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Time for FDA to free up political hostage - RU 486

Posted: Monday, June 19, 2000

BOSTON - It's been stuck on the tarmac for so long that by now RU 486 sounds like the flight number of a plane taken hostage. And that's not far from the truth.

RU 486, otherwise known as mifepristone, is the drug developed back in the 1980s by a French doctor so women could choose a nonsurgical abortion very privately and very early in pregnancy.

In the past dozen years, 500,000 French women have used it safely and effectively. It's been distributed to 20 other countries ranging from the United Kingdom and Finland to Greece and Israel. But RU 486 remains grounded in America.

For a while, everyone blamed the weather. RU 486 couldn't take off because of ``the climate.'' During the Reagan and Bush years, the political turbulence was so great, it was simply banned.

But when Clinton was elected, the skies became friendly. In 1993, the new president promised to bring the pill here. Yet it took years to complete the required clinical trials, however redundant, and more years to find a manufacturer.

During this time, the pro-life movement changed tactics. They went from trying to make abortion illegal to trying to make it impossible. The number of providers performing abortions shrank to 2000. Today, 86 percent of counties have no providers at all.

Clinton has come and almost gone, and just months before the scheduled approval date, the FDA has apparently come up with yet another set of restrictions that could keep the drug off the runway. In a recent meeting in the endless negotiating process, we are told, they added some doozies:

Only doctors who perform surgical abortions will be allowed to used mifepristone. And only doctors who have privileges at hospitals less than an hour away.

Caution is fine. I don't want an FDA that is blase about health risks for women. But the new restrictions for this drug are out of all proportion.

RU 486 is meant to provide an early medical alternative to surgical abortions. And to increase access for many women--especially in rural counties.

Today one-quarter of women travel 50 miles or more to obtain an abortion. A recent Kaiser study said that one in three gynecologists who don't currently perform abortions would prescribe mifepristone - but the more restrictions the FDA adds, the fewer doctors would sign on.

Under these restraints, the pill would be available only at the same facilities, by the same providers. Women would have to travel to the same distant clinics, run the same pro-life gantlets. So much for the privacy of a doctor's office.

There is no medical reason for such limits. The FDA does not normally determine which doctors can provide which drugs. You can get Viagra from your ophthalmologist.

As for the requirement that the doctor be near a hospital? Mifepristone is a safe drug with very few side effects. Only 5 percent of the women who take this pill need further treatment. In essence, it produces a miscarriage. Yet, no one makes location rules for doctors who deal routinely with miscarriages.

``It's very reasonable for the FDA to be concerned about safety, but they go way overboard into regulating the practice of medicine,'' says Dr. Eric Schaff who conducted some of the trials. Why? He says bluntly, ``I suspect the FDA people are positioning themselves to retain their jobs depending on who becomes the next president.''

In short, the motives are not medical but political. Indeed, the FDA approval deadline for RU 486 - up or down - is Sept. 30, right in the middle of the presidential campaign.

After seven years, the Clinton administration hasn't come through on one of its earliest promises. Meanwhile Bush the Second will be running on a Republican platform that in essence labels abortion a capital crime.

Ironically, for almost two decades RU 486 has been the best hope of muting the endless public and political struggle over abortion. It offers women the possibility of making a decision early and privately with their own doctor.

The entire argument has been stuck way too long. It's time the traffic controllers at the FDA to let RU 486 off the ground.



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