Obama Administration Overrules FDA Approval Of Plan B – Right Wing Politics
Trumps Science Again

For the first time ever, the Health and Human Services secretary – Kathleen
Sebelius - has publicly overruled the Food and Drug Administration's
approval of a medication. Her decision continues the policy of refusing to
allow the emergency contraceptive Plan B to be sold over the counter to
women under 17 without a prescription from a doctor. It overruled the FDA
that was finally prepared to approve over-the-counter access to minors - a
policy that is recommended by the entire scientific and medical community.

On December 7, after years of delays in approval that have kept young women
under 17 from having over-the-counter access to Plan B emergency
contraceptives, FDA Commissioner Margaret Hamburg, M.D. released a
statement voicing FDA approval:

"I reviewed and thoughtfully considered the data, clinical information, and
analysis provided by CDER, and I agree with the Center that there is
adequate and reasonable, well-supported, and science-based evidence that
Plan B One-Step is safe and effective and should be approved for
nonprescription use for all females of child-bearing potential."

In her statement the same day rejecting Plan B and reversing the FDA
decision, Sebelius tried to put a “scientific” veneer on her crudely
political decision claiming that the company producing the medicine (Teva
Pharmaceuticals) had not provided enough data to show that young girls of
reproductive age would have the ability to use the product correctly. But
this was studied for women as young as 11 years old. Also, ex-FDA
administrator Susan Wood noted the hypocrisy and double standard involved
in this “logic” saying that there were many drugs already available over
the counter that had not been studied in pre-adolescents and that were far
more dangerous to them.

“Acetaminophen can be fatal, but it’s available to everyone,” Dr. Wood
noted. “So why are contraceptives singled out every single time when
they’re actually far safer than what’s already out there?”

Common Sense?! For Whom? And on what basis?

President Obama, in a press conference, called this decision
“common-sense”: "As the father of two daughters," he said,
"I think it is important for us to make sure that we apply some common
sense to various rules when it comes to over-the-counter medicine."

The NYT on Dec. 7 got closer to what was really going on: "The decision
avoided what could have been a bruising political battle over parental
control and contraception during a presidential election."

We live in a society where today ½ of all pregnancies are unplanned, more
than 40 percent of children are born to unwed mothers and 1.2 million
abortions are performed every year involving one in every 50 women of
reproductive age. (see “Plan to Widen Availability of Morning-After Pill is
Rejected” NY Times 12/7/2011)

We live in a society with reactionary forces hounding women, especially
young women and trying to control their reproduction rights and their
lives. Many among the forces that oppose emergency contraception also
oppose all contraception – for example the Catholic Church opposes a
mandate in the medical insurance plan that private medical insurers provide
women with contraceptives for free.

And many others continue to promote abstinence only sex education.
The American Medical Association, the American Congress of Obstetricians
and Gynecologists, and the American Academy of Pediatrics have all strongly
endorsed over-the-counter access to Plan B with no age restrictions. And
they have all criticized this rejection as the intrusion of politics into
what should be a scientific decision. see Footnote 1

The FDA's own scientists have thoroughly studied Plan B and repeatedly over
a 10 year period given their approval for it's general use only to be
repeatedly over-ruled. In 2005 Bush-appointee Susan Wood, then Assistant
Commissioner for Women's Health and Director, Office of Women's Health at
FDA resigned in protest of this same trampling by reactionary politics on
science, stating:

"I can no longer serve as staff when scientific and clinical evidence,
fully evaluated and recommended for approval by the professional staff
here, has been overruled."

Reacting to this current rejection, Wood added that the administration is
“…abandoning its scientific integrity principles, and blocking a safe and
effective contraceptive”.

In 2009 A U.S. District Judge ruled that the FDA had "repeatedly and
unreasonably delayed issuing a decision on Plan B for suspect reasons" and
forced the FDA to lower the age to 17 and re-review the rationale for its

Kirsten Moore, president of the Reproductive Health Care Technologies
Project voiced what many are feeling:
"For me personally this is an incredibly disappointing moment, because I
was in the East Room of the White House in March 2009 when [President
Obama] signed an executive order saying this administration was committed
to restoring scientific integrity to the policymaking process. And that
commitment just went up in smoke today."

Footnote 1: Statements from Medical Groups
American Academy of Pediatrics
“As advocates for the health and well-being of all young people, the AAP
recommends that adolescents postpone sexual activity until they are fully
ready for the emotional, physical and financial consequences of sex,” said
Dr. Robert Block, AAP president. “However, as physicians who care for our
nation’s children, it is our responsibility to protect the health of our
teenage patients, and an unintended pregnancy can have significant
implications for adolescents’ physical and emotional health.”

American Society for Reproductive Medicine
The ASRM issued a statement from Dolores J. Lamb, the organization's
president, that said in part: "We are very disappointed that Secretary
Sebelius opted to insert herself into what should be a scientific decision
made by the experts at FDA. The data are clear that emergency contraception
can be safely used by adolescent women without requiring a prescription.
Sadly, it appears that once again our leaders are putting political
expediency ahead of reproductive health."

Society For Adolescent Health and Medicine
Added Dr. Leslie Walker, president of SAHM: “Today’s decision by the
Department of Health and Human Services is a profound disappointment for
the health of adolescent girls and is inconsistent with what we know about
the safety and benefits of emergency contraception. Emergency contraception
is a safe, effective back-up birth control method for teens and women of
all ages to prevent unintended pregnancy.”

--Defend Science
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