PHM-Exch> USA: Plan B for contraception - a shocking intervention

[Claudio Schuftan]

From: David Legge <D.Legge at latrobe.edu.au>


http://www.washingtonpost.com/national/health-science/obama-administration-refuses-to-relax-plan-b-restrictions/2011/12/07/gIQAF5HicO_story.html
Obama administration refuses to relax Plan B restrictions
By Rob Stein, Published: December 7

The Obama administration stunned women’s health advocates and
abortion opponents alike Wednesday by rejecting a request to let anyone
of any age buy the controversial morning-after pill Plan B directly off
drugstore and supermarket shelves.

For what the Food and Drug Administration thinks is the first time, the
Department of Health and Human Services overruled the agency, vetoing
the FDA’s decision to make the contraceptive available without any
restrictions. Revealing a rare public split, FDA Administrator Margaret
A. Hamburg said her conclusion that the drug could be used safely by
women of all ages was nullified by Health and Human Services Secretary
Kathleen Sebelius.

“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,” Hamburg said in a statement.

“However, this morning I received a memorandum from the Secretary of
Health and Human Services invoking her authority under the Federal Food,
Drug, and Cosmetic Act to execute its provisions and stating that she
does not agree with the Agency’s decision.”

In a statement and separate letter to Hamburg, Sebelius said she
reversed the FDA’s decision because she had concluded that data
submitted by the drug’s maker did not “conclusively establish”
that Plan B could be used safely by the youngest girls.

“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,” Sebelius
said.

Her action means that instead of being able to pick up Plan B off store
shelves, like condoms and spermicides, girls 16 and younger still need a
doctor’s prescription to obtain it. Women 17 and older can buy the
pill without a prescription but must show proof of age to a pharmacist.

The decision shocked and angered the doctors, health advocates,
family-planning activists, lawmakers and others who supported relaxing
the restrictions to help women, including teenagers, prevent unwanted
pregnancies.

“We are outraged that this administration has let politics trump
science,” said Kirsten Moore of the Reproductive Health Technologies
Project, a Washington-based advocacy group. “This administration is
unwilling to stand up to any controversy and do the right thing for
women’s health. That’s shameful.”

Susan F. Wood of George Washington University, who resigned from the
FDA in 2005 because of delays by the George W. Bush administration in
relaxing restrictions on Plan B, said she was “beyond stunned” by
the decision.

“There is no rationale that can justify HHS reaching in and
overturning the FDA on the decision about this safe and effective
contraception,” Wood said. “I never thought I’d see this happen
again.”

Opponents of easier access, meanwhile, hailed the decision, saying
relaxing the rules would have exposed girls and women to risks from
taking high doses of a potent hormone and misusing the medication;
interfered with parents’ ability to monitor their children; and made
it easier for men to prey on vulnerable minors.

“Plan B can act in a way that can destroy life,” said Jeanne
Monahan of the Family Research Council, a conservative advocacy group.
“A decision to make Plan B available for girls under the age of 17
without a prescription would not have been in the interest of young
women’s health.”

A long controversy

Plan B has long been controversial and was the focus of one of the most
contentious health disputes during the Bush administration. It works
primarily by preventing an egg from being fertilized. But critics focus
on the chance that it might prevent a very early embryo from implanting
in the womb, an action they consider equivalent to an abortion. As a
result, some doctors refuse to write prescriptions for it, some
pharmacists refuse to fill requests, and some hospitals refuse to
provide it to patients.

Wednesday’s decision came as the administration is trying to defuse
rising tensions with the Catholic Church over several issues, including
a proposed mandate that private insurers provide women with
contraceptives for free and a federal denial of an
anti-human-trafficking grant to the U.S. Conference of Catholic
Bishops.

“I welcome the . . . decision not to expand nonprescription use of
Plan B to all minors of childbearing age,” said the conference’s
Deirdre McQuade. Plan B “could endanger the lives of newly conceived
children through its abortifacient action, put minors at risk for
unnecessary side effects, undermine parental rights and contribute to
higher STD [sexually transmitted disease] rates.”

A senior White House official, who spoke on the condition of anonymity
to freely discuss the internal process, said the decision rested
entirely with Sebelius, who informed the White House of her conclusion
ahead of time. The administration trusted her on both the substance and
politics of the issue, the official said, noting that Sebelius had been
governor of Kansas, a conservative state that required deft
decision-making by a Democratic governor.

A Health and Human Services spokesperson said in an e-mail that the
“decision was based on a careful consideration of the science.”

President Obama pledged in 2009 to prevent politics from interfering
with scientific decisions. The Bush administration had been accused of
censoring federal scientists on climate change and other hot-button
issues.

But Wednesday’s decision was not the first time the Obama
administration has overruled the scientific advice of senior officials.
In September, Obama pulled back smog standards proposed by Environmental
Protection Agency Administrator Lisa P. Jackson, saying they would
impose too heavy an economic burden.

The administration has long tried to find common ground on issues
related to abortion and birth control. The White House hosted meetings
aimed at finding areas of agreement among activists, but the effort
foundered. In 2010, the administration tried to appease both sides in
the debate over sex education and abstinence, launching a campaign
supporting programs of both types.
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