prescribing the drug to have admitting privileges in hospitals and be able to conduct a surgical abortion.
If passed, the rules effectively would stifle one of the most promising benefits to this drug, Chavkin tells WebMD. As is, RU-486 offers the opportunity for women to avoid harassment and violence because the abortion can be done in the doctor's office rather than an abortion clinic, Chavkin explains. But if the restrictions are passed, many health care providers will not be able to offer the drug -- especially in rural areas where access to hospitals is limited -- or to prescribe the drug due to their lack of experience with surgical abortions, she says.
"It's not normal for the FDA to impose this kind of micromanagement," adds Chavkin, while noting that under normal circumstances, physicians usually are permitted to prescribe almost any drug regardless of their specialty.
Short of being able to block the approval of RU-486, it is this set of restrictions that anti-abortion rights groups are likely to pursue, Cirmo confirms. "First and foremost, we are against all abortions," she tells WebMD. However, at a bare minimum, the group would accept these restrictions as sort of a temporary compromise, she says.
The RU-486 abortion process is similar to having a miscarriage, during which there could be cramps and bleeding, Cirmo explains. "Women are not always informed about that process," she says, noting that the drug also is not an easy fix for the emotional trauma that often accompanies an abortion.
Still, there is a chance that the drug will be approved with no restrictions even as a treatment for other disease conditions. It also has been used to treat glaucoma, Cushing's syndrome, various tumors, and to induce labor. In 1995, RU-486 was shown to inhibit the growth of cancer cells and the activation of a receptor that plays a role in the reproduction of HIV, the AIDS virus. Once approved for these indications, physicians could legally use the drug to induce abortions as well.
Over the summer, FDA officials backed down on a number of the initially proposed set of restrictions, says Sandra Waldman, a spokeswoman for the Population Council, the nonprofit group and owner of the RU-486 patent. "I wouldn't anticipate anything," Waldman says. "We have had very positive discussions."
And, argues Chavkin, there is little merit to the FDA's safety concerns. The majority of women are unlikely to use an abortion pill more than once in their lifetime and the side effects, while possibly severe, generally are quickly resolved, she tells WebMD. Considering the drug's risk and benefit profile, "American women will not tolerate being deprived of this important option," Chavkin says.
But because of past blunders, pro-choice groups such as the National Abortion Rights Action League (NARAL) are taking no chances. Politics historically has surrounded the process and, as a result, the group is making a concerted effort to ensure that people see the approval as a political issue, Betsy Cavendish, JD, legal director of NARAL, tells WebMD.
"If Bush is elected, it could be the end of the day. We can't take that chance," Cavendish says. "Women deserve to have access to the full range of reproductive options."
Anti-abortion rights groups also are making special preparations for the day-after battle. That fight will take place on a number of fronts, Cirmo assures WebMD. For example, in the early 1990s, anti-abortion rights forces even managed to convince the drug's French developer, Roussel Uclaf, to abandon the drug by boycotting its other products, she points out.
If approved, RU-486 will now be made and marketed by a New York City-based group of investors who have incorporated under the name Danco and have a licensing agreement with the Population Council. Compared with other drugmakers, Danco is a "mom and pop" operation reportedly operating on a limited budget. But despite a possible profit of tens of millions of dollars, the big pharmaceutical makers have all declined to manufacture the drug.
Ironically, this manufacturing arrangement ultimately could be the greatest obstacle to the eventual distribution of RU-486. According to the latest reports, this group of investors intends to manufacture the drug in China, which reportedly has raised concerns among FDA officials about their ability to oversee and inspect that process.
In the end, whether the drug is distributed and used in the U.S. also may depend more upon what voters do during the November elections rather than what the FDA does this week, Cavendish reiterates. Even if RU-486 is approved prior to the elections, pro-choice Americans will still need to take the fight to the voting booth if they want to ensure that the drug is made and distributed, Cavendish insists.
"They [anti-abortion groups] are relentless, and now, we need to be relentless," she tells WebMD.