State Policymakers Chart Untested Waters Around RU-486
By Mary Guiden, Staff Writer
Abortion has long been a bitterly divisive political topic in the United States, and debate on the issue promises to intensify this year as state lawmakers confront the latest element in the philosophical and moral divide: a drug that ends an unwanted pregnancy.
Known in this country by the brand name Mifeprex and the chemical compound name mifepristone, the drug is frequently referred to as RU-486, a term derived from its creator, French pharmaceutical giant Roussel Uclaf.
Mifepristone first became available in France in 1988. A few years later, in July 1991, the United Kingdom okayed its use; Sweden gave the drug the thumbs up in 1992.
Seeking to distance itself from U.S. politics and avoid possible boycotts, Roussel in 1994 donated patent rights for mifepristone to the Population Council--an international, nonprofit organization established in 1952 by John D. Rockefeller III that conducts research on new birth control devices and prevention efforts for sexually transmitted diseases.
In passing on the patent rights, the name RU-486 remains with Roussel, hence the name variation here in the U.S.
The council sponsored clinical trials in the mid 1990s involving more than 2,100 American women in 15 states, and the U.S. Food and Drug Administration (FDA) hosted hearings in July 1996 on whether or not to approve the drug.
Following heated debate and based on the U.S. and French experience with the drug, FDA's Reproductive Health Drugs Advisory Committee voted 6-0, with two abstentions, that benefits exceeded the risk for bringing mifepristone to the U.S. market.FDA officially approved the drug last September, more than seven years after former President Bill Clinton issued an executive order requesting a re-evaluation of a ban on the importation of mifepristone.
Arkansas, Kentucky, New Jersey and Oklahoma are among states that will consider mifepristone-specific measures this year. (Groups on both sides of the issue say most existing abortion-related laws, such as parental notification statutes, already apply.) The proposals range from an outright ban on the drug to further restrictions on prescribing the drug. A look at two legislators' efforts demonstrates the polarity that surrounds the issue.
In Oklahoma, state Rep. Bill Graves has prefiled legislation that would ban the prescription, dispensing and distribution of mifepristone. Inspired to act by recently retired Republican U.S. Rep. Tom Coburn, who unsuccessfully tried to block the FDA approval of mifepristone. Graves, a Republican, says that "the FDA rushed this thing through the approval process."
Citing Coburn-compiled information about women bleeding excessively after using the drug, Graves says that he's "not sure they put the right thing on the market." He also notes that the drug "is manufactured in Red China, and they have a very aggressive abortion policy over there."
Since Oklahoma's legislative session doesn't get rolling until Feb. 5, the lawmaker hasn't really had a chance to gauge colleagues' support. "I don't know why we can't regulate something like [this drug]," Graves adds. "It's one of the reserved powers left to the states."
At the other end of the political spectrum, New Jersey Assemblyman Neil Cohen backs a measure that would require health plans to cover abortion-causing drugs, including mifepristone. Cohen, a Democrat, introduced his bill last December, based on what he heard during last year's presidential campaign.
"There was a question about whether or not then-Governor Bush would go to the FDA and try to get things changed," Cohen says. "I wanted to make sure New Jersey took steps quickly to make sure RU-486 would be available to" women in the state.
Though he doesn't expect the bill to go far this year, Cohen said he's found support for covering the drug from the state health benefits plan, which serve tens of thousands of state employees, and from individual health plans, which serve ordinary citizens.
"I expect the RU-486 issue to be big this year. Once FDA issued its approval, that provided a medical basis for the drug. There's still a danger lurking in the new Administration, however, if officials want to revisit the issue," he says.
Though President Bush has not ordered a FDA review of the drug, Tommy Thompson, the nominee for Secretary of the Dept. of Health and Human Services, hinted in recent confirmation hearings that he'll do so.
There are many questions about whether states have the power to regulate mifepristone. Though FDA spokesperson Crystal Rice said it would be legal for a state to ban the drug because "intrastate commerce is out of the department's jurisdiction," other legal experts differ.
A ban on the drug would be "preposterous," says Karen Raschke, staff attorney for the Center for Reproductive Law and Policy, a nonprofit advocacy group that promotes women's reproductive rights. She says state legislators "cannot intervene with a FDA decision like this" because abortion is legal.
The National Right To Life Committee's Laura Echevarria says her group opposes mifepristone "not just because it's an abortion drug," but also on public health and safety grounds.
"If you're dealing with a drug that's generally dangerous, the U.S. government has an obligation to people not to allow a drug or leave it on the market," Echevarria says.