What regulations is the FDA proposing for RU486's release?
It is not the FDA's policy to comment on drugs currently under consideration.(1) Leaders of pro-abortion organizations have told members of the press, however, that Danco and the Population Council, U.S. sponsors of the pill, disclosed regulations being considered by the FDA at a June 2, 2000 meeting.(2) While precise details of those proposed regulations are known only to the FDA, the Population Council, and Danco, newspaper summaries mention the following conditions:
* Monitored distribution(3)
* Prescription by physicians only.(4)
* Requiring training in use of the drug.(5)
* Requiring prescribing physicians to be trained in the reading of ultrasounds(6)
* Limiting to doctors with surgical abortion experience or training(7)
* Limiting use to doctors with admitting privileges to hospitals with emergency services within an hour's drive of the doctor's office.(8)
* Follow-up studies/long term tracking on the health of women taking RU486.(9)
A report from Planned Parenthood also indicates that the FDA would require that misoprostol, the second drug used in the RU486/PG abortion, be taken in the care of a "certified provider," as it was in clinical trials, rather than allowing it to be self-administered at home. Planned Parenthood also says that the FDA wants a "black box" label on RU486 indicating "it induces abortion and can have grave health effects on the fetus."(10)
Several reports also mention a proposed registration requirement or database of doctors authorized to prescribe the drug,(11) though at least one source quotes a representative from the Population Council as calling news of the registry a "mischaracterization."(12)
Not likely. If any pressure has been exerted on the FDA, it would have come from those in the Clinton administration who were pushing for the pill's approval (see above). And there is no "compromise" under which the pro-life movement would simply accede to the loss of thousands of unborn lives.
The regulations reportedly currently under consideration by the FDA are actually a reflection of concerns expressed by the regulatory agency at least as far back as 1996, when an FDA appointed panel first considered the drug.
Before the July 19, 1996 advisory panel ever began its formal discussion on the drug's safety or efficacy, at least two presenters, one from the Population Council, the other from the FDA, laid out several of the conditions the pill's promoters today decry.
Beverly Winikoff, the Population Council's program director for reproductive health, after discussing the pill's "acceptability" with women participating in the U.S. trial, indicated that because the method would be new for American physicians, it would not be sold in pharmacies but "provided to physicians who have training in the dating of pregnancy, the diagnosis of ectopic pregnancy and surgical abortion, and who have access to facilities for surgical abortion and for emergency treatment of complications."(13)
Speaking later in the hearing, Lisa Rarick, the Acting Director of the FDA's Division of Reproductive and Urologic Drugs, confirmed that conditions such as these were under consideration. In discussing "provider requirements,"Rarick told the panel that the labeling the FDA was considering indicated it was "for physicians only for distribution." She further elaborated that "These are providers that must be trained in the dating of pregnancy, the diagnosis of ectopic pregnancy, and how to do a surgical abortion." She added that "they must have access to all these facilities for surgical abortion and emergency treatment."(15)
Under the rubric of "patient attributes," Rarick also noted that "ultrasound can be used as needed to confirm length of gestation" and said that "Living requires residing and working within one hour of appropriate medical facilities."(16)
Despite their endorsement of the abortion pill's safety and efficacy, members of the 1996 FDA advisory panel expressed grave concerns about expanding the provider pool to include physicians or other medical personnel which lacked the requisite skills or training to handle chemical abortion "failures" or complications.
Panel members were aghast when they heard that the sponsor proposed to hold seminars to train non-surgeons not only to administer the drug but also to perform surgical abortions for those chemical abortions which "failed."
Dr. Richard Azziz, the FDA's special guest speaker for the panel, said the sponsor was "treading on very dangerous ground" and labeled efforts to "train nonsurgeons to do a procedure which is a D&C on a pregnant uterus" as "extremely risky."(17)
Panelist Vivian Lewis, M.D., was even more emphatic in expressing her concern. "If you're talking about in an emergency situation having the skill to do this deftly, appropriately, and with minimal complication," Lewis 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."(18)
After hearing Azziz, Lewis, and several other members of the panel, committee chair Ezra Davidson, M.D. summarized the panel's reaction for the FDA by saying, "I think what you are hearing from the committee [in regard to] the issue of skills being discussed, [is that] there is considerable unease about how that certification and documentation is going to be done to ensure safe delivery of this regimen and management of its complications."(19)
If not political, what would be the basis for regulations such as these?
The regulations under consideration reflect some of the unique medical risks and logistical complexities associated with the drug.
Monitored distribution: Drugs that reach the black market or are prescribed by those unfamiliar with drug could prove deadly when taken by women for whom the drug is contraindicated or unprepared for the drug's nastier side effects.
Prescription by physicians only : Despite the popular image of RU486 as some sort of simple anti-pregnancy pill, the RU486/PG regimen is actually a painful, drawn out, complex, two-drug, multiple visit, chemical abortion technique that carries a great many risks and potential dangers.(20) Limiting prescription to physicians trained to recognize and deal with these risks and complexities would insure a greater level of knowledge and responsibility
Requiring prescribing physicians to be trained in the reading of ultrasounds: The "effectiveness" of RU486 as an abortifacient drops off precipitously after the 49th day of pregnancy. Ultrasounds not only enable the physician to more accurately date the pregnancy, but to diagnose ectopic pregnancies for which the drug would be ineffective.(21)
Requiring training in use of the drug: Due to the hype associated with RU486, many doctors have gotten mistaken ideas about the ease or safety of chemical abortions.(22) Those prescribing the drug will have to be prepared to conduct extensive counseling and screening of possible candidates to ensure that a woman has no physical conditions that could make the drug dangerous or deadly for her, and to prepare those that receive the drug for potentially serious side effects and complications the pill could evoke. Physicians should be prepared to monitor those side effects and to recognize and deal with complications if and when they arise.
Limiting to doctors with surgical abortion experience or training: Not every chemical abortion works. Depending on the age of the baby/the date of the pregnancy, U.S. trials indicate the RU486/PG method "fails" anywhere between 8% and 23% of the time.(23) If the drugs have worked partially, but not completely, the baby could be dead or chemically damaged without being aborted. Tissue may remain in the mother's womb even if the child has been aborted. Doctors lacking surgical abortion experience or training will not be able to handle such circumstances or other complications that may arise in the course of the chemical abortion.
Limiting use to doctors with admitting privileges to hospitals with emergency services within an hour's drive of the doctor's office: Most women who take RU486 and its accompanying prostaglandin face intense side effects and heavy bleeding. With some women in the U.S. trials, the pain, nausea, vomiting, and diarrhea were themselves sufficient to require hospitalization.(24) Though dismissed as equivalent to a "heavy period," the bleeding from an RU486/PG abortion can be so severe that some women may require transfusions, surgery, and special uterotonic agents to stop the bleeding and replace the blood lost.(25) A woman who begins to bleed heavily and cannot reach an emergency room in time could die.Follow-up studies/long term tracking on the health of women taking RU486: Effects of the RU486/PG regimen on a woman's future pregnancies, or upon the fertility of her children, such as were seen with DES, are largely unstudied and unknown. Because the regimen involves at least two drugs and multiple visits to the doctor's office, and because women do not always return for these visits or for the full chemical regimen, there are special concerns about the health of these lost women and the unborn children they may still carry. Some 106 out the 2,121 women participating in the U.S. trials never returned for their third office visit to confirm the completion of their abortions, including at least 5 known to be still pregnant at visit two.(26) Animal testing has shown skull deformities in the offspring of rabbits exposed to RU486, and cranial nerve damage and deformed digits have been associated with misoprostol exposed infants in Brazil.(27)
Other possible regulations: Warnings informing doctors and patients of risks and dangers associated with given drugs are a standard part of government approved labeling. Every drug approved for use by the FDA includes a designation of its safety for pregnant mothers and their children. Given that the purpose of RU486 is to take the life of an unborn child, it would be peculiar for the FDA to categorize this drug as an "A,""B," or "C" drug in which there are no human studies demonstrating "fetal risk."(28)
Efforts by the pill's promoters to change the protocol and eliminate the second of the three doctor's visits would put the woman in the position of facing the most arduous, dangerous, difficult part of her abortion, when she begins her most violent cramping and her heaviest bleeding, without the benefit of direct medical observation or supervision.
What do outside experts and more objective reporters say about the proposed regulations?
Though abortion advocates have decried these proposed regulations as politically inspired(29) "extraordinary restrictions," more objective observers admit there is some basis and precedent for the FDA's measures.TIME magazine's medical contributor Dr. Ian Smith says there are some genuine medical concerns that the FDA is attempting to address. "There are legitimate medical questions here that we will have to watch carefully as the drug is used," Smith says. "How will doctors ensure the safety of an unsupervised patient with a history of hemorrhaging? Will doctors 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?"(30)
Lauran Neergard, the Associated Press's medical writer, reports a high rate of effectiveness for RU486, but says "a very small percentage of patients required additional surgical treatment or blood transfusions, something the FDA must consider in determining how the pill should be used." Neergard also raised compliance issues, saying "One question is how to ensure that women return for an exam to be sure the pregnancy was terminated."(31)
Advocates to the abortion pill have often claimed a strong safety record for the abortifacient in countries where the pill is already approved without mentioning the rigorous controls in place there.(32) Marc Kauffman of the Washington Post, while noting the discontent of the abortion lobby with some of the discussed regulations, nevertheless reported that "At least initially, many countries have imposed some restrictions on how the drug is used, in part to ensure that the small percentage of women who experience excess bleeding or other complications receive prompt care."(33)
Despite supporters' claims that these regulations are "unprecedented," Lars Noah, a University of Florida law professor specializing in FDA issues, admitted to the Baltimore Sun that the FDA has imposed restrictions such as these before. While Noah expresses suspicions about the influence of politics on the FDA's decision, he acknowledges that FDA approvals for both thalidomide and acutane came with significant limitations on their use because of their risk to the developing fetus.(34)
Do all the abortion pill's supporters dismiss the FDA's concerns?
Even the National Coalition of Abortion Providers (NCAP), while identifying RU486 as a "welcome medical option," warned that the abortion drug was "not a panacea" and outlined several conditions for its use. While perhaps not going as far as the FDA, NCAP's caution demonstrates that the hype about the pill's ease and safety is, at the very least, overblown.
A press release from NCAP declares "We are very concerned about the emergence of less-than-reputable physicians who will advertise abortion services 'Via a Pill.' They will prey on less-educated or unsuspecting women, making them think they just need to swallow a pill, go home and expel the tissue. The damage done to these women could be catastrophic."
Concerns the FDA has about an RU486 patient's need for access to a doctor with surgical training take a different form in NCAP's release, but are reflected nonetheless. NCAP says nothing directly about the RU486/PG 8%-23% "failure" rate, but does say "A new physician who decides to dispense RU-486, but who has never performed a surgical abortion, will need a back-up doctor in case a surgical abortion becomes necessary." Offering implicit confirmation that chemical abortions are neither trivial nor simple, NCAP also declares that "It is imperative that any new physician entering this field hire trained counselors with years of experience to help guide these women through the abortion process."
Arguing their position that there is a "need" to continue recruiting and training doctors to perform surgical abortions, NCAP declares "there is much more to abortion than dispensing a pill."(35)
1. Rita Rubin, "Abortion-pill backers fear a lack of access," USA Today, June 7, 2000.
2. Marc Kaufman, "Abortion Drug Proposal Criticized," Washington Post, June 7, 2000, p. A1; Rita Rubin, "Abortion-pill backers fear a lack of access," USA Today, June 7, 2000.
3. Rita Rubin, "Abortion-pill backers fear a lack of access," USA Today, June 7, 2000.
4. Sheryl Gay Stolberg, "F.D.A. Adds Hurdles in Approval of Abortion Pill," New York Times, June 8, 2000.
5. Sheryl Gay Stolberg, "F.D.A. Adds Hurdles in Approval of Abortion Pill," New York Times, June 8, 2000.
6. Sheryl Gay Stolberg, "F.D.A. Adds Hurdles in Approval of Abortion Pill," New York Times, June 8, 2000. Marc Kauffman, "Abortion Drug Proposal Criticized," Washington Post, June 7, 2000, p. A1, speaks similarly of "providers" as needing "certification and licensing before they can provide the drug."
7. Sarah Lueck, "FDA Restrictions May Deter Doctors From Prescribing the Abortion Pill," Wall Street Journal, June 8, 2000; Marc Kauffman, "Abortion Drug Proposal Criticized," Washington Post, June 7, 2000, p. A1; Sheryl Gay Stolberg, "F.D.A. Adds Hurdles in Approval of Abortion Pill," New York Times, June 8, 2000.
8. Sheryl Gay Stolberg, "F.D.A. Adds Hurdles in Approval of Abortion Pill," New York Times, June 8, 2000; Jessica Reeves, "RU 486 Arrives, Limping, on American Soil," TIME Daily, www.time.com/time/daily/0,2960,46864,00.html; Rita Rubin, "Abortion-pill backers fear a lack of access," USA Today, June 7, 2000; Marc Kauffman, "Abortion Drug Proposal Criticized," Washington Post, June 7, 2000, p. A1; Planned Parenthood, What's Up, vol. 4, no. 14 (June 9, 2000), at www.plannedparenthood.org/rchoices/lac/whatsup060900.asp; Sheryl Gay Stolberg, "F.D.A. Adds Hurdles in Approval of Abortion Pill," New York Times, June 8, 2000.
9. Jessica Reeves, "RU 486 Arrives, Limping, on American Soil," TIME Daily, www.time.com/time/daily/0,2960,46864,00.html and Marc Kauffman "Abortion Drup Proposal Criticized, Washington Post, June 7, 2000, p. A1 both speak of follow-up studies on all women who take the drug, though AP Medical Writer Lauran Neergard, "Abortion Pill May Have Restrictions," Los Angeles Times, June 7, 2000 speaks only of "long-term health tracking of at least some RU/486 recipients" (emphasis added). Whether this means all women will be followed up, with only some being tracked long term, or whether this points to a discrepancy in the reporters' accounts is unclear.
10. Planned Parenthood, What's Up, vol. 4, no. 18 (June 9, 2000), at www.plannedparenthood.org/rchoices/lac/whatsup060900.asp
11. Sheryl Gay Stolberg, "F.D.A. Adds Hurdles in Approval of Abortion Pill," New York Times, June 8, 2000; Lauran Neergard, AP Medical Writer, "Abortion Pill May Have Restrictions," Los Angeles Times, June 7, 2000; Jean Marbella, "FDA fuels abortion pill debate," Baltimore Sun, June 12, 2000.
12. "Suggested FDA restrictions might curtail access to mifepristone," Contraceptive Technology Today, Vol. 21, No. 8 (August 2000), p. 2, quoting Sandra Arnold, Population Council vice president for corporate affairs.
13. FDA Reproductive Drugs Advisory Committee, Transcript, "New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy," July 19, 1996, FDA Technical Center, Gaithersburg, Maryland, p. 81. Transcript by CASET Associates, Ltd, Fairfax, Virginia.
14. FDA Reproductive Drugs Advisory Committee, Transcript, "New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy," July 19, 1996, FDA Technical Center, Gaithersburg, Maryland, p. 81. Transcript by CASET Associates, Ltd, Fairfax, Virginia.
15. FDA Reproductive Drugs Advisory Committee, Transcript, "New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy," July 19, 1996, FDA Technical Center, Gaithersburg, Maryland, p. 135. Transcript by CASET Associates, Ltd, Fairfax, Virginia.
16. FDA Reproductive Drugs Advisory Committee, Transcript, "New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy," July 19, 1996, FDA Technical Center, Gaithersburg, Maryland, p. 136. Transcript by CASET Associates, Ltd, Fairfax, Virginia.
17. FDA Reproductive Drugs Advisory Committee, Transcript, "New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy," July 19, 1996, FDA Technical Center, Gaithersburg, Maryland, p. 320. Transcript by CASET Associates, Ltd, Fairfax, Virginia.
18. FDA Reproductive Drugs Advisory Committee, Transcript, "New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy," July 19, 1996, FDA Technical Center, Gaithersburg, Maryland, p. 322-323. Transcript by CASET Associates, Ltd, Fairfax, Virginia.
19. FDA Reproductive Drugs Advisory Committee, Transcript, "New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy," July 19, 1996, FDA Technical Center, Gaithersburg, Maryland, p. 324. Transcript by CASET Associates, Ltd, Fairfax, Virginia.
20. See NRL Educational Trust Fund factsheet, "RU486, The Abortion Pill: Risks & Dangers," January 2000, NRL Ed Trust Fund, 419 7th Street, NW, Washington DC 20004.
21. Etienne-Emile Baulieu, The "Abortion Pill", (New York: Simon & Schuster, 1990), p. 91.
22. Carole Joffe, "Reactions to Medical Abortion Among Providers of Surgical Abortions," Family Planning Perspectives, Vol. 31, No. 1 (January/February 1999), pp. 35-38.
23. Irving Spitz, et al, "Early Pregnancy Termination with Mifepristone and Misoprostol in the United States," New England Journal of Medicine, Vol. 338, No. 18, pp. 1241-1247.
24. Irving Spitz, et al, "Early Pregnancy Termination with Mifepristone and Misoprostol in the United States," New England Journal of Medicine, Vol. 338, No. 18, pp. 1241-1247.
25. Irving Spitz, et al, "Early Pregnancy Termination with Mifepristone and Misoprostol in the United States," New England Journal of Medicine, Vol. 338, No. 18, pp. 1241-1247.
26. Irving Spitz, et al, "Early Pregnancy Termination with Mifepristone and Misoprostol in the United States," New England Journal of Medicine, Vol. 338, No. 18, pp. 1246.
27. Irving Spitz, et al, "Early Pregnancy Termination with Mifepristone and Misoprostol in the United States," New England Journal of Medicine, Vol. 338, No. 18, pp. 1246.
28. Physician's Desk Reference, 50th edition (Montvale, NJ: Medical Economics Company, 1996), p. 2888.
29. Sheryl Gay Stolberg, "F.D.A. Adds Hurdles in Approval of Abortion Pill," New York Times, June 8, 2000.
30. Jessica Reeves, "RU 486 Arrives, Limping, on American Soil," TIME Daily, www.time.com/time/daily/0,2960,46864,00.html.
31. Lauran Neergard, "Abortion Pill May Have Restrictions," Los Angeles Times, June 7, 2000.
32. Planned Parenthood, What's Up, vol. 4, no. 18 (June 9, 2000), at www.plannedparenthood.org/rchoices/lac/whatsup060900.asp; Lauran Neergard, "Abortion Pill May Have Restrictions," Los Angeles Times, June 7, 2000; "FDA Caves to the Far Right," Washington Feminist FaxNet, June 9, 2000; Editorial,"Abortion-pill politics," Lexington Courier-Journal, June 16, 2000.
33. Marc Kauffman "Abortion Drup Proposal Criticized, Washington Post, June 7, 2000, p. A1.
34. Jean Marbella, "FDA fuels abortion pill debate," Baltimore Sun, June 12, 2000.
35. National Coalition of Abortion Providers, Release, "RU-486: A Welcome Option, But Not A Panacea," June 30, 1999. NCAP is, according to the release, "an organization representing approximately 200 independent abortion providers.".