The Morning After Pill - Without a Prescription

Some time ago, I served for several years on a U.S. Food and Drug Administration advisory committee. All of us recognized that our role was purely advisory and that our recommendations might either be accepted or rejected.

We did feel, however, that the final decisions were based solely on scientific and medical factors, as they always should be. There is no legitimate place for political influence in the approval of medications.

That's not the case with the FDA's recent approval of over-the-counter purchase of the contraceptive drug popularly known as "Plan B" or "morning after pill." The long-awaited approval hinged on a political compromise that limits nonprescription purchase of the drug to women aged 18 or older.

Andrew von Eschenbach, acting head of the FDA, claimed there was uncertainty about the drug's safety in younger women in an apparent effort to downplay the political motivation for the age limit. Yet staff scientists at the FDA concluded two years ago that nonprescription sales of the drug would be safe for women of all reproductive ages.

Back in 1994, the FDA approved sales of Plan B pills by prescription only with no age restriction, and today teenagers younger than 18 can still obtain Plan B with a prescription. Several years ago an FDA advisory committee recommended over-the-counter sales of Plan B by an overwhelming 23-4 vote.

But political appointees at the FDA did not implement the committee's recommendation, presumably bowing to pressure from high-ranking members of the administration - probably the president himself. Apparently, the conservative right worries that availability of a morning after pill would increase teenage promiscuity.

I suppose it's all right for a 17-year-old girl and her family to face the many problems of an unwanted pregnancy because she couldn't get Plan B pills. After all, her sacrifice is protecting other teenagers, who might be more tempted to practice unprotected sex if they knew they could get Plan B pills without a prescription. Give me a break!

There is no evidence of dramatic increases in teen sex in the nine states that have allowed nonprescription sales of Plan B to women of all ages. For now, over-the-counter sales of Plan B must remain a limited victory, because it will do nothing to reduce the high rate of teenage pregnancy in this country. (And, as with all other non-barrier methods of birth control, Plan B will not protect against sexually transmitted infections.)

Groups in favor of allowing nonprescription sales of Plan B to women of all ages will continue their fight. Meanwhile, the long political impasse on the confirmation of the FDA's chief will undoubtedly end with congressional confirmation of Dr. von Eschenbach.

The "morning after pill" is not a very accurate name for this drug. Plan B requires taking two pills, each containing a large dose of levonorgestrel, a component of many birth control pills already on the market. It should more appropriately be called the "72 hours after" pill, because the first of the two pills must be taken within 72 hours after unprotected sex. The second pill is taken 12 hours after the first.

Plan B is said to be 90 percent effective in preventing pregnancy, though its effectiveness is a function of how soon after intercourse the first pill is taken. How many teenagers too young to buy Plan B over the counter will be sophisticated enough to get and fill a Plan B prescription after unprotected sex on a Saturday night? Even if she were eligible for nonprescription Plan B, could the teenager afford $25 to $50, the projected cost of the two Plan B pills? Unlike prescription Plan B, the cost of nonprescription Plan B is unlikely to be covered by health insurance.

Nonprescription Plan B is expected to be available in pharmacies in early 2007. A photo ID will be required to enforce the age requirement. At least these women will not have to take off their shoes as they do at airports.