HEALTH CARE/Joan Retsinas

A Regime Change at FDA

Democracy! This administration loves it. The president is trying to turn theocratic fiefdoms all over the globe into democracies, so they can function just like us. Of course, we don't want those fiefdoms to hold elections just yet. We need to wait until their citizens stop loathing us -&endash; lest they elect leaders committed to our destruction, or leaders who vow a return to the theocracies that we know they want to be rid of. But this administration believes in the democratic way: popular elections (well, maybe electoral college elections), and majority rule.

Ironically, on the domestic front, the administration's enthusiasm for the democratic way has dulled. Consider the Food and Drug Administration's latest decision on emergency contraceptives. This pill will not abort a pregnancy, but will stop one from happening.

This pill is one of those miracles we wish we had more of, like the "undo typing" button on the computer. If taken within 72 hours of intercourse, it lets a woman stop the pregnancy-that-might-be, leaving her with the memory of the tryst, but not the possible sequelae. Many hospitals routinely prescribe these pills to rape victims, who absolutely don't want a memory of the encounter &endash; indeed, will spend their lives struggling to forget it. (Six states require hospital emergency rooms to provide these pills to women who have been raped.)

The trouble is that, as the rules now stand, in most states women need a prescription. Try getting a prescription for a drug on a weekend, or at night, or in a few hours. Try fnding a nearby 24-hour pharmacy. It's like hiding the "undo typing" button deep in the applications software of the computer. Theoretically, you can get hold of this pill within 72 hours -&endash; but only theoretically. In a few states women can buy these drugs "under the counter," meaning that they can ask a pharmacist; but most women in this country need a prescription. Women in Europe, on the other hand, can buy these contraceptives over the counter.

The Food and Drug Administration holds the key to over-the-counter sales in the United States. The FDA must give a green light, affirming that this pill is safe enough to bypass the prescription route. Over-the-counter a shopper can find lots of pharmaceutical wonders: anti-histamines, pain-killers, shelves full of vitamin and mineral supplements. Soon statins may take their place on the shelves. But the FDA has said "no" to emergency contraceptive pills.

The FDA relies on experts for guidance. A traditional plebiscite won't work for decisions about medication. I don't know whether drug X is safe enough for prescription sales, what the contraindications of drug Y are, whether drug Z can be sold over the counter. And neither do most people who spend their days outside labs. So the FDA convenes scientific advisory committees.

For emergency contraceptives, the scientific advisory committee voted 23-4 to allow over-the-counter sales. Seventy public health associations, including the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, voiced support.

Democracies are promulgated on majority rule. Ideological schisms are often deep, yet the civics books teach children that we vote, and we live with the majority's decision. With the FDA, the majority of scientists voted, yet the powers-that-be did not like the outcome. So ideology trumped democracy. I hope the theocracies around the world weren't watching.

Joan Retsinas is a sociologist who writes about health care in Providence, R.I.

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