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Partito Radicale Matteo - 10 giugno 2000

ru486 in america

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RU-486, the French abortion pill, has long offered the promise of better access to safe abortions for women in this country. But that promise has gone unfulfilled because of political controversies surrounding abortion and earlier difficulties in finding a suitable manufacturer. Now come troubling reports that the Food and Drug Administration, as it moves toward final approval of the drug it pronounced safe and effective in 1996, is considering unreasonable restrictions on the distribution of RU-486 that would virtually eliminate its chief value.

The drug, also known as mifepristone, when used in combination with another already approved drug called misoprostol has been proved to be very safe in terminating pregnancies at their earliest stages. It is used with women who are no more than seven weeks pregnant, commonly producing side effects similar to those of a natural miscarriage.

The drug has been safely used by more than 500,000 women in Europe in the past decade, with 95 percent effectiveness. In France, for example, nonsurgical abortions with RU-486 in 1998 accounted for more than one-third of all abortions. The availability of RU-486 has not increased the total number of abortions in that country, but has meant that women seek to terminate pregnancies earlier. Clinical trials in the United States have found the method to be similarly safe and effective. Nearly 90 percent of women in those trials also reported that they were very satisfied with this option.

But anti-abortion groups have been bitterly opposed to RU-486 because it would make abortion more readily available. Doctors who currently do not perform abortions would be able to use RU-486 to terminate early pregnancies without having to do surgical procedures. That would improve access to abortion services, particularly for women in rural areas and in parts of the country where abortion services are nonexistent. Allowing more doctors to provide these services in their own offices may also make it harder for anti-abortion groups to target patients and doctors as they do at abortion clinics.

In February the F.D.A. notified Danco Laboratories, the company that will market and distribute RU-486 in the United States, that it would give final approval to the drug if certain labeling and manufacturing issues were resolved. Negotiations are now under way, but the F.D.A. recently proposed some conditions that could severely undermine access to the drug.

The F.D.A. is said to want only doctors who are trained to perform surgical abortions to prescribe RU-486. That restriction would essentially wipe out broader access to the drug. The requirement seems unnecessary. Clinical trials have found that about 5 percent of women using RU-486 in early pregnancies needed additional medical intervention because of incomplete abortions (doctors often intervene at higher rates in cases of natural miscarriages). If a surgical abortion were required, a doctor could refer the patient to another doctor able to perform the procedure. Another suggestion, that doctors prescribing RU-486 have admitting privileges to hospitals within an hour of their offices, seems odd when doctors prescribe myriad other drugs without having to meet such a requirement.

The F.D.A. should be cautious in approving the marketing and use of any new drug. It should require precise labeling and urge that doctors become trained in using RU-486. But it should not impose excessive restrictions that are not necessary to protect patient health simply because it might fear political opposition. In the final approval process, the Clinton administration needs to make sure this proven drug is made safely and broadly available to all American women.

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