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.

In the RU-486 Suspension and Review Act, Congress finds that mifepristone used with misoprostol for chemically induced abortion “has caused a significant number of deaths, near deaths, and adverse reactions.” The Act would withdraw the approval of RU-486 and determine that misoprostol “shall be considered misbranded” if the drug’s label says the drug may be used by itself or in conjunction with another drug for the medical termination of pregnancy. The Comptroller General of the United States shall review the process by which RU-486 was approved. If it is determined the process was in accord with regulations, then the suspension of approval of the drug would no longer have effect.

The RU-486 Suspension and Review Act is 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.

In a March 29, 2006 press conference on Capitol Hill in support of Holly’ Law, Deirdre A. McQuade, Director of Planning and Information at the Bishops’ Secretariat for Pro-Life Activities, stated, “It is time to take a close second look at this potent, risky and poorly scrutinized abortion drug. Women deserve better from their federal government. We urge Congress to bring this measure to a vote at the earliest possible opportunity.”

For more information on RU-486  see:

House: On March 3, 2005, Rep. Roscoe Bartlett (R-MD) introduced the RU-486 Suspension and Review Act of 2005 (H.R. 1079). The bill had 86 cosponsors and was referred to the Subcommittee on Health of the House Energy and Commerce Committee. No further action was taken. Rep. Bartlett’s introductory remarks can be found in the Congressional Record, March 3, 2005, E357.

On May 17, 2006, the Criminal Justice, Drug Policy and Human Resources Subcommittee of the House Committee on Government Reform held a hearing titled, “RU-486: Demonstrating a Low Standard for Women’s Health.” Chairman Mark Souder (R-IN) presided. Monty Patterson, father of Holly Patterson, was one of six witnesses who testified.

Senate: On March 3, 2005, Sen. Jim DeMint (R-SC) introduced the companion bill (S. 511). The measure had 12 cosponsors and was referred to the Committee on Health, Education, Labor, and Pensions. No further action was taken. For Sen. DeMint’s introductory remarks see: