RU-486 Suspension and Review Act: Holly’s Law

 

Introduction: On September 28, 2000, the Federal Food and Drug Administration (FDA) approved the use of mifepristone (brand names Mifeprex and Early Option, commonly called RU-486) for the termination of early pregnancies (49 days or less, counting from beginning of last menstrual period). According to the FDA’s approved regimen, the woman takes three 200 mg pills by mouth, followed two days later by two 200 mg pills of misoprostol (brand name Cytotec). After 14 days the woman returns for a follow-up visit to determine if the pregnancy has been terminated.

RU-486 is an artificial steroid that blocks progesterone, a hormone needed to continue a pregnancy. Taken alone, RU-486 causes a complete abortion only about 60% of the time. Misoprostol is a prostaglandin that causes uterine contractions and thereby increases the effectiveness of RU-486.

In its approval of RU-486, the FDA employed a special process normally reserved for the expedited approval of life-saving drugs for such diseases as AIDS or cancer. Also, the manufacturer of misoprostol rejects the use of the drug to induce abortion. Misoprostol is an anti-ulcer drug.

The RU-486 Suspension and Review Act called for the suspension of the FDA approval of RU- 486 and a review of the process by which the approval was made.

This measure was also known as Holly's Law in memory of Holly Patterson, an 18-year-old California woman who died after taking RU-486 at a Planned Parenthood clinic. The Alameda County Coroner's report indicated that Patterson's death was due to septic shock following an incomplete RU-486 chemically induced abortion. Monty and Helen Patterson, Holly's parents, in an open letter, urged passage of the bill. To date, 10 known deaths have resulted from taking RU-486. More than 950 adverse event cases have been associated with the drug’s use. In “Stop the bloodshed and pass Holly’s law,” Washington Times (Feb. 5, 2006), Susan E. Wills reported that FDA adverse event reports “chronicle fatalities, near-fatalities, hospitalizations of up to a week, heart attacks, ruptured ectopic pregnancies, failed and incomplete abortions, serious-to-lethal infections, women who lost consciousness at home and required sutures to close head wounds, and hemorrhaging so extreme some women required replacement of half to all their blood volume.” Ms. Wills also cited a New England Journal of Medicine study that calculates the risk of death from infection following RU-486 abortions as ten times the mortality rate from all causes in surgical abortions in early pregnancy.

For more information on the abortion drug RU-486, see: www.ru486facts.org.

House: On January 4, 2007, Rep. Roscoe Bartlett (R-MD) introduced the RU-486 Suspension and Review Act of 2007 (H.R. 63). The bill had 46 cosponsors and was referred to the Energy and Commerce Committee, Subcommittee on Health. No further action was taken.

H.R. 63 began with a statement of Findings: “The Congress finds that the use of the drug mifepristone (marketed as Mifeprex, and commonly known as RU-486) in conjunction with the off-label use of misoprostol to chemically induce abortion has caused a significant number of deaths, near deaths, and adverse reactions.” Fourteen days after enactment of the bill, the FDA’s approval of RU-486 will be withdrawn and the drug misoprostol “shall be considered misbranded” if the drug is labeled, by itself or in conjunction with another drug, for use in medical termination of a pregnancy. The Comptroller General of the United States shall review the process by which the FDA approved RU-486 and determine whether the process was in accord with section 505 of the Federal Food, Drug, and Cosmetic Act. This review shall be completed within 180 days and a report submitted to Congress and the Secretary of HHS. If the report determines that the approval process was in accord with section 505, then the Secretary of HHS shall publish this result in the Federal Register. Thirty days after publication, the suspension of RU-486 will no longer have effect.