RU 486 Promoters Upset over Reports of Proposed FDA Protective Measures

By Randall K. O'Bannon, Ph.D.
NRL-ETF Director of Education & Research

Launching a full-blown media offensive, representatives of major pro-abortion groups are vigorously protesting that safety precautions, said to be recently proposed by the Food and Drug Administration (FDA), are too onerous and will, if adopted, inhibit women's access to the abortifacient RU 486.

While pro-lifers maintain that the FDA would be more faithful to its mission of guarding public health if it protected the unborn child and rejected the drug altogether, concerns about the health of women taking the abortion pill are neither new nor unjustified.

Even though the FDA has twice deemed RU 486 "approvable," first in 1996 and then this past February, it has held up final approval pending the resolution of certain manufacturing, labeling, and other issues whose details have generally not been divulged to the public.

Had reporters who uncritically accepted pro-abortion complaints bothered to read the transcript of a 1996 FDA advisory panel that examined RU 486, they would have seen that the reported FDA safety measures are intended to address some of the panel's major safety concerns.

Among the possible protective regulations the pill's promoters say the FDA is proposing are initiating a national registry of doctors who would be allowed to offer the two-drug abortion technique; monitoring distribution of the abortifacient pills; limiting the use of the technique to doctors who also know how to perform surgical abortions, read ultrasounds, and practice within an hour of an emergency room; and long-term tracking of the health of women taking the abortifacient.

Considering the complexity of the drugs involved, the side effects experienced by women, and the differences between the much more decentralized American health system and those found in the (largely) European nations where RU 486 is now used, the regulations purportedly proposed by the FDA would appear necessary to establish at least some minimal protection for the women taking this drug, though they would do nothing for their unborn children.

Members of the abortion establishment found out about the reported safety measures at a June 2, 2000, gathering of abortion activists. Representatives of the Population Council (RU 486's U.S. sponsor and patent holder) and Danco Laboratories (the manufacturing and distributing licensee) divulged elements of the FDA's latest communication, according to press accounts

Reaction from the Abortion Lobby and the FDA

Reaction to the proposed regulations among RU 486's promoters was prompt and loud. "We are deeply concerned that FDA is considering restrictions that in my view would virtually assure that very few doctors would ever make mifepristone [RU 486] available," said Planned Parent-hood president Gloria Feldt (Los Angeles Times, 6/7/00).

Vicki Saporta, director of the National Abortion Federation, concurred with Feldt. Saporta told USA Today (6/7/00), "The FDA is considering placing so many restrictions on doctors who want to use the drug that few will be interested in using it." Added Saporta, "The great promise that it has to improve access to women who are seeking early abortion services will be lost."

Paul Blumenthal, medical director of Planned Parenthood of Maryland, vigorously complained about the requirement that dispensers of RU 486 must also be able to perform conventional abortions.

Moreover, pro-abortionists cited the "successful" use of RU 486 in Europe to protest that long-term health tracking of at least some women is unnecessary.

The FDA, usually restrained in public comments about drugs currently under consideration, offered few details but defended itself. FDA spokesperson Susan Cruzan told USA Today, "For any new product, FDA's job is to examine not only whether that product is effective, but also whether it can be used safely."

Going further, Cruzan said that, in fact, the notion of a " credentialing system" had been raised four years earlier by the FDA advisory committee that first recommended approval of the drug.

Advisory Panel is Uneasy

Despite its approval recommendation, the FDA advisory panel that looked at the drug in 1996 did raise a number of concerns, both about the training of the doctors who would use RU 486 and their ability to handle complications.

For example, members were aghast when they heard that the sponsor proposed to hold seminars to train non-surgeons not just to administer the drug but also then to perform surgical abortions for those chemical abortions which "failed."

Dr. Richard Azziz, professor of obstetrics and gynecology at the University of Alabama at Birmingham, said at the hearing that the sponsor was "treading on very dangerous ground." He labeled efforts to "train nonsurgeons to do a procedure which is a D&C on a pregnant uterus" as "extremely risky."

Vivian Lewis, M.D., director of reproductive endocrinology at the University of Rochester Medical Center, was even more emphatic in expressing her concern. "If you're talking about in an emergency situation having the skill to be able to do this deftly, appropriately, and with minimal complication," she said, " such a person who has never been trained in that and has only attended a seminar is the worst possible choice of person to do that."

Other panelists expressed concern that physicians without obstetrical training would not be able to accurately date pregnancies, vitally important because of the steep drop-off in " effectiveness" after seven weeks. They also worried about what would be done about women who failed to return for their second or third visits in the multi-step process.

Advisory committee members were also made aware of the case of one Iowa woman who participated in the U.S. trials of RU 486 who would have probably bled to death if she hadn't been taken to the emergency room and received emergency surgery. They also heard about other women in the trials who were hospitalized and required transfusions and "surgical interventions" to stop the bleeding.

Ezra Davidson, M.D., chair of the advisory committee, admitted, " I think there is considerable unease about how the certification and documentation is going to be done to ensure safe delivery of this regimen and management of its complications."

Members of the panel also indicated at that hearing that they wanted tracking of complications and assurance that doctors using the drug were adequately credentialed.

But even before the advisory panel raised these issues, an FDA spokesman had already laid out a number of pre-conditions the pill's promoters is now decrying: distribution to physicians only, and requirements that physicians be trained in the dating of pregnancy, the diagnosis of ectopic pregnancy, the performance of surgical abortion, and have access to facilities for surgical abortion and emergency treatment.

The FDA noted at the 1996 hearing that records would have to be kept of each dose - - and that prospective patients would need to reside and work within one hour of appropriate medical facilities.

Complications

Statistics from the abortion pill's own sponsor show that approximately 1 out of every 50 women will hemorrhage and require surgical intervention to stop the bleeding. Out of every 100 women who take the drug, one will end up in the hospital. The method will fail for at least 8% of the women who take it, and someone will have to deal with the medical consequences. With that in mind, the protective regulations now apparently being proposed by the FDA are hardly "extreme."

More objective medical experts recognize the potential dangers. In the June 7 edition of timedaily (found on Time's www.time. com Web site), medical contributor Dr. Ian Smith said, "There are legitimate medical questions here that we will have to watch carefully as the drug is used."

"How will doctors ensure the safety of an unsupervised patient with a history of hemorrhaging?" he asked. "Will doctors only prescribe the drug within the designated window of gestation? What if the drug makes its way to the black market, and women take it outside of the prescribed time frame?"

RU 486's Future

Careful not to openly criticize the FDA while the agency still holds the fate of RU 486 in its hands, Danco spokeswoman Heather O'Neil said, "The agency's initial approach is more restrictive than we had envisioned for a drug that has been used safely by so many women." She declined to elaborate, adding only, "We are in the very early stages of a delicate negotiation process with the FDA" (New York Times, 6/8/00).

Those negotiations are critical to the drug's future in the United States.

If the FDA caves in to the political pressure of the abortion lobby and drops the proposed regulations, both the FDA and pill's producers could face serious public health and public relations problems when women begin to be injured or die because of the drug.

The FDA has until September 30, 2000, to either give the drug final approval, reject it, or issue another "approvable" letter.