The FDA and the Abortion Pill
KABBANY, JENNIFER
The FDA and the Abortion Pill The approval of RU-486 has become a study in political malpractice. BY JENNIFER KABBANY AT HIS RECENT Senate confirmation hearing for secretary of Health and Human...
...The threat to public health posed by the shipment of contaminated medicines, and other violations...
...The senators objected to the FDA's refusal to reveal where the drug would be made...
...But speed, rather than safety, seems to have governed the process of approving the abortion pill...
...I do not believe the FDA's position is acceptable for a public health agency...
...company Searle, cytotec has been legal in the United States for 13 years to combat stomach ulcers...
...BY JENNIFER KABBANY AT HIS RECENT Senate confirmation hearing for secretary of Health and Human Services, Wisconsin governor Tommy Thompson hinted that the clinton administration's approval of the abortion pill might be revisited...
...An article in the January/February issue of Mother Jones magazine based on documents released pursuant to a Freedom of Information Act request states that in the last three years, the FDA "has received reports of 30 cases of uterine rupture in connection with the use of cytotec...
...But that argument fell apart once the Washington Post broke the news on October 12 that America's supply of RU-486 would be made by Hua Lian Pharmaceutical in Shanghai, China...
...But because of its possible side-effects, cytotec carries a "Black Box" warning...
...Last September, the Food and Drug Administration approved the drug mifepristone, commonly known as RU-486, for use in the United States...
...By that time, damage had already been done...
...In fact, a week before RU-486 was approved last summer, nine senators wrote to HHS secretary Donna Sha-lala asking her to delay a decision until more was known about the drug's manufacturer...
...Guidelines specify that to be considered on the fast track, a drug must "provide meaningful therapeutic benefits to patients over existing treatments" to combat a "serious or life-threatening illness...
...This explains that the drug, if taken by a pregnant woman, can induce labor and cause the uterus to rupture, resulting in severe bleeding, hospitalization, surgery, infertility, or death...
...Virginia Republican Tom Bliley, chairman of the House Commerce Committee, wrote to FDA commissioner Jane Henney on November 1 chastising the agency for disregarding the manufacturer's history...
...As for Thompson's boss, George W. Bush said in the October 3 presidential debate: "Once the decision's made, it's been made . . . unless it's proven to be unsafe to women...
...Apparently eager to get RU-486 to market before the Clinton administration left office, the FDA reviewed it on a "fast-track" timetable intended to hasten the approval of treatments for diseases like cancer and AIDS...
...hospitals told obstetricians and gynecologists to stop using cytotec for off-label purposes, according to a survey by the University HealthSystem Consortium...
...In July 2000 in Cincinnati, the FDA confiscated a shipment from Hua Lian's factory "for false or misleading labeling and misbranding...
...Around the same time, questions were raised about Hua Lian Pharmaceutical's repeated failure over the course of ten years to meet FDA standards...
...In August 2000, just before the FDA approved RU-486, Searle sent a "Dear Doctor" letter to 200,000 health care providers reminding them that Searle has not studied, and the FDA has not approved, cytotec's use to induce abortions...
...He added, "The administration rushed a drug through that will take lives instead of save them...
...The FDA declines to comment on the investigation or Thompson's suggestion that the approval of RU-486 might be reexamined...
...The day RU-486 was approved, Republican senator Tim Hutchinson noted that the "FDA review time was a mere six months, . . . even faster than the average time for 'fast-tracked' drugs...
...Two days after the mother takes a dose of mifepristone, to kill her embryo, she takes cytotec, which causes uterine contractions to expel it from her body...
...But Thompson, responding to questions from senator Hillary Rodham Clinton, said, "It's a new drug, it's contentious and controversial, and the safety of it, as I understand, is in question...
...FDA officials said their reason for withholding the identity of the manufacturer was concern for the company's safety from antiabortion groups...
...After the letter was circulated, nearly half of U.S...
...Made by the U.S...
...is a pattern of conduct that reflects on the honesty and integrity of the management of [Hua Lian Pharmaceutical]," Bliley wrote...
...Doubt was also being cast, meanwhile, on the safety of cytotec, the second component of the "abortion pill"—a misnomer for a two-drug abortion-inducing treatment usually spread out over three days...
...As recently as 1998, the California Health Department found not only that the company had illeJennifer Kabbany is an editorial assistant at THE WEEKLY STANDARD...
...Now chaired by pro-life Republican Billy Tauzin, the House Energy and Commerce Committee is investigating...
...gally sent a shipment of drugs to America, but that it contained the unapproved drug fluorouracil...
Vol. 6 • February 2001 • No. 20
