Some government decisions are legitimately political; others are not. For example, politics should never play a role in the decision to approve or disapprove drugs for human consumption. By law, such decisions are supposed to be made solely on the basis of medical evidence that determines first whether the drugs are safe, and second whether they are effective.
That's no longer the case. The integrity of the nation's drug-approval process has been compromised by the Bush administration for crass political purposes, another in a long line of cases in which it has ignored or distorted scientific evidence.
The professional staff of the U.S. Food and Drug Administration, along with two outside panels of medical experts, recently examined more than 40 scientific studies and recommended that the Plan B "morning-after" emergency oral contraceptive be approved for over-the-counter sale. Testing and research — as well as years of experience with Plan B as a prescription drug — had established that its primary side effect was temporary nausea, and that it prevented pregnancies 89 percent of the time when used within 72 hours of sex.
However, anti-abortion groups such as the U.S. Conference of Catholic Bishops and Concerned Women for America have lobbied against over-the-counter sales of the drug, in part because it can sometimes prevent a fertilized egg from attaching to the womb, which they consider a form of abortion. In the late '90s, they had also opposed approval of the drug for prescription use, calling it a "post-pregnancy abortion pill."
This year, 49 Republican members of Congress also wrote President Bush urging the FDA to block sale of the drug over the counter, arguing that its availability might make teenagers more promiscuous. "The morning-after pill is a pedophile's best friend," Wendy Wright, senior policy director for Concerned Women of America, told one reporter. "Morning-after pill proponents treat women like sex machines."
There is no evidence whatsoever that the availability of a morning-after pill changes adolescent behavior; in fact, repeated studies of the issue have come to the opposite conclusion. Given that evidence and the fact that the FDA rarely if ever overturns the recommendations of its staff and expert panels, approval of Plan B as an over-the-counter drug should have been routine.
Last month, the acting director of the FDA's Center for Drug Evaluation and Research overrode the recommendations of the Nonprescription Drugs Advisory Committee, the Advisory Committee for Reproductive Health Drugs and his own staff reviewers. According to Steven Galson, insufficient research had been done about the drug's impact among girls aged 11-14 to guarantee they would not become more promiscuous if the drug was available.
That is an excuse, not a reason. If little research has been done about the drug's impact on girls in that specific age group, it's because so few of them are even aware of the drug's existence, let alone its use.
Besides, if a drug's supposed impact on social behavior is now a legitimate cause for concern, a lot of previous FDA decisions ought to be reconsidered. Maybe the FDA should revoke its approval of the Pill, the birth control device that many conservatives blame for inspiring the sexual revolution and women's liberation. Perhaps it should also restrict prescriptions of Viagra, Cialis and other male-potency drugs to married men, lest they fall into the hands of unmarried men who might use those drugs for, shall we say, unapproved purposes.
Or better yet, maybe such drugs should be barred from men altogether and be issued only to their wives. That way, the women could dole out the pills as required and ensure that their chemically enhanced husbands don't start chasing 22-year-old blondes. That could do wonders in reducing the divorce rate, don't you think?
I can see the law now: The Middle-Aged Male Fidelity Control Act. Wonder how many congressmen we could sign up to support that one?
Jay Bookman is deputy editorial page editor.
© 2004 The Atlanta Journal-Constitution
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