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The Door Left Open

Kenneth Whitehead

A federal agency rejected over-the-counter sales of the “morning-after” pill—at least for now.

Jun 2004 (CWR) - In an unusual turn of events in the current culture wars, the US Food and Drug Administration (FDA) on May 6 rejected the proposal of the Barr Laboratories company for the sale, over the counter and without a prescription, of the company’s “morning-after pill”—or, as it has increasingly come to be called, “emergency contraception.”

The pill in question, marketed as Plan B, is designed to be used in case of a lack or failure of regular contraception (ordinary contraceptives being accepted as Plan A). It consists of very high doses of some of the same hormones used in regular contraceptive pills. If taken within 72 hours after intercourse, these doses can prevent ovulation; if fertilization has already occurred, the drugs prevent the implantation of the fertilized ovum in the uterine wall, causing a spontaneous abortion.

The FDA approved the sale by prescription of Plan B in 1999, but that step never satisfied the makers and supporters of this powerful drug. There have been widespread and unremitting efforts to make this morning-after pill available without medical supervision. In some locales these efforts have succeeded, and Plan B can now be legally obtained without a prescription in five American states. FDA approval, however, would have obviated the need to go on lobbying in state after state to secure the unrestricted sales. Hence Barr Laboratories applied for blanket approval of a prescriptionless Plan B.

At a hearing last December, an FDA advisory panel voted 23 to 4 to approve the pharmaceutical company’s application. Usually approval by an advisory panel is tantamount to approval by the FDA itself. Nearly all the mainstream medical associations and societies had also signaled their approval.

In this case, however, as CWR reported in its February issue, there was a strong and effective opposition mounted at the December FDA hearing by such pro-life and pro-family organizations as the Family Research Council and Concerned Women for America. The US Catholic bishops’ conference also offered cogent testimony against the unrestricted sale of morning-after pills. Strong substantive arguments were brought forward casting doubt on the wisdom of allowing unsupervised access by girls of any age to such powerful drugs. Forty-four Congressmen wrote to the FDA urging that so-called emergency contraception should not be “as accessible to our nation’s teenage daughters as aspirin or hair spray.”

As a result of this opposition, the FDA postponed its decision from February until May, and it did so in the face of continuing pressures from the regular medical associations, as well as from Planned Parenthood and its allies. No fewer than 76 US Representatives joined Democratic Congressman Carolyn B. Maloney of New York in warning the FDA that “politics” should not be allowed to “trump science.” At the same time, however, 49 Republican Congressmen signed a letter which Florida Republican David J. Weldon, a physician, had sent directly to President Bush, urging the Administration to side with America’s teens and their health.

A TEST FOR THE WHITE HOUSE

All along there was some question of whether the Bush Administration would allow its professed pro-life principles to figure in the decision (CWR, February, 2004). Responsibility for the decision at that point devolved upon FDA Commissioner Mark B. McClellan, the brother of President Bush’s principal White House spokesman, Scott McClellan. But then, while the decision was still pending, Mark McClellan was transferred to the Department of Health and Human Services; his replacement as FDA Commissioner has not yet been named. Hence the decision, when it came on May 6, was taken at a much lower level in the FDA hierarchy: by Dr. Steven Galson, acting director of the FDA’s Center for Drug Education and Research.

Dr. Galson rejected the application of Barr Laboratories on the fairly narrow grounds that the company had not provided sufficient information about how teenagers would be able to use the morning-after pill properly and safely without medical supervision. The door was left open, however, for later possible approval, if the company could produce research showing it was indeed safe or devise a plan for keeping it on a prescription basis for girls younger than sixteen. Dr. Galson expressly denied that his decision was made to please social conservatives, or that the White House had any input. Thus, although one can only applaud the FDA decision, made in the face of terrific contrary pressures, the decision hardly represents a principled pro-life victory in the culture wars.

Both the decision itself, and most of the arguments offered in favor of it, were based almost entirely on questions about how the approval of Plan B would affect the health of younger women. While this is certainly a valid concern, the arguments that were advanced on that score did not require any recognition of the abortifacient properties of this so-called “emergency contraception”—the fact that it can cause very early abortions by preventing the implantation of an embryo or blastocyst. This fact seems not to have figured at all in the FDA decision. Indeed, in light of the agency’s silence on the question, it would seem that the FDA officially now accepts the current mischaracterization popularized by the medical and pharmaceutical establishment, to the effect that “emergency contraception” is merely “contraception”—in spite of the solid contrary proofs offered by the Catholic bishops, among others.

Acceptance of the very term “emergency contraception” means that its purveyors are able to argue, plausibly, that the use of morning-after pills will cut down on abortions—rather than actually adding to the number. It allows them to ask why pro-lifers are opposing access to Plan B.

The “pro-choice” forces in today’s culture wars clearly understand how important the acceptance of Plan B is to their cause. The same cannot be said of some pro-life groups, such as the National Right to Life Committee—which took “no position” on “emergency contraception,” thus conceding without argument that it is nothing more than “contraception.”

If deliberate abortion can be accepted even in the very early stages of pregnancy—provided that there is a suitable “cover” for the process, and a different name—then the advocates of unrestricted legal abortion have effectively won their argument. Clearly the advocates of abortion understand that reality. As soon as the FDA rendered its decision—which might actually have meant nothing more than delaying eventual approval—Democratic Rep. Louis M. Slaughter of New York gathered a dozen other members of Congress to a press conference at which they demanded the resignation not only of Dr. Galson, who made the decision for the FDA, but his superior, acting FDA Commission Lester M. Crawford, as well. The legislators, using the well-rehearsed rhetoric they had learned during the FDA hearings, charged that “politics” had indeed trumped “science” in this decision. More than 40 other members of Congress wrote directly to acting Commissioner Crawford, insisting that the decision had to be reversed; one—Democratic Rep. Carolyn Maloney of New York—announced her intention to introduce legislation that would reverse the FDA decision. (Thus, to rectify a case in which politics had allegedly trumped science, a political body would overturn a scientist’s technical decision.)

The issue of “emergency contraception” in the form of the “morning-after pills” has hardly been settled by the FDA’s action. Proponents of open sales for the drug seem determined to see it made available on pharmacy shelves as readily as nail polish or hand lotion. The proven lethal character of this drug no longer even figures in the debate.

And while pro-life advocates are now discouraged from introducing moral arguments into the debate, proponents of the “morning-after” pill feel no compunction about invoking moral language for their own purposes. Thus the president of the American College of Obstetricians and Gynecologists issued a statement following the FDA decision deploring “the failure to approve over-the-counter status for Plan B, despite the nearly unanimous recommendation of its own advisory panels.” He labeled the FDA decision “morally repugnant—a tragedy for American women, and a dark stain on the reputation of…the FDA.” —Kenneth D. Whitehead

 

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