Proposed Bill Would Reinstate Safeguards for Women Taking RU486

Under pressure from pro-abortion groups and many of their sympathizers in the medical establishment, the Food and Drug Administration (FDA) modified or set aside many of the patient protections the FDA had considered just months before when it approved the abortifacient RU486 last September. Now, two pro- life legislators want to put those safeguards back in place and have introduced a bill in Congress that will offer these women a higher degree of protection.

On February 6, 2001, Senator Tim Hutchinson (R-Ar.) and Congressman David Vitter (R-La.) introduced the "RU-486 Patient Health and Safety Protection Act." Senator Hutchinson and former Congressman Tom Coburn (R-Ok.) offered similar legislation last fall when approval of RU486 was first announced. However, the measure never came up for a vote. Coburn, a physician, retired from Congress at the end of last term, allowing Rep. Vitter to take up the banner in the House.

Hutchinson and Vitter's bill would require that physicians prescribing RU486 meet the following five conditions:

1. Be qualified to handle complications of an incomplete abortion.

2. Be legally authorized to perform an abortion and trained to do so.

3. Be certified to read an ultrasound in order to date the pregnancy and identify an ectopic pregnancy.

4. Be properly trained in the administration of this drug through an FDA-approved curriculum.

5. Have admitting privileges at a nearby hospital, in case of complications requiring emergency care, such as heavy bleeding, which is relatively common with this procedure.

Press accounts which surfaced in June 2000 indicate that each of these measures was under consideration as a condition of approval as late as last summer. Those regulations addressed concerns of the FDA panel which met and originally recommended approval in July 1996.

Despite that recommendation, panel members expressed serious reservations about the ability of prescribing physicians without surgical or obstetrical training to handle complications, date pregnancies, or handle the surgical backup for those chemical abortions which "failed" (see NRL News, October 9, 1996, and June 2000)precisely some of those concerns the earlier regulations considered by the FDA and the measures proposed by Hutchinson and Vitter sought to address.

The rationale behind these patient protections bears examination.

Owing to the abortion lobby hype extolling the so-called safety and simplicity of "the abortion pill," a great deal of misunderstanding and misinformation exists about RU486, not only in the general public, but even among doctors. Few realize that the chemical method is actually a painful, drawn out, complex, two-drug, multiple-visit regimen that carries a great many risks and potential dangers (see NRL News, August 10, 1999).

In place of the training in the use of the drug that the FDA once considered calling for, the FDA now asks only that a physician sign a letter attesting that he or she has "read and understood" the prescribing information for the drug and will follow the guidelines set out in the letter. Though better than nothing, there are serious doubts about whether a physician merely reading about the process can fully appreciate or be fully prepared for the medically complex, messy reality of chemical abortions.

Indeed, in U.S. clinical trials, abortionists' discomfort with the quantity of blood loss was one of the reasons cited for the higher percentage of surgical interventions and lower "success" rates in this country.

Current FDA policy calls for ultrasound only "as needed," leaving the decision to the "medical judgment of the physician." Yet ultrasound is critical for two reasons: first, because the " effectiveness" of RU486 as an abortifacient drops off precipitously after the 49th day of pregnancy; second, because RU486 will not work against ectopic pregnancy.

Giving a woman RU486 without giving her an ultrasound thus invites futility, if not outright disaster, if a doctor miscalculates the length of a woman's pregnancy or fails to eliminate the possibility of a tubal pregnancy.

Despite claims of RU486's safety and efficacy, complications and failure are actually quite common.

Even at the time frame mandated by the FDA (up to the 49th day of pregnancy), U.S. trials showed there was a "failure" rate of 8%. This means nearly 1 out of every 12 women taking RU486 did not abort at all or did not completely abort. At least 2% of women in the U.S. trials hemorrhaged (current FDA labeling actually appears to put this figure at 5%) and as many required some form of what the researchers termed "surgical intervention."

Who will provide those "surgical interventions" or handle those " failures"? The FDA's original proposal limiting prescription to physicians with surgical abortion experience or training at least gave the woman the benefit of knowing that the doctor who gave her the pills could handle the situation if she showed up at his office doorstep gushing blood. Now, under current guidelines, she may have to rely on some other doctor, a stranger whom she has never met, whose number is scrawled on the back of some crumpled-up piece of paper at the bottom of her purse.

Doctors who originally could have been called upon to practice within an hour of appropriate emergency facilities and have admitting privileges at local hospitals now only have to "assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary."

Whether this means more than pointing out appropriately equipped facilities in the phone book is unclear. It could mean that when a woman gets there, the doctor who gave her the drug will be nowhere to be found -- if she can get to the designated place in time.

Even with the patient protections called for in Hutchinson and Vitter's bill, the U.S. would still have milder regulations on RU486 than those in place overseas. In France, where the drug originated, women can only get RU486 at specially authorized health centers equipped with an electrocardiograph and emergency resuscitative equipment nearby.

In Britain, another one of the handful of countries with nearly a decade of experience with the drug, pills are numbered to ensure that they are released only to trained personnel. Women are not actually allowed to leave the hospital or clinic until they abort, even if that entails an overnight stay.

The abortion lobby has squawked/ complained nonetheless, dismissing Hutchinson and Vitter's bill as a political ploy and calling the proposed regulations "medically unnecessary."

It is worth asking, therefore, whose interests and agenda the FDA had in mind when it decided to go with the more minimal standards. The truth is that the guidelines put out by the FDA in September 2000 made things more convenient for abortionists, but did not make things safer for the women involved.

The net effect of dropping the more stringent requirements was to vastly expand the pool of potential prescribers, to open the method up to family practitioners, pediatricians, and any other doctor with a prescription pad, something the abortion lobby desperately wanted. Because of the FDA's capitulation, those prescribing RU486 no longer need have any special training or skills beyond their medical school diploma.

The FDA also reduced potential overhead for would-be prescribers. With ultrasounds no longer mandatory, there is no additional expensive equipment to buy, no ultrasound specialists to hire or train. By dropping the requirement that doctors prescribing the drug have surgical experience, the FDA allows doctors to make complications and late-night emergency phone calls somebody else's problem.

In announcing the introduction of his bill, Sen. Hutchinson said in a statement, "The FDA must ensure the safety of all drugs it approves, and RU-486 is no exception. I have no doubt that if women were asked whether their doctor should be required to be able to read an ultrasound, handle complications, and get them admitted to the hospital in case of emergency, they would not hesitate to demand those levels of competence."

Hutchinson said that this bill "seeks to ensure that the health of women who take this drug will not be jeopardized due to improper administration of the drug by an inadequately trained health professional."

In his own press release, Congressman Vitter added, "The politicized approval of RU-486 last year will not only increase the number of abortions performed each year, it will create serious and potentially dangerous side effects for women using the drug...The least we can do is ensure that this drug does not endanger the health of the mother."