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.
