Background: Previously introduced in 2003, this legislation would suspend the approval of the drug mifepristone (marketed as Mifeprex and commonly known as RU-486) while the Comptroller General of the United States reviews the process by which the FDA approved the drug. RU-486 was approved under an FDA protocol reserved for drugs intended to treat life-threatening illnesses. The FDA included a protocol for administering RU-486 in its approval of the drug.
The bill requires that the Comptroller General report the findings to Congress and the Secretary of Health and Human Services. If it was determined that the drug's approval was in accordance with the Federal Food, Drug and Cosmetic Act, the approval would be reinstated after 30 days. This bill 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. Planned Parenthood's standard procedure for administration of RU-486 differs from the FDA-approved protocol. The Alameda County (CA) Coroner's initial report indicates that Patterson's death was due to septic shock following an incomplete drug-induced abortion. Monty and Helen Patterson, Holly's parents, submitted an open letter to the media, urging passage of the RU-486 Suspension and Review Act.
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 has 77 cosponsors and was referred to the Subcommittee on Health of the House Energy and Commerce Committee. For Rep. Bartlett’s introductory remarks on the measure see: frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2005_record&page=E357& position=all.
Senate: On March 3, 2005, Sen. Jim DeMint (R-SC) introduced the companion bill (S. 511). The measure has 11 cosponsors and was referred to the Committee on Health, Education, Labor, and Pensions. For Sen. DeMint’s introductory remarks see: frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2005_record&page=S2020&position=all.