Less than two months after the death of a San Francisco-area teen who took RU486, several members of Congress, led by Rep. Roscoe Bartlett (R-Md.), Rep. Jim DeMint (R-SC), and Sen.
Sam Brownback (R-Ks.), have introduced bills to suspend the Food and Drug Administration's approval of the abortion bill and investigate the process by which the drug was approved during the Clinton Administration.
The "RU-486 Suspension and Review Act of 2003" (H.R. 3453) was introduced in the House on November 6, by Bartlett and DeMint. As of December 6, it had 68 additional House sponsors. The measure would withdraw the drug's approval, and directs the Comptroller General to review whether the 2000 approval was done in accordance with regulations of the Federal Food, Drug, and Cosmetic Act which govern such approvals.
A very similar bill (S. 1930) was introduced in the Senate by Brownback and seven co-sponsors on November 21.
National Right to Life has endorsed the bill.
A number of questions have been raised about the propriety of the Clinton Administration approval of RU486. Many believe the original Food and Drug Administration (FDA) panel reviewing the application, stacked with abortion supporters, cut too many regulatory corners and ignored legitimate safety concerns.
In its "Finding" section, the bill declares, "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 [the prostaglandin] misoprostol to chemically induce abortion, has caused a significant number of deaths, near deaths, and adverse reactions."
Some information about the tribulations and tragedies associated with the use of RU486 had trickled out in reports issued by Danco, the pill's U.S. sponsor and distributor. However, the national media did not pay much attention to the pill's medical problems until the terrible details surrounding the death of 18-year-old Holly Patterson became known in September.
Holly received RU486 from her local Planned Parenthood on September 10, and died a week later at the Pleasanton Valley Medical Center from a massive septic infection brought on by retained fetal tissue, her father told the San Francisco Chronicle (9/20/03). Her parents said they never even knew she was pregnant until they were called to the emergency room on the day Holly died.
The most visible, obvious symptoms associated with infection, or with ectopic or tubal pregnancy, are hard to distinguish from the ordinary side effects that go along with chemical abortion. Women in all three situations are likely to experience significant bleeding, pain, and cramping. Some women in these circumstances have gastrointestinal manifestations such as nausea, vomiting, or diarrhea.
Four days after she took the RU486, Holly experience such severe bleeding and cramping, according to the Chronicle, that her boyfriend rushed her to the emergency room at the Valley Care Medical Center. The emergency room physicians who saw Holly gave her painkillers and released her, Holly's father told the San Jose Mercury News (9/20/03).
Of the three North American women known to have died following the use of RU486, two died of infections and a third from an untreated ectopic pregnancy. Other women have nearly died. All told, at least 264 women who took RU486 in the first three years it's been on the American market have suffered from what Danco describes as "adverse reactions." (According to the San Francisco Chronicle, Danco's Richard Hausknecht puts the number of adverse events reported by the company to the FDA at about 400.)
In a lengthy public letter released to the press and dated November 6, Holly's parents endorsed the bill. "Holly depended on the safety of the FDA approved pill administered by Planned Parenthood," Monty and Helen Patterson wrote. "The FDA has failed to carry out its mission.
"As parents, we cannot allow our beautiful Holly's horrible death to be in vain. RU 486 has caused serious injury and has been implicated in the deaths of other young women. Now it has killed our daughter."
The RU486 abortion drug, the Pattersons wrote, "should not be either a Pro Life or Pro Choice issue," adding that government officials "should now have enough evidence to pull this drug from the market." Asking that the bill be known as "Holly's Law," the Pattersons say their daughter was "yet another victim who was subject to an unacceptable risk to a drug that has a significant failure rate." 1
The bill gives the Comptroller General six months to review the RU486 approval process and submit a report to Congress and the Secretary of Health and Human Services that details the Comptroller General's findings.
If the review were to find that all approval procedures were appropriately followed, the suspension of the drug would be withdrawn. Otherwise, it appears, the suspension would stand.
FOOTNOTE
1. Clinical trials showed the RU486/misoprostol combination failed to work 8% of the time within the given 49-day limit.