The nation was rightfully outraged at the failure of Pennsylvania State University officials to protect young children from rape (assuming the charges against former Coach Sandusky are true). Those were, however, the actions of a few men acting in their private capacity affecting a dozen (?) children-victims. So much worse is the Obama Administration in its consideration of policies that would facilitate child sex.
Let's remember why Plan B is called Plan B. It is, in the first instance, a brand name of a particular emergency contraceptive (just as Kleenex™ is for facial tissue or Xerox™ for photocopier). Another brand name for an emergency contraceptive is Next Choice™. In normal parlance, a "plan B" is a plan of action in the event the first plan should fail. So, the drug manufacturer chose "Plan B" as a name for its emergency contraceptive drug because a customer's (or patient's) first plan did not work. What first plan? Either not using a contraceptive or using one that failed.
Before last week Plan B had been approved by the FDA as safe and effective. Girls under the age of 17 could obtain it only by prescription. Girls and women 17 and older could obtain it without prescription but, because of the age restriction, had to purchase it from a pharmacist. The narrow issue before the FDA last week was whether girls under the age of 17 could understand and follow the drug's label, including instructions concerning side effects. If they could, the prescription requirement would drop for them, letting all girls and women of any age purchase the drug off the shelf (or, over the counter). While the issue was narrow, we should expect our elected and appointed officials to place the issue in a larger context. The very purpose of emergency contraception was never addressed in the statements made last week by the Obama Administration.
First up was Food and Drug (FDA) Administrator (and medical doctor) Margaret Hamburg who announced her approval of the use of Plan B by girls under the age of 17 without prescription. Within a day, Health and Human Services (HHS) Secretary Kathleen Sebelius overruled that decision. On the next day, December 8, President Obama expressed his support of Sebelius at a press conference. (Obama denied inserting himself into Sebelius' decision, but newspapers had reported on December 5 that the FDA decision was imminent and the next day, December 6, Sebelius flew with Obama on his flight to Osawatomie.)
Hamburg asserted, both before and after Sebelius' ruling, that the scientific evidence was that "all females of child-bearing potential" could follow the label, based on "scientific findings, input from external scientific advisory committees, and data contained in the application [made by Teva Women's Health, Inc., a subsidiary of Teva Pharmaceuticals Industries] that included studies designed specifically to address the regulatory standards for nonprescription drugs.…[E]xperts, include[ed] obstetrician/gynecologists and pediatricians."
Teva, for its part, stated the study it submitted with its application showed that "nearly 90%" of girls ages 11 to 17 could understand and follow it. (Wall Street Journal, Dec. 8, 2011.) In overruling Hamburg on December 7, Sebelius stated her concern that girls as young as 11.1 years of age could not understand and follow the label:
The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.
Obama declared in his December 8 press conference that he agreed with Sebelius and that it was important to apply "common sense" to over-the-counter medications.
Criticism from the left has focused on whether the Obama Administration was more concerned about the politics of the issue than the science (contrary to his March 9, 2009, executive order on the subject), how the pro-abortion Sebelius must have yielded to the President's political ambition for re-election, how Obama has forsaken his pro-abortion base, how outraged so-called women's health groups are. (Note: While this is about girls' health, not women's, because users of the drug must be 17 or older, women 17 and older must show pharmacists proof of age and of course this is limited to times when pharmacies are open. This is a small price to pay by women to protect those under age 17, as I shall point out.)
The right has continued to raise the issue that Plan B serves to prevent implantation of a fertilized egg and is thus an abortifacient. The right also raises issues of whether use of the drug by minors without prescription would promote promiscuity, eliminate an opportunity for girls to discuss STDs with parents or a doctor, deprive parents of the right to raise their daughters, and allow men and boys to prey on girls. It is this last point that is my focus.
The statements by Obama and his Administration's officials, and the criticism from the left, miss the forest for the trees (in a way not meant by Jessica Arons, Center for American Progress, when she criticized Obama's politics for missing the forest). The forest is this: No girl under the age of 17 can lawfully consent to sexual intercourse (with some exceptions in some states). If a girl believes that an emergency contraceptive may be useful to her, it can only be that she has engaged in sexual intercourse. If a girl wants an emergency contraceptive -- the label of which warns that it is a one-time contraceptive not intended to replace routine birth control pills (that are available only by prescription) and must be taken within 72 hours of intercourse to be effective, she is not trying to regulate her menstrual cycle. Rather, she has engaged in sexual intercourse. Bells and whistles must go off. It is an emergency. The emergency is not only that she may be pregnant; the emergency is also that she has engaged in sexual intercourse. That is an emergency because the law of some states may allow a 16 year old to consent to sex with a 19 year old, but not with a 25 year old. And then there are the 8 and 9 and 10 year olds who can never consent under the law. Even without such laws, there are some parents who would perceive it to be an emergency.
The FDA rule as proposed by Hamburg may still go into effect. For one, Teva still has an interest in obtaining a larger market for its product. We can expect that Teva will submit additional studies to address Sebelius's concerns. For another, a federal judge in Brooklyn is presiding over a lawsuit on the subject and could order the FDA and Sebelius to issue the rule. Look at the effect of such a rule:
• As Sebelius pointed out, fully 10% of all girls experience the onset of menstruation (technically "menarche") before age 11.1. What she did not say is that the age of the onset of menarche continues to drop, so younger and younger girls would be able to buy emergency contraception. One cause of the drop in age is living without a father. (Michele K. Surbey, "Family Composition, Stress, and the Timing of Human Menarche," in Socioendocrinology of Primate Reproduction,pp. 11 -- 32 (1990); R. Quinlan, "Father Absence, Parental Care, and Female Reproductive Development," Evolution and Human Behavior, vol. 24, no. 6, p. 376 (2003).
The number and percentage of girls living without their father continues to grow. According to a 2011 report by the Census Bureau, in 2009 it had climbed to 24% of all children, 50% of African American children.. Another cause of the drop in age is obesity. (D.H. Morris, et al., "Determinants of Age at Menarche in the UK: Analyses from the Breakthrough Generations Study", British Journal of Cancer, vol. 103, no. 11, pp. 1760 -- 4 (2010).) And it is well known that the number of such children continues to climb.
• If a girl, age 10, were to present the emergency contraceptive for purchase to a drug store sales clerk, the sales clerk would be under no legal obligation to report it to a pharmacist, doctor or police. Pharmacists, by contrast, may be required by law to report evidence of sexual abuse of minors.
• There would be nothing to prohibit a boy or a man from buying an emergency contraceptive off the shelf and giving it to a girl. In fact, the boy or man may buy it ahead of time since the label for Plan B states that its effectiveness increases the closer in time it is used after the act of intercourse.
• Although Plan B was approved by FDA as effective, and has been approved for use by girls under 17 by prescription because it is effective, the label for Plan B describes precisely how ineffective it is: It will fail in 1 out of 8 cases. Girls reading the label's description of the failure rate, as well as the portion of the label that says there is no problem from overdosing, may well be tempted to think that a double dose will be more effective. In any case, the label concedes that one girl in eight will need a Plan C.
• While emergency contraception is not supposed to be used as a routine contraception (which requires a prescription), there would be no legal obstacle to doing so. And, if it is true that the side effects may only be menstrual bleeding, menstrual cramps, headache, vomiting, and nausea, then a girl might use it with some frequency.
• A November 2011 report by the Census Bureau stated that 15.75 million children are living in poverty. How would a poor girl come up with $50 to purchase emergency contraception in a drugstore? Maybe the girl would obtain it free or at a discount from Planned Parenthood, a school nurse, a camp counselor. There may be no obstacle to Planned Parenthood, school nurses, camp counselors, and others from stocking up on the drug and providing it to minors -- without parental knowledge much less consent.
• Finally, there is the effect of an FDA rule on the prerogative of the states. Our states define incest, rape, statutory rape, sexual abuse, and child abuse and neglect, and the states mandate that certain categories of people must report evidence of these offenses to the authorities. State law also defines the responsibilities of parents. Federal agencies that would affect state prerogatives such as these ought to, at a minimum, explicitly consider and discuss them. Every federal agency should appoint an advisory committee consisting of representatives of state government to ensure that this occurs.
President Obama stated that the FDA rule as adopted by Hamburg did not satisfy the test of common sense. Implicitly he stated that his FDA Administrator lacked common sense. Should he retain an official in his Administration who lacks common sense?
It is bad enough for our federal government to facilitate child sex. But it is even worse that this occurs in an environment where, as noted, so many of our girls are living without fathers who could help protect them from men and boys. And an equal number of boys are living without fathers who could model for them, and instruct them on, how to treat girls.
President Obama delivered a speech on December 6 in Osawatamie, Kansas. He selected the town in imitation of President Teddy Roosevelt who delivered a speech there in 1910. TR liked popping his p's when he spoke. Let me pop them as I say: Put a stop to public policies that don't protect our pubescent children.
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