The Doctor Is Out: Plan B and the FDA

Posted: Apr 18, 2007 3:18 PM

How often does the Food and Drug Administration advise Americans to deliberately take an overdose? Apparently, only when the drug in question is something the good people at Planned Parenthood want to sell over the counter. That's the conclusion that comes to mind after reviewing the Food and Drug Administration's decision late last year to allow the "morning after pill" – also called Plan B – to be sold to people over age 18 in pharmacies without a prescription.

Plan B is basically a pill package that contains five times the typical dose of an oral contraceptive. It is a remedy for a faulty memory (or perhaps, as often happens, condom failure). A woman (or girl, since Planned Parenthood makes these drugs and devices available to children as young as 11 or 12 years old) takes the Plan B regimen within 72 hours after "unprotected" intercourse to prevent pregnancy. Also labeled "emergency contraception," the drug's greatest utility may really be in those situations where the user "forgot" to take the wiser action of forgoing sex outside of marriage.

More than anything else, Plan B offered over the counter, or OTC, is a social experiment. There are many reasons for this. The drug is a social experiment because this method of delivering a potent hormone raises a number of questions to which the FDA gave short shrift. First, despite its moniker as "contraception," the high doses of hormone delivered by Plan B not only prevent ovulation and inhibit conception, but they also help render the wall of a woman's uterus inhospitable to a developing human life after conception has occurred. This mode of action has long been understood to be abortifacient. No one, however, will catch Planned Parenthood telling young women where to get their "emergency occasional abortifacient."

The package insert with detailed information on Plan B does contain this information, but it is found in the fine print that often gets little attention when a drug has been certified by the government as safe for wider use. Surely safety means that a drug has been tested by its manufacturer (in this case, Barr Laboratories) for its effects on people when taken on multiple occasions. That has not been done with Plan B in the United States because its styling as an "emergency" medicine implies that girls and women won't resort to it as a regular means of preventing pregnancy. A trial in which women took the drug three or four times a year for five years would be unethical, since there are clearly healthier ways to avoid sexual contact and pregnancy (although the People's Republic of China has reportedly conducted such trials and the state of New York will fund Medicaid recipients to deploy Plan B up to six times a year).

Partly to address this concern, the drug's package insert advises the user that it is not a substitute for regular contraception and that women should use hormonal contraception under a doctor's care. Only in this way would the woman (or teenage girl, if she should happen to know her family's medical history) be thoroughly advised of contraindications arguing against her use of Plan B. The package warning is helpful, but the FDA's own study of patient comprehension of the insert showed an alarmingly high (almost one in every three women, and more than half in the low-literacy group) number who misunderstood the fact that Plan B is not a substitute for medical care from a physician.

In this sense, Plan B helps trivialize what women's (and adolescent girls') reproductive systems and sexual decision-making are all about. It operates in concert with our sexually permissive culture, which has done so much to change a society that once relied on family and morality into one that relies instead on instant gratification and a prescription bottle.

On April 12 a coalition of groups including the American Association of Physicians and Surgeons, Family Research Council, Concerned Women for America, and Safe Drugs for Women sued the FDA and its commissioner, Dr. Andrew von Eschenbach. The suit challenges the FDA's politically driven decision to put on the market a large dose of a drug that is available by prescription-only when it is administered in small doses. This is the pretzel logic that convinced the coalition of the need for Congress, not the FDA, to debate and resolve the vast social experiment that is Plan B. For the sake of the health of women and girls, this lawsuit should succeed, and the Congress should step up to its role in addressing major social questions.