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Denogean: ‘Morning-after’ over-counter sales due

The U.S. Food and Drug Administration is expected to act soon on whether the “morning-after” pill should be sold over the counter.

It’s about time. This no-brainer decision on Plan B, a medication as safe as aspirin, has dragged on for far too long and for all the wrong reasons.

Don’t attribute to science the nearly three-year delay in approval of Plan B as an over-the-counter pill.

The science is clear: The medication safely prevents most pregnancies in women who have had unprotected sex when taken within 72 hours.

But politics, or rather the appeasement of “pro-family” and anti-abortion groups that believe the consequence of sex outside of marriage should be pregnancy or, at least, a nasty sexually transmitted disease, have kept Plan B off drugstore shelves.

Barr Laboratories first applied for nonprescription sales in 2003, which sent the opponents, who sometimes falsely tag Plan B as a drug that causes an abortion, into a tizzy.

Plan B works mainly by preventing ovulation and fertilization. It may also work, to a lesser degree, by preventing a fertilized egg from implanting in the womb. It doesn’t interfere with an established pregnancy.

Though an FDA advisory panel voted overwhelmingly for approval, and the FDA almost always follows the recommendations of its panels, the FDA commissioner rejected the application on the grounds that Barr hadn’t provided enough information to prove girls younger than 16 can safely use the drug without professional supervision (the regimen is two pills taken 12 hours apart).

As to Barr’s alternative proposal that it market the nonprescription product only to women age 16 and older, the FDA ruled it inadequate for a full review.

The application was the only one of 67 proposed prescription-to-OTC switch applications from 1994-2004 not approved after an advisory committee’s recommended approval.

Barr reapplied, asking for over-the-counter sales to people 17 and over. Last year, the FDA, in a nondecision widely viewed as influenced by the upper echelons of the Bush administration, cited problems with enforcing an age restriction and delayed an answer indefinitely.

The head of the FDA’s Office for Women’s Health was so ticked off she quit in protest.

Where it stands now is the FDA has signaled a willingness to approve the medication as over-the-counter for adults only.

It’s a half-victory for those who view unhindered access to birth control for women and teen girls as an essential part of health care.

The ideal would be that Plan B be available over the counter to women of all ages, as are other common medications with similarly strong records of safety, said Patti Caldwell, executive director of Planned Parenthood of Southern Arizona.

Plan B has been on the market since 1999, available to teens and adults. Similar regimens of high-dose hormones given over a short period to prevent pregnancy have been used in this country and others for much longer, without adverse affects.

Caldwell said it’s not clear what over-the-counter will mean in the case of Plan B, with an 18-and-over restriction.

Such a rule probably would require the buyer to have contact with pharmacy personnel, which raises one of the same issues that has arisen with prescription sales of Plan B. That is pharmacists who refuse to fill legitimate prescriptions because of their moral beliefs.

Would they also refuse to sell Plan B over the counter?

When it comes to Plan B, time is critically important. It works best when used in the first 24 hours after unprotected sex.

That’s not a lot of time for a woman to consult a doctor and do battle with a pharmacist with a Bible in his pocket.

Unhindered access to Plan B on the drugstore shelves would put matters back in her control, as well as eliminate the financial burden of paying for a doctor visit.

Easy access to Plan B doesn’t, according to a growing body of research – including a big study by the Center For Reproductive Health Research and Policy at the University of California, San Francisco – increase promiscuity and sexually transmitted infections, nor does it lead to the abandonment of other forms of birth control.

Most women seem to understand that Plan B is not Plan A.

Wendy Wright, president of Concerned Women for America, said Monday in a phone interview from Washington, D.C., that the drug absolutely should not go over the counter because the FDA and the manufacturer cannot guarantee it won’t end up in the hands of teenagers.

Let’s be honest. There are worse things that could end up in the hands of a teenager – a baby, for instance.

Anne T. Denogean can be reached at 573-4582 and adenogean@tucsoncitizen.com. Address letters to P.O. Box 26767, Tucson, AZ 85726-6767. Her column runs Tuesdays and Fridays.

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