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Ruth Lesnewski is trying to find a spot in her office for a sonogram machine. "We'll need to have that nearby," says Lesnewski, a physician with East 13th Street Family Practice in Manhattan. Lesnewski has never provided abortions before. But since last Thursday, when the Food and Drug administration approved RU-486, or Mifepristonea pill than can induce abortion in the first seven weeks after conceptionshe's been preparing to start.
"We're reeling from this," says Lesnewski, who is working on logistics like how to order the drug, which, after more than a decade of delays (see Voice, September 5), should be available in the next four to six weeks. "There's not really a procedure code for this yet. I'm sure our billing department is going to be running around trying to figure out how to get reimbursed." Like all doctors who plan to use mifepristone, which will be marketed under the name Mifeprex, Lesnewski also has to arrange for a surgeon who can provide "backup" in those rare instances in which a medical abortion is incomplete.
Nobody is yet certain how many family practice physicians, internists, and OB-GYNs will follow Lesnewski's lead. But abortion rights advocates hope the numbers will be large enough to change the face of the abortion battle, making it far more difficult for right-to-lifers to selectively intimidate abortion patients and providers. They are also pushing to make the pill as widely available and as easy to dispense as possibleeven if that means taking liberties with the FDA's new rules.
While several severe restrictions that were reportedly being considered by the FDA did not make it into the agency's final announcement, the approval did come with some strict rules about administering mifepristone that could make it more cumbersome for many women to take the pill.
Perhaps the most critical issue is the number of office visits required for an abortion with mifepristone. The FDA's approval letter specifies that a Mifeprex abortion should involve three visits: the first to get counseling and three Mifeprex pills, the second to take two tablets of a drug called misoprostol, which induces contractions, and the third for follow-up about 12 days later. This procedure is just what the drug's sponsor, the Population Council, spelled out in its initial application to the FDA in 1996.
But while mifepristone was tangled in politics, new research clarified simpler ways to use the abortion drug effectively. One is to take the misoprostol at home. "There have been a lot of studies showing that at-home administration of the second medication is extremely safe," says Vicki Breitbart, director of the Clinician Training Initiative, a division of Planned Parenthood of New York City that trains hundreds of private and clinic-based abortion providers.
For the providers, having a woman in the office to take some pillsand sometimes abort therecould be inconvenient. "If a patient has to come back to the clinic, that means that she'll need to stay in the office for several hours," says Breitbart.
A second visit could also be a problem for those who live a considerable distance from the doctor's office. "It's going to be a lot better for you not to have to drive the two hours just to take a second medication," says Donna Lieberman, director of the New York Civil Liberties Union Reproductive Rights Project.
If providers don't follow the FDA-prescribed protocol to the letter, they could reach more women by offering Mifeprex abortions later in pregnancysince newer studies show that the drug can be used safely as late as nine weeks after a woman's last period. They could also administer one Mifeprex pill, which is 200 milligrams, rather than three; though the FDA recommends the higher dose, recent studies have shown only one pill to be just as effective when the misoprostol is taken vaginally instead of orally. The smaller dose could substantially lower the cost of a Mifeprex abortion, which is now expected to be somewhere between $300 and $500.
Lieberman, an attorney, is convinced that using mifepristone in these ways is perfectly legal. "Physicians are authorized to use drugs for purposes other than the FDA approves," says Lieberman.
But Danco, the company that's marketing Mifeprex, has devised an unusual plan for distributing the drug that seems designed to prevent such "off-label" uses. It won't sell Mifeprex through pharmacies, which will force patients to come to physicians. And the order forms those doctors will sign commit them to dispensing Mifeprex only in the way specified by the FDA. "If you do not follow these guidelines," the Danco Web site (www.earlyoptionpill.com) warns doctors ordering pills, "the distributor may discontinue distribution of the drug to you."
Lieberman says this "agreement doesn't trump the legal provision that drugs can be used off-label." Nevertheless, she acknowledges that the company's contract allows Danco to stop supplying the drug and could conflict with doctors' rights to prescribe as they see fit. "That's a contradiction that we lawyers are going to have to take a close look at," says Lieberman.