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The Patient Health and Safety Protection Act: H.R. 486 5/20/2003
By Michael Schwartz Protecting women from needless risks should be a consensus position H.R. 486, the "RU-486 Patient Health and Safety Protection Act," was introduced this year at the beginning of the 108th Congress by Rep. David Vitter (R-Louisiana). It is virtually identical to legislation he sponsored in the 107th Congress and Rep. Tom Coburn (R-Oklahoma) sponsored in the closing days of the 106th Congress. These bills followed the Food and Drug Administration (FDA) approval of the abortion pill RU-486 (mifeprestone) on September 28, 2000.
H.R. 486 does not address whether RU-486 should have been approved.1 This
legislation's sole focus is to correct the disregard the FDA showed for the lives and health of women to whom this drug will be given. This is an issue on which supporters of abortion should be just as concerned as are those who support the right to life.
H.R. 486 limits the right to prescribe RU-486 only to licensed physicians who meet five qualifications. The FDA itself proposed these five qualifications2 in the summer of 2000 because of the anticipated high incidence of serious complications. But under intense political pressure, the FDA dropped them from the approval protocol.
A Matter of Law
If passed, H.R. 486 would make it a matter of law that physicians who prescribe RU-486 must have:
- qualifications to handle complications resulting from an incomplete abortion or ectopic pregnancy;
- training to perform surgical abortions;
- certification for ultrasound dating of pregnancy and detecting ectopic pregnancy;
- completed an approved training program on the use of RU-486;
- admitting privileges at a nearby hospital.
The current FDA rules allow anyone with a medical license - a psychiatrist, a podiatrist, a pathologist - or anyone under the supervision of a physician - to prescribe this dangerous drug and simply refer patients to the nearest emergency room in the event of complications. This puts the woman at risk of long delays before receiving emergency treatment. Physicians who prescribe and administer RU-486 should be ready and able to treat potential complications.
The five qualifications outlined in H.R. 486 are necessary to protect women from foreseeable life-threatening complications. It is undeniable that RU-486 is a dangerous drug that can kill or seriously injure women, even when it is used according to instructions. Danco, Laboratories, distributor of RU-486, sent a warning letter3 to health care providers admitting several cases of severe complications, including:
- the September 2001 death of a Tennessee woman from an undiagnosed, ruptured ectopic pregnancy;
- a heart attack in a 21-year-old woman;
- two cases of near-fatal infections.
Complications posed by RU-486 include:
- Incomplete abortion, a serious and potentially life-threatening complication of RU-486 that requires surgery.4 Other, even more serious complications such as severe blood loss occur with less frequency.
- Ectopic pregnancy: Ultrasound diagnosis is the most reliable way of dating and locating a pregnancy.
- RU-486 does not kill an embryo that has not implanted in the uterus - an ectopic, or tubal, pregnancy. If this type of pregnancy remains undetected, it can mean that her fallopian tube will rupture and the woman could die.
- Accurately dating the pregnancy is critical. The FDA authorizes the use of RU-486 only through 7 weeks of pregnancy, when the rate of incomplete abortions is 8 percent. At 9 weeks, this rate increases to 23 percent.5
- For dating a pregnancy, the only alternative to ultrasound is the patient's own recall and a physical exam - an unreliable basis for life-and-death decisions.
Summary
Danco is responsible for limiting distribution of RU-486 only to doctors who use it according to the FDA's instructions. Since this post-approval requirement already exists, it is important to the best interest of patients to limit distribution of the drug only to physicians who are trained in its use and who are capable of handling the foreseeable medical complications.
CWA believes that the approval of RU-486 by the FDA was unlawful and that this drug should be removed from the market. Abortion advocates may be less concerned about safety in the drug-approval process and desire to keep RU-486 on the market at all costs. But, surely, they ought to be able to agree that, if it is on the market, it should not be distributed in a way that places the lives of women who take it in increased jeopardy. Protecting women from needless risks should be a consensus position.
Michael Schwartz is Vice President for Government Relations for Concerned Women for America.
End Notes
- The ultimate goal of Concerned Women for America is the removal of RU-486 from the market. We filed a legal document known as a Citizen Petition with the FDA on August 20, 2002, which outlines significant problems with this drug's approval process. Not only does it kill the unborn baby, which is unacceptable, it also places the mother at serious medical risk. To view the Citizen Petition, click here, or call 1-800-458-8797.
- Citizen Petition, Section G, page 49 and following.
- Letter from Danco to providers of RU-486, April 19, 2002, available at http://www.fda.gov/medwatch/SAFETY/2002/mifepres_deardoc.pdf.
- An incomplete abortion occurs when a part of the baby remains in the uterus. Because this will likely cause an infection and endanger the mother's life, a procedure similar to that used in a miscarriage must be performed to remove the uterus' contents. In an unknown number of cases, RU-486 fails to kill the developing baby. At this point, the mother must choose to have a surgical abortion or to carry the baby to term.
- FDA, "Medical Officer Review of Amendments 024 and 033: Final Reports for the U.S. Clinical Trials Inducing Abortion up to 63 Days Gestation Age and Complete Responses Regarding Distribution System and Phase 4 Commitments," at 11 (Table 1) (reporting a failure rate of 8% for pregnancies less than or equal to 49 days'duration) ("Medical Officer's Review").
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