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Regulations too heavy on RU-486
© St. Petersburg Times, published June 13, 2000
Limiting access to abortion services by enacting stringent health and safety regulations on clinics is an old anti-abortion ploy.
By passing strict rules on clinic floor plans, lighting, and staffing -- rules that are not equally applied to other out-patient health care clinics -- legislators can try to drive abortion clinics out of business under the guise of protecting women's health and safety.
It seems the Food and Drug Administration is taking a page out of this anti-abortion activist handbook.
The agency's approval of the abortion drug mifepristone, also known as RU-486, may come with a number of strings attached. Extra regulations that the FDA apparently sees as health-related precautions, are, in fact, mostly unnecessary and could sharply limit the availability of the drug.
In the majority of cases, once the FDA approves a drug as safe and effective, any doctor can prescribe it. But before giving final approval to RU-486, a drug that has been used safely by half-a-million women in Europe, the FDA is reportedly asking for unusual and burdensome restrictions. Among the proposed requirements: physicians who prescribe it also be qualified to perform surgical abortions and must register with the drug's distributor.
While the drug is preferable as a safe alternative to surgical abortions, the real benefit of RU-486 is that it can be taken in the privacy of a doctor's office -- potentially broadening the universe of primary-care physicians willing to provide the abortion pill. Anti-abortion activists who stake out this nation's ever-dwindling number of abortion clinics have been fearful of RU-486's approval, since doctors and patients could insulate themselves from their pressure tactics. But if the FDA requires registration of the physicians willing to prescribe it, they could be targeted for intimidation.
Why the FDA would take such an unusual step is a mystery. It appears politics is guiding the agency as much as science.
After more than a decade of use in Europe and years of clinical trials here, the abortion pill regimen has proven effective 95 percent of the time. For those remaining women, a surgical abortion was needed. It is not necessary, however, for doctors who prescribe RU-486 to be trained in surgical abortions. If those services are needed, the patient can be referred to another qualified doctor.
That said, prescribing RU-486 is more complicated than many other medications. It would not be unreasonble to require some special training for physicians who intend to provide it to patients. It also is important that women understand that the pill should be taken under close medical supervision.
Since this non-surgical abortion alternative can only be done within the first 49 days of pregnancy, the availability of RU-486 could encourage women to have an abortion earlier in their pregnancy. For most Americans, even those who are staunchly pro-choice, the earlier an abortion occurs the more comfortable they are with the procedure.
The non-profit Population Council, which holds the U.S. rights to the drug, recently had to scramble to find a willing manufacturer. Now, just as the drug is on the verge of approval, the FDA is proposing a number of onerous regulations. The agency has more than a decade of medical evidence that indicates RU-486 works safely and effectively. For it to allow any other considerations to influence the approval process is playing politics with women's reproductive health.
© St. Petersburg Times. All rights reserved.