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© St. Petersburg Times, published February 24, 2002
The nicotine patch? No problem. Minoxidil for hair loss? Sure. Ibuprofen? Accepted. All these medications and dozens more have been approved for over-the-counter use. It is time for the Food and Drug Administration to add one more to the list: emergency contraceptives.
More than a year ago a coalition of 76 health and public policy organizations petitioned the FDA to alter the status of emergency contraceptives from prescription to over the counter. But so far, no final word has come. According to FDA spokesperson Susan Cruzan, the petition is still under review and there is no telling when a response will be forthcoming.
Emergency contraception, or morning-after birth control, is a valuable tool for women in their effort to take charge of their reproductive lives. So what's the holdup in approving an over-the-counter version? Could abortion politics be getting in the way?
Emergency contraception is essentially a concentrated dose of birth control pills. If taken within 72 hours of intercourse, the pills can prevent pregnancy 75 percent of the time and that rate sharply rises the sooner the pills are taken following sex. Their use is widely considered to be safe, so much so that the American Medical Association and the American College of Obstetricians and Gynecologists support over-the-counter access.
The kinds of hurdles that would reasonably prevent a drug from being converted to over-the-counter use just don't apply to emergency contraceptives. The pills are safe for almost every woman. The only real side effect is nausea. And their use is not complicated: two pills have to be taken 12 hours apart.
Then there are the upside benefits. On average there are nearly 3-million unwanted pregnancies annually. Readily available emergency contraception could cut this number in half. For opponents to abortion, emergency contraception could be a lifesaver -- literally.
That is what is so dang confusing about the political opposition to this idea. Some abortion opponents see the pills as a form of abortion. Why? Because although the pills most often work to delay or prevent ovulation (no fertilized egg, no person), sometimes they prevent implantation of the egg on the uterine wall.
"Anti-implantation drugs starve the new life to death," wrote Teresa Wagner, special counsel of the Family Research Council, in a paper opposing emergency contraception.
Of course, the "life" to be starved is a dot-sized cluster of about a hundred cells. Are our national medical policies really influenced by people who think like this?
Sharon Camp, president of Women's Capital Corp., distributors of "Plan B," one form of morning-after pill, has met with the FDA about submitting an application for Plan B to be converted to over-the-counter status. Her chances for approval, she says, "depend on whether they will look at the science or will play abortion politics."
Camp says some of the demands by the FDA go well beyond the typical application: "They are requiring a substantial amount of data and not just about safety and efficacy, which is what they typically look at, but into the behavioral aspects of Plan B's use."
The FDA is asking for long-term studies on whether women change their contraceptive use habits if emergency contraception is readily available. The agency wants to know whether women will eschew condoms which may result in an increase in sexually transmitted diseases; and whether women will stop using birth control pills thereby trading a highly effective form of birth control for a less dependable form.
Camp says these questions ask, in effect, "whether women can be trusted" to continue to act responsibly relative to pregnancy and disease prevention.
These extra data requests are insulting. You shouldn't have to show that people will still bundle up against freezing temperatures before a cold remedy is approved. The proper inquisition is whether the remedy is safe and effective. End of story.
Any adverse changes some women might make in contraceptive use will be more than offset by the benefits of millions of unwanted pregnancies averted. Since there is only a 72-hour window, emergency contraception is useless if women have to wait to see a doctor for a prescription. There is no reason why the FDA has to wait for the Plan B application. Federal regulations say the agency has the authority to approve over-the-counter status for emergency contraception without a company request. The time to do so is now.