The Food and Drug Administration recently approved over-the-counter sale of the “emergency contraceptive” or “Plan B” for men and women 18 and older. Under a novel distribution scheme, girls younger than 18 will continue to need a prescription for Plan B.

Or will they?

There’s nothing to prevent an older boyfriend of the minor girl, or older “friend” of the underage couple from buying Plan B for them. So much for ensuring medical supervision of minors’ use!

Let’s look at who wins and loses from the FDA decision.

Barr Pharmaceutical projects $38 million in Plan B sales for 2006, and that figure is expected to double next year.

Planned Parenthood also stands to profit. Internal documents reveal that Barr agreed to extend “special” pricing to Planned Parenthood at $4.25/packet through 2008. Planned Parenthood charges customers an average of $25 per packet nationwide, yielding an average profit of more than $20 on each sale. With Planned Parenthood sales of 774,482 kits in 2003, Plan B alone raked in more than $15 million for Planned Parenthood.

Acting FDA Commissioner Andrew von Eschenbach also wins. Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., blocked his nomination to head the FDA because of the agency’s delay in approving Plan B for over-the-counter sale. Within hours of approval, both senators announced support for his nomination.

Also among the winners are the legions of boys who will pressure a girl to have sex, but don’t want to father a child. Cynthia Harper and fellow researchers at the University of California-San Francisco studied the role of male partners and relationships in determining whether women seek emergency contraception (EC) “when needed.”

The researchers reported their findings in the American Journal of Obstetrics & Gynecology. They found that “factors measuring power dynamics, such as male dominant decision-making … pressure for sex … as well as a strong desire to avoid pregnancy on the part of the male partner … have a significant association with the use of EC. However, relationship factors known to be associated with use of other contraceptive methods, such as communication, satisfaction and commitment, show no association with EC use.”

This is the perfect drug for male predators, who will now be able to purchase that drug without question as long as they (not the girl) are 18.

Losers include millions of women who will take Plan B, thinking it is an innocuous, safe and effective way to avoid pregnancy. The FDA’s press release and accompanying “Plan B: Questions and Answers” refer to Plan B as “contraception” and claim it “safely and effectively prevents pregnancy.”

Plan B consumers are entitled to know in clear language what they are taking and when they should or should not take it. Here the FDA has failed to protect the public.

Barr is allowed to recommend Plan B use after unprotected intercourse, condom failure or if a woman forgets her daily contraceptive pills two days in a row. But unprotected intercourse and condom failure during the three weeks of the monthly fertility cycle when a woman is naturally infertile cannot result in pregnancy. Taking Plan B to “prevent pregnancy” during these three weeks each month subjects women to unnecessary discomfort, risk and expense for no earthly reason.

Because many women do not understand the basics of the fertility cycle, should not the FDA require Barr to tell women when it is unnecessary to take Plan B, to reduce the likelihood and risks of repeat use?

The Plan B package insert describes the following as common side effects: nausea, vomiting, stomach pain, tiredness, diarrhea, dizziness, breast pain, headache and menstrual changes.

Below are some important things the FDA and Barr did not tell the media and consumers about Plan B, its mode of action, risks and questionable effectiveness.

Can Plan B cause an early abortion?

Apparently pharmacists and doctors can handle the truth about Plan B.

A special report on emergency contraception by the American Pharmaceutical Association states that emergency contraception “might prevent pregnancy” by “inhibiting,” inter alia, “implantation of the blastocyst in the endometrium (by creating changes in the endometrium unreceptive to implantation).”

In the Plan B prescribing information for doctors, the FDA and Barr state that: “it may inhibit implantation (by altering the endometrium).”

But someone at Barr decided women can’t handle that truth! In the package insert for consumers, the FDA has approved this notice:

“Plan B works like a birth control pill to prevent pregnancy mainly by stopping the release of an egg from the ovary. It is possible that Plan B may also work … by preventing attachment (implantation) to the uterus (womb), which usually occurs beginning 7 days after release of an egg from the ovary. Plan B will not do anything to a fertilized egg already attached to the uterus. The pregnancy will continue.”

Does this confusing language satisfy the standard of informed consent? There’s no mention of the event of conception or the creation of a new human life. It refers only to the “release of an egg from the ovary.” Instead of pointing out that a week-old human being is prevented from attaching to the uterus, the patient information calls the child a “fertilized egg,” perpetuating what Germaine Greer has called the “cynical deception of women by selling abortifacients as if they were contraceptives.”

Is Plan B really ‘safe’?

The safety of repeatedly taking emergency contraception has not been proved, so it is misleading to claim that it’s safe. Plan B (1.5 mg of levonorgestrel) is equivalent to taking 40 daily Ovrette pills (0.0375 mg levonorgestrel) in a 12-hour period!

Dr. Carol Ben-Maimon, testifying on behalf of Plan B’s manufacturer before the FDA, conceded that with “repeat use, … intermenstrual bleeding occurs in about 40% of women … [and] there’s a whole host of bleeding disorders when used initially. “

Dr. David Grimes, an abortionist and champion of Plan B, stated in a 2002 interview: “Repeated use of EC wreaks havoc on a woman’s cycle, so the resulting menstrual chaos acts as a powerful deterrent to using this method too often.”

How reassuring. It’s so dangerous that it’s safe!

The United Kingdom’s Department of Health warned doctors of a “significantly increased risk” of ectopic pregnancy (6% versus the 2% occurring naturally) following use of emergency contraception containing levonorgestrel, the active ingredient in Plan B. The Plan B prescribing information for doctors notes a potential risk up to five times greater than normal.

Does easy access to Plan B reduce abortions?

Kirsten Moore, president and chief executive officer of Reproductive Health Technologies Project (Plan B advocates), told a National Press Club audience in December 2005 that “the experts had estimated that we would see a drop by up to half in the rates of unintended pregnancy and the rates of abortion. And in fact in the real world we’re not seeing that.”

Here’s what we’re seeing in the real world:

Studies in Scotland (Anna Glasier, 2004), Sweden (T. Tyden, 2002), the UK (Sourafel Girma and David Paton, 2006), California (Tina Raine, 2005) and Washington state (Jacqueline Gardner, 2001) all show no reduction in abortion rates from greater access to emergency contraception. More information can be found by clicking on “Life Issues” at USCCB.org.

Lastly, pharmacists in Illinois, Texas and Wisconsin have already been fired for exercising their conscience right to refuse to dispense emergency contraception. They will only face greater pressure in the months ahead.

Susan E. Wills is associate director for education, USCCB Secretariat for Pro-Life Activities. This is a longer version of a piece she wrote for USCCB.org.