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When pressed to explain, however, why a federal agency would break the law and endanger women's health at the behest of a tiny startup company, Mifeprex's critics can cite nothing more than the ideology, in Wright's words, of "some people in the FDA." They accuse the drug's defenders of now turning an equally blind eye to the dangers signaled by Holly's death. "The groups that are making excuses now are the same groups that pressured the White House," Hart says.
The response to these accusations from the Population Council, Danco, Planned Parenthood, and other pro-choice organizations is uniform and to the point: "The FDA's review process was always very thorough and very complete. No corners were cut," says Danco spokeswoman O'Neill.
The FDA, likewise, defends its process. "The agency carefully reviewed the new-drug application for mifepristone according to our usual procedural standards and timelines. A decision to approve the application was not rushed," says an FDA spokeswoman, who points out that Danco's application took more than four years to approve. Subpart H, she adds, was employed solely to put additional restrictions on distribution of Mifeprex. "It wasn't to fast-track the drug," the spokeswoman says.
Concerned Women for America describes its mission as to "protect and promote Biblical values among all citizens -- first through prayer, then education, and finally by influencing our society." The group, if you read its Web site, is also concerned about secular humanism, sexual promiscuity, Norplant, child abuse, drug abuse, genetic engineering, the erosion of traditional gender roles, and the "homosexual agenda."
It was also Concerned Women that matched up Monty and Helen Patterson with the authors of Holly's Law. The group sent flowers to Holly's funeral, Wright says, and when Monty Patterson called to say thanks, they offered him information on the hazards of Mifeprex. "Monty Patterson is very interested in any information he can get his hands on because this is what caused his daughter's death," Wright says. "We were the ones doing all the research."
Soon after Holly's death made headlines, DeMint's office contacted the CWA to say the congressman was interested in drafting a bill to suspend RU-486. "We were like, 'Great! That's just what we've been asking for for over a year,'" Wright recalls. "What caught their attention was Holly, so at that point it was me who told them how to get in contact with the parents."
DeMint is a Republican staunchly opposed to abortion. He has written legislation designed to encourage adoption as an alternative, and previously cosponsored Vitter's RU-486 Patient Health and Safety Act. "He has a 100 percent pro-life voting record and he believes the FDA's mission is to protect the health and safety of Americans, not to facilitate the taking of life," DeMint spokesman Hart says. The congressman, he adds, would prefer to suspend RU-486 from the market, not simply place further limits on its distribution. "There were a lot of congressmembers who were discussing doing a bill of this nature," Hart says. "People concluded that ours was the one that was most measured and reasonable and had the greatest chance of enactment."
Having a recent, tragic case in point helped the cause immensely. "Holly Patterson's death has galvanized an effort that was going on for quite a while to encourage the FDA to take a second look at RU-486," Hart says. "It's unfortunate that it took a very public tragedy for that to happen, but it has focused attention on the issue."
Wright, too, acknowledges the public-relations advantage Holly's name and face has given her cause. "We had filed all this information with the FDA in August of 2002, and we couldn't get hardly any attention at all to all these very serious things we'd found," she says. "Holly personalized that. People can see this picture of this beautiful young girl who had everything going for her and think, 'This could be my sister, my daughter.' It's really frightened and saddened people."
The offer to use Holly's name, Hart says, came from Monty and Helen Patterson. In the weeks immediately following her death, the couple had appeared on Buchanan & Press, The Today Show, and the CBS Evening News. In those interviews they were careful to stress that they were neither for nor against abortion rights, but rather "pro-Holly."
But in their public letter, which was drafted in support of DeMint's legislation, the Pattersons come out strongly against the continued marketing of Mifeprex. "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," they write. "We have learned that the initial trials were rushed and the drug was lumped in and approved with drugs designed for life-threatening illnesses such as cancer and AIDS. ... The FDA has failed to carry out its mission to ensuring RU-486 is a safe and effective abortion-drug regimen."
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