To: Lane3 who wrote (78990 ) 11/12/2003 9:31:28 AM From: epicure Read Replies (2) | Respond to of 82486 Did you know about this: National Politics & Policy | Lawmakers Introduce Legislation That Would Suspend FDA Approval of Mifepristone for Use in Medical Abortion [Nov 07, 2003] As expected, Rep. Jim DeMint (R-S.C.) on Thursday introduced legislation that would suspend FDA approval of mifepristone for use in medical abortions pending an audit by the General Accounting Office, Reuters Health reports (Rovner, Reuters Health, 11/6). The bill, called the "RU-486 Suspension and Review Act of 2003," would immediately suspend mifepristone's FDA approval and call for the GAO to conduct an independent review of the FDA's approval process of the drug. Some lawmakers have renewed their attempts to stop the U.S. sale of mifepristone after California teenager Holly Patterson in September died from complications related to a medical abortion. The Alameda County, Calif., Coroner's Office on Oct. 31 released a preliminary autopsy report that concluded that 18-year-old Patterson died of septic shock "due to endomyometritis (inflammation) due to therapeutic, drug-induced abortion." The preliminary report does not say that endomyometritis was directly caused by Patterson taking mifepristone or misoprostol -- which is used in conjunction with mifepristone for medical abortion -- and does not say whether the drugs were properly administered. The coroner's office is expected to release a final report later this month describing what part mifepristone played in Patterson's death. DeMint said the measure would also be known as "Holly's Law" in honor of Patterson (Kaiser Daily Reproductive Health Report, 11/6). Monty and Helen Patterson, Holly's parents, at a news conference on Thursday called for others in similar situations to engage in "open family dialogue about unintended pregnancy," the Contra Costa Times reports (English, Contra Costa Times, 11/7). The measure, which is co-sponsored by 56 members of the House, will be introduced in the Senate by Sen. Sam Brownback (R-Kan.), according to Reuters Health. Reaction DeMint said that mifepristone "is clearly a dangerous drug," adding that the legislation "is about the health of women, about the protection of their lives." Rep. Chris Smith (R-N.J.) said that the FDA used a fast-track approval process for the drug, which is meant for treatments of "life-threatening ailments," according to Reuters Health. He added, "The last time I checked, pregnancy was not a disease" (Reuters Health, 11/7). Planned Parenthood Federation of America Vice President of Medical Affairs Vanessa Cullins said that since receiving FDA approval, mifepristone has been used "safely and effectively" by more than 200,000 women in the United States. She added that the drug is "an established and promising part of medicine." Cullins said, "This politically motivated legislation is a classic case of ideology versus legitimate medical science," adding, "No drug should be singled out for political purposes" (PPFA release, 11/6).